Decree 163/2025/ND-CP detailling the Law on Pharmacy

THE GOVERNMENT  ______ No. 163/2025/ND-CP

THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ____________________ Hanoi, June 29, 2025

 

DECREE

Detailing a number of articles, and prescribing measures for organizing and guiding the implementation, of the Law on Pharmacy

 

Pursuant to the Law on Organization of the Government dated February 18, 2025;

Pursuant to the Law on Organization of Local Administration dated June 16, 2025;

Pursuant to the Law on Pharmacy dated April 06, 2016; the Law Amending and Supplementing a Number of Articles of the Law on Pharmacy dated November 21, 2024;

At the proposal of the Minister of Health;

The Government hereby promulgates the Decree detailing a number of articles, and prescribing measures for organizing and guiding the implementation, of the Law on Pharmacy.

 

Chapter I

GENERAL PROVISIONS

 

Article 1. Scope of regulation and subjects of application

1. This Decree details Point d, Clause 26, Article 2; Point b, Clause 2, Article 13; Clause 4, Article 29; Clause 3, Article 34; Clause 5, Article 38; Clause 2, Article 41; Clause 6, Article 54; Clauses 4 and 5, Article 60; Clause 3, Article 69 of Law on Pharmacy No. 105/2016/QH13; Clause 4, Clause 5, Clause 9; Points a and c, Clause 18; Points d and dd, Clause 32; Clause 33, Clause 39, Clause 43, Article 1 of Law No. 44/2024/QH15 Amending and Supplementing a Number of Articles of Law No. 105/2016/QH13 on Pharmacy (hereinafter collectively referred to as the Law on Pharmacy).

2. Measures for the organization and implementation of the Law on Pharmacy:

a) Management of the import of medicinal products not yet granted marketing authorization in Vietnam;

b) Regulations on the remaining shelf life of imported medicinal products and medicinal materials at the time of customs clearance;

c) Regulations on border gates of import; requirements for establishments supplying the imported medicinal products and medicinal materials; suspension of receipt of dossiers of application for licenses, suspension of issuance of licenses to import medicinal products and medicinal materials; suspension of importing medicinal products and medicinal materials; regulations on reporting of import and export of medicinal products and medicinal materials; regulations on suspension of receipt of dossiers of application for issuance or renewal of marketing authorization for medicinal products and medicinal materials; suspension of receipt of new dossiers of application and suspension of processing of submitted dossiers of application from establishments applying for confirmation of medicinal product advertising content;

d) Regulations on specialized documents to be submitted for customs clearance of exported and imported medicinal products and medicinal materials.

3. This Decree applies to domestic and foreign agencies, organizations, and individuals involved in pharmaceutical operations in Vietnam.

 

Chapter II

PHARMACY PRACTISING CERTIFICATE

 

Section 1

DOSSIERS AND PROCEDURES FOR ISSUANCE, RE-ISSUANCE, MODIFICATION, AND REVOCATION OF PHARMACY PRACTISING CERTIFICATES

 

Article 2. Detailed regulations on the dossier of application for a Pharmacy Practising Certificate

1. The dossier of application for a Pharmacy Practising Certificate shall comply with Article 24 of the Law on Pharmacy and comprise:

a) An application for a Pharmacy Practising Certificate made using Form No. 02 in Appendix I to this Decree;

b) A certificate of equivalence recognition issued by a competent authority for equivalence recognition as prescribed in Clause 2, Article 12 of this Decree for professional credentials granted by foreign training institutions;

c) A written confirmation of the period of practice made using Form No. 03 in Appendix I to this Decree. In cases where the practice is conducted at multiple establishments, the period of practice shall be the total time of practice at all establishments, provided that a written confirmation of the period of practice from each establishment is available.

In cases where a Pharmacy Practising Certificate is applied for with different scopes of operation that require different periods of practice and establishments for professional practice, the dossier must include a written confirmation of the period of practice and particulars of professional practice from one or more establishments that meet the requirements of each scope and position of practice. In cases where the scopes of professional operation have the same requirements for the period of practice and establishment for professional practice, a separate written confirmation for each scope of professional operation is not required;

d) The submission of a Judicial Record Card is not required from the date on which judicial record data is shared in accordance with Clause 5, Article 127 of this Decree.

2. Documents issued by competent foreign authorities must be granted consular legalization as prescribed, have their Vietnamese translations, and have the respective translators’ signatures authenticated as prescribed.

3. The dossier quantity prescribed in this Article is 01. The documents prescribed in Clauses 2, 3, 4, 5, and 7, Article 24 of the Law on Pharmacy must be originals, certified true copies, or copies presented with their originals for collation.

Article 3. Detailed regulations on the dossier of application for re-issuance of a Pharmacy Practising Certificate

1. The dossier of application for re-issuance of a Pharmacy Practising Certificate shall comply with Article 25 of the Law on Pharmacy and comprise:

a) An application for re-issuance of a Pharmacy Practising Certificate made using Form No. 04 in Appendix I to this Decree;

b) The issued Pharmacy Practising Certificate unless it is lost.

2. The dossier quantity prescribed in this Article is 01. The document prescribed at Point b, Clause 1 of this Article must be the original, a certified true copy, or a copy presented with its original for collation.

Article 4. Detailed regulations on the dossier of application for modification of a Pharmacy Practising Certificate

1. The dossier of application for modification of a Pharmacy Practising Certificate shall comply with Article 26 of the Law on Pharmacy and comprise:

a) An application for modification of a Pharmacy Practising Certificate made using Form No. 05 in Appendix I to this Decree;

b) The corresponding professional credential and a written confirmation of the period of professional practice at a suitable pharmaceutical establishment in case of a change in the scope of professional operation. For any degree granted by a foreign training institution, a certificate of equivalence recognition issued by a competent authority for equivalence recognition as prescribed in Clause 2, Article 12 of this Decree must be enclosed.

2. The documents prescribed at Point b, Clause 1 of this Article issued by competent foreign authorities must be granted consular legalization as prescribed. These documents must have their Vietnamese translations and the respective translators’ signatures authenticated as prescribed.

3. The dossier quantity prescribed in this Article is 01. The documents prescribed at Point b, Clause 1 of this Article and Clauses 2 and 3, Article 26 of the Law on Pharmacy must be originals, certified true copies, or copies presented with their originals for collation.

Article 5. Detailed regulations on the procedures for issuance of a Pharmacy Practising Certificate by examination

1. An applicant for a Pharmacy Practising Certificate shall submit a dossier either directly, via postal service, or online to the Ministry of Health.

2. After receiving a dossier, the Ministry of Health shall issue the applicant a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree.

3. In cases where there is no request to amend or supplement the dossier:

a) Within 03 working days from the date stated on the Dossier Receipt Note, the Ministry of Health shall designate an establishment that meets the requirements, Article 17 of this Decree and is suitable for the applicant's place of residence to organize the examination for the issuance of a Pharmacy Practising Certificate;

b) The establishment prescribed at Point a of this Clause shall be responsible for organizing the examination for the issuance of a Pharmacy Practising Certificate within 07 working days and sending the examination results to the Ministry of Health within 03 working days from the end of the examination;

c) In cases where the examination results are satisfactory, within 07 working days from the date of receiving the examination results from the examination-organizing establishment, the Ministry of Health shall issue and return to the applicant 01 copy of the Pharmacy Practising Certificate;

d) In cases where the examination results are not satisfactory, within 07 working days from the date of receiving the examination results from the examination-organizing establishment, the Ministry of Health shall send a written notice to the applicant made using Form No. 16 in Appendix I to this Decree regarding the non-issuance of the Pharmacy Practising Certificate;

dd) In cases where the Pharmacy Practising Certificate is issued in accordance with Clause 8, Article 24 of the Law on Pharmacy, the Ministry of Health shall issue the Pharmacy Practising Certificate to the applicant within 05 working days from the date stated on the Dossier Receipt Note without organizing an examination.

4. In cases where amendment or supplementation to the dossier is required, within 07 working days from the date stated on the Dossier Receipt Note, the Ministry of Health shall send a written notice of the required amendments and supplementations made using Form No. 16 in Appendix I to this Decree to the applicant.

5. After receiving the amended or supplemented dossier, the Ministry of Health shall issue the applicant a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree.

a) In cases where the amended or supplemented dossier is unsatisfactory, within 07 working days from the date stated on the Receipt Note for the amended or supplemented dossier, the Ministry of Health shall send a written notice to the applicant made using Form No. 16 in Appendix I to this Decree regarding the non-issuance of the Pharmacy Practising Certificate;

b) In cases where no amendment or supplementation to the amended or supplemented dossier is required, the Ministry of Health and the designated examination-organizing establishment shall proceed in accordance with Clause 3 of this Article.

6. Within 06 months from the date of the Ministry of Health's written notice of amendment or supplementation, the applicant for a Pharmacy Practising Certificate must submit the amended or supplemented dossier as required. After the above time limit, if the applicant fails to make any amended or supplemented dossier, the submitted dossier will no longer be valid.

7. Within 03 working days from the date of issuance of the Pharmacy Practising Certificate, the Ministry of Health shall publicly announce and update the following information on its electronic portal:

a) Full name and date of birth of the person issued with the Pharmacy Practising Certificate;

b) The reference number of the Pharmacy Practising Certificate of the person issued with the Pharmacy Practising Certificate;

c) The scope of professional operations stated on the Pharmacy Practising Certificate.

8. The Pharmacy Practising Certificate issued by examination shall be made using Form No. 07 in Appendix I to this Decree.

9. In cases where the Pharmacy Practising Certificate is issued in accordance with Clause 8, Article 24 of the Law on Pharmacy, the applicant for the Pharmacy Practising Certificate shall not be required to pay a fee.

Article 6. Detailed regulations on the procedures for issuance, re-issuance, and modification of a Pharmacy Practising Certificate by dossier review

1. An applicant for issuance, re-issuance, or modification of a Pharmacy Practising Certificate shall submit a dossier either directly, via postal service, or online to the provincial-level Department of Health.

2. After receiving a dossier, the provincial-level Department of Health shall issue the applicant for issuance, re-issuance, or modification of a Pharmacy Practising Certificate a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree.

3. In cases where no amendment or supplementation to the dossier is required, the provincial-level Department of Health shall be responsible for:

a) Issuing and returning to the applicant 01 copy of the Pharmacy Practising Certificate within 20 days from the date stated on the Dossier Receipt Note;

b) Issuing and returning to the applicant 01 copy of the Pharmacy Practising Certificate within 05 working days from the date stated on the Dossier Receipt Note in cases where the Pharmacy Practising Certificate has been revoked in accordance with Clause 3, Article 28 of the Law on Pharmacy;

c) Re-issuing, modifying the details of, and returning to the applicant 01 copy of the Pharmacy Practising Certificate within 10 days from the date stated on the Dossier Receipt Note.

4. In cases where amendment or supplementation to the dossier is required, the provincial-level Department of Health shall send a written notice of the required amendments or supplementations made using Form No. 16 in Appendix I to this Decree to the applicant within the following time limits:

a) 07 working days from the date stated on the Dossier Receipt Note, if it is a dossier of application for a Pharmacy Practising Certificate;

b) 05 working days from the date stated on the Dossier Receipt Note, if it is a dossier of application for re-issuance or modification of a Pharmacy Practising Certificate.

5. After receiving the amended or supplemented dossier, the provincial-level Department of Health shall issue the applicant a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree.

a) In cases where the amended or supplemented dossier is unsatisfactory, within 07 working days from the date stated on the Dossier Receipt Note, if it is the amended or supplemented dossier for a dossier of application for a Pharmacy Practising Certificate, or within 05 working days from the date stated on the Dossier Receipt Note, if it is the amended or supplemented dossier for a dossier of application for re-issuance or modification of a Pharmacy Practising Certificate, the provincial-level Department of Health shall send a written notice to the applicant made using Form No. 16 in Appendix I to this Decree regarding the non-issuance, non-re-issuance, or non-modification of the details of the Pharmacy Practising Certificate;

b) In cases where no amendment or supplementation to the amended or supplemented dossier is required, the provincial-level Department of Health shall proceed in accordance with Clause 3 of this Article.

6. Within 06 months from the date of the provincial-level Department of Health's written notice of amendment or supplementation, the applicant for issuance, re-issuance, or modification of a Pharmacy Practising Certificate must submit the amended or supplemented dossier as required. After the above time limit, if the applicant fails to make any amended or supplemented dossier, the submitted dossier will no longer be valid.

7. Within 03 working days from the date of issuance, re-issuance, or modification of the details of the Pharmacy Practising Certificate, the provincial-level Department of Health shall publicly announce and update the following information on its website:

a) Full name and date of birth of the person issued with the Pharmacy Practising Certificate;

b) The reference number of the Pharmacy Practising Certificate of the person issued with the Pharmacy Practising Certificate;

c) The scope of professional operations stated on the Pharmacy Practising Certificate.

8. Upon receiving a re-issued or modified Pharmacy Practising Certificate, the applicant for the Pharmacy Practising Certificate must return the previously issued Pharmacy Practising Certificate, unless the Pharmacy Practising Certificate was lost, the original Pharmacy Practising Certificate has been submitted in the dossier of application for re-issuance or modification of the details of the Pharmacy Practising Certificate, or the previously issued Pharmacy Practising Certificate was issued online.

9. The Pharmacy Practising Certificate returned to the pharmacy practitioner in case of issuance, re-issuance, or modification of the details thereof by dossier review shall be made using Form No. 06 in Appendix I to this Decree.

10. The Minister of Health shall prescribe the organization and operation of the Advisory Council for the Issuance of Pharmacy Practising Certificates.

11. In cases where the Pharmacy Practising Certificate is issued in accordance with Clause 8, Article 24 of the Law on Pharmacy, the applicant for the Pharmacy Practising Certificate shall not be required to pay a fee.

Article 7. Procedures for revoking a Pharmacy Practising Certificate

1. Revocation of a Pharmacy Practising Certificate in the cases prescribed in Clauses 1, 4, 5, 6, 7, 8, 9, 10, and 11, Article 28 of the Law on Pharmacy: Within 05 working days from the date of receiving an inspection or examination conclusion that recommends the revocation of the Pharmacy Practising Certificate, or upon discovering any of the cases prescribed in Clauses 1, 4, 5, 6, 7, 8, 9, 10, and 11, Article 28 of the Law on Pharmacy, the authority that issued the Pharmacy Practising Certificate shall issue a decision to revoke the Pharmacy Practising Certificate under its management. In cases where the Pharmacy Practising Certificate is not revoked, a written response must be sent to the authority that recommended the revocation, stating the reasons.

2. Revocation of a Pharmacy Practising Certificate in the cases prescribed in Clauses 2 and 3, Article 28 of the Law on Pharmacy: Within 05 working days from the time of discovering that the Pharmacy Practising Certificate was incorrectly issued, or receiving a request for revocation of the Pharmacy Practising Certificate or a petition regarding an incorrectly issued Pharmacy Practising Certificate from the holder of the Pharmacy Practising Certificate, the authority that issued the Pharmacy Practising Certificate shall issue a decision to revoke the Pharmacy Practising Certificate under its management. In cases where the Pharmacy Practising Certificate is not revoked, a written response must be sent to the organization or individual that made the request, stating the reasons.

3. Within 03 working days from the date of issuing a decision to revoke a Pharmacy Practising Certificate, the authority that issued the revocation decision shall be responsible for:

a) Uploading the decision to revoke the Pharmacy Practising Certificate on its electronic portal or website and sending this decision to the Ministry of Health and other provincial-level Departments of Health nationwide;

b) Updating the information on the revocation of the Pharmacy Practising Certificate on its electronic portal or website.

4. Within 05 working days from the date of receiving the decision to revoke a Pharmacy Practising Certificate from the authority that issued the Pharmacy Practising Certificate, the Ministry of Health shall be responsible for uploading this decision on its electronic portal.

 

Section 2

TRAINING AND UPDATING OF PROFESSIONAL KNOWLEDGE IN PHARMACY

 

Article 8. Institutions for training and updating professional knowledge in pharmacy

1. Institutions for training and updating professional knowledge in pharmacy include: Higher education institutions, vocational education institutions with training programs in medical and pharmaceutical fields; research institutes with training functions in medical and pharmaceutical fields; institutions with functions of training healthcare personnel; and pharmacy associations.

2. Institutions for training and updating professional knowledge in pharmacy must develop training programs with the following main details:

a) Training details including specialized knowledge, law, and professional management in pharmacy;

b) The duration for training and updating professional knowledge in pharmacy shall be at least 08 hours.

Article 9. Responsibilities of institutions for training and updating professional knowledge in pharmacy

1. To assess and issue certificates of completion of the training and updating program of professional knowledge in pharmacy made using Form No. 08 in Appendix I to this Decree.

2. To report to the provincial-level Departments of Health of the localities where the institutions are headquartered and publicly announce on their websites the start and end of their operations related to training and updating of professional knowledge in pharmacy; lists of persons who have been issued with written confirmations of completion of the training and updating program of professional knowledge in pharmacy at the institutions, enclosed with information on the reference numbers and issuance dates of the Pharmacy Practising Certificates of the trainees; the details of the training and updating programs stated in the written confirmations of completion of the training and updating program of professional knowledge, and the dates of issuance of the certificates.

Article 10. Responsibilities of pharmaceutical regulatory authorities

1. The Ministry of Health shall be responsible for inspecting and supervising the institutions for training and updating professional knowledge in pharmacy as prescribed in Article 8 of this Decree.

2. Provincial-level Departments of Health are responsible for:

a) Publicly announcing on their websites the operational status of the institutions for training and updating professional knowledge in pharmacy in their respective localities;

b) Updating on their websites lists of persons who have completed the training and updating programs of professional knowledge in pharmacy at the training institutions in their respective localities;

c) Inspecting, supervising, and coordinating with the institutions for training and updating professional knowledge in pharmacy in their respective localities as prescribed in Article 8 of this Decree in organizing training and updating of professional knowledge in pharmacy.

 

Section 3

STANDARDIZATION OF PROFESSIONAL CREDENTIALS AND PROFESSIONAL TITLES FOR THE ISSUANCE OF PHARMACY PRACTISING CERTIFICATES

 

Article 11. Professional credentials and professional titles for which Pharmacy Practising Certificates are issued

1. A university degree in pharmacy means a university-level degree in pharmacy issued by a domestic educational institution with the title "Dược sĩ" (Pharmacist), "Dược sĩ đại học" (University Pharmacist), or "Dược sĩ cao cấp" (Senior Pharmacist).

2. A university degree in general medicine means a university-level degree in general medicine issued by a domestic educational institution with the title "Bác sĩ" (Doctor) or "Bác sĩ đa khoa" (General Practitioner).

3. A university degree in traditional medicine or traditional pharmacy means a university-level degree in traditional medicine or traditional pharmacy issued by a domestic educational institution.

4. A university degree in biology means a university-level degree in biology issued by a domestic educational institution.

5. A university degree in chemistry means a university-level degree in chemistry issued by a domestic educational institution.

6. An advanced diploma in pharmacy means a college-level diploma in pharmacy issued by a domestic educational institution.

7. A diploma in pharmacy means an intermediate-level diploma in pharmacy issued by a domestic educational institution with the title "Dược sĩ trung cấp" (Intermediate Pharmacist) or "Dược sĩ trung học" (Secondary Pharmacist) or stating "bằng tốt nghiệp trung cấp ngành dược" (diploma in pharmacy).

8. An advanced diploma or a diploma in medicine means a college-level or intermediate-level diploma in medicine issued by a domestic educational institution.

9. A diploma in traditional medicine or traditional pharmacy means an intermediate-level diploma in traditional medicine or traditional pharmacy issued by a domestic educational institution.

10. A primary certificate in pharmacy means a certification or certificate issued by a domestic educational institution with the title "Dược tá" (Pharmacy Assistant) or "Sơ cấp dược" (Primary Pharmacy).

Article 12. Determination of the scope of practice for undefined professional credentials and professional titles

1. If a credential or certificate is issued by a domestic training institution but the professional title stated on such credential/certificate is not prescribed in Clauses 1, 2, 7, and 10, Article 11 of this Decree, the determination of the scope of practice shall be considered and decided by the authority competent to issue the Pharmacy Practising Certificate based on the advice of the Advisory Council for the Issuance of Pharmacy Practising Certificates during the process of considering the issuance of the Pharmacy Practising Certificate.

2. For credentials and certificates issued by foreign training institutions, they must be recognized in accordance with the regulations of the Minister of Education and Training. The determination of the scope of practice for credentials and certificates issued by foreign training institutions shall comply with Clause 1 of this Article.

 

Section 4

PROFESSIONAL PRACTICE IN PHARMACY

 

Article 13. Establishments for professional practice

1. Establishments for professional practice mean the establishments prescribed in Clause 2, Article 13 of the Law on Pharmacy, including: pharmaceutical businesses, pharmacy departments of medical examination and treatment establishments, pharmaceutical training schools, pharmaceutical research institutions (including institutions for research and development of medicinal products and medicinal materials, institutions for research on vaccines and biologicals, medicinal product information and pharmacovigilance centres, institutions for research on pharmacology and clinical pharmacy), establishments for testing medicinal products and medicinal materials, pharmaceutical regulatory authorities, or representative offices of foreign traders operating in the pharmaceutical sector in Vietnam (hereinafter collectively referred to as pharmaceutical establishments); medical examination and treatment establishments suitable for the professional expertise of practitioners.

2. A suitable establishment for professional practice means an establishment for professional practice prescribed in Clause 1 of this Article with operations that are suitable for the particulars of professional practice of the practitioner as prescribed in Article 14 of this Decree.

3. The establishment for professional practice shall certify the period of professional practice for the practitioner at the establishment using Form No. 03 in Appendix I to this Decree and shall be responsible for its certification.

Article 14. Particulars of professional practice

1. For the position of a person professionally responsible for pharmacy at an establishment manufacturing medicinal products, active pharmaceutical ingredients, excipients, or capsule shells:

a) A person professionally responsible for pharmacy at an establishment manufacturing medicinal products, unless otherwise prescribed at Points c and d of this Clause, must practice one of the following professional operations: Manufacturing of medicinal products, testing of medicinal products, research and development of medicinal products, pharmaceutical administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school;

b) A person professionally responsible for pharmacy at an establishment manufacturing medicinal materials that are active pharmaceutical ingredients, excipients, or capsule shells must practice one of the following professional operations: Manufacturing of medicinal products; testing of medicinal products; research and development of medicinal products and medicinal materials; manufacturing of medicinal materials, manufacturing of chemicals; pharmaceutical administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school;

c) A person professionally responsible for pharmacy at an establishment manufacturing vaccines, biologicals, and raw materials for the manufacture of vaccines and biologicals must practice one of the following professional operations: Manufacturing of vaccines and biologicals, quality control of vaccines and biologicals, research and development of vaccines and biologicals; pharmaceutical administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school;

d) A person professionally responsible for pharmacy at an establishment manufacturing traditional medicinal products must practice one of the following professional operations: Manufacturing and processing of traditional medicinal products, testing of traditional medicinal products, quality assurance, research and development of traditional medicinal products, administration of pharmacy or traditional medicine and pharmacy at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school.

2. For the position of a person in charge of quality assurance at an establishment manufacturing medicinal products, active pharmaceutical ingredients, excipients, or capsule shells:

a) A person in charge of quality assurance at an establishment manufacturing medicinal products, unless otherwise prescribed at Point c of this Clause, must practice one of the following professional operations: Manufacturing, testing, quality assurance, research, and development of products at an establishment manufacturing medicinal products or an establishment testing medicinal products;

b) A person in charge of quality assurance at an establishment manufacturing medicinal materials that are active pharmaceutical ingredients, excipients, or capsule shells must practice one of the following professional operations: Manufacturing, testing, quality assurance, research, and development of products at an establishment manufacturing medicinal products and medicinal materials or an establishment testing medicinal products;

c) A person in charge of quality assurance at an establishment manufacturing vaccines, biologicals, and raw materials for the manufacture of vaccines and biologicals must practice one of the following professional operations: Manufacturing, testing, quality assurance, research, and development of products at an establishment manufacturing or testing vaccines and medical biologicals.

3. For the position of a person professionally responsible for pharmacy and a person in charge of quality assurance at an establishment manufacturing herbal medicinal materials:

a) A person professionally responsible for pharmacy or a person in charge of quality assurance at an establishment manufacturing herbal medicinal materials must practice one of the following professional operations: Manufacturing, preparing, and processing of herbal medicinal products, traditional medicinal products, and herbal medicinal materials, testing of medicinal products, quality assurance in the manufacturing process, medicinal materials, preparation and processing of traditional medicinal products; pharmaceutical administration or traditional medicine and pharmacy administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school;

b) A person professionally responsible for pharmacy or a person in charge of quality assurance at a business household or cooperative manufacturing herbal medicinal materials must practice one of the following professional operations: Manufacturing of medicinal materials, testing of medicinal products; quality assurance in the manufacturing process, research on herbal medicinal materials and traditional medicine; preparation and processing of traditional medicinal products; pharmaceutical administration or traditional medicine and pharmacy administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school.

4. For the position of a person professionally responsible for pharmacy at an establishment wholesaling medicinal products and medicinal materials:

a) A person professionally responsible for pharmacy at an establishment wholesaling medicinal products, unless otherwise prescribed at Points c and d of this Clause, must practice one of the following professional operations: Wholesaling of medicinal products and medicinal materials; pharmaceutical administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school; registration of medicinal products at a representative office of a foreign trader operating in the pharmaceutical sector in Vietnam;

b) A person professionally responsible for pharmacy at an establishment wholesaling medicinal materials must practice one of the following professional operations: Manufacturing of medicinal materials, manufacturing of chemicals, testing of medicinal products and medicinal materials, research on chemical technology and pharmaceutical technology; wholesaling of medicinal products, exporting and importing of medicinal products; storage of medicinal products and medicinal materials; pharmaceutical administration or traditional medicine and pharmacy administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school; registration of medicinal products at a representative office of a foreign trader operating in the pharmaceutical sector in Vietnam;

c) A person professionally responsible for pharmacy at an establishment wholesaling vaccines and biologicals must practice one of the following professional operations: Manufacturing, wholesaling, storage, and testing of vaccines and biologicals; research on vaccines and biologicals; pharmaceutical administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school; registration of vaccines and biologicals at a representative office of a foreign trader operating in the pharmaceutical sector in Vietnam;

d) A person professionally responsible for pharmacy at an establishment wholesaling herbal medicinal materials, herbal medicinal products, and traditional medicinal products must practice one of the following professional operations: Wholesaling of medicinal products and herbal medicinal materials; service of storing medicinal products and herbal medicinal materials, manufacturing of medicinal products, manufacturing of herbal medicinal materials, testing of medicinal products, herbal medicinal materials, and traditional medicine; research on herbal medicinal materials and traditional medicine; pharmaceutical administration or traditional medicine and pharmacy administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school.

5. For the position of a person professionally responsible for pharmacy at an establishment exporting or importing medicinal products and medicinal materials:

a) A person professionally responsible for pharmacy at an establishment exporting or importing medicinal products and medicinal materials, unless otherwise prescribed at Points b and c of this Clause, must practice one of the following professional operations: Wholesaling of medicinal products; exporting and importing of medicinal products; manufacturing of medicinal products; testing of medicinal products and medicinal materials; good storage practices for medicinal products; pharmaceutical administration related to the marketing, export, import, and wholesale of medicinal products and medicinal materials; pharmaceutical administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school; registration of medicinal products at a representative office of a foreign trader operating in the pharmaceutical sector in Vietnam;

b) A person professionally responsible for pharmacy at an establishment exporting or importing vaccines and biologicals must practice one of the following professional operations: Exporting and importing of vaccines and biologicals; manufacturing of vaccines and biologicals; wholesaling of vaccines and biologicals; service of storing vaccines and biologicals; testing of vaccines and biologicals; research on vaccines and biologicals; administration of vaccines and biologicals; use of vaccines and biologicals; pharmaceutical administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school; registration of vaccines and biologicals at a representative office of a foreign trader operating in the pharmaceutical sector in Vietnam;

c) A person professionally responsible for pharmacy at an establishment exporting or importing herbal medicinal materials, herbal medicinal products, and traditional medicinal products must practice one of the following professional operations: Wholesaling of medicinal products and medicinal materials; storage of medicinal products and medicinal materials; manufacturing of medicinal products and medicinal materials, testing of medicinal products, medicinal materials, and traditional medicine; research on herbal medicinal materials and traditional medicine; pharmaceutical administration or traditional medicine and pharmacy administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school; registration of herbal medicinal materials, herbal medicinal products, and traditional medicinal products at a representative office of a foreign trader operating in the pharmaceutical sector in Vietnam.

6. For the position of a person professionally responsible for pharmacy at an establishment retailing medicinal products:

a) A person professionally responsible for pharmacy at a pharmacy, dispensary, or medicine counter of a commune-level health station must practice one of the following professional operations: Wholesaling of medicinal products; retailing of medicinal products; exporting and importing of medicinal products; clinical pharmacy or medicinal product supply in a medical examination and treatment establishment; manufacturing of medicinal products; testing of medicinal products and medicinal materials; pharmaceutical research; storage of medicinal products; distribution of medicinal products; pharmaceutical administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school;

b) A person professionally responsible for pharmacy at an establishment retailing herbal medicinal materials, herbal medicinal products, and traditional medicinal products, unless otherwise prescribed at Point c, Clause 2, Article 13 of the Law on Pharmacy, must practice one of the professional operations related to the manufacturing, research, business, and medical examination and treatment using traditional medicine, or pharmaceutical administration or traditional medicine and pharmacy administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school.

7. For the position of a person professionally responsible for pharmacy at an establishment providing the service of testing medicinal products and medicinal materials:

a) A person professionally responsible for pharmacy at an establishment providing the service of testing medicinal products and medicinal materials, unless otherwise prescribed at Point b of this Clause, must practice one of the following professional operations: Testing of medicinal products and medicinal materials; research related to the manufacturing, testing, and analysis of medicinal products and medicinal materials; pharmaceutical administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school;

b) A person professionally responsible for pharmacy at an establishment providing the service of testing vaccines and biologicals must practice one of the following professional operations: Testing of medicinal products, testing of medicinal materials; quality control of vaccines and biologicals; research related to the manufacturing and testing of vaccines and biologicals; storage of medicinal products with the scope of vaccines and biologicals; pharmaceutical administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school.

8. For the position of a person professionally responsible for pharmacy at an establishment providing the service of clinical trial or bioequivalence trial of medicinal products, one of the following professional operations must be practiced: Bioequivalence trial of medicinal products; clinical trial of medicinal products; testing of medicinal products and medicinal materials; pharmacological and clinical pharmacy research; pharmaceutical administration or traditional medicine and pharmacy administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school.

9. For the position of a person in charge of clinical pharmacy at a medical examination and treatment establishment:

a) A person in charge of clinical pharmacy at a medical examination and treatment establishment, unless otherwise prescribed at Point b of this Clause, must practice one of the following professional operations: Bioequivalence trial of medicinal products; clinical trial of medicinal products; teaching pharmacology or clinical pharmacy at a pharmaceutical training school; pharmacological or clinical pharmacy research; pharmacovigilance at a drug information and adverse drug reaction centre; clinical pharmacy at a medical examination and treatment establishment;

b) A person in charge of clinical pharmacy at a medical examination and treatment establishment using traditional medicine must practice one of the following professional operations: Clinical trial of medicinal products; pharmacological and clinical pharmacy research; pharmacovigilance at a drug information and adverse drug reaction centre, clinical pharmacy practice at a medical examination and treatment establishment using traditional medicine.

10. For the position of a person professionally responsible for pharmacy at an establishment providing the service of storing medicinal products and medicinal materials:

a) A person professionally responsible for pharmacy at an establishment providing the service of storing medicinal products and medicinal materials, unless otherwise prescribed at Point b of this Clause, must practice one of the following professional operations: Storage of medicinal products and medicinal materials; pharmaceutical administration or traditional medicine and pharmacy administration at a pharmaceutical regulatory authority; teaching a specialized subject in pharmacy at a pharmaceutical training school;

b) A person professionally responsible for pharmacy at an establishment providing the service of storing vaccines and biologicals must practice one of the following professional operations: Storage of medicinal products with the scope of vaccines and biologicals; manufacturing of vaccines and biologicals; quality control of vaccines and biologicals; pharmaceutical administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school.

11. For the position of a person professionally responsible for pharmacy at an establishment organizing a pharmacy chain: A person professionally responsible for pharmacy at an establishment organizing a pharmacy chain must practice one of the following professional operations: Management of professional operations of the establishment organizing a pharmacy chain; wholesaling of medicinal products and medicinal materials; pharmaceutical administration at a pharmaceutical regulatory authority; teaching a specialized subject or a major in pharmacy at a pharmaceutical training school.

Article 15. Period of professional practice for persons with postgraduate specialist qualifications

1. A person with a postgraduate specialist qualification means a person holding one of the following degrees:

a) Master's degree in pharmacy, medicine, traditional medicine, chemistry, or biology (hereinafter referred to as a master's degree);

b) Doctoral degree in pharmacy, medicine, traditional medicine, chemistry, or biology (hereinafter referred to as a doctoral degree);

c) Level I or Level II Specialist degree according to the postgraduate specialist training system as prescribed by the Minister of Health.

2. The period of professional practice at a suitable pharmaceutical establishment as prescribed in Articles 15, 16, 17, 17a, 18, 19, 20, 21, and 22 of the Law on Pharmacy shall be reduced by:

a) 3/4 of the period for a person holding a doctoral degree or a Level II Specialist degree;

b) 1/2 of the period for a person holding a master's degree or a Level I Specialist degree.

 

Section 5

EXAMINATION FOR THE ISSUANCE OF PHARMACY PRACTISING CERTIFICATES

 

Article 16. Form, details, and program of the examination

1. Form of examination: Centralized examination at an examination-organizing establishment or online examination.

2. Details of the examination include:

a) General knowledge for pharmacy practitioners;

b) Specialized knowledge suitable for the position of employment that requires a Pharmacy Practising Certificate as prescribed in Article 11 of the Law on Pharmacy.

3. The Minister of Health shall detail the regulations, examination details, bank of examination questions, and passing score for the issuance of a Pharmacy Practising Certificate.

Article 17. Requirements for an establishment organizing the examination for the issuance of a Pharmacy Practising Certificate

It must be one of the higher education or postgraduate training institutions specializing in pharmacy or traditional medicine and pharmacy.

Article 18. Examination fees

An examinee taking the examination for the issuance of a Pharmacy Practising Certificate must pay a fee for the examination as prescribed by the law.

 

Chapter III

PHARMACEUTICAL BUSINESS

 

Section 1

CERTIFICATE OF ELIGIBILITY FOR PHARMACEUTICAL BUSINESS

 

Article 19. Conditions for trading in traditional medicinal products

1. Establishments manufacturing traditional medicinal products to be placed on the market nationwide must comply with Points a, c, and d, Clause 2, Article 69 of the Law on Pharmacy.

2. Establishments exporting or importing traditional medicinal products must have physical infrastructure, technical and professional documents, and personnel that comply with Good Storage Practices for medicinal products. The person professionally responsible for pharmacy at an establishment exporting or importing traditional medicinal products shall comply with Clause 3, Article 17 of the Law on Pharmacy.

3. Establishments providing the service of storing traditional medicinal products must have physical infrastructure, technical and professional documents, and personnel that comply with Good Storage Practices for medicinal products. The person professionally responsible for pharmacy at an establishment providing the service of storing traditional medicinal products shall comply with Clause 1, Article 22 of the Law on Pharmacy.

4. Establishments wholesaling traditional medicinal products must have physical infrastructure, technical and professional documents, and personnel that comply with Good Distribution Practices for medicinal products. The person professionally responsible for pharmacy at an establishment wholesaling traditional medicinal products shall comply with Clause 3, Article 16 of the Law on Pharmacy.

5. Conditions for an establishment retailing herbal medicinal materials, herbal medicinal products, and traditional medicinal products:

a) The person professionally responsible for pharmacy at an establishment retailing herbal medicinal materials, herbal medicinal products, and traditional medicinal products shall comply with Clause 4, Article 18 of the Law on Pharmacy;

b) It must have a fixed, separate location; be solidly built; have an area suitable for the scale of business; be located in a high, airy, safe place, away from sources of pollution;

c) It must have a storage area and storage equipment suitable for the storage requirements stated on the label.

Toxic herbal medicinal materials must be displayed (if any) and stored in a separate area; in cases where they are displayed and stored in the same area as other herbal medicinal materials, they must be kept separate and clearly labelled "dược liệu độc" (toxic herbal medicinal materials) to avoid confusion.

An establishment retailing herbal medicinal products, traditional medicinal products, or herbal medicinal materials only need to have a corresponding storage area for storing herbal medicinal products, traditional medicinal products, or for storing herbal medicinal materials and traditional medicinal ingredients;

d) Tools and packaging in direct contact with herbal medicinal products, traditional medicinal products, and herbal medicinal materials must not affect the quality of the herbal medicinal products, traditional medicinal products, and herbal medicinal materials;

dd) It must have logbooks or appropriate measures to keep information on import and export operations and traceability;

e) A person retailing herbal medicinal materials, herbal medicinal products, and traditional medicinal products must have one of the credentials prescribed at Points a, c, e, g, i, or l, Clause 1, Article 13 of the Law on Pharmacy.

For toxic herbal medicinal materials, prescription herbal medicinal products, and prescription traditional medicinal products, the person who directly retails and provides consultation to the buyers must be the person professionally responsible for the retailing establishment;

g) In cases where the retailing establishment also trades in other items as prescribed by the law, these items must be displayed and stored in a separate area and must not affect the herbal medicinal materials, herbal medicinal products, and traditional medicinal products.

Article 20. Detailed regulations on the dossier of application for issuance, re-issuance, and modification of a Certificate of Eligibility for Pharmaceutical Business

The dossier of application for issuance, re-issuance, or modification of a Certificate of Eligibility for Pharmaceutical Business shall comply with Article 38 of the Law on Pharmacy and comprise:

1. An application for issuance, re-issuance, or modification of a Certificate of Eligibility for Pharmaceutical Business shall be made using Forms No. 10, 11, and 12 in Appendix I to this Decree.

2. The technical documents prescribed at Point b, Clause 1, Article 38 of the Law on Pharmacy include the following:

a) For an establishment manufacturing medicinal products and medicinal materials: Documents on physical infrastructure, technical and professional documents, and personnel documents in accordance with the principles and standards of Good Manufacturing Practices for medicinal products and medicinal materials.

In cases where an establishment applies for a Certificate of Eligibility for Pharmaceutical Business with the scope of manufacturing medicinal products and medicinal materials and also sells or delivers the medicinal products and medicinal materials manufactured by the establishment to wholesaling establishments, retailing establishments, or medical examination and treatment establishments, it must provide additional technical and professional documents and personnel documents in accordance with the principles and standards of Good Distribution Practices for medicinal products and medicinal materials, unless the delivery is made at the warehouse of the manufacturing establishment;

b) For an establishment importing medicinal products and medicinal materials, an establishment exporting medicinal products and medicinal materials, or an establishment providing the service of storing medicinal products and medicinal materials: Documents on physical infrastructure, technical and professional documents, and personnel documents in accordance with the principles and standards of Good Storage Practices for medicinal products and medicinal materials;

c) For an establishment wholesaling medicinal products and medicinal materials: Documents on physical infrastructure, technical and professional documents, and personnel documents in accordance with the principles and standards of Good Distribution Practices for medicinal products and medicinal materials;

d) For an establishment retailing medicinal products: Documents on physical infrastructure, technical and professional documents, and personnel documents in accordance with the principles and standards of Good Retailing Practices for medicinal products.

For an establishment retailing herbal medicinal materials, herbal medicinal products, and traditional medicinal products: Documents proving compliance with Clause 5, Article 19 of this Decree as prescribed by the Minister of Health;

dd) For an establishment providing the service of testing medicinal products and medicinal materials: Documents on physical infrastructure, technical and professional documents, and personnel documents in accordance with the principles and standards of Good Laboratory Practices for the quality control of medicinal products;

e) For an establishment providing the service of clinical trial of medicinal products: Documents on physical infrastructure, technical and professional documents, and personnel documents in accordance with the principles and standards of Good Clinical Practices for medicinal products;

g) For an establishment providing the service of bioequivalence trial of medicinal products: Documents on physical infrastructure, technical and professional documents, and personnel documents in accordance with the principles and standards of Good Laboratory Practices for the stage of biofluid analysis and Good Clinical Practices for the stage of clinical research.

In cases where an establishment providing the service of bioequivalence trial of medicinal products enters into a contract or cooperates with an establishment conducting clinical trial of medicinal products that complies with Good Clinical Practices to carry out the clinical research stage in the bioequivalence trial of medicinal products, the technical documents are not required to include documents on physical infrastructure, technical and professional documents, and personnel documents in accordance with the principles and standards of Good Clinical Practices;

h) For an establishment organizing a pharmacy chain: Documents on physical infrastructure, technical and professional documents, and personnel documents in accordance with the principles and standards of Good Distribution Practices for medicinal products and medicinal materials.

3. The technical documents prescribed at Point b, Clause 2, Article 38 of the Law on Pharmacy include documents on physical infrastructure, technical and professional documents, and personnel documents as prescribed in Clause 2 of this Article corresponding to the changed business conditions.

4. The dossier quantity prescribed in this Article is 01 dossier. The documents submitted in the dossier of application for issuance, re-issuance, or modification of a Certificate of Eligibility for Pharmaceutical Business as prescribed at Points c and d, Clause 1; Points c and d, Clause 2; and Points b and c, Clause 4, Article 38 of the Law on Pharmacy must be originals, certified true copies, or copies presented with their originals for collation.

Article 21. Sequence and procedures for issuance of a Certificate of Eligibility for Pharmaceutical Business

1. An establishment applying for a Certificate of Eligibility for Pharmaceutical Business shall submit a dossier either directly, via postal service, or online to:

a) The Ministry of Health, in case of application for a Certificate of Eligibility for Pharmaceutical Business in one of the cases prescribed at Points a, b, c, e, g, h, and i, Clause 2, Article 32 of the Law on Pharmacy;

b) The provincial-level Department of Health of the locality where the establishment's business location is located, in case of application for a Certificate of Eligibility for Pharmaceutical Business in one of the cases prescribed at Points d and dd, Clause 2, Article 32 of the Law on Pharmacy.

2. After receiving a dossier, the dossier-receiving authority shall issue the applying establishment a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree.

3. The dossier-receiving authority shall:

a) Issue a Certificate of Eligibility for Pharmaceutical Business within 30 days from the date stated on the Dossier Receipt Note in cases where the physical infrastructure, technical conditions, and personnel have been inspected and assessed as compliant with Good Practices suitable for the scope of business, without having to conduct an on-site assessment at the establishment applying for the Certificate of Eligibility for Pharmaceutical Business;

b) Organize an on-site assessment at the establishment applying for a Certificate of Eligibility for Pharmaceutical Business within 20 days from the date stated on the Dossier Receipt Note.

4. When amendment or supplementation to the dossier is required in the case prescribed at Point a, Clause 3 of this Article, within 07 working days from the date stated on the Dossier Receipt Note, the dossier-receiving authority shall send a written notice to the applying establishment, specifying the documents and details to be amended or supplemented, made using Form No. 16 in Appendix I to this Decree.

5. After receiving the amended or supplemented dossier, the dossier-receiving authority shall issue the applying establishment a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree.

a) In cases where the amended or supplemented dossier is unsatisfactory, within 10 days from the date stated on the Dossier Receipt Note, the dossier-receiving authority shall send a written notice to the establishment regarding the non-issuance of the Certificate of Eligibility for Pharmaceutical Business, made using Form No. 16 in Appendix I to this Decree;

b) In cases where no amendment or supplementation to the amended or supplemented dossier is required, the dossier-receiving authority shall proceed as prescribed at Point a, Clause 3 of this Article.

6. After conducting an on-site assessment at the establishment as prescribed at Point b, Clause 3 of this Article, the authority issuing the Certificate of Eligibility for Pharmaceutical Business shall be responsible for:

a) Issuing a Certificate of Eligibility for Pharmaceutical Business within 10 days from the date of completion of the on-site assessment in cases where no corrective or remedial actions are required;

b) Issuing a written notice of the non-issuance of the Certificate of Eligibility for Pharmaceutical Business in cases where the establishment does not meet the prescribed conditions, or a written notice of the details to be corrected and remedied, made using Form No. 16 in Appendix I to this Decree, within 10 days from the date of completion of the on-site assessment in cases where corrective or remedial actions are required.

7. Within 20 days from the date of receiving the establishment's report on the completion of corrective and remedial actions, enclosed with supporting documents, the dossier-receiving authority shall issue a Certificate of Eligibility for Pharmaceutical Business or send a written notice of amendment or supplementation.

8. Within 06 months from the date the dossier-receiving authority sends a written notice of amendment or supplementation or a written notice of the details to be corrected and remedied, the applying establishment must submit the amended or supplemented dossier as required or a report on the completion of corrective and remedial actions, enclosed with supporting documents. After this period, if the establishment fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid.

9. Within 03 working days from the date of issuance of the Certificate of Eligibility for Pharmaceutical Business, the dossier-receiving authority shall publicly announce and update the following information on the electronic portal or website of the issuing authority:

a) The name and address of the establishment issued with the Certificate of Eligibility for Pharmaceutical Business;

b) The full name of the person professionally responsible for pharmacy, and the reference number of his/her Pharmacy Practising Certificate;

c) Reference number of the Certificate of Eligibility for Pharmaceutical Business;

d) The scope of pharmaceutical business.

10. Upon receiving a Certificate of Eligibility for Pharmaceutical Business issued in the case prescribed at Point b, Clause 1, Article 36 of the Law on Pharmacy, the establishment must return the previously issued Certificate of Eligibility for Pharmaceutical Business, unless it was lost or issued online.

11. The dossier-receiving authority shall issue 01 copy of the Certificate of Eligibility for Pharmaceutical Business made using Form No. 13 in Appendix I to this Decree to the applying establishment.

12. In cases where an establishment has been assessed as compliant with Good Practices, the dossier-receiving authority shall issue a Good Practices certificate if requested by the establishment.

Article 22. Sequence and procedures for re-issuance and modification of a Certificate of Eligibility for Pharmaceutical Business

1. An establishment applying for re-issuance or modification of a Certificate of Eligibility for Pharmaceutical Business shall submit a dossier either directly, via postal service, or online to:

a) The Ministry of Health, in case of application for re-issuance or modification of a Certificate of Eligibility for Pharmaceutical Business in one of the cases prescribed at Points a, b, c, e, g, h, and i, Clause 2, Article 32 of the Law on Pharmacy;

b) The provincial-level Department of Health of the locality where the establishment's business location is located, in case of application for re-issuance or modification of a Certificate of Eligibility for Pharmaceutical Business in one of the cases prescribed at Points d and dd, Clause 2, Article 32 of the Law on Pharmacy.

2. After receiving a dossier, the dossier-receiving authority shall issue the applying establishment a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree.

3. In cases where no amendment or supplementation to the dossier is required, the authority re-issuing or modifying the Certificate of Eligibility for Pharmaceutical Business shall be responsible for:

a) Re-issuing or modifying the Certificate of Eligibility for Pharmaceutical Business within 20 days from the date stated on the Dossier Receipt Note in the cases prescribed at Point a, Clause 2 and Clause 3, Article 36 of the Law on Pharmacy;

b) Re-issuing the Certificate of Eligibility for Pharmaceutical Business within 07 working days from the date stated on the Dossier Receipt Note in the case prescribed at Point b, Clause 2, Article 36 of the Law on Pharmacy.

4. In cases where amendment or supplementation to the dossier is required, the dossier-receiving authority must send a written notice to the establishment requesting amendment or supplementation to the dossier of application for re-issuance or modification of the Certificate of Eligibility for Pharmaceutical Business within 05 working days from the date stated on the Dossier Receipt Note, made using Form No. 16 in Appendix I to this Decree.

5. After receiving the amended or supplemented dossier, the dossier-receiving authority shall issue the applicant a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree.

a) In cases where the amended or supplemented dossier is unsatisfactory, within 05 working days from the date stated on the Dossier Receipt Note, the dossier-receiving authority shall send a written notice to the establishment regarding the non-re-issuance or non-modification of the Certificate of Eligibility for Pharmaceutical Business, made using Form No. 16 in Appendix I to this Decree;

b) In cases where no amendment or supplementation is required, the dossier-receiving authority shall re-issue or modify the Certificate of Eligibility for Pharmaceutical Business as prescribed in Clause 3 of this Article.

6. Within 06 months from the date the dossier-receiving authority sends a written notice of amendment or supplementation, the applying establishment must submit the amended or supplemented dossier as required. After this period, if the establishment fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid.

7. Within 03 working days from the date of re-issuance or modification of the Certificate of Eligibility for Pharmaceutical Business, the dossier-receiving authority shall publicly announce and update the following information on the electronic portal or website of the issuing authority:

a) The name and address of the establishment re-issued or modified with the Certificate of Eligibility for Pharmaceutical Business;

b) The full name of the person professionally responsible for pharmacy, and the reference number of his/her Pharmacy Practising Certificate;

c) Reference number of the Certificate of Eligibility for Pharmaceutical Business;

d) The scope of pharmaceutical business.

8. Upon receiving a new Certificate of Eligibility for Pharmaceutical Business, the establishment must return the previously issued Certificate, unless it was lost or issued online.

9. The authority re-issuing or modifying the Certificate of Eligibility for Pharmaceutical Business shall issue 01 copy of the Certificate made using Form No. 13 in Appendix I to this Decree to the establishment applying for re-issuance or modification.

Article 23. Procedures for revoking a Certificate of Eligibility for Pharmaceutical Business

1. Within 05 working days from the date of receiving an inspection or examination conclusion that recommends the revocation of the Certificate of Eligibility for Pharmaceutical Business, or upon discovering any of the cases prescribed in Article 40 of the Law on Pharmacy, the authority that issued the Certificate of Eligibility for Pharmaceutical Business must issue a decision to revoke the Certificate under its management. In cases where the Certificate is not revoked, a written response must be sent to the authority that recommended the revocation, stating the reasons.

2. Within 03 working days from the date of issuing a decision to revoke a Certificate of Eligibility for Pharmaceutical Business, the authority that issued the revocation decision shall be responsible for:

a) Uploading the decision to revoke the Certificate of Eligibility for Pharmaceutical Business on its electronic portal or website and sending this decision to the Ministry of Health and other provincial-level Departments of Health nationwide;

b) Updating the information on the revocation of the Certificate of Eligibility for Pharmaceutical Business on its electronic portal or website.

3. Within 05 working days from the date of receiving the decision to revoke a Certificate of Eligibility for Pharmaceutical Business, the Ministry of Health shall be responsible for uploading this decision on its electronic portal.

 

Section 2

GEOGRAPHICAL AREAS AND SCOPE OF BUSINESS OF RETAILING ESTABLISHMENTS BEING DISPENSARIES AND MEDICINE COUNTERS

 

Article 24. Geographical areas for opening dispensaries and medicine counters of commune-level health stations

1. Geographical areas for opening dispensaries:

a) Communes and special zones on islands;

b) In areas newly converted from communes and special zones on islands into wards, if there is not yet one establishment retailing medicinal products serving every 2,000 residents at the time of conversion, new dispensaries may be opened and shall be allowed to operate for no more than 03 years from the date of conversion;

c) Dispensaries not in the areas prescribed at Point a of this Clause that were issued with Certificates of Eligibility for Pharmaceutical Business before the area was converted into a ward shall be allowed to operate for no more than 03 years from the date of conversion.

2. Geographical areas for opening medicine counters of commune-level health stations:

Health stations of communes and special zones on islands.

Article 25. Scope of business of dispensaries and medicine counters of commune-level health stations

1. The scope of business of a dispensary shall comply with Point b, Clause 1, Article 48 of the Law on Pharmacy.

2. The scope of business of a medicine counter of a commune-level health station shall comply with Point b, Clause 1, Article 49 of the Law on Pharmacy.

 

Section 3

ORGANIZATION OF MOBILE MEDICINAL PRODUCT RETAILING

 

Article 26. Conditions for mobile medicinal product retailing

1. Establishments organizing mobile medicinal product retailing include:

a) Establishments manufacturing medicinal products;

b) Establishments wholesaling medicinal products;

c) Establishments retailing medicinal products;

d) Medical establishments of the people's armed forces, and military-civilian medical examination and treatment establishments with medicinal product supply operations in ethnic minority-inhabited areas, mountainous areas, islands, socio-economically disadvantaged areas, and extremely socio-economically disadvantaged areas;

dd) Establishments organizing pharmacy chains.

2. A mobile medicinal product retailer must be an employee of an establishment prescribed in Clause 1 of this Article and must have one of the professional credentials prescribed at Points a, b, c, e, g, h, i, and k, Clause 1, Article 13 of the Law on Pharmacy.

3. Mobile retailed medicinal products must have a remaining shelf life of at least 06 months and be stored using tools and devices that ensure hygiene and weather protection.

4. At the place of mobile medicinal product retailing, there must be a sign clearly stating the name and address of the establishment organizing the mobile medicinal product retailing, the full name of the retailer, and the area of operation.

Article 27. List and geographical areas for mobile medicinal product retailing

1. The list of mobile retailed medicinal products includes medicinal products that meet the following criteria:

a) They are on the list of over-the-counter medicinal products;

b) They only require storage under normal conditions;

c) They serve the common needs of the local population, with priority given to herbal medicinal materials cultivated and harvested in ethnic minority-inhabited areas.

2. Based on the criteria prescribed in Clause 1 of this Article, the provincial-level Departments of Health shall publicly announce the lists of medicinal products and the geographical areas where mobile medicinal product retailing is licensed.

Article 28. Procedures for notification of mobile medicinal product retailing

1. Before organizing mobile medicinal product retailing, the establishment organizing the mobile medicinal product retailing is responsible for sending a written notification made using Form No. 14 in Appendix I to this Decree to the provincial-level Department of Health in the locality where the mobile medicinal product retailing is planned.

2. Within 03 working days from the date of receiving the notice from the establishment organizing the mobile medicinal product retailing, the provincial-level Department of Health is responsible for publicly announcing the information of the establishment organizing the mobile medicinal product retailing on its website and is responsible for organizing supervision and inspection.

 

Section 4

MEASURES TO ENSURE SECURITY AND NO LOSS OF MEDICINAL PRODUCTS AND MEDICINAL MATERIALS SUBJECT TO SPECIAL CONTROL, SEQUENCE AND PROCEDURES FOR PERMITTING THE BUSINESS OF MEDICINAL PRODUCTS SUBJECT TO SPECIAL CONTROL AND MEDICINAL PRODUCTS ON THE LIST OF MEDICINAL PRODUCTS RESTRICTED FROM RETAIL

 

Article 29. List of medicinal materials that are radioactive substances and list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields

1. The list of medicinal materials that are radioactive substances is issued in Appendix IV to this Decree.

2. Public announcement of the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields:

a) The Ministry of Agriculture and Environment, the Ministry of Industry and Trade, the Ministry of Construction, and other ministries and ministerial-level agencies that issue or amend or supplement the lists of substances prohibited from use in the sectors and fields under their management are responsible for sending the respective lists to the Ministry of Health;

b) After receiving the lists of prohibited substances issued by the ministries and ministerial-level agencies prescribed at Point a of this Clause, the Ministry of Health shall review the substances that are medicinal products and active pharmaceutical ingredients to issue a decision on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields, and publicly announce it on the electronic portal of the Ministry of Health.

Article 30. Measures to ensure security and no loss of medicinal products and medicinal materials subject to special control

1. Establishments trading in medicinal products subject to special control must comply with Articles 31, 32, 33, 34, 35, and 36 of this Decree.

2. In case of trading in radioactive medicinal products, in addition to complying with Clause 1 of this Article, the establishment must also comply with the Law on Atomic Energy and other relevant law regulations.

3. The Ministry of Health and provincial-level Departments of Health shall, on a 3-year or ad-hoc basis, inspect and assess compliance with the security measures prescribed in this Section of establishments trading in medicinal products subject to special control as prescribed by the Minister of Health or in international treaties to which the Socialist Republic of Vietnam is a contracting party.

Article 31. Regulations on physical infrastructure of establishments trading in medicinal products subject to special control

1. For establishments manufacturing habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients:

a) There must be a separate warehouse or a separate area that meets the principles and standards of Good Storage Practices for medicinal products and medicinal materials for storing habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients. This warehouse or area must have a door and a secure lock;

b) There must be a camera system to monitor each stage of the manufacturing and storage process of medicinal products and medicinal materials;

c) There must be a management and monitoring system using records and books as prescribed by the Minister of Health.

2. For establishments manufacturing combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients:

a) There must be a separate warehouse or a separate area that meets the principles and standards of Good Storage Practices for medicinal products and medicinal materials for storing medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients. This warehouse or area must have a door and a secure lock;

b) There must be a separate warehouse or a separate area that meets the principles and standards of Good Storage Practices for medicinal products and medicinal materials for storing combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients. The warehouse must have a door and a secure lock;

c) There must be a camera system to monitor each stage of the manufacturing and storage process of medicinal products and medicinal materials;

d) There must be a management and monitoring system using records and books as prescribed by the Minister of Health.

3. For establishments manufacturing radioactive medicinal products:

a) There must be a separate warehouse or a separate area that meets the principles and standards of Good Storage Practices for medicinal products and medicinal materials for storing radioactive medicinal products;

b) There must be a management and monitoring system using records and books as prescribed by the Minister of Health;

c) There must be a camera system in the manufacturing and storage areas of medicinal products.

4. For establishments exporting, importing, and providing the service of storing habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients:

a) There must be a separate warehouse or a separate area that meets the principles and standards of Good Storage Practices for medicinal products and medicinal materials for storing habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients. This warehouse or area must have a door and a secure lock;

b) There must be a camera system in the warehouse for storing medicinal products and medicinal materials;

c) There must be a management and monitoring system using records and books as prescribed by the Minister of Health.

5. For establishments exporting, importing, wholesaling, and providing the service of storing combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients: There must be a separate warehouse or a separate area that meets the principles and standards of Good Storage Practices for medicinal products and medicinal materials for storing combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients. The warehouse must have a door and a secure lock; and there must be a management and monitoring system using records and books as prescribed by the Minister of Health.

6. For establishments exporting, importing, and wholesaling radioactive medicinal products and medicinal materials that are radioactive substances: There must be a management and monitoring system using records and books as prescribed by the Minister of Health.

7. For establishments wholesaling habit-forming medicinal products, psychotropic medicinal products, and precursor medicinal products:

a) There must be a separate warehouse or a separate area that meets the principles and standards of Good Storage Practices for medicinal products and medicinal materials for storing habit-forming medicinal products, psychotropic medicinal products, and precursor medicinal products. The warehouse or separate area must have a door and a secure lock;

b) There must be a camera system in the storage area of medicinal products;

c) There must be a management and monitoring system using records and books as prescribed by the Minister of Health.

8. For establishments retailing habit-forming medicinal products, psychotropic medicinal products, and precursor medicinal products:

a) Habit-forming medicinal products, psychotropic medicinal products, and precursor medicinal products must be stored in a separate cabinet or compartment with a secure lock;

b) There must be a management and monitoring system using records and books as prescribed by the Minister of Health.

9. For establishments retailing combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients, they must use a software system or records and books for monitoring as prescribed by the Minister of Health.

10. For establishments retailing radioactive medicinal products:

a) There must be a separate area for storing radioactive medicinal products;

b) There must be a management and monitoring system using records and books as prescribed by the Minister of Health.

11. For establishments providing the service of clinical trial of medicinal products, providing the service of bioequivalence trial of medicinal products, providing the service of testing, and providing the service of storing radioactive medicinal products:

a) There must be a separate warehouse or a separate area that meets the principles and standards of Good Storage Practices for medicinal products and medicinal materials for storing radioactive medicinal products; there must be a management and monitoring system using records and books as prescribed by the Minister of Health; there must be a camera system for establishments providing the service of storing radioactive medicinal products;

b) There must be a management and monitoring system using records and books as prescribed by the Minister of Health;

c) There must be a camera system for establishments providing the service of storing radioactive medicinal products.

12. For establishments providing the service of clinical trial of medicinal products, providing the service of bioequivalence trial of medicinal products, and providing the service of testing medicinal products subject to special control, unless otherwise prescribed in Clause 11 of this Article, they must store habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, precursor active pharmaceutical ingredients, combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients in a separate area with a secure lock or in a separate cabinet or compartment with a secure lock.

13. For establishments trading in toxic medicinal products, toxic medicinal materials, and medicinal products and active pharmaceutical ingredients on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields, they must use a software system or records and books to manage the entire process of import, export, and inventory as prescribed by the Minister of Health.

Article 32. Regulations on personnel of establishments trading in medicinal products subject to special control

1. For establishments manufacturing habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients:

a) The warehouse keeper for habit-forming medicinal products and medicinal materials that are habit-forming active pharmaceutical ingredients must have a university degree in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business;

b) The warehouse keeper for psychotropic medicinal products, precursor medicinal products, and medicinal materials that are psychotropic active pharmaceutical ingredients or precursor active pharmaceutical ingredients must have a diploma in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business.

2. For establishments manufacturing combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients:

a) The warehouse keeper for medicinal materials that are habit-forming active pharmaceutical ingredients must have a university degree in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business;

b) The warehouse keeper for medicinal materials that are psychotropic active pharmaceutical ingredients or precursor active pharmaceutical ingredients must have a diploma in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business.

3. For establishments manufacturing radioactive medicinal products:

a) The warehouse keeper must have a diploma in pharmacy or higher, or a bachelor's degree in radiochemistry, radiation medicine, or nuclear medicine or higher;

b) The person responsible for supervising the research, manufacturing, analysis, and testing process must have a bachelor's degree in radiochemistry, radiation medicine, or nuclear medicine, or have a university degree in pharmacy or higher.

4. For establishments exporting or importing habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients: The warehouse keeper for habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients must have a university degree in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business.

5. For establishments wholesaling habit-forming medicinal products, psychotropic medicinal products, and precursor medicinal products:

a) The warehouse keeper for habit-forming medicinal products must have a university degree in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business;

b) The warehouse keeper for psychotropic medicinal products and precursor medicinal products must have a diploma in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business.

6. For establishments retailing habit-forming medicinal products, psychotropic medicinal products, and precursor medicinal products:

a) The person responsible for retailing habit-forming medicinal products must have a university degree in pharmacy or higher;

b) The person responsible for retailing psychotropic medicinal products and precursor medicinal products must have a diploma in pharmacy or higher.

7. For establishments retailing radioactive medicinal products: The person responsible for retailing must have a diploma in pharmacy or higher.

8. For establishments providing the service of storing habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients: The warehouse keeper for habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients must have a university degree in pharmacy or higher and have at least 12 months of professional practice at a pharmaceutical business.

9. For establishments providing the service of clinical trial of medicinal products, providing the service of bioequivalence trial of medicinal products, and providing the service of testing habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients: The person who monitors and manages habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients must have a diploma in pharmacy or higher.

10. For establishments providing the service of clinical trial of medicinal products, providing the service of bioequivalence trial of medicinal products, providing the service of testing, and providing the service of storing radioactive medicinal products:

a) The warehouse keeper must have a diploma in pharmacy or higher, or a bachelor's degree in radiochemistry, radiation medicine, or nuclear medicine or higher; the person responsible for supervising the research, manufacturing, analysis, and testing process must be a bachelor of radiochemistry, a bachelor of radiation medicine or nuclear medicine or higher, or have a university degree in pharmacy or higher;

b) The person responsible for supervising the research, manufacturing, analysis, and testing process must have a bachelor's degree in radiochemistry, radiation medicine, or nuclear medicine or higher, or have a university degree in pharmacy or higher.

Article 33. Regulations on delivery, receipt, and transportation of medicinal products and medicinal materials by establishments trading in medicinal products subject to special control

1. A person who delivers or receives medicinal products and medicinal materials subject to special control must have a diploma in pharmacy or higher; in the case of delivery and receipt of radioactive medicinal products, the person who delivers or receives radioactive medicinal products must also have a certificate of radiation safety as prescribed by the law on atomic energy.

2. A person who transports habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients must carry a written assignment from the head of the establishment, a valid personal identification document, a sales invoice or a warehouse release note. In case of transporting radioactive medicinal products, the transporter must also carry a certificate of radiation safety.

3. When delivering or receiving habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients, a written record of delivery and receipt must be made using Form No. 01 in Appendix II to this Decree.

4. Medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, precursor active pharmaceutical ingredients, habit-forming medicinal products, psychotropic medicinal products, and precursor medicinal products must be secured during transportation to prevent loss thereof. In case of transporting radioactive medicinal products, radiation safety must be ensured in accordance with the regulations and guidelines on the safe transport of radioactive materials of the law regulations on atomic energy.

5. Establishments involved in the process of delivering and receiving radioactive medicinal products must have licenses to conduct radiation work within the scope of transporting radioactive sources as prescribed by the law on atomic energy.

Article 34. Regulations on purchase and sale of medicinal products subject to special control

1. For medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients:

a) An establishment manufacturing medicinal products may only import materials for its own manufacturing operations;

b) An importing establishment may only sell imported materials nationwide to the following establishments: establishments manufacturing medicinal products for their own manufacturing operations; medical examination and treatment establishments for preparing medicinal products to serve their treatment needs; state-owned establishments for testing medicinal products and medicinal materials for their testing operations and for research and development of standards for research and testing of medicinal products and medicinal materials, scientific and technological organizations for their research operations; training institutions with research and teaching operations related to pharmacy for their research and teaching operations;

c) An establishment manufacturing medicinal products that does not use all of its materials may transfer them to another manufacturing establishment with written permission from the Ministry of Health as prescribed in Article 39 of this Decree.

2. The sale of habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and combination medicinal products containing precursor active pharmaceutical ingredients by an establishment manufacturing medicinal products:

a) The establishment may sell the medicinal products it manufactures nationwide to establishments that concurrently hold Certificates of Eligibility for Pharmaceutical Business with the scope of exporting and importing medicinal products and Certificates of Eligibility for Pharmaceutical Business with the scope of wholesaling medicinal products; pharmacies; establishments providing the service of clinical trial of medicinal products for their clinical trial operations; establishments providing the service of bioequivalence trial of medicinal products for their bioequivalence trial operations; establishments providing the service of testing medicinal products and medicinal materials and state-owned establishments for testing medicinal products and medicinal materials for their testing operations; medical examination and treatment establishments, immunization establishments, and other medical establishments, and medicinal product addiction treatment centres for their medical examination and treatment work; scientific and technological organizations for their research operations; training institutions with research and teaching operations related to pharmacy for their research and teaching operations;

b) The establishment may only select 01 establishment wholesaling medicinal products in each provincial-level locality to sell all the items it manufactures.

3. The sale of habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and combination medicinal products containing precursor active pharmaceutical ingredients by an establishment importing medicinal products:

a) The establishment may sell the medicinal products it imports nationwide to pharmacies; establishments providing the service of clinical trial of medicinal products for their clinical trial operations; establishments providing the service of bioequivalence trial of medicinal products for their bioequivalence trial operations; establishments providing the service of testing medicinal products and medicinal materials and state-owned establishments for testing medicinal products and medicinal materials for their testing operations; medical examination and treatment establishments, immunization establishments, and other medical establishments, and medicinal product addiction treatment centres for their medical examination and treatment work; scientific and technological organizations for their research operations; training institutions with research and teaching operations related to pharmacy for their research and teaching operations;

b) The establishment may only select 01 establishment wholesaling medicinal products in each provincial-level locality to sell all the items it imports;

c) A foreign-invested establishment importing medicinal products may only sell medicinal products as prescribed at Point b of this Clause.

4. The sale of habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and combination medicinal products containing precursor active pharmaceutical ingredients by an establishment that concurrently holds a Certificate of Eligibility for Pharmaceutical Business with the scope of exporting and importing medicinal products and a Certificate of Eligibility for Pharmaceutical Business with the scope of wholesaling medicinal products:

a) It may sell the medicinal products it trades nationwide to pharmacies and establishments that concurrently hold Certificates of Eligibility for Pharmaceutical Business with the scope of exporting and importing medicinal products and Certificates of Eligibility for Pharmaceutical Business with the scope of wholesaling medicinal products; establishments providing the service of clinical trial of medicinal products for their clinical trial operations; establishments providing the service of bioequivalence trial of medicinal products for their bioequivalence trial operations; establishments providing the service of testing medicinal products and medicinal materials and state-owned establishments for testing medicinal products and medicinal materials for their testing operations; medical examination and treatment establishments, immunization establishments, and other medical establishments, and medicinal product addiction treatment centres for their medical examination and treatment work; scientific and technological organizations for their research operations; training institutions with research and teaching operations related to pharmacy for their research and teaching operations;

b) It may only select 01 establishment wholesaling medicinal products in each provincial-level locality to sell all the items it trades.

5. An establishment wholesaling medicinal products may only sell habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and combination medicinal products containing precursor active pharmaceutical ingredients to establishments in the provincial-level locality where the wholesaling establishment's business location is located, including:

a) Establishments retailing medicinal products;

b) Establishments providing the service of clinical trial of medicinal products for their clinical trial operations;

c) Establishments providing the service of bioequivalence trial of medicinal products for their bioequivalence trial operations;

d) Establishments providing the service of testing medicinal products and medicinal materials and state-owned establishments for testing medicinal products and medicinal materials for their testing operations;

dd) Medical examination and treatment establishments, immunization establishments, and other medical establishments, and medicinal product addiction treatment centres for their medical examination and treatment work;

e) Scientific and technological organizations for their research operations; training institutions with research and teaching operations related to pharmacy for their research and teaching operations.

6. The purchase and sale of medicinal products and medicinal materials between the establishments prescribed in Clauses 1, 2, 3, 4, and 5 of this Article shall be carried out according to Purchase Orders approved by a competent authority, except for the following purchase of medicinal products:

a) Purchase of medicinal products according to the approved bidding results by the provincial-level People's Committee of the locality where the medical examination and treatment establishment, immunization establishment, other medical establishment, or medicinal product addiction treatment centre is located;

b) Purchase of medicinal products according to the approved bidding results by the Ministry of National Defence for establishments under the Ministry of National Defence;

c) Purchase of medicinal products according to the approved bidding results by the Ministry of Public Security for establishments under the Ministry of Public Security.

7. For combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, radioactive medicinal products, medicinal materials that are radioactive substances, toxic medicinal products, toxic medicinal materials, and medicinal products and active pharmaceutical ingredients on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields of establishments trading in medicinal products and medicinal materials, the purchase and sale shall comply with Chapter IV of the Law on Pharmacy.

8. In cases where there is no establishment retailing medicinal products subject to special control in a locality, the provincial-level People's Committee is responsible for designating a medical examination and treatment establishment to transfer medicinal products subject to special control to ensure sufficient supply for patients.

Article 35. Regulations on reporting of medicinal products subject to special control

1. For manufacturing, exporting, and importing establishments:

a) Within 10 days from the date of export or import, the establishment must prepare an export or import report for habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients, made using Form No. 02 in Appendix II to this Decree, and send it to the Ministry of Public Security and the report-receiving authority as prescribed in Article 124 of this Decree;

b) Before July 15 and January 15 of each year, the establishment must prepare a semi-annual and annual report on the import and export of combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, combination medicinal products containing precursor active pharmaceutical ingredients, radioactive medicinal products, toxic medicinal products, and medicinal products on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields, made using Form No. 03 in Appendix II to this Decree, and send it to the report-receiving authority as prescribed in Article 124 of this Decree;

c) Before July 15 and January 15 of each year, the establishment shall prepare a semi-annual and annual report on the export, import, inventory, and use of habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, combination medicinal products containing precursor active pharmaceutical ingredients, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients, made using Forms No. 04 and 05 in Appendix II to this Decree, and send it to the report-receiving authority as prescribed in Article 124 of this Decree;

d) Before January 15 of each year, the establishment must prepare a periodic report on the export, import, inventory, and use of radioactive medicinal products, medicinal materials that are radioactive substances, toxic medicinal products, toxic medicinal materials, and medicinal products and active pharmaceutical ingredients on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields, made using Form No. 04 in Appendix II to this Decree, and send it to the report-receiving authority as prescribed in Article 124 of this Decree.

2. For wholesaling establishments, retailing establishments, and establishments organizing pharmacy chains:

a) Before July 15 and January 15 of each year, the wholesaling establishment, retailing establishment, or establishment organizing a pharmacy chain shall submit a semi-annual and annual report, respectively, on the export, import, inventory, and use of habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients, made using Form No. 06 in Appendix II to this Decree, to the provincial-level People's Committee of the locality where the establishment is headquartered;

b) Before January 15 of each year, the wholesaling establishment shall prepare a report on the export, import, and inventory of radioactive medicinal products, toxic medicinal products, toxic medicinal materials, and medicinal products and active pharmaceutical ingredients on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields, made using Form No. 06 in Appendix II to this Decree; the retailing establishment or establishment organizing a pharmacy chain shall submit an annual report on the export, import, and inventory of radioactive medicinal products, made using Form No. 06 in Appendix II to this Decree, to the provincial-level People's Committee of the locality where the establishment is headquartered.

3. For provincial-level People's Committees:

a) Before January 30 of each year, the provincial-level People's Committee shall send reports to the Ministry of Health on the lists of establishments wholesaling and retailing habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and combination medicinal products containing precursor active pharmaceutical ingredients in their respective provincial localities, made using Form No. 08 in Appendix II to this Decree;

b) Before the 15^th day of the first month of each quarter, the provincial-level People's Committees shall send reports to the Ministry of Health on the import and export of habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients by establishments in their respective provincial localities, made using Form No. 09 in Appendix II to this Decree.

4. In case of detecting mistakes or loss of radioactive medicinal products, habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products; medicinal materials that are radioactive substances, habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients, the pharmaceutical business shall prepare a report and send it to the provincial-level People's Committee of the locality where the establishment is headquartered within 48 hours from the time of detection, made using Form No. 07 in Appendix II to this Decree.

5. In cases where an establishment trading in or using medicinal products subject to special control fails to comply with the reporting regime as prescribed in Clauses 1, 2, and 4 of this Article, the receipt and consideration of its dossiers of application for purchase, export, or import of medicinal products and medicinal materials shall be suspended until the establishment fully complies with the reporting regulations.

Article 36. Regulations on destruction of medicinal products subject to special control

1. In cases where there is a need to destroy habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients, the establishment shall destroy the medicinal products and medicinal materials as follows:

a) At least 07 working days before the destruction, the establishment must send a written notice of the destruction time, enclosed with a list of the medicinal products and medicinal materials to be destroyed, to the competent authority prescribed in Clause 2 of this Article. The head of the establishment shall form a Destruction Council. The Council shall consist of at least 03 members, including the person professionally responsible for pharmacy of the establishment. The Destruction Council is responsible for organizing the destruction of the medicinal products, deciding on the destruction method, and supervising the destruction of the medicinal products by the establishment;

b) The destruction of medicinal products and medicinal materials must be witnessed by a representative of the competent authority prescribed in Clause 2 of this Article and a written record must be made using Form No. 10 in Appendix II to this Decree. The establishment is responsible for ensuring that the destruction of medicinal products and medicinal materials does not result in loss or residual active pharmaceutical ingredients in the products after destruction, and for complying with the law regulations on environmental protection during the destruction;

c) Within 07 working days from the end of the destruction of medicinal products and medicinal materials, the establishment must send the written record of destruction to the competent authority prescribed in Clause 2 of this Article.

2. Competence to receive notices of the destruction of habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients:

a) The Ministry of National Defence and the Ministry of Public Security, for establishments under their management, except for pharmaceutical businesses;

b) The provincial-level People's Committee of the locality where the business location of the pharmaceutical business is located, for pharmaceutical businesses, including those under the management of the Ministry of Public Security and the Ministry of National Defence;

c) The provincial-level People's Committee of the locality where the establishment is headquartered, for the establishments not prescribed at Points a and b of this Clause.

3. Unused radioactive medicinal products; medicinal materials that are radioactive substances; and packaging that has been in direct contact with radioactive medicinal products or medicinal materials that are radioactive substances must be stored, archived, and handled in accordance with the law on atomic energy.

4. Waste originating from radioactive medicinal products and medicinal materials that are radioactive substances must be managed in accordance with the law on atomic energy.

5. In cases where there is a need to destroy surplus products and waste products containing habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, and precursor active pharmaceutical ingredients during the manufacturing process; combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, combination medicinal products containing precursor active pharmaceutical ingredients; packaging that has been in direct contact with habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, and precursor active pharmaceutical ingredients that are no longer in use; toxic medicinal products, toxic medicinal materials, and medicinal products and active pharmaceutical ingredients on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields, the establishment shall proceed as follows:

a) The establishment must collect all types of surplus products, waste products, medicinal products, medicinal materials, and packaging that has been in direct contact with the medicinal products and store them in a segregated area as prescribed, and shall be responsible for security to ensure no loss during storage;

b) The head of the establishment shall form a Destruction Council consisting of at least 03 members, including the person professionally responsible for pharmacy of the establishment. The Destruction Council is responsible for organizing the destruction of the medicinal products, deciding on the destruction method, supervising the destruction of the medicinal products by the establishment, and keeping the destruction records at the establishment;

c) The establishment must ensure compliance with the law regulations on environmental protection during the destruction.

6. For habit-forming medicinal products, psychotropic medicinal products, and precursor medicinal products in liquid form where the smallest packaging unit has not been fully used and needs to be destroyed, the establishment shall prepare a written record of the condition of the medicinal products at the time of receipt and store them in a segregated area as prescribed, and shall be responsible for security to ensure no loss during storage. When destroying the medicinal products, the Destruction Council shall record the actual condition at the time of destruction and carry out the destruction in accordance with Clauses 1 and 2 or Clause 5 of this Article.

Article 37. Sequence and procedures for permitting the business of medicinal products subject to special control

1. For an establishment that submits a dossier of application for a Certificate of Eligibility for Pharmaceutical Business as prescribed in Article 20 of this Decree and also applies for permission to trade in medicinal products subject to special control, it must submit the following additional documents:

a) A document explaining that the establishment meets the security measures to ensure no loss of medicinal products subject to special control, made using Form No. 11 in Appendix II to this Decree;

b) A list of medicinal products and the compounding procedures for such medicinal products, for a retailing establishment that is a pharmacy, if it organizes the compounding of medicinal products subject to special control according to prescriptions;

c) The dossier quantity prescribed in this Clause is 01 dossier.

2. In cases where an establishment has been granted a Certificate of Eligibility for Pharmaceutical Business and applies for permission to trade in medicinal products subject to special control, it must submit a dossier as prescribed in Clause 1 of this Article.

3. Sequence and procedures for permitting the business of medicinal products subject to special control:

a) In cases prescribed in Clause 1 of this Article, the permission shall be granted in accordance with the sequence and procedures for issuing a Certificate of Eligibility for Pharmaceutical Business as prescribed in Article 21 of this Decree;

b) In cases prescribed in Clause 2 of this Article, the permission shall be granted in accordance with the sequence and procedures for modifying a Certificate of Eligibility for Pharmaceutical Business as prescribed in Article 22 of this Decree.

Article 38. Dossier of application for purchase of habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, combination medicinal products containing precursor active pharmaceutical ingredients, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, and precursor active pharmaceutical ingredients; dossier of application for transfer of medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, and precursor active pharmaceutical ingredients

1. A dossier of application for purchase of habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and combination medicinal products containing precursor active pharmaceutical ingredients shall comprise the following documents:

a) 03 originals of the Purchase Order for habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and combination medicinal products containing precursor active pharmaceutical ingredients, made using Form No. 12 in Appendix II, enclosed with an Import - Export - Inventory Report for medicinal products, made using Form No. 13 in Appendix II to this Decree;

b) A written explanation of the reasons when the total quantity of medicinal products ordered for purchase and the inventory quantity exceed 150% of the total trading and use demand in the reporting period; for a pharmaceutical business, there must be documents proving the approved bidding results or a sales contract or a framework agreement, which must be enclosed with a purchase order clearly stating the name and quantity of the medicinal product. An establishment purchasing medicinal products for the first time must have a projected plan for trading in the medicinal products ordered for purchase.

2. A dossier of application for purchase of medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, and precursor active pharmaceutical ingredients shall comprise the following documents:

a) 01 original of the Purchase Order for medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, and precursor active pharmaceutical ingredients, made using Form No. 12 in Appendix II to this Decree;

b) A report on the use of medicinal materials, made using Form No. 05 in Appendix II to this Decree;

c) An Import - Export - Inventory Report for medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, and precursor active pharmaceutical ingredients, made using Form No. 13 in Appendix II to this Decree;

d) A plan for the use of the materials ordered for purchase;

dd) A written explanation of the reasons when the total quantity of medicinal materials ordered for purchase and the inventory quantity exceed 150% of the total trading and use demand in the reporting period; for a pharmaceutical business, there must be documents proving the approved bidding results or a sales contract or a framework agreement, which must be enclosed with a purchase order clearly stating the name and quantity of the medicinal product to ensure correspondence with the quantity of materials ordered for purchase. An establishment purchasing materials for the first time must have a projected plan for trading in the medicinal product to be manufactured from the materials ordered for purchase.

3. A dossier of application for transfer of medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, and precursor active pharmaceutical ingredients shall comprise the following documents:

a) An application for transfer of medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, and precursor active pharmaceutical ingredients from the transferring establishment, made using Form No. 14 in Appendix II to this Decree, enclosed with the material use plan of the establishment that is the transferee;

b) 01 original of the Purchase Order for transfer of medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, and precursor active pharmaceutical ingredients, made using Form No. 12 in Appendix II to this Decree;

c) A report on the use of medicinal materials, made using Form No. 05, and an Import - Export - Inventory Report for materials, made using Form No. 13 in Appendix II to this Decree.

4. The dossier quantity prescribed in Clauses 1, 2, and 3 of this Article is 01 dossier.

Article 39. Sequence and procedures for permitting the purchase of habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, combination medicinal products containing precursor active pharmaceutical ingredients, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, and precursor active pharmaceutical ingredients; transfer of medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, and precursor active pharmaceutical ingredients

1. An establishment applying for the purchase of medicinal products, medicinal materials, or the transfer of medicinal materials shall submit a dossier either directly, via postal service, or online to:

a) The Ministry of Health, if it is a dossier of purchase or transfer of medicinal materials of establishments;

b) The Ministry of National Defence, if it is a dossier of purchase of medicinal products by establishments under the Ministry of National Defence, except for pharmaceutical businesses;

c) The Ministry of Public Security, if it is a dossier of purchase of medicinal products by an establishment under the Ministry of Public Security, except for pharmaceutical businesses;

d) The provincial-level People's Committee of the locality where the establishment's business location is located, if it is a dossier of purchase of medicinal products by a pharmaceutical business, including those under the management of the Ministry of Public Security and the Ministry of National Defence;

dd) The provincial-level People's Committee of the locality where the establishment is headquartered, if it is a dossier of purchase of medicinal products by an establishment not prescribed at Points b, c, and d of this Clause.

2. The dossier-receiving authority shall issue the applying establishment a Dossier Receipt Note for the application for approval of purchase of medicinal products or the dossier of application for approval of purchase of medicinal materials or the dossier of application for transfer of medicinal materials, made using Form No. 01 in Appendix I to this Decree.

3. In cases where no amendment or supplementation to the dossier is required, the dossier-receiving authority shall approve the Purchase Order or grant written permission to the establishment purchasing or transferring the materials within 30 days from the date stated on the Dossier Receipt Note.

4. In cases where amendment or supplementation to the purchase or transfer dossier is required, the dossier-receiving authority shall send a written notice made using Form No. 16 in Appendix I to this Decree to the applying establishment within 30 days from the date stated on the Dossier Receipt Note, specifying the documents and details to be amended or supplemented.

5. After the establishment submits the amended or supplemented dossier, the dossier-receiving authority shall issue the establishment a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree.

a) In cases where the amended or supplemented dossier is unsatisfactory, within 30 days from the date stated on the Dossier Receipt Note, the dossier-receiving authority shall send a written response refusing to approve the Purchase Order and stating the reasons, made using Form No. 16 in Appendix I to this Decree;

b) In cases where no amendment or supplementation to the amended or supplemented dossier is required, the dossier-receiving authority shall approve the Purchase Order or grant written permission to the establishment purchasing or transferring the materials as prescribed in Clause 3 of this Article.

6. Within 06 months from the date the dossier-receiving authority sends a written notice of amendment or supplementation, the applying establishment must submit the amended or supplemented dossier as required. After this period, if the establishment fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid.

Article 40. Sequence and procedures for permitting the business of medicinal products on the list of medicinal products restricted from retail

1. For an establishment submitting a dossier of application for a Certificate of Eligibility for Pharmaceutical Business with the scope of medicinal product retailing that includes a request for permission to trade in medicinal products on the list of medicinal products restricted from retail:

a) The establishment shall submit a dossier as prescribed in Article 20 of this Decree, and the application for a Certificate of Eligibility for Pharmaceutical Business must include a section requesting permission to trade in medicinal products on the list of medicinal products restricted from retail;

b) The permission to trade in medicinal products on the list of medicinal products restricted from retail shall follow the sequence and procedures for issuance of a Certificate of Eligibility for Pharmaceutical Business as prescribed in Article 21 of this Decree.

2. For an establishment that has been issued with a Certificate of Eligibility for Pharmaceutical Business with the scope of medicinal product retailing and requests permission to trade in medicinal products on the list of medicinal products restricted from retail:

a) The establishment shall submit 01 original of the application for modification of the Certificate of Eligibility for Pharmaceutical Business, made using Form No. 12 in Appendix I to this Decree, and the application must include a section requesting permission to trade in medicinal products on the list of medicinal products restricted from retail;

b) The permission to trade in medicinal products on the list of medicinal products restricted from retail shall follow the sequence and procedures for modification of a Certificate of Eligibility for Pharmaceutical Business as prescribed in Article 22 of this Decree.

 

Section 5

PHARMACEUTICAL E-COMMERCE BUSINESS

 

Article 41. Regulations on the uploading of information when conducting pharmaceutical e-commerce business

1. An establishment conducting pharmaceutical e-commerce business must upload the following information in full:

a) Information about the Certificate of Eligibility for Pharmaceutical Business, including the name of the business establishment, the address of the business location, the Certificate number, the date of issuance, and the issuing authority;

b) Information about the Pharmacy Practising Certificate of the person professionally responsible for pharmacy of the establishment, including the full name of the person professionally responsible, the Pharmacy Practising Certificate number, the date of issuance, and the issuing authority;

c) Information about the medicinal product, including the name of the medicinal product, the reference number of the marketing authorization or the import license; the ingredient(s), concentration, strength or amount of active pharmaceutical ingredients or herbal medicinal materials of the medicinal product; the dosage form; the packaging specifications; the expiry date of the medicinal product; the name of the manufacturing establishment; the country of manufacture; the use or effect, indications, contraindications, dosage, route of administration, and matters to be noted during the use of the medicinal product; and an actual image of the product.

2. Regulations on the uploading of information:

a) The information prescribed at Points a and b, Clause 1 of this Article must be uploaded on the e-commerce application, the e-commerce website, or the storefront of the pharmaceutical business on an e-commerce platform;

b) The information about medicinal products prescribed at Point c, Clause 1 of this Article must be uploaded in a separate section and must not be mixed with information of other products that are not medicinal products;

c) The information and images uploaded in accordance with Clause 1 of this Article must be displayed fully, clearly, and in a position that is easy to see and read;

d) For an establishment organizing a pharmacy chain, the details prescribed in Clause 1 of this Article must include information of both the establishment organizing the pharmacy chain and the pharmacies in the chain that participate in e-commerce business;

dd) The pharmaceutical business shall be responsible for the accuracy and legality of the uploaded information and images.

Article 42. Other regulations when conducting pharmaceutical e-commerce business

1. An establishment selling medicinal products and medicinal materials is responsible for providing its Certificate of Eligibility for Pharmaceutical Business and information on the marketing authorization or import license of the medicinal products and medicinal materials to the trader or organization providing the e-commerce platform service for inspection and supervision before registering to use the service on the trading platform.

2. The information printed on the packaging of goods delivered to customers in the case of retailing medicinal products via e-commerce must include the name, address, and phone number of the customer and the phone number of the consultant.

3. The information printed on the packaging of goods delivered to customers who are pharmaceutical businesses wholesaling medicinal products and medicinal materials via e-commerce must include the reference numbers and dates of issuance of the Certificates of Eligibility for Pharmaceutical Business of the wholesaling establishments.

 

Chapter IV

EXPORT AND IMPORT OF MEDICINAL PRODUCTS AND MEDICINAL MATERIALS

 

Section 1

EXPORT OF MEDICINAL PRODUCTS SUBJECT TO SPECIAL CONTROL, AND HERBAL MEDICINAL MATERIALS ON THE LIST OF PRECIOUS, RARE, AND ENDEMIC HERB SPECIES AND VARIETIES SUBJECT TO CONTROL

 

Article 43. Criteria and dossier of application for a license to export habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, combination medicinal products containing precursor active pharmaceutical ingredients, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients

1. A license to export the medicinal product shall only be issued when it meets one of the following criteria:

a) It is manufactured in Vietnam, is granted a marketing authorization in Vietnam, and is permitted by the competent regulatory authority of the importing country to be imported;

b) It is manufactured abroad, is granted a marketing authorization in Vietnam, and is permitted by the competent regulatory authority of the importing country to be imported.

2. A license to export the medicinal material shall only be issued when it meets one of the following criteria:

a) It is manufactured in Vietnam, is granted a marketing authorization in Vietnam or not, and is permitted by the competent regulatory authority of the importing country to be imported;

b) It is manufactured abroad, is granted a marketing authorization in Vietnam, and is permitted by the competent regulatory authority of the importing country to be imported.

3. A dossier of application for an export license shall comprise:

a) 01 original of the Export Order made using Form No. 01 or 02 in Appendix III to this Decree;

b) A report on the quantity and origin of the medicinal product or medicinal material, made using Form No. 03 in Appendix III to this Decree;

c) The original of the valid license to import the medicinal product or medicinal material issued by the competent regulatory authority of the importing country. In cases where the import license is not in Vietnamese or English, a translation of the license into Vietnamese or English must be submitted, and the translator's signature must be authenticated as prescribed. In cases where the importing country does not require a license to import the medicinal product or medicinal material, the establishment applying for an export license shall provide a document from the competent regulatory authority confirming the regulation of the host country regarding the non-requirement of an import license.

The import license and the confirmation document must be granted a consular legalization as prescribed by the law on consular legalization, unless exempted by law.

4. The dossier quantity prescribed in this Article is 01 dossier.

Article 44. Criteria and dossier of application for a license to export radioactive medicinal products, medicinal materials that are radioactive substances; medicinal products and active pharmaceutical ingredients on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields; toxic medicinal products and toxic medicinal materials

1. A license to export the medicinal product or medicinal material shall only be issued when it meets one of the following criteria:

a) They are manufactured in Vietnam, are granted or not granted marketing authorizations in Vietnam;

b) They are manufactured abroad and are granted marketing authorizations in Vietnam.

2. A dossier of application for an export license shall comprise:

03 originals of the Export Order made using Form No. 04 or 05 in Appendix III to this Decree.

3. The dossier quantity prescribed in this Article is 01 dossier.

Article 45. Criteria and dossier of application for a license to export herbal medicinal materials on the list of precious, rare, and endemic herb species and varieties subject to control

1. Licenses to export herbal medicinal materials on the list of precious, rare, and endemic herb species and varieties subject to control shall only be issued when they are not naturally exploited herbal medicinal materials and are not on the list of herbal medicinal materials banned from export announced by the Minister of Health. In case of export for non-commercial purposes, the law regulations on biodiversity shall apply.

2. A dossier of application for an export license shall comprise:

a) 03 originals of the Export Order made using Form No. 06 in Appendix III to this Decree;

b) A certified true copy of the written confirmation from the commune-level People's Committee regarding the origin of the cultivated herbal medicinal materials, or a copy bearing the seal of the exporting establishment. In case of a copy bearing the establishment's seal, the original must be presented for collation when submitting the dossier;

c) A certified true copy or a copy bearing the seal of the exporting establishment of the contract for the purchase of the herbal medicinal materials. In case of a copy bearing the establishment's seal, the original must be presented for collation when submitting the dossier;

d) In case of export for non-commercial purposes, the documents prescribed at Points b and c of this Clause are not required.

3. The dossier quantity prescribed in this Article is 01 dossier.

Article 46. Regulations on the issuance of licenses to export medicinal products subject to special control for non-commercial purposes

1. Medicinal products subject to special control to be exported for non-commercial purposes must be granted marketing authorizations in Vietnam and fall under one of the following cases:

a) They are part of the personal baggage of an organization or individual exiting the country, sent under a bill of lading, or goods carried by an organization or individual exiting the country for the treatment of the exiting person's illness and are not medicinal materials subject to special control;

b) They are exported for aid or humanitarian aid;

c) Import licenses are issued for them for humanitarian medical examination and treatment but they were not fully used.

2. A license must be obtained before exporting the medicinal product, unless the medicinal product is prescribed at Point a, Clause 1 of this Article and the quantity does not exceed:

a) A 07-day supply for habit-forming medicinal products, according to the dosage stated in the enclosed prescription;

b) A 10-day supply for psychotropic medicinal products and precursor medicinal products, according to the dosage stated in the enclosed prescription;

c) A 30-day supply for combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, combination medicinal products containing precursor active pharmaceutical ingredients, toxic medicinal products, and medicinal products on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields, according to the dosage stated in the enclosed prescription.

3. A dossier of application for a license to export a medicinal product prescribed at Point a, Clause 1 of this Article shall comprise:

a) An application for export of the medicinal product, made using Form No. 07 in Appendix III to this Decree;

b) A certified true copy of the prescription or outpatient treatment record, or a copy signed by the applicant or stamped by the applying organization. These documents must contain the following information: The patient's name and age; the name of the medicinal product, its strength or concentration and volume; the quantity of the medicinal product (or the number of days of use); the dosage; the full name and signature of the doctor; and the address of the hospital or clinic where the physician practices.

In case of a copy signed by the applicant or stamped by the applying organization, the original must be presented for collation when submitting the dossier;

c) If a document prescribed at Point b of this Clause are not in Vietnamese or English, a translation of such document into Vietnamese or English must be submitted, and the translator's signature must be authenticated as prescribed.

4. A dossier of application for a license to export a medicinal product prescribed at Point b, Clause 1 of this Article shall comprise:

a) 03 originals of the Order made using Form No. 01 or 04 in Appendix III to this Decree;

b) The original or a certified true copy of the written approval for the use of the medicinal product for aid or humanitarian aid, issued by the competent regulatory authority of the importing country;

c) The original of the valid license to import the medicinal product issued by the competent regulatory authority in the importing country for habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients;

d) If a document prescribed at Points b and c of this Clause are not in Vietnamese or English, a translation into Vietnamese or English must be submitted, and the translator's signature must be authenticated as prescribed. The documents must be granted a consular legalization as prescribed by the law on consular legalization, unless exempted by law.

5. A dossier of application for a license to export a medicinal product prescribed at Point c, Clause 1 of this Article shall comprise:

a) 03 originals of the Order made using Form No. 01 or 04 in Appendix III to this Decree;

b) A report on the quantity of medicinal products used for humanitarian medical examination and treatment, made using Form No. 08 in Appendix III to this Decree.

6. The dossier quantity prescribed in Clauses 3, 4, and 5 of this Article is 01 dossier.

Article 47. Criteria and dossier of application for a license to export medicinal products subject to special control for display at exhibitions and fairs

1. Licenses to export habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, precursor active pharmaceutical ingredients, combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients shall only be issued when they meet one of the following criteria:

a) They are manufactured in Vietnam, are granted or not granted marketing authorizations in Vietnam, and subject to import licenses issued by the competent regulatory authorities of the importing countries;

b) They are manufactured abroad, are granted marketing authorizations in Vietnam, and subject to import licenses issued by the competent regulatory authorities of the importing countries.

2. A dossier of application for a license to export habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, precursor active pharmaceutical ingredients, combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients:

a) 01 original of the Export Order made using Form No. 01 or 02 in Appendix III to this Decree;

b) The original of the valid license to import the medicinal product or medicinal material issued by the competent regulatory authority of the importing country. In cases where the import license is not in Vietnamese or English, a translation of the license into Vietnamese or English must be submitted, and the translator's signature must be authenticated as prescribed. In cases where the importing country does not require a license to import the medicinal product or medicinal material, the establishment applying for an export license shall provide a document from the competent regulatory authority confirming the regulation of the host country regarding the non-requirement of an import license.

The import license and the confirmation document must be granted a consular legalization as prescribed by the law on consular legalization, unless exempted by law;

c) The dossier quantity prescribed in this Clause is 01 dossier.

3. The export of radioactive medicinal products, medicinal materials that are radioactive substances; toxic medicinal products, toxic medicinal materials; and medicinal products and active pharmaceutical ingredients on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields for display at exhibitions and fairs shall comply with the law regulations on temporary export and re-import of goods.

Article 48. Criteria and dossier of application for a license to export medicinal products subject to special control for the purpose of clinical trial, bioequivalence trial, bioavailability assessment, testing sample, scientific research, or registration sample

1. Licenses to export habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, precursor active pharmaceutical ingredients, combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients shall only be issued when they meet one of the following criteria:

a) They are manufactured in Vietnam, are granted or not granted marketing authorizations in Vietnam, and subject to import licenses issued by the competent regulatory authorities of the importing countries;

b) They are manufactured abroad, have been granted marketing authorizations in Vietnam, and subject to import licenses issued by the competent regulatory authorities of the importing countries.

2. A dossier of application for a license to export habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, precursor active pharmaceutical ingredients, combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients:

a) 01 original of the Export Order made using Form No. 01 or 02 in Appendix III to this Decree;

b) The original of the valid license to import the medicinal product or medicinal material issued by the competent regulatory authority of the importing country. In cases where the import license is not in Vietnamese or English, a translation of the license into Vietnamese or English must be submitted, and the translator's signature must be authenticated as prescribed. In cases where the importing country does not require a license to import the medicinal product or medicinal material, the establishment applying for an export license shall provide a document from the competent regulatory authority confirming the regulation of the host country regarding the non-requirement of an import license.

The import license and the confirmation document must be granted a consular legalization as prescribed by the law on consular legalization, unless exempted by law;

c) The dossier quantity prescribed in this Clause is 01 dossier.

3. Licenses to export radioactive medicinal products, medicinal materials that are radioactive substances; toxic medicinal products, toxic medicinal materials; and medicinal products and active pharmaceutical ingredients on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields shall only be issued when they meet one of the following criteria:

a) They are manufactured in Vietnam, are granted or not granted marketing authorizations in Vietnam;

b) They are manufactured abroad and are granted marketing authorizations in Vietnam.

4. A dossier of application for a license to export radioactive medicinal products, medicinal materials that are radioactive substances; toxic medicinal products, toxic medicinal materials; and medicinal products and active pharmaceutical ingredients on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields: 01 original of the Export Order made using Form No. 04 or 05 in Appendix III to this Decree.

Article 49. Procedures and time limits for issuance of licenses to export medicinal products subject to special control, and herbal medicinal materials on the list of precious, rare, and endemic herb species and varieties subject to control

1. Procedures and time limits for issuance of licenses to export medicinal products subject to special control, and herbal medicinal materials on the list of precious, rare, and endemic herb species and varieties subject to control, as prescribed in Articles 43, 44, 45, Points b and c, Clause 1, Article 46, Clause 1, Article 47, and Article 48 of this Decree:

a) An establishment applying for an export license shall submit a dossier either directly, via postal service, or online to the Ministry of Health or the provincial-level People's Committee of the locality where the establishment is headquartered, according to the roadmap prescribed in Article 123 of this Decree.

In cases where the establishment submits the dossier prescribed in Articles 43, 46, 47, and 48 of this Decree online, the original license to import the medicinal product or medicinal material must be submitted separately via postal service or directly to the competent authority.

b) After receiving the dossier, the dossier-receiving authority shall issue the applying establishment a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree;

c) In cases where no amendment or supplementation to the dossier is required, the dossier-receiving authority shall issue an export license within 07 working days from the date stated on the Dossier Receipt Note;

d) In cases where amendment or supplementation to the dossier is required, the dossier-receiving authority shall send a written response made using Form No. 16 in Appendix I to this Decree to request amendment or supplementation to the dossier within 07 working days from the date stated on the Dossier Receipt Note;

dd) After receiving the amended or supplemented dossier, the dossier-receiving authority shall issue the establishment a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree. In cases where the amended or supplemented dossier is unsatisfactory, the dossier-receiving authority shall send a written response stating the reasons for not issuing the export license, made using Form No. 16 in Appendix I to this Decree, within 07 working days from the date stated on the Dossier Receipt Note. In cases where no amendment or supplementation to the amended or supplemented dossier is required, the dossier-receiving authority shall issue an export license as prescribed at Point c of this Clause;

e) Within 06 months from the date the dossier-receiving authority sends a written notice of amendment or supplementation, the establishment applying for an export license must submit the amended or supplemented dossier as required. After this period, if the establishment fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid.

2. Procedures and time limits for issuance of licenses to export medicinal products prescribed at Point a, Clause 1, Article 46 of this Decree:

a) An organization or individual applying for an export license shall submit a dossier either directly, via postal service, or online to the provincial-level People's Committee at the border gate where the exit procedures are carried out, or where the patient resides or is legally temporarily residing, or where the organization is headquartered;

b) After receiving the dossier, the provincial-level People's Committee shall issue the applicant a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree;

c) In cases where no amendment or supplementation to the dossier is required, the provincial-level People's Committee shall issue an export license within 07 working days from the date stated on the Dossier Receipt Note;

d) In cases where amendment or supplementation to the dossier is required, the provincial-level People's Committee shall send a written response made using Form No. 16 in Appendix I to this Decree to request amendment or supplementation to the dossier within 05 working days from the date stated on the Dossier Receipt Note;

dd) After receiving the amended or supplemented dossier, the provincial-level People's Committee shall issue the organization or individual a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree. In cases where the amended or supplemented dossier is unsatisfactory, the provincial-level People's Committee shall send a written response stating the reasons for not issuing the export license, made using Form No. 16 in Appendix I to this Decree, within 05 working days from the date stated on the Dossier Receipt Note. In cases where no amendment or supplementation to the amended or supplemented dossier is required, the provincial-level People's Committee shall issue an export license as prescribed at Point c of this Clause;

e) Within 03 months from the date the provincial-level People's Committee sends a written notice of amendment or supplementation, the organization or individual applying for an export license must submit the amended or supplemented dossier as required. After this time limit, if the organization or individual fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid.

3. Within 03 working days from the date of issuance of a license, the issuing authority is responsible for publicly announcing information related to the herbal medicinal material, for which the export license has been issued, on the list of precious, rare, and endemic herb species and varieties subject to control on its electronic portal.

4. The templates of export licenses are prescribed in Forms No. 09, 10, 11, 12, and 13 in Appendix III to this Decree.

Article 50. Management of the export of medicinal products and medicinal materials

1. A license to export habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, combination medicinal products containing precursor active pharmaceutical ingredients, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients shall be issued for each export shipment; the quantity of medicinal products and medicinal materials for which the export license is issued shall not exceed the quantity stated in the import license issued by the competent regulatory authority of the importing country. In cases where the host country confirms that the import of the medicinal product or medicinal material does not require a license, the quantity for which the export license is issued shall be based on the demand of the exporting establishment.

2. A license to export herbal medicinal materials on the list of precious, rare, and endemic herb species and varieties subject to control shall be issued for each export shipment.

3. Habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, radioactive medicinal products, herbal medicinal materials that are radioactive substances, combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, combination medicinal products containing precursor active pharmaceutical ingredients, herbal medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, precursor active pharmaceutical ingredients, and herbal medicinal materials on the list of precious, rare, and endemic herb species and varieties subject to control may only be exported through international border gates, except for the medicinal products prescribed at Point a, Clause 1, Article 46 of this Decree.

4. An establishment manufacturing habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients may export the medicinal products and medicinal materials it manufactures.

5. An establishment exporting or importing habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients may export the medicinal products and medicinal materials it trades.

6. An individual or organization applying to export medicinal products subject to special control for non-commercial purposes as prescribed at Point a, Clause 1, Article 46 of this Decree shall be responsible for the origin, quality, safety, and efficacy of the exported medicinal products and for meeting the regulations of the importing countries.

7. An exporting establishment is responsible for re-importing all habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, precursor active pharmaceutical ingredients, combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, and combination medicinal products containing precursor active pharmaceutical ingredients that were temporarily exported for display at exhibitions and fairs.

 

Section 2

IMPORT OF MEDICINAL PRODUCTS WITHOUT ANY MARKETING AUTHORIZATION IN VIETNAM

 

Article 51. Criteria and dossier of application for a license to import medicinal products containing active pharmaceutical ingredients without marketing authorization, and medicinal products containing herbal medicinal materials used for the first time in Vietnam

1. A license to import the medicinal product shall only be issued when it meets the following criteria:

a) It is granted a marketing authorization in one of the following countries: The country of manufacture or a country that is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) or Australia;

b) The medicinal product falls under one of the following cases:

It is included in the guidelines for diagnosis, prevention, and treatment of diseases issued or approved by the Ministry of Health;

It is a medicinal product used for emergency, detoxification, or anti-rejection purposes;

It is a medicinal product used for the diagnosis, prevention, or treatment of Group A infectious diseases; cancer; HIV/AIDS; viral hepatitis; tuberculosis; malaria; and other diseases as decided by the Minister of Health.

2. A dossier of application for an import license shall comprise:

a) 03 originals of the Import Order made using Form No. 15, 16, or 17 in Appendix III to this Decree;

b) The original or a certified true copy or a copy presented with its original for collation of the Certificate of Pharmaceutical Product;

c) A copy of the quality standards and testing methods of the medicinal product from the manufacturing establishment, bearing the seal of the importing establishment;

d) 01 set of the sample label and package insert/patient information leaflet of the medicinal product as actually placed on the market in the country of manufacture or the exporting country, bearing the confirmation seal of the manufacturing establishment or the product owner or the product license holder (as stated on the Certificate of Pharmaceutical Product) and the importing establishment (a colour printout of the label currently placed on the market in the host country is acceptable);

dd) 02 sets of the label intended for marketing in Vietnam, enclosed with the package insert in Vietnamese, bearing the seal of the importing establishment;

e) Clinical data on safety and efficacy as prescribed in the regulations on medicinal product registration of the Minister of Health, which must include Phase 3 clinical data.

Submission of this document is exempted in cases where the medicinal product has previously been granted an import license under this Article and there is no change in information related to indications, dosage, or user population;

g) A report on the results of trading in the medicinal product in cases where the imported medicinal product is a habit-forming medicinal product, a psychotropic medicinal product, a precursor medicinal product, a combination medicinal product containing a habit-forming active pharmaceutical ingredient, a combination medicinal product containing a psychotropic active pharmaceutical ingredient, or a combination medicinal product containing a precursor active pharmaceutical ingredient, made using Form No. 18 in Appendix III to this Decree;

h) Originals or certified true copies or copies presented with their originals for collation of the Good Manufacturing Practices certificates or manufacturing licenses of all establishments involved in the manufacture of the imported medicinal product. In cases where the competent regulatory authorities have not yet issued such Good Manufacturing Practices certificates or manufacturing licenses, the importing establishment shall submit the originals or certified true copies, or copies presented with their originals for collation of the Good Manufacturing Practices inspection reports of the most recent inspections of all establishments involved in the manufacture of the imported medicinal product.

Submission of these documents is exempted in cases where the manufacturing establishment has been confirmed to meet the principles and standards of Good Manufacturing Practices on the Certificate of Pharmaceutical Product.

3. The dossier quantity prescribed in this Article is 01 dossier.

Article 52. Criteria and dossier of application for a license to import medicinal products containing active pharmaceutical ingredients with marketing authorizations in Vietnam but with insufficient supply to serve treatment needs, and medicinal products containing herbal medicinal materials previously used to make medicinal products in Vietnam but with insufficient supply to serve treatment needs

1. A license to import the medicinal product shall only be issued when it meets the following criteria:

a) It is on the list of medicinal products with insufficient supply to serve treatment needs, announced by the Minister of Health;

b) It is granted a marketing authorization in one of the following countries: The country of manufacture or an ICH member country or Australia.

2. A dossier of application for an import license shall comprise:

a) 03 originals of the Import Order made using Form No. 15, 16, or 17 in Appendix III to this Decree;

b) The original or a certified true copy or a copy presented with its original for collation of the Certificate of Pharmaceutical Product;

c) A quality dossier in accordance with the regulations of the Minister of Health on the application of the ASEAN Common Technical Dossier (ACTD) or the ICH Common Technical Dossier (ICH-CTD) in medicinal product registration, or quality standards and bioequivalence study results as prescribed in Clause 6, Article 61 of this Decree;

d) 01 set of the sample label and package insert/patient information leaflet of the medicinal product as actually placed on the market in the country of manufacture or the exporting country, bearing the confirmation seal of the manufacturing establishment or the product owner or the product license holder (as stated on the Certificate of Pharmaceutical Product) and the importing establishment (a colour printout of the label currently placed on the market in the host country is acceptable);

dd) 02 sets of the label intended for marketing in Vietnam, enclosed with the package insert in Vietnamese, bearing the seal of the importing establishment;

e) A clinical dossier for medicinal products that require a clinical dossier as prescribed by the Minister of Health on medicinal product registration.

Submission of this document is exempted in cases where the medicinal product has previously been granted an import license under this Article and there is no change in information related to indications, dosage, or user population;

g) For traditional medicinal products with a new combination of herbal medicinal materials previously used to make medicinal products in Vietnam, a full clinical dossier proving safety and efficacy as prescribed in Article 89 of the Law on Pharmacy and documents proving the method of processing, preparation, or combination according to the theory of traditional medicine are required;

h) A report on the results of trading in the medicinal product in cases where the imported medicinal product is a habit-forming medicinal product, a psychotropic medicinal product, a precursor medicinal product, a combination medicinal product containing a habit-forming active pharmaceutical ingredient, a combination medicinal product containing a psychotropic active pharmaceutical ingredient, or a combination medicinal product containing a precursor active pharmaceutical ingredient, made using Form No. 18 in Appendix III to this Decree;

i) Originals or certified true copies or copies presented with their originals for collation of the Good Manufacturing Practices certificates or manufacturing licenses of all establishments involved in the manufacture of the imported medicinal product. In cases where the competent regulatory authorities have not yet issued such Good Manufacturing Practices certificates or manufacturing licenses, the importing establishment shall submit the originals or certified true copies, or copies presented with their originals for collation of the Good Manufacturing Practices inspection reports of the most recent inspections of all establishments involved in the manufacture of the imported medicinal product.

Submission of these documents is exempted in cases where the manufacturing establishment has been confirmed to meet the principles and standards of Good Manufacturing Practices on the Certificate of Pharmaceutical Product.

3. The dossier quantity prescribed in this Article is 01 dossier.

Article 53. Criteria and dossier of application for a license to import medicinal products to serve urgent needs for national defence, security, disease prevention and control, and overcoming the consequences of natural disasters and catastrophes

1. A license to import the medicinal product shall only be issued when it meets all following criteria:

a) It has been granted a marketing authorization in at least one country worldwide;

b) It serves the urgent needs for national defence, security, disease prevention and control, and overcoming the consequences of natural disasters and catastrophes.

2. A dossier of application for a license to import a medicinal product to serve urgent needs for national defence and security shall comprise:

a) 03 originals of the Import Order made using Form No. 15, 16, or 17 in Appendix III to this Decree;

b) The original or a certified true copy or a copy presented with its original for collation of the Certificate of Pharmaceutical Product or a confirmation from the competent regulatory authority of the exporting country regarding the marketing of the medicinal product in at least 01 country in the world;

c) The original or a copy bearing the seal of the competent authority of the written request for the import of the medicinal product to serve urgent needs for national defence from the Ministry of National Defence, or the written request for the import of the medicinal product to serve urgent needs for security from the Ministry of Public Security. The written request must specify the following information: The active substance, if it is a chemical medicinal product or biological product, or the names of the herbal medicinal materials, if it is an herbal medicinal product or traditional medicinal product; the dosage form; the concentration or strength of the active substance, if it is a chemical medicinal product or biological product, or the amount of herbal medicinal materials, if it is an herbal medicinal product or traditional medicinal product; the packaging specifications; the manufacturer; and the country of manufacture of the medicinal product.

3. A dossier of application for a license to import a medicinal product to serve urgent needs for disease prevention and control, and overcoming the consequences of natural disasters and catastrophes, unless otherwise prescribed in Clause 4 of this Article shall comprise:

a) 03 originals of the Import Order made using Form No. 15, 16, or 17 in Appendix III to this Decree;

b) The original or a certified true copy or a copy presented with its original for collation of the Certificate of Pharmaceutical Product or a confirmation from the competent regulatory authority of the exporting country regarding the marketing of the medicinal product in at least 01 country in the world;

c) The original of the Power of Attorney from the manufacturing establishment or the marketing authorization holder on the Certificate of Pharmaceutical Product to the establishment requesting the import of the medicinal product in Vietnam, in cases where the establishment requesting the import is not the manufacturing establishment or the marketing authorization holder in the country of manufacture or the exporting country;

d) 01 set of the sample label and package insert/patient information leaflet of the medicinal product as actually placed on the market in the country of manufacture or the exporting country, bearing the confirmation seal of the manufacturing establishment or the product owner or the product license holder (as stated on the Certificate of Pharmaceutical Product) and the importing establishment (a colour printout of the label currently placed on the market in the host country is acceptable);

dd) A quality dossier;

e) A clinical dossier;

g) Originals or certified true copies or copies presented with their originals for collation of the Good Manufacturing Practices certificates or manufacturing licenses of all establishments involved in the manufacture of the imported medicinal product. In cases where the competent regulatory authorities have not yet issued such Good Manufacturing Practices certificates or manufacturing licenses, the importing establishment shall submit the originals or certified true copies, or copies presented with their originals for collation of the Good Manufacturing Practices inspection reports of the most recent inspections of all establishments involved in the manufacture of the imported medicinal product.

Submission of these documents is exempted in cases where the manufacturing establishment has been confirmed to meet the principles and standards of Good Manufacturing Practices on the Certificate of Pharmaceutical Product.

4. A dossier of application for a license to import a medicinal product to serve urgent needs for disease prevention and control, and overcoming the consequences of natural disasters and catastrophes, and which has been approved in writing by the Minister of Health for such urgent needs shall comprise:

a) The dossiers prescribed at Points a and b, Clause 3 of this Article;

b) The original or a copy of the written approval from the Ministry of Health for the urgent need in disease prevention and control, and overcoming the consequences of natural disasters and catastrophes, which must specify the following information: The active substance, if it is a chemical medicinal product or biological product, or the names of the herbal medicinal materials, if it is an herbal medicinal product or traditional medicinal product; the dosage form; the concentration or strength of the active substance, if it is a chemical medicinal product or biological product, or the amount of herbal medicinal materials, if it is an herbal medicinal product or traditional medicinal product; the packaging specifications; the manufacturer; and the country of manufacture of the medicinal product.

5. The dossier quantity prescribed in this Article is 01 dossier.

Article 54. Criteria and dossier of application for a license to import medicinal products to serve special treatment needs

1. A license to import a medicinal product (except for vaccines) shall be issued when it meets the following criteria:

A medicinal product (except for vaccines) is necessary for special treatment needs when there is no medicinal product with the same active substance, concentration, strength, and dosage form that is granted a marketing authorization in Vietnam, or when a medicinal product with a marketing authorization in Vietnam is not sufficiently supplied to serve treatment needs, or when a medicinal product with a marketing authorization in Vietnam has a different therapeutic effect compared to the medicinal product with a marketing authorization in Vietnam, in one of the following cases:

a) It is used for emergency, detoxification, or anti-rejection purposes, or is on the list of orphan medicinal products;

b) It is included in the guidelines for the prevention and management of anaphylactic shock issued or approved by the Ministry of Health;

c) It is used for a specific patient undergoing treatment at a medical examination and treatment establishment for the diagnosis, prevention, or treatment of Group A infectious diseases; cancer; HIV/AIDS; tuberculosis; malaria; or other serious diseases as decided by the Minister of Health;

d) It is used to treat diseases on the list of rare diseases issued by the Minister of Health.

2. A license to import a vaccine shall be issued when it meets the following criterion: the vaccine is necessary for the vaccination needs of people traveling to countries or territories where a disease not present in Vietnam exists, and there is no vaccine of the same type with a marketing authorization in Vietnam.

3. A dossier of application for an import license shall comprise:

a) 03 originals of the Import Order made using Form No. 15, 16, or 17 in Appendix III to this Decree;

b) Documents proving the quality, safety, and efficacy of the vaccine of which the import is requested in the case prescribed in Clause 2 of this Article.

Submission of these documents is exempted in cases where the vaccine has been pre-qualified by the World Health Organization.

Submission of documents proving safety and efficacy is exempted in cases where the vaccine is on the list of orphan medicinal products;

c) The original of the written request from the medical examination and treatment establishment, stating the reason for the import of the medicinal product, the expected number of patients needing the medicinal product, the corresponding demand for the medicinal product, and a commitment to take full responsibility for the use of the imported medicinal product; the original of the written request from the immunization establishment, stating the reason for the import of the vaccine, the expected number of people needing the vaccine, the corresponding demand for the vaccine, and a commitment to take full responsibility for the use of the imported vaccine. The written request must be enclosed with the original or a copy bearing the seal of the medical examination and treatment establishment of the minutes of the meeting of the Medicine and Treatment Council regarding the need for the import of the medicinal product. In cases where the immunization establishment does not have a Medicine and Treatment Council, or in cases where the medicinal product is used for emergency or detoxification purposes and the written request from the medical examination and treatment establishment has clearly listed the patients in need of the medicinal product, the minutes are not required;

d) The list of medicinal products of which the import is requested by the medical examination and treatment establishment or immunization establishment, made using Form No. 19, 20, or 21 in Appendix III to this Decree;

dd) A report from the medical examination and treatment establishment or immunization establishment on the medicinal product of which the import is requested, made using Form No. 22 in Appendix III to this Decree;

e) The original of the Letter of Commitment from the foreign manufacturing establishment and supplying establishment regarding the quality, safety, and efficacy of the vaccine supplied to Vietnam, made using Form No. 23 in Appendix III to this Decree;

g) The establishment supplying the medicinal product is not required to comply with Article 78 of this Decree if it has a certified and granted a consular legalization copy of its pharmaceutical business license issued by the competent authority of the host country.

4. The dossier quantity prescribed in Clause 3 of this Article is 01 dossier.

Article 55. Criteria and dossier of application for a license to import orphan medicinal products

1. A license to import the medicinal product shall only be issued when it meets the following criteria:

a) It is on the list of orphan medicinal products;

b) It has been granted a marketing authorization in at least one country worldwide.

2. A dossier of application for an import license shall comprise:

a) 03 originals of the Import Order made using Form No. 15, 16, or 17 in Appendix III to this Decree;

b) The original or a certified true copy or a copy presented with its original for collation of the Certificate of Pharmaceutical Product;

c) A copy of the quality standards and testing methods of the medicinal product from the manufacturing establishment, bearing the seal of the importing establishment;

d) 01 set of the sample label and package insert/patient information leaflet of the medicinal product as actually placed on the market in the country of manufacture or the exporting country, bearing the confirmation seal of the manufacturing establishment or the product owner or the product license holder (as stated on the Certificate of Pharmaceutical Product) and the importing establishment (a colour printout of the label currently placed on the market in the host country is acceptable);

dd) 02 sets of the label intended for marketing in Vietnam, enclosed with the package insert in Vietnamese, bearing the seal of the importing establishment;

e) A report on the results of trading in the medicinal product in cases where the imported medicinal product is a habit-forming medicinal product, a psychotropic medicinal product, a precursor medicinal product, a combination medicinal product containing a habit-forming active pharmaceutical ingredient, a combination medicinal product containing a psychotropic active pharmaceutical ingredient, or a combination medicinal product containing a precursor active pharmaceutical ingredient, made using Form No. 18 in Appendix III to this Decree;

g) Originals or certified true copies or copies presented with their originals for collation of the Good Manufacturing Practices certificates or manufacturing licenses of all establishments involved in the manufacture of the imported medicinal product. In cases where the competent regulatory authorities have not yet issued such Good Manufacturing Practices certificates or manufacturing licenses, the importing establishment shall submit the originals or certified true copies, or copies presented with their originals for collation of the Good Manufacturing Practices inspection reports of the most recent inspections of all establishments involved in the manufacture of the imported medicinal product.

Submission of these documents is exempted in cases where the manufacturing establishment has been confirmed to meet the principles and standards of Good Manufacturing Practices on the Certificate of Pharmaceutical Product.

3. The dossier quantity prescribed in this Article is 01 dossier.

Article 56. Criteria and dossier of application for a license to import medicinal products with the same brand trade, active substance(s), strength or concentration, and dosage form as a brand-name medicinal product with a marketing authorization in Vietnam, manufactured by the brand-name manufacturer or by an authorized manufacturer, at a lower price than the brand-name medicinal product placed on the market in Vietnam

1. A medicinal product shall only be imported when it meets the following criteria:

a) It complies with Point dd, Clause 2, Article 60 of the Law on Pharmacy;

b) Its proposed wholesale price is at least 20% lower than the successful bid price of the brand-name medicinal product with a marketing authorization in Vietnam;

c) It is granted a marketing authorization in and exported to Vietnam from the country of manufacture or an ICH member country or Australia;

d) It is not a radioactive medicinal product, a vaccine, or a biological product.

2. A dossier of application for an import license shall comprise:

a) 03 originals of the Import Order made using Form No. 15, 16, or 17 in Appendix III to this Decree;

b) Documents proving that the medicinal product is legally placed on the market in the country of manufacture or a reference country;

c) 01 set of the sample label and package insert/patient information leaflet of the medicinal product as actually placed on the market in the country of manufacture or the exporting country, bearing the confirmation seal of the manufacturing establishment or the product owner or the product license holder (as stated on the Certificate of Pharmaceutical Product) and the importing establishment (a colour printout of the label currently placed on the market in the host country is acceptable);

d) 02 sets of the supplementary label, enclosed with the package insert in Vietnamese, bearing the seal of the importing establishment. The details of the Vietnamese package insert must be consistent with the details approved by the Ministry of Health for the brand-name medicinal product with a marketing authorization in Vietnam.

3. The dossier quantity prescribed in this Article is 01 dossier.

Article 57. Criteria and dossier of application for a license to import medicinal products for aid and humanitarian aid

1. A license to import the medicinal product shall only be issued when it meets the following criterion:

The medicinal product is granted a marketing authorization in the country of manufacture or an ICH member country or Australia and falls under one of the following cases:

a) It is an aid medicinal product brought by foreign humanitarian medical examination and treatment missions for their humanitarian medical examination and treatment work;

b) It is an aid medicinal product used for a specific patient undergoing treatment at a medical examination and treatment establishment at the request of the medical examination and treatment establishment;

c) It is an aid medicinal product used for state health programs or state health projects;

d) It is an aid medicinal product not prescribed at Points a, b, and c of this Clause and not a habit-forming medicinal product, radioactive medicinal product, or a vaccine.

2. A dossier of application for an import license shall comprise:

a) 03 originals of the Import Order made using Form No. 24, 25, or 26 in Appendix III to this Decree;

b) The original of the written request from the establishment receiving the aid or humanitarian aid, clearly stating the quantity of each type of aid or humanitarian aid medicinal product and a commitment to use the medicinal product for the right purpose and for the right beneficiaries;

c) The original or a certified true copy of the written approval from the competent state regulatory authority for the receipt of the aid or humanitarian aid, or the original of the written approval from the competent authority for the implementation of the humanitarian medical examination and treatment activity, enclosed with a list of aid medicinal products in case of import as prescribed at Point a, Clause 1 of this Article;

d) The original or a certified true copy or a copy presented with its original for collation of the Certificate of Pharmaceutical Product;

dd) A quality dossier in accordance with the regulations of the Minister of Health on the application of the ASEAN Common Technical Dossier (ACTD) or the ICH Common Technical Dossier (ICH-CTD) in medicinal product registration, or quality standards and bioequivalence study results as prescribed in Clause 6, Article 61 of this Decree;

e) A clinical dossier in cases where a clinical dossier as prescribed by the Minister of Health on medicinal product registration is required.

Submission of this document is exempted in cases where the medicinal product has previously been granted an import license under this Article and there is no change in information related to indications, dosage, or user population;

g) 01 set of the sample label and package insert/patient information leaflet of the medicinal product as actually placed on the market in the country of manufacture or the exporting country, bearing the confirmation seal of the manufacturing establishment or the product owner or the product license holder (as stated on the Certificate of Pharmaceutical Product) and the importing establishment (a colour printout of the label currently placed on the market in the host country is acceptable);

h) 02 sets of the label intended for marketing in Vietnam and the package insert in Vietnamese, bearing the seal of the importing establishment;

i) Originals or certified true copies or copies presented with their originals for collation of the Good Manufacturing Practices certificates or manufacturing licenses of all establishments involved in the manufacture of the imported medicinal product. In cases where the competent regulatory authorities have not yet issued such Good Manufacturing Practices certificates or manufacturing licenses, the importing establishment shall submit the originals or certified true copies, or copies presented with their originals for collation of the Good Manufacturing Practices inspection reports of the most recent inspections of all establishments involved in the manufacture of the imported medicinal product.

Submission of these documents is exempted in cases where the manufacturing establishment has been confirmed to meet the principles and standards of Good Manufacturing Practices on the Certificate of Pharmaceutical Product;

k) The documents prescribed at Points d, dd, e, g, h, and i of this Clause are exempted in case of importing medicinal products prescribed at Points a and b, Clause 1 of this Article, but there must be a written commitment from the establishment receiving the aid that the medicinal product is granted a marketing authorization in the country of manufacture or an ICH member country or Australia, and the written request from the establishment receiving the aid must clearly list the patients in need of the medicinal product in the case prescribed at Point b, Clause 1 of this Article.

3. The dossier quantity prescribed in this Article is 01 dossier.

Article 58. Criteria and dossier of application for a license to import medicinal products for the purpose of clinical trial, bioequivalence trial, bioavailability assessment, testing sample, and scientific research

1. A license to import the medicinal product shall only be issued when it falls under one of the following cases:

a) It is a medicinal product subject to special control used in a clinical trial study with a clinical trial research protocol approved by the Minister of Health as prescribed in Clause 1, Article 94 of the Law on Pharmacy and with full information on the medicinal product of which the import is proposed, including: Name of the medicinal product, name of the active substance, strength, dosage form, packaging specifications, quantity, expiry date, quality standards, indications, name of the manufacturing establishment, and country of manufacture;

b) It is used as a test medicinal product in a bioequivalence trial or bioavailability assessment in Vietnam according to a protocol approved in accordance with Clause 1, Article 100 of the Law on Pharmacy;

c) It is used as a reference medicinal product in a bioequivalence trial. In cases where the reference medicinal product is a new medicinal product, it shall only be used in a study according to a protocol approved in accordance with Clause 1, Article 100 of the Law on Pharmacy;

d) It is used in testing and verification at establishments manufacturing medicinal products or at establishments testing and verifying medicinal products;

dd) Used in scientific research not in the cases prescribed at Points a, b, and c of this Clause.

2. A dossier of application for an import license shall comprise:

a) 03 originals of the Import Order made using Form No. 15, 16, or 17 in Appendix III to this Decree;

b) The original or a certified true copy or a copy presented with its original for collation of the written approval from the competent authority or organization in cases where the medicinal product is prescribed at Points a, b, and dd, Clause 1 of this Article;

c) The original or a certified true copy or a copy presented with its original for collation of the written approval of the bioequivalence trial protocol as prescribed in Article 100 of the Law on Pharmacy in cases where the new medicinal product is prescribed at Point c, Clause 1 of this Article;

d) An explanatory document bearing the seal of the importing establishment regarding the purpose, import quantity, and a commitment to use the medicinal product for the right purpose.

3. The dossier quantity prescribed in this Article is 01 dossier.

Article 59. Criteria and dossier of application for a license to import medicinal products for display at exhibitions and fairs

1. A license to import the medicinal product shall only be issued when it meets all following criteria:

a) It is only used for display at exhibitions and fairs related to medicine, pharmacy, and medical equipment;

b) It is not a habit-forming medicinal product, a psychotropic medicinal product, a precursor medicinal product, or a radioactive medicinal product.

2. A dossier of application for an import license: 03 originals of the Import Order made using Form No. 15, 16, and 17 in Appendix III to this Decree.

3. The dossier quantity prescribed in this Article is 01 dossier.

4. The medicinal products prescribed in this Article must comply with the law regulations on temporary import and re-export of goods.

Article 60. Criteria and dossier of application for a license to import medicinal products for non-commercial purposes as prescribed at Point i, Clause 2, Article 60 of the Law on Pharmacy, except for medicinal products imported by medical examination and treatment establishments for special treatment of their patients

1. A medicinal product shall be imported for non-commercial purposes when it falls under one of the following cases:

a) It is part of the personal baggage of a person entering Vietnam, sent under a bill of lading, or goods carried by a person entering Vietnam for the treatment of his/her own illness;

b) It is not a habit-forming medicinal product, a psychotropic medicinal product, or a precursor medicinal product and is the property of a diplomatic mission, consular post, or representative office of an international organization in Vietnam, or of a diplomatic mission of Vietnam abroad, of the people working at these agencies and organizations, or of organizations introduced by a diplomatic mission of Vietnam or a diplomatic mission of Vietnam abroad.

2. The medicinal product prescribed in Clause 1 of this Article may be imported without an import license when they fall under one of the following cases:

a) The imported quantity does not exceed a maximum of a 07-day supply if it is a habit-forming medicinal product, or a 10-day supply if it is a psychotropic medicinal product or precursor medicinal product, according to the dosage stated in the enclosed prescription;

b) The imported medicinal product is not a habit-forming medicinal product, a psychotropic medicinal product, or a precursor medicinal product, and has a total customs value not exceeding 200 (two hundred) US dollars (calculated at the exchange rate for tax purposes as prescribed by the customs law regulations at the time of customs clearance) per shipment, and the maximum number of shipments received is no more than 03 per year for 01 organization or individual.

In cases where the medicinal product is used for a person with a disease on the list of serious diseases as prescribed in the Government's Decree No. 134/2016/ND-CP dated September 01, 2016, detailing a number of articles, and measures for the implementation, of the Law on Import Duty and Export Duty, the medicinal product has a total customs value not exceeding 10,000,000 (ten million) Vietnamese dong per shipment, and the maximum number of shipments received is no more than 04 per year for 01 individual;

c) The imported medicinal product is not a habit-forming medicinal product, a psychotropic medicinal product, or a precursor medicinal product, and the imported quantity does not exceed a maximum of a 30-day supply according to the dosage stated in the prescription.

3. A dossier of application for an import license shall comprise:

a) An application for import of the medicinal product, made using Form No. 27 in Appendix III to this Decree;

b) A certified true copy or a copy signed by the applicant for an import license of the prescription or outpatient treatment record. These documents must contain the following information: The patient's name and age; the name of the medicinal product, its strength or concentration and volume; the quantity of the medicinal product (or the number of days of use); the dosage; the full name and signature of the doctor; and the address of the hospital or clinic where the physician practices.

In case of submitting a copy signed by the applicant for an import license, the original must be presented for collation when submitting the dossier.

In cases where it is a medicinal product prescribed at Point b, Clause 1 of this Article, the submission of the document prescribed at this Point is not required.

4. The dossier quantity prescribed in this Article is 01 dossier.

Article 61. Specific regulations on documents in the dossier of application for a license to import medicinal products

1. For medicinal products imported in accordance with Articles 51, 52, and 55 of this Decree, a separate Import Order must be made for each imported medicinal product, unless the medicinal products share all of the following factors:

a) Medicinal product name;

b) Dosage form and route of administration;

c) Concentration or strength of the active pharmaceutical ingredient, if they are liquid and semi-solid medicinal products;

d) Medicinal product quality standards;

dd) Medicinal product expiry date;

e) Name and address of the manufacturing establishment.

2. If the documents in the dossier are not in Vietnamese or English, translations of these documents into Vietnamese or English must be submitted, and the translators' signatures must be authenticated as prescribed.

3. The following documents must be granted a consular legalization as prescribed by the law on consular legalization, unless exempted by law:

a) Certificate of Pharmaceutical Product;

b) Certificate of Good Manufacturing Practices if they are medicinal products, or manufacturing license or Good Manufacturing Practices inspection report.

4. A Certificate of Pharmaceutical Product, unless the medicinal product is imported to serve the urgent needs for national defence, security, disease prevention and control, or overcoming the consequences of natural disasters and catastrophes as prescribed in Article 53 of this Decree, must:

a) Comply with Clauses 2, 3, and 5 of this Article;

b) Bear the signature, name, and title of the signatory, the date of issuance, and the seal of the competent state regulatory authority that issued the Certificate of Pharmaceutical Product in the host country;

c) Be fully authenticated regarding the signature, name, and title of the signatory and the seal of the competent state regulatory authority that issued the Certificate of Pharmaceutical Product in the host country by a diplomatic mission, consular post, or other agency authorized to perform consular functions of the host country, unless the Certificate of Pharmaceutical Product is an electronic version without a signature, the name of the signatory, or the confirmation seal of the competent authority that issued the Certificate of Pharmaceutical Product;

d) Be the original when submitted for consular legalization procedures;

dd) Have a confirmation that the medicinal product is granted a marketing authorization in the country that issued the Certificate of Pharmaceutical Product;

e) Clearly state the name, address, and role of each establishment in cases where the manufacture of the medicinal product involves multiple manufacturing establishments;

g) Contain all the information as required by the World Health Organization (WHO) model applicable to the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce;

h) Be acceptable if it is an electronic Certificate of Pharmaceutical Product published on the website or in the English database of the issuing competent authority or of the competent authorities of other countries, or on the website or in the English database operated by a regional pharmaceutical regulatory authority, even in cases where the electronic version does not have a signature, the name of the signatory, or the confirmation seal of the competent authority that issued the Certificate of Pharmaceutical Product.

In cases where the issued Certificate of Pharmaceutical Product is an electronic version, the importing establishment must submit the original or a certified true copy of the Certificate of Pharmaceutical Product, which has been certified by a foreign competent authority and granted a consular legalization as prescribed, or the result of a self-lookup of the Certificate of Pharmaceutical Product, bearing the confirmation seal of the importing establishment, enclosed with a document providing the lookup link to the Ministry of Health.

In cases where the legal papers cannot be looked up, the importing establishment shall submit a document providing the official contact information (phone number, email) of the issuing authority for the Ministry of Health to directly communicate and verify the authenticity of the Certificate of Pharmaceutical Product.

5. Documents with stated validity periods in the dossier must be valid at the time of receipt as stated on the Dossier Receipt Note.

6. Regulations on quality standards, testing methods, and bioequivalence study results:

a) They must be copies bearing the seal of the manufacturing establishment or the product owner or the product license holder (as stated on the Certificate of Pharmaceutical Product) and of the importing establishment;

b) Bioequivalence study results are only required in cases where a report on bioequivalence study data is required as prescribed by the Minister of Health on medicinal product registration.

Submission of this document is exempted in cases where the medicinal product is manufactured and granted a marketing authorization (as stated on the Certificate of Pharmaceutical Product) in a permanent or founding ICH member country or Australia.

Article 62. Competence, procedures, and time limits for issuance of licenses to import medicinal products without marketing authorizations in Vietnam

1. Competence to issue licenses to import medicinal products without marketing authorizations in Vietnam:

a) The Ministry of Health shall issue licenses to import medicinal products in case of import as prescribed in Articles 51, 52, 53, 54, 55, and 56 of this Decree, unless otherwise prescribed by law regulations;

b) The Ministry of Health or the provincial-level People's Committee of the locality where the establishment is headquartered, according to the roadmap prescribed in Article 123 of this Decree, shall issue licenses to import medicinal products in case of import as prescribed in Articles 57, 58, and 59 of this Decree;

c) The provincial-level People's Committee at the border gate where the entry procedures are carried out, or where the patient resides or is legally temporarily residing, or where the organization is headquartered shall issue licenses to import medicinal products in case of import as prescribed in Article 60 of this Decree;

d) The Ministry of Health or the provincial-level People's Committee, exercising its competence to issue licenses to import medicinal products, shall establish a council with the function of advising on the issuance of licenses to import medicinal products to provide advice on the issuance of licenses to import medicinal products as prescribed in Articles 51, 52, Clause 3, Article 53, Article 55, and Points c and d, Clause 1, Article 57 of this Decree.

2. Procedures and time limits for issuance of import licenses in case of importing medicinal products as prescribed in Articles 51, 52, 55, and Points c and d, Clause 1, Article 57 of this Decree:

a) An establishment applying for an import license shall submit a dossier either directly, via postal service, or online to the Ministry of Health in case of importing medicinal products as prescribed in Articles 51, 52, and 55 of this Decree.

An establishment applying for an import license shall submit a dossier either directly, via postal service, or online to the Ministry of Health or the provincial-level People's Committee of the locality where the establishment is headquartered, according to the roadmap prescribed in Article 123 of this Decree, in case of importing medicinal products as prescribed at Points c and d, Clause 1, Article 57 of this Decree;

b) After receiving the dossier, the dossier-receiving authority shall issue the applying establishment a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree;

c) For dossiers of application for an import license as prescribed in Articles 51, 52, and 55 of this Decree, in cases where no amendment or supplementation to the dossier is required, from the date stated on the Dossier Receipt Note, within 60 days if it is a dossier that does not require clinical data or documents proving similarity to a reference biological product, or 90 days if it is a dossier that requires clinical data or documents proving similarity to a reference biological product, the Ministry of Health shall issue an import license based on the dossier validation and the advice of the council with the function of advising on the issuance of licenses to import medicinal products.

For dossiers of application for an import license as prescribed at Points c and d, Clause 1, Article 57 of this Decree, in cases where no amendment or supplementation to the dossier is required, from the date stated on the Dossier Receipt Note, within 60 days if it is a dossier that does not require clinical data or documents proving similarity to a reference biological product, or 90 days if it is a dossier that requires clinical data or documents proving similarity to a reference biological product, the provincial-level People's Committee shall issue an import license based on the dossier validation and the advice of the council with the function of advising on the issuance of licenses to import medicinal products;

d) In cases where amendment or supplementation to the dossier is required, from the date stated on the Dossier Receipt Note, within 60 days if it is a dossier that does not require clinical data or documents proving similarity to a reference biological product, or 90 days if it is a dossier that requires clinical data or documents proving similarity to a reference biological product, the dossier-receiving authority shall send a written notice to the establishment to request amendment or supplementation to the dossier, made using Form No. 16 in Appendix I to this Decree;

dd) After receiving the amended or supplemented dossier, the dossier-receiving authority shall issue the establishment a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree. In cases where the amended or supplemented dossier is unsatisfactory, from the date stated on the Dossier Receipt Note, within 60 days if it is a dossier that does not require clinical data or documents proving similarity to a reference biological product, or 90 days if it is a dossier that requires clinical data or documents proving similarity to a reference biological product, the dossier-receiving authority shall send a written notice to the establishment regarding the non-issuance of the import license, made using Form No. 16 in Appendix I to this Decree. In cases where no amendment or supplementation to the amended or supplemented dossier is required, the dossier-receiving authority shall issue an import license as prescribed at Point c of this Clause;

e) Within 06 months from the date the dossier-receiving authority sends a written notice of amendment or supplementation, the establishment applying for an import license must submit the amended or supplemented dossier as required. After this time limit, if the establishment fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid;

g) In case of importing a medicinal product without being able to provide the documents prescribed at Points d, dd, e, g, h, and i, Clause 2, Article 57 of this Decree, but it is necessary for treatment needs, the Ministry of Health or the provincial-level People's Committee shall consider and decide based on the advice of the council with the function of advising on the issuance of licenses to import medicinal products and the commitment of the establishment providing the aid medicinal product that the medicinal product has been granted a marketing authorization in the country of manufacture or an ICH member country or Australia, and the commitment of the establishment receiving the aid to take responsibility for the safety and efficacy of the medicinal product;

h) The time limit for issuing an import license or a written notice of amendment or supplementation if it is a dossier of application for a license to import new medicinal products, orphan medicinal products, and vaccines that have been pre-qualified by the World Health Organization, high-tech medicinal products, and medicinal products that have undergone clinical trials in Vietnam as prescribed in Articles 51, 52, and 55 of this Decree shall be shortened by 10 days compared to the time limit for issuing an import license or the time limit for a written notice of amendment or supplementation as prescribed at Points c, d, and dd of this Clause.

3. Procedures and time limits for issuance of import licenses in case of importing medicinal products as prescribed in Clauses 2 and 4, Article 53 of this Decree:

a) An establishment applying for an import license shall submit a dossier either directly, via postal service, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health shall issue the applying establishment a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree;

c) In cases where no amendment or supplementation to the dossier is required, within 03 working days from the date stated on the Dossier Receipt Note, the Ministry of Health shall issue an import license;

d) In cases where amendment or supplementation to the dossier is required, within 03 working days from the date stated on the Dossier Receipt Note, the Ministry of Health shall send a written notice to the establishment, made using Form No. 16 in Appendix I to this Decree;

dd) After receiving the amended or supplemented dossier, the Ministry of Health shall issue the establishment a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree. In cases where the amended or supplemented dossier does not meet the requirements, the Ministry of Health shall send a written notice to the establishment as prescribed at Point d of this Clause. In cases where no amendment or supplementation to the amended or supplemented dossier is required, the Ministry of Health shall issue an import license as prescribed at Point c of this Clause;

e) In cases where the importing establishment cannot provide the document prescribed at Point b, Clause 2 or Point b, Clause 3, Article 53 of this Decree, but it is necessary for the prevention and treatment of diseases, the Minister of Health shall consider and decide based on the request and self-responsibility of the relevant Ministries.

4. Procedures and time limits for issuance of import licenses in case of importing medicinal products as prescribed in Clause 3, Article 53 of this Decree:

a) An establishment applying for an import license shall submit a dossier either directly, via postal service, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health shall issue the applying establishment a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree;

c) In cases where no amendment or supplementation to the dossier is required, within 07 working days from the date stated on the Dossier Receipt Note, the Ministry of Health shall issue a decision approving the medicinal product for urgent needs in disease prevention and control, and overcoming the consequences of natural disasters and catastrophes, and issue a license to import the medicinal product based on the dossier validation and the advice of the council with the function of advising on the issuance of licenses to import medicinal products;

d) In cases where amendment or supplementation to the dossier is required, within 07 working days from the date stated on the Dossier Receipt Note, the Ministry of Health shall send a written notice to the establishment, made using Form No. 16 in Appendix I to this Decree;

dd) After receiving the amended or supplemented dossier, the Ministry of Health shall issue the establishment a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree. In cases where the amended or supplemented dossier does not meet the requirements, the Ministry of Health shall send a written notice to the establishment as prescribed at Point d of this Clause. In cases where no amendment or supplementation to the amended or supplemented dossier is required, the Ministry of Health shall approve and issue an import license as prescribed at Point c of this Clause;

e) In cases where the importing establishment cannot provide the document prescribed at Point b, Clause 3, Article 53 of this Decree, but it is necessary for the prevention and treatment of diseases, the Minister of Health shall consider and decide.

5. Procedures and time limits for issuance of import licenses in case of importing medicinal products as prescribed in Article 54, Article 56, Points a and b, Clause 1, Article 57, Article 58, and Article 59 of this Decree:

a) An establishment applying for an import license shall submit a dossier either directly, via postal service, or online to the Ministry of Health in case of importing medicinal products as prescribed in Articles 54 and 56 of this Decree, unless otherwise prescribed by law regulations.

An establishment applying for an import license shall submit a dossier either directly, via postal service, or online to the Ministry of Health or the provincial-level People's Committee of the locality where the establishment is headquartered, according to the roadmap prescribed in Article 123 of this Decree, in case of importing medicinal products as prescribed at Points a and b, Clause 1, Article 57, Article 58, and Article 59 of this Decree;

b) After receiving the dossier, the dossier-receiving authority shall issue the applying establishment a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree;

c) In cases where no amendment or supplementation to the dossier is required, within 15 days from the date stated on the Dossier Receipt Note, the dossier-receiving authority shall issue an import license;

d) In cases where amendment or supplementation to the dossier is required, within 15 days from the date stated on the Dossier Receipt Note, the dossier-receiving authority shall send a written notice to the establishment to request amendment or supplementation to the dossier, made using Form No. 16 in Appendix I to this Decree;

dd) After receiving the amended or supplemented dossier, the dossier-receiving authority shall issue the establishment a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree. In cases where the amended or supplemented dossier is unsatisfactory, within 15 days from the date stated on the Dossier Receipt Note, the dossier-receiving authority shall send a written notice to the establishment regarding the non-issuance of the import license, made using Form No. 16 in Appendix I to this Decree. In cases where no amendment or supplementation to the amended or supplemented dossier is required, the dossier-receiving authority shall issue an import license as prescribed at Point c of this Clause;

e) Within 06 months from the date the dossier-receiving authority sends a written notice of amendment or supplementation, the establishment applying for an import license must submit the amended or supplemented dossier as required. After this time limit, if the establishment fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid;

g) The time limit for issuing an import license or a written notice of amendment or supplementation if it is a dossier of application for a license to import new medicinal products, orphan medicinal products, and vaccines that have been pre-qualified by the World Health Organization, high-tech medicinal products, and medicinal products that have undergone clinical trials in Vietnam as prescribed in Articles 54 and 56 of this Decree shall be shortened by 05 days compared to the time limit for issuing an import license or the time limit for a written notice of amendment or supplementation as prescribed at Points c, d, and dd of this Clause.

6. Procedures and time limits for issuance of import licenses in case of importing medicinal products as prescribed in Article 60 of this Decree:

a) An organization or individual applying for an import license shall submit a dossier either directly, via postal service, or online to the provincial-level People's Committee at the border gate where the entry procedures are carried out, or where the patient resides or is legally temporarily residing, or where the organization is headquartered;

b) After receiving the dossier, the provincial-level People's Committee shall issue the applicant a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree;

c) In cases where no amendment or supplementation to the dossier is required, within 07 working days from the date stated on the Dossier Receipt Note, the provincial-level People's Committee shall issue an import license;

d) In cases where amendment or supplementation to the dossier is required, within 07 working days from the date stated on the Dossier Receipt Note, the provincial-level People's Committee shall send a written notice to the organization or individual to request amendment or supplementation to the dossier, made using Form No. 16 in Appendix I to this Decree;

dd) After receiving the amended or supplemented dossier, the provincial-level People's Committee shall issue the organization or individual a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree. In cases where the amended or supplemented dossier is unsatisfactory, within 07 working days from the date stated on the Dossier Receipt Note, the provincial-level People's Committee shall send a written notice to the organization or individual regarding the non-issuance of the import license, made using Form No. 16 in Appendix I to this Decree. In cases where no amendment or supplementation to the amended or supplemented dossier is required, the provincial-level People's Committee shall issue an import license as prescribed at Point c of this Clause;

e) Within 03 months from the date the provincial-level People's Committee sends a written notice of amendment or supplementation, the organization or individual applying for an import license must submit the amended or supplemented dossier as required. After this time limit, if the organization or individual fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid.

7. Within 05 working days from the date of issuance of a license to import a medicinal product as prescribed in Articles 51, 52, 53, 54, and 55 of this Decree, the Ministry of Health is responsible for publicly announcing on the electronic portal of the Ministry of Health as prescribed in Clause 6, Article 60 of the Law on Pharmacy.

8. The templates of licenses to import medicinal products are prescribed in Forms No. 28, 29, 30, 31, or 32 in Appendix III to this Decree.

Article 63. Management of the import of medicinal products without marketing authorizations in Vietnam

1. Medicinal products without marketing authorizations, of which the import is licensed in accordance with Articles 51, 54, and 55 of this Decree, shall be supplied as follows:

a) Medicinal products imported in accordance with Articles 51 and 55 of this Decree shall be supplied directly or through an establishment wholesaling medicinal products to medical examination and treatment establishments and immunization establishments;

b) Medicinal products imported in accordance with Article 54 of this Decree shall be supplied directly or through an establishment wholesaling medicinal products to the medical examination and treatment establishment or immunization establishment stated in the import license or the document permitting the import, unless the medicinal product is transferred in accordance with Clause 1, Article 85 of this Decree.

2. A medicinal product without a marketing authorization imported in accordance with Article 56 of this Decree must be tested for quality by a state-owned medicinal product and medicinal material testing agency according to the quality standards of the brand-name medicinal product with a marketing authorization in Vietnam before being placed on the market.

3. A medical examination and treatment establishment or immunization establishment that uses a medicinal product or vaccine imported in accordance with Article 54 of this Decree is responsible for informing the user, patient, or patient's representative of the information that the medicinal product has been granted an import license, but a full legal and technical dossier of the medicinal product cannot be provided. The medicinal product shall only be used after obtaining the consent of the user, patient, or patient's representative.

4. A medicinal product that has been granted an import license to serve a state health program, for the purpose of a clinical trial, or to serve research, testing, and verification must be used for the right purpose and for the right beneficiaries.

5. A medicinal product subject to special control that has been granted an import license to serve humanitarian medical examination and treatment operations, if not fully used in the program, the establishment must export it as prescribed in Clause 5, Article 46 of this Decree and must not use it for other purposes.

6. A medicinal product that has been granted an import license for display at exhibitions and fairs related to medicine, pharmacy, and medical equipment as prescribed in Article 59 of this Decree must be re-exported in its entirety after the exhibition or fair ends and must not be used or placed on the market in Vietnam.

7. An individual or organization applying to import a medicinal product for non-commercial purposes as prescribed in Article 60 of this Decree shall be responsible for the origin and quality of the imported medicinal product.

8. Within 01 year from the date of importing a medicinal product without a marketing authorization in Vietnam as prescribed in Article 51 of this Decree, the importing establishment shall send a report on the use of the imported medicinal product to the Ministry of Health, made using Form No. 48 in Appendix III to this Decree.

Article 64. Regulations on the import of medicinal products to serve the needs for prevention and treatment of a Group A infectious disease which has been declared as an epidemic in accordance with the law on prevention and control of infectious diseases

1. An establishment that has submitted a dossier of application for an import license may register a customs declaration and bring the goods to be stored at the warehouses of the importing establishment that comply with the Good Storage Practices for medicinal products and medicinal materials, suitable for the storage conditions stated on the label, while waiting for the license to be issued, and shall provide information to the border gate customs authority about the location where the goods will be stored for supervision and management.

2. The customs authority shall only allow customs clearance of the medicinal product batch when the importing establishment provides a complete customs clearance dossier as prescribed.

3. An importing establishment shall:

a) Report to the Ministry of Health on the registration of the customs declaration within 02 working days from the time of registering the customs declaration;

b) Urgently complete the dossier of application for a license to import the medicinal product as prescribed in cases where amendment or supplementation to the dossier is requested by the licensing authority;

c) Submit the import license to the customs authority within 30 days from the date of registering the customs declaration. If the import license cannot be provided within the above period, the establishment shall report to the Ministry of Health for the Ministry of Health to send a written notice to the customs authority for management and supervision;

d) Keep the product in its original state and only allow its marketing after customs clearance and compliance with Article 103 of the Law on Pharmacy.

 

Section 3

IMPORT OF MEDICINAL PRODUCTS SUBJECT TO SPECIAL CONTROL WITH MARKETING AUTHORIZATIONS IN VIETNAM, AND MEDICINAL MATERIALS SUBJECT TO SPECIAL CONTROL

 

Article 65. Dossier of application for a license to import medicinal products subject to special control with marketing authorizations in Vietnam

A dossier of application for a license to import habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, combination medicinal products containing habit-forming active pharmaceutical ingredients, combination medicinal products containing psychotropic active pharmaceutical ingredients, combination medicinal products containing precursor active pharmaceutical ingredients, radioactive medicinal products, toxic medicinal products, and medicinal products on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields with a valid marketing authorization in Vietnam shall comprise the following documents:

1. 01 original of the Import Order made using Form No. 33 or 03 originals of the Import Order made using Form No. 34 in Appendix III to this Decree.

2. A report on results of trading in the imported medicinal product, made using Form No. 18 in Appendix III to this Decree, except for toxic medicinal products.

3. For medicinal products subject to special control, except for toxic medicinal products, in cases where the total quantity of medicinal products of which the import is requested, the inventory quantity at the time of making the Order, and the quantity that can still be imported from previously issued import licenses exceed 150% of the total actual business demand in the preceding reporting period, a written explanation must be provided, enclosed with documents proving the approved bidding results or a sales contract or a framework agreement with a purchase order clearly stating the name, reference number of the marketing authorization, and quantity of the medicinal product, unless it is the first time the medicinal product is imported, in which case a projected plan for trading in the medicinal product of which the import is requested shall be submitted instead.

4. The dossier quantity prescribed in this Article is 01 dossier.

Article 66. Dossier and regulations on the issuance of licenses to import medicinal materials subject to special control

1. A dossier of application for import of medicinal materials subject to special control shall comprise:

a) 01 original of the Import Order made using Form No. 35 or 03 originals of the Import Order made using Form No. 36 or 03 originals of the Import Order made using Form No. 41 in Appendix III to this Decree;

b) A copy of the quality standards and testing methods of the medicinal material from the manufacturing establishment, bearing the seal of the importing establishment;

c) A certified true copy of the manufacturing license of the establishment manufacturing the material or the certificate of Good Manufacturing Practices for materials issued by a foreign competent regulatory authority. The manufacturing license or certificate of Good Manufacturing Practices must be granted a consular legalization as prescribed by the law on consular legalization, unless exempted by law;

d) A report on the use of the medicinal material, made using Form No. 37 in Appendix III to this Decree, except for the import of toxic medicinal materials, and a report on the results of trading in the medicinal product or semi-finished medicinal product manufactured from the medicinal material, made using Form No. 38 in Appendix III to this Decree, except for the import of toxic medicinal materials.

Submission of the report on results of trading prescribed at this Point is exempted for the import of materials for testing and research of medicinal products and medicinal materials;

dd) A plan for the manufacture, use, and trading in the material of which the import is requested and a projected plan for trading in the medicinal product or semi-finished medicinal product to be manufactured from the material of which the import is requested, except for the import of toxic medicinal materials.

Submission of the projected plan for trading in the finished product to be manufactured from the material of which the import is requested as prescribed at this Point is exempted in case of importing materials for the purpose of testing and research of medicinal products and medicinal materials.

For medicinal materials subject to special control, except for toxic medicinal materials, in cases where the total quantity of materials of which the import is requested, the inventory quantity at the time of making the Order, and the quantity that can still be imported from previously issued import licenses exceed 150% of the total actual trading and use demand in the preceding reporting period, documents proving the approved bidding results or a sales contract or a framework agreement with a purchase order clearly stating the name and quantity of the corresponding medicinal product or medicinal material must be provided, unless it is for the import for testing and research of medicinal products and medicinal materials and it is the first import;

e) In cases where the material is imported for testing and research of medicinal products and medicinal materials; toxic medicinal materials, medicinal materials that are radioactive substances; active pharmaceutical ingredients on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields are imported for the manufacture of medicinal products or semi-finished medicinal products for export; medicinal materials have a marketing authorization in Vietnam or are for the manufacture of medicinal products or semi-finished medicinal products that already have a marketing authorization in Vietnam, the submission of the documents prescribed at Points b and c of this Clause is not required;

g) The original of the written explanation from the importing establishment regarding the purpose and quantity of the imported material and a commitment to use it for the right purpose in case of importing medicinal materials for testing and research;

h) In case of importing a medicinal material subject to special control that is not granted a marketing authorization in Vietnam or is not on the list of active pharmaceutical ingredients, excipients, or semi-finished medicinal products for the manufacture of a medicinal product according to the medicinal product registration dossier for which a marketing authorization in Vietnam has already been granted, for the purpose of manufacturing or preparing to serve the treatment needs at a medical examination and treatment establishment, the dossier must also include an application from the preparing establishment, made using Form No. 39 in Appendix III to this Decree.

2. If the documents prescribed at Points b and c, Clause 1 of this Article are not in Vietnamese or English, translations of these documents into Vietnamese or English must be submitted, and the translators' signatures must be authenticated as prescribed.

3. The dossier quantity prescribed in Clauses 1 and 2 of this Article is 01 dossier.

4. Licenses to import medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients shall only be issued for the purpose of displaying at exhibitions and fairs.

5. The import of toxic medicinal materials and active pharmaceutical ingredients on the list of medicinal products and active pharmaceutical ingredients on the lists of substances prohibited from use in certain sectors and fields for display at exhibitions and fairs shall comply with Article 69 of this Decree.

Article 67. Procedures and time limits for issuance of licenses to import medicinal products subject to special control with marketing authorizations in Vietnam and medicinal materials subject to special control

1. An establishment applying for an import license shall submit a dossier either directly, via postal service, or online to:

a) The Ministry of Health or the provincial-level People's Committee of the locality where the establishment is headquartered, according to the roadmap prescribed in Article 123 of this Decree, if it is a dossier of application for a license to import a medicinal product subject to special control with a marketing authorization in Vietnam;

b) The Ministry of Health, if it is a dossier of application for a license to import a medicinal material subject to special control.

2. After receiving the dossier, the dossier-receiving authority shall issue the applying establishment a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree.

3. In cases where no amendment or supplementation to the dossier is required, within 15 days from the date stated on the Dossier Receipt Note, the dossier-receiving authority shall issue an import license.

4. In cases where amendment or supplementation to the dossier is required, within 15 days from the date stated on the Dossier Receipt Note, the dossier-receiving authority shall send a written response made using Form No. 16 in Appendix I to this Decree to request amendment or supplementation to the dossier.

5. After receiving the amended or supplemented dossier, the dossier-receiving authority shall issue the establishment a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree. In cases where the amended or supplemented dossier is unsatisfactory, within 15 days from the date stated on the Dossier Receipt Note, the dossier-receiving authority shall send a written response stating the reasons for not issuing the import license, made using Form No. 16 in Appendix I to this Decree. In cases where no amendment or supplementation to the amended or supplemented dossier is required, the dossier-receiving authority shall issue an import license as prescribed in Clause 3 of this Article.

6. Within 06 months from the date the dossier-receiving authority sends a written notice of amendment or supplementation, the establishment applying for an import license must submit the amended or supplemented dossier as required. After this period, if the establishment fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid.

7. The time limit for issuing an import license or a written notice of amendment or supplementation if it is a dossier of application for a license to import new medicinal products, orphan medicinal products, high-tech medicinal products, and medicinal products that have undergone clinical trials in Vietnam as prescribed in Article 65 of this Decree shall be shortened by 05 days compared to the time limit for issuing an import license or a written notice of amendment or supplementation as prescribed in Clauses 3, 4, and 5 of this Article.

8. The templates of licenses to import medicinal products and medicinal materials are prescribed in Forms No. 28, 29, 30, 40, 43, and 44 in Appendix III to this Decree.

 

Section 4

IMPORT OF MEDICINAL MATERIALS WITHOUT MARKETING AUTHORIZATIONS IN VIETNAM, EXCEPT FOR MEDICINAL MATERIALS SUBJECT TO SPECIAL CONTROL

 

Article 68. Criteria and dossier of application for a license to import active pharmaceutical ingredients, herbal medicinal materials, semi-finished medicinal products, semi-finished herbal medicinal materials, excipients, and capsules for testing, research of medicinal products, or preparation of medicinal products at medical examination and treatment establishments

1. Licenses to import active pharmaceutical ingredients, herbal medicinal materials, semi-finished medicinal products, semi-finished products for the manufacture of medicinal products of herbal origin in the form of extracts, granules, powders, tinctures, essential oils, resins, gums, and jellies (hereinafter collectively referred to as semi-finished herbal medicinal materials), excipients, and capsules without marketing authorizations in Vietnam shall only be issued when they fall under one of the following cases:

a) They are used in testing and research at manufacturing establishments, establishments that have been issued with Investment Registration Certificates for medicinal product manufacturing but have not yet been issued with Certificates of Eligibility for Pharmaceutical Business, or at medicinal product and medicinal material testing and research establishments;

b) They are used in manufacturing and preparation to serve the treatment needs at medical examination and treatment establishments.

2. A dossier of application for an import license shall comprise the following documents:

a) 03 originals of the Import Order made using Form No. 36 or 41 in Appendix III to this Decree;

b) A copy of the quality standards and testing methods of the medicinal material from the manufacturing establishment, bearing the seal of the importing establishment, in case of importing the materials as prescribed at Point b, Clause 1 of this Article;

c) A certified true copy of the manufacturing license of the material manufacturing establishment or the certificate of Good Manufacturing Practices for materials issued by a foreign competent regulatory authority, in case of importing the materials as prescribed at Point b, Clause 1 of this Article. The manufacturing license or certificate of Good Manufacturing Practices must be granted a consular legalization as prescribed by the law on consular legalization, unless exempted by law;

d) An application from the medical examination and treatment establishment, made using Form No. 42 in Appendix III to this Decree, in case of importing materials as prescribed at Point b, Clause 1 of this Article;

dd) If the documents prescribed at Points b and c of this Clause are not in Vietnamese or English, translations of these documents into Vietnamese or English must be submitted, and the translators' signatures must be authenticated as prescribed.

3. The dossier quantity prescribed in this Article is 01 dossier.

Article 69. Regulations on the import of active pharmaceutical ingredients, semi-finished medicinal products, herbal medicinal materials, and semi-finished herbal medicinal materials for display at exhibitions and fairs

1. Licenses to import medicinal materials shall be issued for the purpose of displaying only at exhibitions and fairs related to medicine, pharmacy, and medical equipment.

2. The import of medicinal materials for display at exhibitions and fairs must comply with the law regulations on temporary import and re-export.

3. Medicinal materials for which import licenses have been issued in accordance with this Article shall not be placed on the market in Vietnam and must be re-exported in their entirety after the exhibition or fair ends.

Article 70. Dossier of application for a license to import active pharmaceutical ingredients, semi-finished medicinal products, herbal medicinal materials, semi-finished herbal medicinal materials, excipients, and capsules for the manufacture of medicinal products for export

1. A dossier shall comprise 03 originals of the Import Order made using Form No. 36 or 41 in Appendix III to this Decree.

2. The dossier quantity prescribed in this Article is 01 dossier.

Article 71. Criteria and dossier of application for a license to import active pharmaceutical ingredients, semi-finished medicinal products, herbal medicinal materials, and semi-finished herbal medicinal materials for the manufacture of medicinal products to serve national defence and security needs, to serve the needs for prevention and treatment of a Group A infectious disease which has been declared as an epidemic in accordance with the law on prevention and control of infectious diseases, and to overcome the consequences of incidents, natural disasters, and catastrophes

1. Licenses to import medicinal materials shall be issued for the purpose of manufacturing only medicinal products in one of the following cases:

a) To serve the needs for national defence;

b) To serve the needs for security;

c) To serve the needs for prevention and treatment of a Group A infectious disease which has been declared as an epidemic in accordance with the law on prevention and control of infectious diseases, and to overcome the consequences of incidents, natural disasters, and catastrophes.

2. A dossier shall comprise the following documents:

a) 03 originals of the Import Order made using Form No. 36 or 41 in Appendix III to this Decree;

b) In cases where medicinal materials are imported to manufacture medicinal products to serve the needs for national defence or security, the dossier must include the original of the written request from the Ministry of National Defence or the Ministry of Public Security. The written approval must contain the following minimum information: Name of the medicinal product, name of the establishment manufacturing the medicinal product, active substance, concentration or strength, dosage form, packaging specifications, route of administration, and indications;

c) In cases where medicinal materials are imported to manufacture medicinal products to serve the needs for prevention and treatment of a Group A infectious disease which has been declared as an epidemic in accordance with the law on prevention and control of infectious diseases, and to overcome the consequences of incidents, natural disasters, and catastrophes, the dossier must include a written approval of the List of medicinal products from the Ministry of Health. The written approval must contain the following minimum information: Name of the medicinal product, name of the establishment manufacturing the medicinal product, active substance, concentration or strength, dosage form, packaging specifications, route of administration, and indications;

d) A copy of the quality standards and testing methods of the medicinal material from the manufacturing establishment, bearing the seal of the importing establishment;

dd) A certified true copy of the manufacturing license of the establishment manufacturing the material or the certificate of Good Manufacturing Practices for materials issued by a foreign competent regulatory authority. The manufacturing license or certificate of Good Manufacturing Practices must be granted a consular legalization as prescribed by the law on consular legalization, unless exempted by law;

e) If the documents prescribed at Points d and dd of this Clause are not in Vietnamese or English, translations of these documents into Vietnamese or English must be submitted, and the translators' signatures must be authenticated as prescribed.

3. The dossier quantity prescribed in this Article is 01 dossier.

Article 72. Dossier of application for a license to import herbal medicinal materials prescribed in Articles 68, 69, 70, and 71 of this Decree

1. A dossier of application for an import license shall comprise the following documents:

a) 03 originals of the Import Order made using Form No. 41 in Appendix III to this Decree;

b) Quality standards of the medicinal material that are consistent with the corresponding national technical regulations on herbal medicinal materials in the Pharmacopoeia of Vietnam or a foreign pharmacopoeia recognized by the Ministry of Health.

In cases where the corresponding national technical regulations on herbal medicinal materials are not available in the Pharmacopoeia of Vietnam or a foreign pharmacopoeia recognized by the Ministry of Health, the establishment shall provide the quality standards, including the testing methods, developed by the establishment and appraised by a state-owned medicinal product and medicinal material testing establishment;

c) A certified true copy of the Establishment License of the Representative Office in Vietnam of the foreign establishment that supplies herbal medicinal materials to Vietnam, with the scope of business covering herbal medicinal materials, and semi-processed and processed herbal medicinal materials;

d) A certified and granted a consular legalization copy of the pharmaceutical business license issued by the competent authority of the host country. In cases where the host country does not issue a pharmaceutical business license to the establishment supplying herbal medicinal materials or semi-finished herbal medicinal materials, the establishment shall submit a certified true copy of the business license or equivalent legal papers issued by the competent authority of the host country, with the scope of business covering herbal medicinal materials. The foreign establishment supplying herbal medicinal materials or semi-finished herbal medicinal materials is not required to comply with Article 78 of this Decree if it has all the documents mentioned in this Clause;

dd) A certified and granted a consular legalization copy of the Certificate of Good Manufacturing Practices of the manufacturing establishment, issued by the competent authority of the host country. In cases where the host country does not issue a Certificate of Good Manufacturing Practices, the establishment shall submit a certified true copy of the manufacturing license or legal papers equivalent to a Certificate of Good Manufacturing Practices, with the scope of manufacturing covering herbal medicinal materials or semi-finished herbal medicinal materials;

e) A copy, bearing the seal of the importing establishment, of the power of attorney from the establishment manufacturing the herbal medicinal material to the foreign establishment supplying medicinal products, unless they are the same. The power of attorney shall comply with Point dd, Clause 1, Article 78 of this Decree.

2. The dossier quantity prescribed in this Article is 01 dossier.

Article 73. Procedures and time limits for issuance of licenses to import medicinal materials without marketing authorizations in Vietnam, except for medicinal materials subject to special control

1. Procedures and time limits for issuance of licenses to import medicinal materials as prescribed in Articles 68, 70, and 72 of this Decree:

a) An establishment applying for an import license shall submit a dossier either directly, via postal service, or online to the Ministry of Health or the provincial-level People's Committee of the locality where the establishment is headquartered, according to the roadmap prescribed in Article 123 of this Decree;

b) After receiving the dossier, the dossier-receiving authority shall issue the applying establishment a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree;

c) In cases where no amendment or supplementation to the dossier is required, within 15 days from the date stated on the Dossier Receipt Note, the dossier-receiving authority shall issue an import license;

d) In cases where amendment or supplementation to the dossier is required, within 15 days from the date stated on the Dossier Receipt Note, the dossier-receiving authority shall send a written notice to the establishment to request amendment or supplementation to the dossier, made using Form No. 16 in Appendix I to this Decree;

dd) After receiving the amended or supplemented dossier, the dossier-receiving authority shall issue the establishment a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree. In cases where the amended or supplemented dossier is unsatisfactory, within 15 days from the date stated on the Dossier Receipt Note, the dossier-receiving authority shall send a written notice to the establishment regarding the non-issuance of the import license, made using Form No. 16 in Appendix I to this Decree. In cases where no amendment or supplementation to the amended or supplemented dossier is required, the receiving authority shall issue an import license as prescribed at Point c of this Clause;

e) Within 06 months from the date the dossier-receiving authority sends a written notice of amendment or supplementation, the establishment applying for an import license must submit the amended or supplemented dossier as required. After this period, if the establishment fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid.

2. In case of importing medicinal materials as prescribed in Article 71 of this Decree:

a) An establishment applying for an import license shall submit a dossier either directly, via postal service, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health shall issue the applicant a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree;

c) In cases where no amendment or supplementation to the dossier is required, within 03 working days from the date stated on the Dossier Receipt Note, the Ministry of Health shall issue an import license;

d) In cases where amendment or supplementation to the dossier is required, within 03 working days from the date stated on the Dossier Receipt Note, the Ministry of Health shall send a written response to the establishment to request amendment or supplementation to the dossier, made using Form No. 16 in Appendix I to this Decree;

dd) After receiving the amended or supplemented dossier, the Ministry of Health shall issue the establishment a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree. In cases where the amended or supplemented dossier does not meet the requirements, the Ministry of Health shall send a written notice to the establishment as prescribed at Point d of this Clause. In cases where no amendment or supplementation to the amended or supplemented dossier is required, the Ministry of Health shall issue an import license as prescribed at Point c of this Clause.

3. The templates of licenses to import medicinal materials are prescribed in Form No. 43 or 44 in Appendix III to this Decree.

 

Section 5

REGULATIONS ON EXPORT AND IMPORT OF MEDICINAL PRODUCTS AND MEDICINAL MATERIALS

 

Article 74. Regulations on the validity periods of licenses to export and import medicinal products and medicinal materials

1. The validity period of a license to export a medicinal product or medicinal material is as follows:

a) A maximum of 01 year for medicinal products and medicinal materials for which the export licenses are issued in accordance with Articles 43, 45, 46, Clause 1, Article 47, and Article 48 of this Decree;

b) A maximum of 02 years for medicinal products and medicinal materials for which the export licenses are issued in accordance with Article 44 and Clause 5, Article 82 of this Decree.

2. The validity period of a license to import a medicinal product or medicinal material is as follows:

a) A maximum of 01 year if it is a license to import a medicinal product;

b) A maximum of 01 year and valid for a single import if it is a license to import habit-forming medicinal products, psychotropic medicinal products, precursor medicinal products, and medicinal materials that are habit-forming active pharmaceutical ingredients, psychotropic active pharmaceutical ingredients, or precursor active pharmaceutical ingredients;

c) A maximum of 02 years if it is a license to import a medicinal material, except for the medicinal materials prescribed at Point b of this Clause.

3. The validity period of the license must be clearly stated in the license.

Article 75. Regulations on the remaining shelf life of imported medicinal products and medicinal materials at the time of customs clearance

1. Imported chemical medicinal products, herbal medicinal products, traditional medicinal products, and medicinal materials, except for the medicinal products and medicinal materials prescribed in Clause 3 of this Article, must have a minimum remaining shelf life at the time of customs clearance as follows:

a) 18 months if it is a medicinal product or medicinal material with a shelf life of over 24 months;

b) 1/2 of the shelf life if it is a medicinal product or medicinal material with a shelf life of 24 months or less, unless otherwise prescribed at Point c of this Clause;

c) 1/3 of the shelf life if it is a medicinal product or medicinal material with a shelf life of 9 months or less, unless otherwise prescribed at Point d of this Clause;

d) Any medicinal product with a shelf life of 30 days or less must have a remaining shelf life at the time of customs clearance.

2. Imported vaccines and biological products, unless otherwise prescribed in Clause 3 of this Article, must have a minimum remaining shelf life of 1/2 of their shelf life at the time of customs clearance.

3. Medicinal products and medicinal materials imported in accordance with Article 53, Clause 1, Article 54, Articles 58, 59, 60, 68, 69, 70, and 71 of this Decree; medicinal products imported in accordance with Clause 5a, Article 60 of the Law on Pharmacy; and medicinal materials imported in accordance with Article 66 of this Decree for testing, research, and manufacture of medicinal products for export must have a remaining shelf life at the time of customs clearance.

4. In cases where a medicinal product or medicinal material has a remaining shelf life at the time of customs clearance shorter than that prescribed at Points a, b, and c, Clause 1 or Clause 2 of this Article but is necessary for use in manufacturing, prevention, and treatment of diseases, the provincial-level People's Committee of the locality where the importing establishment is headquartered shall decide to permit the import if the medicinal product or medicinal material falls under one of the following cases:

a) There is no medicinal product with the same active substance and route of administration with a valid marketing authorization in Vietnam;

b) There is a written request and commitment from a medical examination and treatment establishment regarding the necessity of using the medicinal product for prevention and treatment of diseases, but the medicinal product with the same active substance and route of administration that has been granted a marketing authorization cannot be supplied;

c) The medicinal material is for the manufacture of a medicinal product prescribed at Point b of this Clause, but the manufacturer of the medicinal material cannot supply it.

5. A dossier of application for permission to import a medicinal product or medicinal material as prescribed in Clause 4 of this Article shall comprise the following documents:

a) An application from the importing establishment, including the following information: Name of the medicinal product or medicinal material, batch number, quantity, remaining shelf life at the time of customs clearance, reasons why the medicinal product or medicinal material has a remaining shelf life at the time of customs clearance shorter than that prescribed at Points a, b, and c, Clause 1 or Clause 2 of this Article, and the necessity for manufacturing, prevention, and treatment of diseases;

b) A written request and commitment from the medical examination and treatment establishment regarding the necessity of using the medicinal product for prevention and treatment of diseases in the case prescribed in Clause 4 of this Article, and documents proving that the batch of the medicinal product/medicinal material has a remaining shelf life at the time of customs clearance shorter than that prescribed at Points a, b, and c, Clause 1 or Clause 2 of this Article.

c) The dossier quantity prescribed in this Clause is 01 dossier.

6. The sequence and procedures for permitting the import of a medicinal product or medicinal material as prescribed in Clause 4 of this Article:

a) An establishment applying for permission to import shall submit a dossier either directly, via postal service, or online to the provincial-level People's Committee of the locality where the establishment is headquartered;

b) After receiving the dossier, the provincial-level People's Committee shall issue the applying establishment a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree;

c) In cases where no amendment or supplementation is required, within 15 days from the date stated on the Dossier Receipt Note, the provincial-level People's Committee shall issue a written approval made using Form No. 51 in Appendix III to this Decree;

d) In cases where amendment or supplementation to the dossier is required, within 15 days from the date stated on the Dossier Receipt Note, the provincial-level People's Committee shall send a written response made using Form No. 16 in Appendix I to this Decree to request amendment or supplementation to the dossier;

dd) After receiving the amended or supplemented dossier, the provincial-level People's Committee shall issue the establishment a Dossier Receipt Note for the amended or supplemented dossier made using Form No. 01 in Appendix I to this Decree. In cases where the amended or supplemented dossier is unsatisfactory, within 15 days from the date stated on the Dossier Receipt Note, the provincial-level People's Committee shall send a written response stating the reasons for not permitting the import, made using Form No. 16 in Appendix I to this Decree. In cases where no amendment or supplementation to the amended or supplemented dossier is required, the provincial-level People's Committee shall issue a written approval as prescribed at Point c of this Clause;

e) Within 03 months from the date the provincial-level People's Committee sends a written notice of amendment or supplementation, the establishment applying for permission to import must submit the amended or supplemented dossier as required. After this period, if the establishment fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid.

Article 76. Regulations on the quantity of medicinal products and medicinal materials for which the import licenses are issued

1. The quantity of medicinal products and medicinal materials imported in accordance with Articles 51, 55, 65, and 66 of this Decree shall be approved based on the business demand of the establishment requesting the import thereof.

2. The quantity of medicinal products imported in accordance with Articles 52 and 54 of this Decree shall be approved based on the treatment needs of the medical examination and treatment establishment.

3. The quantity of medicinal products imported in accordance with Article 53 of this Decree shall be approved based on the needs for use for security, national defence, disease prevention and control, and overcoming the consequences of natural disasters and catastrophes.

4. The quantity of medicinal products imported in accordance with Article 56 of this Decree shall be approved based on the ability to meet the goal of price stabilization.

5. The quantity of medicinal products imported in accordance with Article 57 of this Decree shall be approved based on the actual use demand of the establishment receiving the aid.

6. The quantity of medicinal products imported in accordance with Article 58 of this Decree shall be approved based on the explanatory notes of the research protocol or the approved research protocol for the clinical trial or bioequivalence trial of the medicinal product, or the needs for use of the medicinal product in testing and research of the establishment.

7. The quantity of medicinal products imported in accordance with Article 60 of this Decree shall be based on the actual use demand for treatment of the organization or individual.

8. The quantity of medicinal materials imported in accordance with Articles 68, 70, 71, and 72 of this Decree shall be based on the needs for use of the materials in the manufacturing and business of the establishment.

Article 77. Regulations on the Certificate of Analysis of an imported batch of a medicinal product or medicinal material

1. The Certificate of Analysis must be presented in Vietnamese or English. In cases where the Certificate of Analysis is not in Vietnamese or English, a translation into Vietnamese or English must be submitted, and the translator's signature must be authenticated as prescribed.

2. In cases where 02 or more manufacturers participate in the manufacturing of the medicinal product, the imported batch of the medicinal product or medicinal material must have a Certificate of Analysis from the manufacturer, the final packaging manufacturer, or the manufacturer responsible for batch release.

3. The Certificate of Analysis shall contain:

a) Name and address of the manufacturer, the reference number of the Certificate of Analysis, the name and signature of the responsible person, and the date of issuance of the Certificate of Analysis;

In cases where an electronic signature is used for the Certificate of Analysis, it must comply with the law regulations on electronic transactions.

In cases where the Certificate of Analysis does not show the signature of the responsible person, a Certificate of Analysis bearing the confirmation seal of the manufacturer is acceptable. The importing establishment shall take full accountability to the law for the accuracy and validity of the Certificate of Analysis;

b) Information about the sample of the medicinal product or medicinal material, including: name of the product; batch number; expiry date of the medicinal product or expiry date or re-test date for the medicinal material; applicable quality standards; quality specifications; test results; and conclusion on the quality of the product batch.

Article 78. Regulations on establishments supplying medicinal products and medicinal materials

1. An establishment supplying a medicinal product or medicinal material means a foreign establishment that signs a sales contract with an importing establishment. The establishment supplying the medicinal product or medicinal material must be one of the following establishments:

a) The establishment manufacturing the imported medicinal product or medicinal material;

b) The product owner or the holder of the marketing authorization of the imported medicinal product or active pharmaceutical ingredient, as stated on the Certificate of Pharmaceutical Product for a medicinal product that has been granted a marketing authorization as prescribed by the Law on Pharmacy and for a medicinal product that has not yet been granted a marketing authorization in Vietnam;

c) A foreign establishment in whose name the medicinal product or medicinal material, for which a marketing authorization in Vietnam has been granted and remains valid at the time of customs clearance, is registered, other than the establishment prescribed at Points a and b of this Clause;

d) An establishment announced by the Ministry of Health at the request of the competent authority of the foreign country where the establishment is headquartered;

dd) In cases where the supplying establishment is not the establishment prescribed at Points a and b of this Clause, it must be authorized in writing by the establishment prescribed at Point a or b to supply the medicinal product to Vietnam.

The written authorization includes a power of attorney, a sales license, or a partnership certificate. The written authorization must be in Vietnamese or English and must contain at least the following information: Name and address of the authorizing establishment and the authorized establishment; scope of authorization, including the supply of the medicinal product or medicinal material to Vietnam; validity period of the authorization or the sales permission period; responsibilities of the parties in ensuring the quality and origin of the medicinal product or medicinal material supplied to Vietnam; and the confirming signatures of the parties;

e) An establishment supplying a medicinal product imported in accordance with Articles 53, 58, and 59 of this Decree is not required to be one of the establishments prescribed at Point a, b, c, or d of this Clause;

g) An establishment supplying a medicinal product imported in accordance with Articles 54 and 56 of this Decree is not required to comply with Point dd of this Clause.

2. An establishment supplying excipients; capsules; primary packaging materials in direct contact with the medicinal product; medicinal materials subject to special control imported for testing, research, or manufacture of medicinal products for export as prescribed in Article 66 of this Decree; medicinal materials imported in accordance with Articles 68, 69, 70, and 71 of this Decree; and aid and humanitarian aid medicinal products is not required to comply with Clause 1 of this Article.

Article 79. Announcement of establishments licensed to supply medicinal products and medicinal materials to Vietnam at the request of the competent authority of the foreign country where the establishment is headquartered

1. The competent authority of the foreign country where the establishment is headquartered shall send a written request to the Ministry of Health to announce the establishment that supplies medicinal products and medicinal materials to Vietnam. The written request for announcement must meet the following requirements:

a) It must clearly state the name, address, and contact information of the competent authority of the foreign country where the establishment is headquartered; information about the country or territory registered to supply medicinal products and medicinal materials to Vietnam; the name of the supplying establishment, its business location, its scope of business, and the contact information of the pharmaceutical businesses applying to supply medicinal products and medicinal materials to Vietnam;

b) It must be the original, in English or Vietnamese. In cases where it is not in English or Vietnamese, a translation into English or Vietnamese must be submitted, and the translator's signature must be authenticated as prescribed.

2. The competent authority of the foreign country where the establishment is headquartered, as prescribed in Clause 1 of this Article, is responsible for sending a written notification to the Ministry of Health as prescribed below:

a) For an establishment supplying a medicinal product or medicinal material, which has been announced by the Ministry of Health and has a change in its name, business location, or scope of business: notification within 01 month from the date of the written approval from the competent authority of the foreign country where the establishment is headquartered for the change of information;

b) For an establishment that has announced a temporary suspension or termination of its pharmaceutical business in the foreign country where the establishment is headquartered: notification within 15 days from the date of the written notice from the competent foreign authority regarding the suspension or termination of the supplying establishment's operations.

3. In cases where the Ministry of Health receives a written request from the competent authority of the foreign country where the establishment is headquartered to announce a pharmaceutical business applying to supply medicinal products and medicinal materials to Vietnam, the Ministry of Health shall:

a) Within 30 days from the date of receiving the written request from the competent authority of the foreign country where the establishment is headquartered, the Ministry of Health shall announce on the electronic portal of the Ministry of Health the information prescribed at Point a, Clause 1 of this Article;

b) In cases where the Ministry of Health receives a written request from the competent authority of the foreign country where the establishment is headquartered to change or supplement information related to a foreign establishment supplying a medicinal product or medicinal material, which has been announced by the Ministry of Health, the Ministry of Health shall comply with Point a of this Clause.

Article 80. Cases where licenses to import medicinal products and medicinal materials shall be revoked

1. A license to import a medicinal product shall be revoked in the following cases:

a) The imported medicinal product is recalled due to a Level 1 defect as prescribed at Point a, Clause 2, Article 63 of the Law on Pharmacy;

b) The marketing authorization of the imported medicinal product is revoked by the competent authority of the country of manufacture, an ICH member country, or Australia;

c) The competent authority concludes that the documents in the dossier of application for the license to import the medicinal product that has been approved are forged;

d) The imported medicinal product is manufactured at a location not in accordance with the dossier of application for the license to import the medicinal product that has been approved;

dd) The imported medicinal product contains an active pharmaceutical ingredient or medicinal material that is recommended by the World Health Organization, the competent regulatory authority of Vietnam, or the country of origin of the medicinal product as unsafe or ineffective for users;

e) The manufacturing establishment or importing establishment requests the revocation of the license to import the medicinal product or medicinal material;

g) There is a notice of recall of the imported batch of the medicinal product from a foreign pharmaceutical regulatory authority;

h) The imported medicinal product does not comply with the regulations on the supply of medicinal products at Clause 1, Article 63 of this Decree.

2. A license to import a medicinal material shall be revoked in the following cases:

a) The medicinal material is recalled as prescribed at Point a, b, d, dd, or e, Clause 2, Article 62 of the Law on Pharmacy;

b) The imported active pharmaceutical ingredient or herbal medicinal material is recommended by the World Health Organization, the competent regulatory authority of Vietnam, or the country of origin of the active pharmaceutical ingredient or herbal medicinal material as unsafe or ineffective for users.

Article 81. Regulations on reporting on the export and import of medicinal products and medicinal materials, except for medicinal products subject to special control

1. Within 10 days from the date of importing a vaccine that is granted a marketing authorization in Vietnam, the importing establishment shall send a report for each imported batch to the Ministry of Health and the National Institute for Control of Vaccines and Biologicals, made using Form No. 46 in Appendix III to this Decree.

2. Within 10 days from the date of importing a medicinal product without a marketing authorization in Vietnam, the importing establishment shall send a report for each imported batch to the Ministry of Health and concurrently to the import licensing authority according to the roadmap prescribed in Article 124 of this Decree, and to the National Institute for Control of Vaccines and Biologicals for vaccines, made using Form No. 47 in Appendix III to this Decree.

3. Before January 15 of each year, an establishment engaged in the import or export of medicinal products or medicinal materials shall submit an annual report on the situation of export and import of medicinal products and medicinal materials, made using Form No. 49 in Appendix III to this Decree, to the Ministry of Health.

Article 82. Other regulations on the export and import of medicinal products and medicinal materials

1. Medicinal materials that are active pharmaceutical ingredients, excipients, capsules, semi-finished medicinal products, and semi-finished herbal medicinal materials without marketing authorizations for the manufacture of medicinal products according to the medicinal product registration dossiers for which marketing authorizations in Vietnam have already been granted shall be announced on the electronic portal of the licensing authority, using Form No. 45 in Appendix III to this Decree, within 15 days from the date of issuance or renewal of the marketing authorizations for the medicinal products in Vietnam. Medicinal materials on the announced list may be imported without any import license, except for medicinal materials subject to special control.

2. Medicinal materials that have been granted marketing authorizations in Vietnam, including herbal medicinal materials, semi-finished herbal medicinal materials, excipients, capsules, and semi-finished medicinal products, except for semi-finished medicinal products subject to special control, may be imported without any import license.

3. Based on the explanatory notes of the approved clinical trial research protocol, the Minister of Health shall announce a list of medicinal products used for clinical trials for customs clearance upon import on the electronic portal of the Ministry of Health, using Form No. 50 in Appendix III to this Decree, within 07 working days from the date of approving the explanatory notes of the research protocol.

4. A trader may import primary packaging materials in direct contact with the medicinal product without an import license from the Ministry of Health.

5. For a medicinal product or medicinal material that may be exported without a license as prescribed in Clause 5, Article 60 of the Law on Pharmacy, for which the establishment wishes to obtain an export license:

a) A dossier of application for an export license shall comprise the original of the Export Order made using Form No. 14 in Appendix III to this Decree and a certified true copy or a copy bearing the seal of the exporting establishment of the Certificate of Eligibility for Pharmaceutical Business of the exporting establishment;

b) The procedures for issuance of an export license shall comply with Clause 1, Article 49 of this Decree.

6. Medicinal products and medicinal materials must be imported through international border gates, except for medicinal products imported for non-commercial purposes as prescribed in Article 60 of this Decree and on-spot export and import as prescribed by law regulations.

7. Medicinal materials imported as prescribed by the Law on Pharmacy and this Decree are not subject to the procedures for declaration of chemicals.

8. The import of herbal medicinal materials that are specimens of species on the list of endangered, precious, and rare species prioritized for protection for testing and research of medicinal products must comply with the law regulations on biodiversity.

9. Medical and pharmaceutical training establishments and medicinal product research and testing establishments may import medicinal products and medicinal materials to serve their own training, research, and testing work.

10. A representative office in Vietnam of an establishment manufacturing a medicinal product for clinical trial or for bioavailability assessment or bioequivalence trial, or an establishment in whose name such medicinal product is registered, or a holder of the marketing authorization of such medicinal product; or an establishment conducting clinical trials, an establishment conducting bioavailability assessment or bioequivalence trials may import medicinal products, medicinal materials, and primary packaging materials in direct contact with the medicinal product to serve the clinical trial, bioavailability assessment, bioequivalence trial, research, and testing of medicinal products and medicinal materials.

11. An agency or organization prescribed in Article 35 of the Law on Pharmacy that complies with the principles and standards of Good Storage Practices may:

a) Import medicinal products prescribed in Article 53 of this Decree when designated by the Ministry of National Defence, the Ministry of Public Security, or the Ministry of Health in the written request for import;

b) Import aid and humanitarian aid medicinal products when approved by a competent state regulatory authority to receive such aid.

12. A medical examination and treatment establishment that has a Medicine and Treatment Council and complies with Article 35 of the Law on Pharmacy may import medicinal products to serve the special treatment needs of its patients. The criteria and dossier of application for a license to import the medicinal product shall comply with Article 54 of this Decree.

13. The list of medicinal products and medicinal materials banned from import and manufacture is provided in Appendix V of this Decree.

14. The receipt of a dossier of application for a license and the issuance of a license to import medicinal products and medicinal materials from an importing establishment shall be suspended in the following cases, unless it is a dossier of application for import of medicinal products as prescribed in Articles 53, 54, and 55 of this Decree:

a) Violations as prescribed at Points a, c, d, and h, Clause 1, Article 80 of this Decree;

b) Within 12 months, having 02 or more imported batches of a medicinal product compulsorily recalled due to a Level 2 quality defect as prescribed at Point b, Clause 2, Article 63 of the Law on Pharmacy, or 03 or more imported batches of a medicinal product compulsorily recalled due to failure to meet quality standards;

c) The information in the dossier of application for an import license is not based on the actual research or manufacturing of the manufacturing establishment.

15. The import of all medicinal products and medicinal materials of an establishment manufacturing medicinal products or medicinal materials shall be suspended if it commits one of the following acts:

a) A serious violation of the principles and standards of Good Manufacturing Practices as prescribed by the Minister of Health;

b) Within 12 months, having 02 or more batches of a medicinal product or medicinal material compulsorily recalled due to a Level 1 quality defect as prescribed at Point a, Clause 2, Article 63 of the Law on Pharmacy, related to the quality of the medicinal product or medicinal material;

c) Within 12 months, having 03 or more batches of a medicinal product or medicinal material compulsorily recalled due to a Level 2 quality defect as prescribed at Point b, Clause 2, Article 63 of the Law on Pharmacy, or having 04 or more batches of a medicinal product or medicinal material compulsorily recalled due to failure to meet quality standards.

16. The period of suspension of receipt of a dossier of application for a license or issuance of a license to import medicinal products and medicinal materials, or suspension of import of medicinal products and medicinal materials for an establishment as prescribed in Clauses 14 and 15 of this Article is as follows:

a) From 01 year to 02 years in the cases prescribed in Clause 14 and Points a and b, Clause 15 of this Article, from the date the regulatory authority issues a written notice of the application of the management measure;

b) From 06 months to 01 year in the cases prescribed at Point c, Clause 15 of this Article, from the date the regulatory authority issues a written notice of the application of the management measure.

17. The sale of a medicinal product without a marketing authorization by an importing establishment that is a foreign-invested pharmaceutical business must comply with Article 53a of the Law on Pharmacy and this Decree.

Article 83. Regulations on specialized documents to be submitted by pharmaceutical businesses, organizations, and individuals during customs clearance for export and import of medicinal products and medicinal materials

In addition to the documents to be submitted as prescribed by the customs law regulations, a pharmaceutical business, organization, or individual must submit the following documents during customs clearance for export and import of medicinal products and medicinal materials:

1. Customs clearance for export of medicinal products and medicinal materials:

a) Submit the original or a certified true copy or a copy bearing the confirmation seal of the exporting establishment of the Certificate of Eligibility for Pharmaceutical Business of the exporting establishment, in cases where the exporting establishment is a pharmaceutical business;

b) Submit the original or a certified true copy or a copy of the export license bearing the confirmation seal of the exporting establishment in case of exporting herbal medicinal materials on the list of precious, rare, and endemic herb species and varieties subject to control; and medicinal products subject to special control, unless otherwise prescribed at Point c of this Clause;

c) Submit the original or a copy of the prescription or outpatient treatment record, certified or signed by the applicant for an export license, or a copy bearing the seal of the organization applying for an export license in one of the cases prescribed in Clause 2, Article 46 of this Decree.

2. Customs clearance for import of medicinal products and medicinal materials with marketing authorizations in Vietnam, and medicinal materials on the list of active pharmaceutical ingredients, excipients, capsules, semi-finished medicinal products, and semi-finished herbal medicinal materials according to the registration dossiers for which marketing authorizations in Vietnam have been granted, except for herbal medicinal materials:

a) Submit the original or a certified true copy or a copy bearing the confirmation seal of the importing establishment of the Certificate of Eligibility for Pharmaceutical Business of the importing establishment, in cases where the importing establishment is a pharmaceutical business;

b) Submit the original or a certified true copy or a copy bearing the confirmation seal of the importing establishment of the import license in case of importing medicinal products subject to special control;

c) Submit the original or a copy of the Certificate of Analysis for each imported batch of a medicinal product or medicinal material, bearing the seal of the importing establishment;

d) Submit a copy, bearing the confirmation seal of the importing establishment, of the power of attorney, sales license, or partnership certificate as prescribed at Point dd, Clause 1, Article 78 of this Decree, except for the import of excipients, capsules, and aid and humanitarian aid medicinal products;

dd) In case of importing a medicinal product or medicinal material as prescribed at Point dd, Clause 1, Article 59 of the Law on Pharmacy and not subject to an import license, the importing establishment shall submit the bill of lading of the batch of the medicinal product or medicinal material, showing that the goods were shipped from the port of departure of the exporting country before the expiry date of the marketing authorization, for customs clearance;

e) In case of importing a medicinal product or medicinal material as prescribed at Point dd, Clause 1, Article 59 of the Law on Pharmacy and subject to an import license, the importing establishment shall submit the bill of lading of the batch of the medicinal product or medicinal material, showing that the goods were shipped from the port of departure of the exporting country before the expiry date of the marketing authorization and the import license, for customs clearance;

g) In case of importing a medicinal material on the list of active pharmaceutical ingredients, excipients, capsules, semi-finished medicinal products, and semi-finished herbal medicinal materials for the manufacture of a medicinal product according to the medicinal product registration dossier for which a marketing authorization in Vietnam has already been granted, and which is not subject to an import license, the importing establishment shall submit the bill of lading of the batch of the medicinal material, showing that the goods were shipped from the port of departure of the exporting country before the expiry date of the marketing authorization of the medicinal product used to announce the material, for customs clearance (in cases where the marketing authorization of the medicinal product used to announce the material expires at the time of customs clearance);

h) In case of importing a medicinal material on the list of active pharmaceutical ingredients, excipients, capsules, semi-finished medicinal products, and semi-finished herbal medicinal materials for the manufacture of a medicinal product according to the medicinal product registration dossier for which a marketing authorization in Vietnam has already been granted, and which is subject to an import license, the importing establishment shall submit the bill of lading of the batch of the medicinal material, showing that the goods were shipped from the port of departure of the exporting country before the expiry date of the marketing authorization of the medicinal product used to announce the material and the license to import the material, for customs clearance (in cases where the marketing authorization of the medicinal product used to announce the material or the license to import the material expires at the time of customs clearance);

i) Submit proof of having made a notice of the import of the medicinal product as prescribed in Clause 1, Article 87 of this Decree, which has been sent to the provincial-level People's Committee of the locality where the international border gate for the import of the medicinal product is located. Submission of this document is exempted when the National Single Window portal is linked with the information technology system for customs procedures for exported and imported goods and means of transport on entry, exit, and in transit.

3. Customs clearance for import of herbal medicinal materials and semi-finished herbal medicinal materials with or without marketing authorization in Vietnam, except for semi-finished herbal medicinal materials for the manufacture of a medicinal product according to the medicinal product registration dossier for which a marketing authorization in Vietnam has already been granted:

a) Submit the original or a certified true copy, or a copy bearing the confirmation seal of the importing establishment of the Certificate of Eligibility for Pharmaceutical Business for collation, in cases where the importing establishment is a pharmaceutical business;

b) For an herbal medicinal material or semi-finished herbal medicinal material with a marketing authorization in Vietnam, submit the original or a certified true copy or a copy of the marketing authorization bearing the seal of the importing establishment;

c) For herbal medicinal materials and semi-finished herbal medicinal materials without marketing authorizations in Vietnam, submit the original or a certified true copy or a copy of the license to import herbal medicinal materials bearing the seal of the importing establishment;

d) A copy, bearing the seal of the importing establishment, of the power of attorney from the establishment manufacturing the herbal medicinal material or semi-finished herbal medicinal material to the foreign establishment supplying medicinal products, unless they are the same. The power of attorney shall comply with Point dd, Clause 1, Article 78 of this Decree;

dd) Submit the original or a copy of the Certificate of Analysis from the manufacturing establishment for each imported batch of an herbal medicinal material or semi-finished herbal medicinal material, bearing the seal of the importing establishment;

e) In case of importing an herbal medicinal material or semi-finished herbal medicinal material as prescribed at Point dd, Clause 1, Article 59 of the Law on Pharmacy and not subject to an import license, the importing establishment shall submit the bill of lading of the batch of the herbal medicinal material or semi-finished herbal medicinal material, showing that the goods were shipped from the port of departure of the exporting country before the expiry date of the marketing authorization;

g) For herbal medicinal materials and semi-finished herbal medicinal materials imported in accordance with Article 68 and Article 69 of this Decree, the submission of the documents prescribed at Points b, d, dd, and e of this Clause is not required;

h) In case of importing an herbal medicinal material or semi-finished herbal medicinal material as prescribed at Point dd, Clause 1, Article 59 of the Law on Pharmacy and subject to an import license, the importing establishment shall submit the bill of lading of the batch of the herbal medicinal material or semi-finished herbal medicinal material, showing that the goods were shipped from the port of departure of the exporting country before the expiry date of the marketing authorization and the import license, for customs clearance;

i) In case of importing an herbal medicinal material or semi-finished herbal medicinal material under an import license without a marketing authorization in Vietnam, and at the time of customs clearance the import license has expired, the importing establishment shall submit the bill of lading of the batch of the herbal medicinal material or semi-finished herbal medicinal material, showing that the goods were shipped from the port of departure of the exporting country before the expiry date of the import license, for customs clearance.

4. Customs clearance for import of medicinal products and medicinal materials without marketing authorization in Vietnam, unless otherwise prescribed in Clauses 2 and 3 of this Article:

a) Submit the original or a certified true copy or a copy bearing the confirmation seal of the importing establishment of the Certificate of Eligibility for Pharmaceutical Business of the importing establishment, in cases where the importing establishment is a pharmaceutical business;

b) Submit the original or a certified true copy or a copy bearing the confirmation seal of the importing establishment of the license to import the medicinal product or medicinal material; except for a medicinal product without a marketing authorization in Vietnam used for a clinical trial of a medicinal product and not being a medicinal product subject to special control, and a medicinal product without a marketing authorization in Vietnam used for a state health program and not being an aid medicinal product;

c) Submit the original or a copy bearing the confirmation seal of the importing establishment of the Certificate of Analysis for each imported batch of a medicinal product or medicinal material in case of importing a medicinal product or medicinal material as prescribed in Article 51; Article 52; Clause 2, Article 54; Article 55; Points c and d, Clause 1, Article 57; Article 65; Article 66; Point b, Clause 1, Article 68; Article 70 and Article 71 of this Decree;

d) Submit a certified true copy or a copy signed by the person entering Vietnam or a copy bearing the seal of the importing organization of the prescription or outpatient treatment record in one of the cases prescribed in Clause 2, Article 60 of this Decree;

dd) Submit a copy, bearing the confirmation seal of the importing establishment, of the power of attorney, sales license, or partnership certificate as prescribed at Point dd, Clause 1, Article 78 of this Decree, except for medicinal products imported in accordance with Articles 53, 54, 56, 57, 58, and 59 of this Decree, primary packaging materials in direct contact with the medicinal product, medicinal materials subject to special control imported for the manufacture of medicinal products for export as prescribed in Article 66 of this Decree, medicinal materials for which import licenses are issued in accordance with Articles 68, 69, 70, and 71 of this Decree, and medicinal materials subject to special control imported for testing and research;

e) In case of importing a medicinal product or medicinal material under an import license without a marketing authorization in Vietnam, and at the time of customs clearance the import license has expired, the importing establishment shall submit the bill of lading of the batch of the medicinal product or medicinal material, showing that the goods were shipped from the port of departure of the exporting country before the expiry date of the import license, for customs clearance;

g) In case of importing a medicinal product without a marketing authorization in Vietnam for use in a state health program and not being an aid medicinal product, the importing establishment shall present a written approval from the competent state regulatory authority for the use of the medicinal product to serve the state health program.

 

Section 6

REGULATIONS ON THE CHANGE OF USE PURPOSE OF MATERIALS FOR THE MANUFACTURE OF MEDICINAL PRODUCTS AND THE TRANSFER OF MEDICINAL PRODUCTS TO SERVE URGENT NEEDS FOR NATIONAL DEFENSE, SECURITY, DISEASE PREVENTION AND CONTROL, OVERCOMING THE CONSEQUENCES OF NATURAL DISASTERS AND CATASTROPHES, AND SPECIAL TREATMENT NEEDS

 

Article 84. Dossier, procedures, and time limit for handling the change of use purpose of active pharmaceutical ingredients and herbal medicinal materials for the manufacture of medicinal products with marketing authorizations for the prevention and treatment of a Group A infectious disease which has been declared as an epidemic in accordance with the law on prevention and control of infectious diseases, for active pharmaceutical ingredients and herbal medicinal materials for which import licenses have been issued for other purposes

1. A dossier of application for a change of use purpose of an active pharmaceutical ingredient or medicinal material shall comprise:

A notification from the medicinal product manufacturing establishment regarding the change of use purpose of the active pharmaceutical ingredient or medicinal material, made using Form No. 52 in Appendix III to this Decree.

2. Procedures and time limit for handling the change of use purpose of an active pharmaceutical ingredient or medicinal material:

a) The medicinal product manufacturing establishment shall send a notification either directly, via postal service, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health shall issue the applying establishment a Dossier Receipt Note made using Form No. 01 in Appendix I to this Decree;

c) Within 05 working days from the date of receiving the dossier, the Ministry of Health shall consider and send a written notice to the establishment that the use purpose may be changed as requested by the manufacturing establishment if the information about the active pharmaceutical ingredient or herbal medicinal material of which the change is requested is consistent with the information about the active pharmaceutical ingredient or herbal medicinal material used for manufacture according to the medicinal product registration dossier for which a marketing authorization in Vietnam has already been granted. In cases where permission is not granted, the reasons must be clearly stated.

Article 85. Regulations on the transfer of medicinal products without marketing authorizations in Vietnam, which are imported to serve urgent needs for national defence, security, disease prevention and control, overcoming the consequences of natural disasters and catastrophes, and special treatment needs

1. For medicinal products imported to serve special treatment needs:

a) A medical examination and treatment establishment that has imported or purchased a medicinal product or vaccine imported to serve its own special treatment needs may transfer the medicinal product or vaccine to serve the special treatment needs of another medical examination and treatment establishment that has a Medicine and Treatment Council, or another immunization establishment nationwide;

b) A pharmaceutical business that imports a medicinal product or vaccine to serve the special treatment needs of a medical examination and treatment establishment or immunization establishment may transfer the medicinal product or vaccine to serve the special treatment needs of another medical examination and treatment establishment that has a Medicine and Treatment Council, or another immunization establishment nationwide;

c) A medical examination and treatment establishment or immunization establishment that receives a transferred medicinal product or vaccine must provide all the documents prescribed at Points c, d, and dd, Clause 3, Article 54 of this Decree to the importing establishment or the medical examination and treatment establishment or immunization establishment that has the transferred medicinal product or vaccine before receiving the transfer.

2. For medicinal products imported to serve urgent needs for national defence, security, disease prevention and control, and overcoming the consequences of natural disasters and catastrophes:

a) A medicinal product without a marketing authorization in Vietnam that is imported to serve urgent needs for national defence, security, disease prevention and control, and overcoming the consequences of natural disasters and catastrophes may be transferred to serve the needs of prevention and treatment of diseases;

b) The transfer of the medicinal products prescribed in this Clause shall comply with the law regulations on the management and use of public assets and other relevant law regulations;

c) An establishment that uses a transferred medicinal product shall be responsible for the safety, efficacy, and quality of the medicinal product after receiving the transfer and shall ensure that the medicinal product is used in accordance with its approved indications.

 

Section 7

REGULATIONS ON MEDICINAL PRODUCTS SUBJECT TO IMPORT CONTROL

 

Article 86. Types of medicinal products subject to import control

A medicinal product that is granted a marketing authorization in Vietnam is subject to import control as prescribed in Articles 87 and 88 of this Decree, unless it is:

1. A medicinal product that serves the needs for prevention and treatment of a Group A infectious disease which has been declared as an epidemic in accordance with the law on prevention and control of infectious diseases.

2. A medicinal product with a shelf life of less than 30 days.

Article 87. Regulations on import notification

1. At least 05 working days before carrying out customs declaration procedures, an importing establishment must notify the provincial-level People's Committee of the locality where the medicinal product is imported of the following information:

a) Name of the medicinal product, active substance, strength, dosage form, and packaging specifications;

b) Name and address of the manufacturing establishment;

c) Reference number of the marketing authorization;

d) Date of manufacture and expiry date;

dd) Batch number;

e) Actual import quantity and unit of measurement;

g) Port of import and expected date of import;

After completing the notification, the importing establishment will be issued a receipt code for the notification. The importing establishment shall take full accountability to the law for the accuracy and truthfulness of the notified details.

In cases where there is a change in the notified information, the importing establishment must make a new notification as prescribed in this Clause, and the new notification must include the details: "This notification replaces the notification with receipt code No. ..." (stating the receipt code of the old notification).

2. Within 05 working days from receiving the notification from the importing establishment, the provincial-level People's Committee shall review the information of the imported medicinal product according to the notification that has been issued a receipt code and cross-check it with the information of the medicinal product that has been granted a marketing authorization and published on the electronic portal of the Ministry of Health according to the following criteria:

a) The information about the imported medicinal product as prescribed at Points a, b, c, and d, Clause 1 of this Article in the notified details must be consistent with the information of the medicinal product that has been granted a marketing authorization in Vietnam;

b) The medicinal product must have a valid marketing authorization in Vietnam, or its marketing authorization may continue to be used in accordance with Point c, Clause 8, Article 56 of the Law on Pharmacy at the time of notification;

c) The medicinal product is not subject to a recommendation from a competent state authority regarding the temporary suspension or termination of its import into Vietnam.

3. In cases where the medicinal product fails to meet one of the criteria prescribed in Clause 2 of this Article at the time of notification, within 05 working days from the date of receiving the notified details, the provincial-level People's Committee shall send a written notice of non-compliance to the customs authority at the port of import of the medicinal product for consideration of customs clearance in accordance with the law regulations, and concurrently notify the establishment importing the medicinal product for review, adjustment, and re-notification in accordance with the regulations.

4. After 05 working days from the date the importing establishment carries out the notification procedure, if the provincial-level People's Committee does not issue a written notice as prescribed in Clause 3 of this Article, the importing establishment may carry out customs procedures in accordance with the law regulations.

In cases where, after customs clearance, the provincial-level People's Committee discovers that the imported batch of the medicinal product does not comply with Point c, Clause 2 of this Article, it is responsible for sending a written notice to the Ministry of Health and the importing establishment to implement the temporary suspension of trading and use as prescribed in Clause 6, Article 77 of the Law on Pharmacy.

5. The customs authority shall inspect the customs dossier in accordance with Article 32 of the Law on Customs and other law regulations on customs.

6. The customs authority shall not allow customs clearance of an imported batch of a medicinal product in one of the following cases:

a) The provincial-level People's Committee has issued a written notice as prescribed in Clause 3 of this Article, unless the imported medicinal product may continue to be placed on the market as prescribed at Point dd, Clause 1, Article 59 of the Law on Pharmacy;

b) The notification of the import of the batch of the medicinal product has not been made for at least 05 working days up to the time of carrying out customs procedures.

c) Other cases as prescribed by law regulations.

7. The operations prescribed in Clauses 1, 2, 3, and 4 of this Article shall be carried out online and integrated into the National Single Window Portal according to the roadmap prescribed in Clause 2, Article 125 of this Decree.

Article 88. Regulations on quality control testing of medicinal products before marketing

1. A medicinal product subject to import control as prescribed in Article 86 of this Decree, falling under the cases prescribed in Clause 3, Article 103 of the Law on Pharmacy, must be tested to determine that its quality meets the requirements before being launched into market.

2. The testing of a medicinal product to determine its quality before marketing shall be carried out in accordance with Clauses 3, 4, and 5, Article 103 of the Law on Pharmacy.

3. An imported batch of a medicinal product that requires quality control testing before marketing as prescribed in Clause 1 of this Article must be stored at a warehouse that meets the principles and standards of Good Storage Practices for medicinal products and medicinal materials of the importing establishment for the purpose of sampling for quality control testing.

4. In cases where the test results do not meet the requirements, the importing establishment shall notify the provincial-level People's Committee of the locality where the medicinal product is imported of these test results within 03 working days from the date of receiving the test results from the testing establishment.

5. An imported batch of a medicinal product with test results that do not meet the quality standards shall be handled in accordance with the regulations of the Minister of Health and other relevant law regulations.

 

Chapter V

MARKETING AUTHORIZATION FOR HERBAL MEDICINAL MATERIALS, EXCIPIENTS, AND CAPSULES, REGULATIONS ON THE QUANTITY OF MARKETING AUTHORIZATIONS, AND ASSESSMENT OF FOREIGN ESTABLISHMENTS MANUFACTURING MEDICINAL PRODUCTS AND MEDICINAL MATERIALS

 

Section 1

MARKETING AUTHORIZATION FOR HERBAL MEDICINAL MATERIALS, EXCIPIENTS, AND CAPSULES, REGULATIONS ON THE QUANTITY OF MARKETING AUTHORIZATIONS

 

Article 89. Subjects and requirements for marketing authorization for herbal medicinal materials, excipients, and capsules

1. An herbal medicinal material in one of the following cases must be registered before being placed on the market in Vietnam:

a) An herbal medicinal material used to make a medicinal product for the first time in Vietnam;

b) A semi-finished herbal medicinal material, except for products manufactured by the same establishment for the manufacture of finished medicinal products, or semi-finished herbal medicinal materials for the manufacture of a medicinal product according to a medicinal product registration dossier for which a marketing authorization in Vietnam has already been granted, or semi-finished products for testing, research, or manufacture of medicinal products for export.

2. An herbal medicinal material not prescribed in Clause 1 of this Article must have its standards announced in accordance with Clause 2, Article 68 of the Law on Pharmacy. In cases where an establishment wishes to apply for a marketing authorization, it shall comply with Section 1, Chapter V of this Decree.

3. A medicinal material that is an excipient for a medicinal product with in-house standards developed by the excipient manufacturing establishment that are not applied or are not available in the Pharmacopoeia of Vietnam, national standards or technical regulations on medicinal products, or do not apply a foreign pharmacopoeia in Vietnam as prescribed by the Minister of Health must be registered before being placed on the market in Vietnam in accordance with Section 1, Chapter V of this Decree, except for excipients used for the manufacture of a medicinal product that has been granted a valid marketing authorization in Vietnam, and excipients used for testing, research, or manufacture of medicinal products for export.

4. A medicinal material that is a capsule must be registered before being placed on the market in Vietnam in accordance with Section 1, Chapter V of this Decree, except for capsules used for the manufacture of a medicinal product that has been granted a valid marketing authorization in Vietnam, and capsules used for testing, research, or manufacture of medicinal products for export.

5. An establishment that may have an herbal medicinal material, excipient, or capsule registered in its name, may be:

a) An establishment as prescribed in Clause 3, Article 54 of the Law on Pharmacy;

b) An establishment as prescribed at Point c, Clause 1, Article 35 of the Law on Pharmacy that is allowed to have an herbal medicinal material registered in its name.

6. The form of registration, and the rights and responsibilities of an establishment registering an herbal medicinal material, excipient, or capsule shall comply with Articles 55 and 57 of the Law on Pharmacy.

Article 90. Competence, dossier, procedures, and time limits for issuance, renewal, modification, supplementation, and revocation of a marketing authorization for an herbal medicinal material, excipient, or capsule

The competence, dossier, procedures, and time limits for issuance, renewal, modification, supplementation, and revocation of a marketing authorization for an herbal medicinal material, excipient, or capsule shall comply with Articles 56 and 58 of the Law on Pharmacy, unless the establishment that cultivates and harvests the herbal medicinal material does not have a Certificate of Eligibility for Pharmaceutical Business, in which case it must submit a certified true copy of its Enterprise Registration Certificate when submitting the dossier of application for marketing authorization for such herbal medicinal material.

Article 91. Quantity of marketing authorizations for medicinal products with the same active pharmaceutical ingredient or herbal medicinal material

Medicinal products with the same active pharmaceutical ingredient or herbal medicinal material, the same dosage form, the same route of administration, and the same strength or concentration in a single-dose unit manufactured at one manufacturing site of one manufacturing establishment shall be granted a maximum of 02 marketing authorizations, unless they are:

1. Medicinal products for export only, not for marketing in Vietnam.

2. Medicinal products manufactured through technology transfer.

3. Medicinal products manufactured through contract manufacturing.

4. Over-the-counter medicinal products:

a) For use in children, in the dosage forms of oral solution; syrup; powder or granules for oral suspension; powder or granules for oral solution, using different flavouring and sweetening excipients;

b) In the dosage form of lozenges, using different flavouring and sweetening excipients.

 

Section 2

ASSESSMENT OF COMPLIANCE WITH GOOD MANUFACTURING PRACTICES OF FOREIGN ESTABLISHMENTS MANUFACTURING MEDICINAL PRODUCTS AND MEDICINAL MATERIALS UPON REGISTRATION FOR MARKETING AUTHORIZATION IN VIETNAM

 

Article 92. Cases where the compliance with Good Manufacturing Practices of foreign establishments manufacturing medicinal products and medicinal materials shall be assessed

1. When an imported medicinal product or medicinal material is registered for marketing authorization in Vietnam, the foreign establishment manufacturing the medicinal product or medicinal material, even in cases where it only participates in one or more manufacturing stages, must be assessed for compliance with Good Manufacturing Practices, unless:

a) The production line of the medicinal product or medicinal material of the establishment has been assessed by the Ministry of Health of Vietnam as compliant with Good Manufacturing Practices in accordance with Clause 5, Article 54 of the Law on Pharmacy;

b) The establishment manufacturing the medicinal product for the purpose of registering it for marketing authorization as prescribed at Point c, Clause 9, Article 56 of the Law on Pharmacy.

2. A foreign establishment manufacturing a medicinal product or medicinal material that has been assessed by the Ministry of Health of Vietnam as compliant with Good Manufacturing Practices in accordance with Clause 5, Article 54 of the Law on Pharmacy must undergo an assessment of maintenance of compliance in the following cases:

a) The validity period of the certificate of compliance with Good Manufacturing Practices regarding the assessed production line has expired;

b) There is a change in the information about the scope of certification in the certificate of compliance with Good Manufacturing Practices that has been announced by the Ministry of Health;

c) There is a change in other information in the certificate of compliance with Good Manufacturing Practices that has been announced by the Ministry of Health, unless otherwise prescribed at Point b of this Clause.

Article 93. Regulations on the assessment of compliance with Good Manufacturing Practices through validation of dossiers related to manufacturing conditions

1. Validation of dossiers related to manufacturing conditions shall be applied unless:

a) The manufacturing establishment falls under the cases where recognition or mutual recognition of inspection results of a competent authority regarding the requirements for compliance with Good Manufacturing Practices as prescribed in Clause 1, Article 94 of this Decree is applied;

b) The manufacturing establishment falls under the cases where on-site inspection at the manufacturing establishment as prescribed at Points a, b, and dd, Clause 1, Article 95 of this Decree is applied.

2. A dossier of application for assessment shall comprise:

a) An application for assessment of Good Manufacturing Practices, made using Form No. 01 in Appendix VIII to this Decree;

b) A Certificate of Good Manufacturing Practices or a manufacturing license issued by the competent authority of the host country;

c) A Good Manufacturing Practices inspection report of the most recent inspection, issued by the competent authority of the host country;

d) A Site Master File of the manufacturing establishment, in accordance with the guidance of the European Union (EU), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), or the World Health Organization;

dd) A list of Good Manufacturing Practices inspections conducted by the competent authority of the host country and the competent authorities of other countries (if any) within 03 years from the date of dossier submission;

e) A Certificate of Good Manufacturing Practices and a Good Manufacturing Practices inspection report with respect to the manufacturing establishment, issued by a Stringent Regulatory Authority (SRA) or a pharmaceutical regulatory authority recognized by the Ministry of Health based on the classification of the World Health Organization (if any).

3. The sequence and procedures for assessment:

a) An establishment applying for assessment of compliance with Good Manufacturing Practices shall submit a dossier either directly, via postal service, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health shall issue the applying establishment a Dossier Receipt Note made using Form No. 02 in Appendix VIII to this Decree;

c) The Ministry of Health shall organize the assessment of the dossier and provide a written response on the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material within a maximum of 40 days from the date of receipt.

In cases where the dossier includes additional documents as prescribed at Point e, Clause 2 of this Article, the maximum assessment time is 20 days from the date of receipt.

In cases where the dossier has not yet met or fails to comply with Good Manufacturing Practices, the written response must clearly state the reasons;

d) Within a maximum of 30 days from the date of receiving the amended or supplemented dossier from the applying establishment, the Ministry of Health shall organize the assessment of the amended or supplemented dossier and provide a written response on the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material.

In cases where the dossier has not yet met or fails to comply with Good Manufacturing Practices, the written response must clearly state the reasons;

dd) Within a maximum of 30 days from the date of receiving the second amended or supplemented dossier from the applying establishment, the Ministry of Health shall organize the assessment of the second amended or supplemented dossier and provide a written response on the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material. In cases where the amended or supplemented dossier is not yet satisfactory or is unsatisfactory, the dossier-receiving authority shall send a written response that the dossier fails to comply with Good Manufacturing Practices and state the reasons;

e) Within 06 months from the date of receiving a written response from the Ministry of Health regarding the failure to comply with Good Manufacturing Practices, the applying establishment must submit an amended or supplemented dossier as required. After this time limit, if the establishment fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid;

g) Within 03 working days from the date of the assessment result concluding compliance with Good Manufacturing Practices, the Ministry of Health shall announce on the electronic portal of the Ministry of Health information about the assessed manufacturing establishment and the principles and standards of Good Manufacturing Practices that the establishment complies with.

4. The details of assessment:

a) Cross-checking the completeness of the dossier as prescribed in Clause 2 of this Article and Article 97 of this Decree;

b) Cross-checking the scope of certification stated on the Certificate of Good Manufacturing Practices or the Good Manufacturing Practices inspection report or the manufacturing license with the dosage form of the registered medicinal product or medicinal material;

c) Assessing the layout of the production line and auxiliary systems; the cleanliness level of the manufacturing rooms; and the production and testing equipment in the Site Master File of the manufacturing establishment, unless the establishment has a scope of certification stated in the document prescribed at Point e, Clause 2 of this Article that is consistent with the scope of the requested assessment;

d) Cross-checking the level of compliance with Good Manufacturing Practices of the manufacturing establishment, and the deficiencies in the manufacturing, testing, and storage of medicinal products and medicinal materials identified in the Good Manufacturing Practices inspection report.

Article 94. Regulations on the assessment of compliance with Good Manufacturing Practices through recognition or mutual recognition of inspection results of the state regulatory authority in charge of pharmacy regarding the requirements for compliance with Good Manufacturing Practices for medicinal products and medicinal materials

1. Recognition or mutual recognition of inspection results of the state regulatory authority in charge of pharmacy regarding the requirements for compliance with Good Manufacturing Practices for medicinal products and medicinal materials shall be applied in the following cases:

a) The manufacturing establishment is in a country announced by the Ministry of Health in the list of countries with which Vietnam has signed a mutual recognition agreement on Good Manufacturing Practices inspection results, on the electronic portal of the Ministry of Health, unless otherwise prescribed at Points a and b, Clause 1, Article 95 of this Decree;

b) The manufacturing establishment is in a country whose competent pharmaceutical authority is a Stringent Regulatory Authority (SRA) or a pharmaceutical regulatory authority recognized by the Ministry of Health based on the classification of the World Health Organization and has been inspected and assessed by one of these authorities as compliant with Good Manufacturing Practices, unless otherwise prescribed at Points a and b, Clause 1, Article 95 of this Decree.

2. A dossier of application for assessment shall comprise:

a) An application for assessment of Good Manufacturing Practices, made using Form No. 01 in Appendix VIII to this Decree;

b) A Certificate of Good Manufacturing Practices or a manufacturing license or a Good Manufacturing Practices inspection report in cases where the competent authority of the host country does not issue a Certificate of Good Manufacturing Practices or a manufacturing license.

3. The sequence and procedures for assessment:

a) An establishment applying for assessment of compliance with Good Manufacturing Practices shall submit a dossier either directly, via postal service, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health shall issue the applying establishment a Dossier Receipt Note made using Form No. 02 in Appendix VIII to this Decree;

c) The Ministry of Health shall organize the assessment of the dossier and provide a written response on the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material within a maximum of 20 days from the date of receipt. In cases where the dossier has not yet met or fails to comply with Good Manufacturing Practices, the written response must clearly state the reasons;

d) Within a maximum of 15 days from the date of receiving the amended or supplemented dossier from the applying establishment, the Ministry of Health shall organize the assessment of the amended or supplemented dossier and provide a written response on the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material. In cases where the dossier has not yet met or fails to comply with Good Manufacturing Practices, the written response must clearly state the reasons;

dd) Within a maximum of 15 days from the date of receiving the second amended or supplemented dossier from the applying establishment, the Ministry of Health shall organize the assessment of the second amended or supplemented dossier and provide a written response on the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material. In cases where the amended or supplemented dossier is not yet satisfactory or is unsatisfactory, the dossier-receiving authority shall send a written response that the dossier fails to comply with Good Manufacturing Practices and state the reasons;

e) Within 06 months from the date of receiving a written response from the Ministry of Health regarding the failure to comply with Good Manufacturing Practices, the applying establishment must submit an amended or supplemented dossier as required. After this time limit, if the establishment fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid;

g) Within 03 working days from the date of the assessment result concluding compliance with Good Manufacturing Practices, the Ministry of Health shall announce on the electronic portal of the Ministry of Health information about the assessed manufacturing establishment and the principles and standards of Good Manufacturing Practices that the establishment complies with.

4. The details and scope of assessment:

a) Cross-checking the completeness of the dossier as prescribed in Clause 2 of this Article and Article 97 of this Decree;

b) Cross-checking the scope of certification stated on the Certificate of Good Manufacturing Practices or the Good Manufacturing Practices inspection report or the manufacturing license with the dosage form of the registered medicinal product or medicinal material;

c) The recognition or mutual recognition of Good Manufacturing Practices inspection results includes the scope of certification, the principles and standards of Good Manufacturing Practices, and other details related to Good Manufacturing Practices and the conditions for the manufacture of medicinal products and medicinal materials.

Article 95. Regulations on the assessment of compliance with Good Manufacturing Practices through on-site inspection at the establishment manufacturing a medicinal product or medicinal material

1. On-site inspection at the establishment manufacturing a medicinal product or medicinal material shall be applied in the following cases:

a) The manufacturing establishment has a dossier for registration of a medicinal product or medicinal material with signs of alteration or suspicion of the authenticity of the information and data in the dossier;

b) The manufacturing establishment has a medicinal product with a Level 1 quality defect, according to the conclusion of the Ministry of Health;

c) The manufacturing establishment has a dossier of application for assessment of manufacturing conditions based on which the Ministry of Health concludes that there are not sufficient grounds to prove that the manufacturing establishment complies with Good Manufacturing Practices;

d) The manufacturing establishment is in the exporting country applies principles and standards of Good Manufacturing Practices that are not consistent with the principles and standards of Good Manufacturing Practices promulgated or recognized for application by the Minister of Health;

dd) The manufacturing establishment has a medicinal product or medicinal material registered for marketing authorization in Vietnam for the first time, except for a manufacturing establishment as prescribed in Clause 1, Article 94 of this Decree or an establishment manufacturing a medicinal product or medicinal material that has been assessed and certified as compliant with Good Manufacturing Practices by a Stringent Regulatory Authority (SRA) or a pharmaceutical regulatory authority recognized by the Ministry of Health based on the classification of the World Health Organization.

2. A dossier of application for assessment shall comprise:

a) An application for assessment of Good Manufacturing Practices, made using Form No. 01 in Appendix VIII to this Decree;

b) The documents prescribed at Points b, c, and d, Clause 2, Article 93 of this Decree.

3. The sequence and procedures for assessment:

a) An establishment applying for assessment of compliance with Good Manufacturing Practices shall submit a dossier either directly, via postal service, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health shall issue the applying establishment a Dossier Receipt Note made using Form No. 02 in Appendix VIII to this Decree;

c) Within a maximum of 90 days from the date of receiving a complete dossier in the cases prescribed at Points b, d, and dd, Clause 1 of this Article, or from the date of announcing the validation results of the medicinal product registration dossier or the dossier of application for assessment of a manufacturing establishment's compliance with Good Manufacturing Practices in the cases prescribed at Points a and c, Clause 1 of this Article, the Ministry of Health shall organize the assessment and provide a written response on the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material. In cases where the manufacturing establishment has not yet met or fails to comply with Good Manufacturing Practices, the written response must clearly state the reasons;

d) Within a maximum of 40 days from the date of receiving the amended or supplemented dossier, the Ministry of Health shall organize the assessment of the amended or supplemented dossier and provide a written response on the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material. In cases where the dossier has not yet met or fails to comply with Good Manufacturing Practices, the written response must clearly state the reasons;

dd) Within a maximum of 40 days from the date of receiving the second amended or supplemented dossier from the applying establishment, the Ministry of Health shall organize the assessment of the second amended or supplemented dossier and provide a written response on the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material. In cases where the amended or supplemented dossier is not yet satisfactory or is unsatisfactory, the dossier-receiving authority shall send a written response that the dossier fails to comply with Good Manufacturing Practices and state the reasons;

e) Within 06 months from the date of receiving a written response from the Ministry of Health regarding the failure to comply with Good Manufacturing Practices, the applying establishment must submit an amended or supplemented dossier as required. After this time limit, if the establishment fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid;

g) Within 03 working days from the date of the assessment result concluding compliance with Good Manufacturing Practices, the Ministry of Health shall announce on the electronic portal of the Ministry of Health information about the assessed manufacturing establishment and the principles and standards of Good Manufacturing Practices that the establishment complies with.

4. The details of assessment:

a) Cross-checking the completeness of the dossier as prescribed in Clause 2 of this Article and Article 97 of this Decree;

b) Assessing the current state of the facilities, including the layout of the facilities, production lines, building materials, manufacturing environment conditions, the arrangement for movement of personnel, raw materials, semi-finished products, and finished products, and the auxiliary systems; the cleanliness level of the manufacturing rooms; and the equipment for manufacturing, testing, and storage of medicinal products and medicinal materials;

c) Assessing the actual manufacturing process of the production line for the registered medicinal product or medicinal material;

d) Assessing the establishment and operation of the quality management system of the manufacturing establishment;

dd) Assessing the actual state of the application of and compliance with Good Manufacturing Practices in all operations of manufacturing, testing, and storing medicinal products and medicinal materials at the manufacturing establishment.

5. An on-site inspection at the manufacturing establishment may be conducted remotely via electronic means in cases where travel is restricted due to epidemics, wars, or catastrophes.

Article 96. Regulations on the assessment of maintenance of compliance with Good Manufacturing Practices

1. A dossier of application for assessment applicable to Points a and b, Clause 2, Article 92 of this Decree shall comprise:

a) An application for assessment of maintenance of compliance with Good Manufacturing Practices, made using Form No. 01 in Appendix VIII to this Decree;

b) A Certificate of Good Manufacturing Practices or a manufacturing license and a Good Manufacturing Practices inspection report of the most recent inspection if it is an establishment manufacturing a medicinal product or medicinal material that has been assessed in accordance with Article 93 of this Decree;

c) A Certificate of Good Manufacturing Practices or a manufacturing license or a Good Manufacturing Practices inspection report if it is an establishment manufacturing a medicinal product or medicinal material that has been assessed in accordance with Article 94 of this Decree;

d) A Certificate of Good Manufacturing Practices or a manufacturing license and a Good Manufacturing Practices inspection report of the most recent inspection if it is an establishment manufacturing a medicinal product or medicinal material that has been assessed in accordance with Article 95 of this Decree;

dd) An updated Site Master File of the manufacturing establishment in cases where there is a change in the layout of the facility or the production line for the medicinal product or medicinal material that has been assessed as compliant with Good Manufacturing Practices in accordance with the regulations of the Ministry of Health;

e) Documents related to the changed information (if any).

2. Regulations on the dossier of application for assessment applicable to Point c, Clause 2, Article 92 of this Decree:

a) An application for assessment of maintenance of compliance with Good Manufacturing Practices, made using Form No. 01 in Appendix VIII to this Decree;

b) Documents related to the changed information, including legal papers issued by a competent authority.

3. The sequence and procedures for assessment:

a) An establishment applying for assessment of maintenance of compliance with Good Manufacturing Practices shall submit a dossier either directly, via postal service, or online to the Ministry of Health;

b) After receiving the dossier, the Ministry of Health shall issue the applying establishment a Dossier Receipt Note made using Form No. 02 in Appendix VIII to this Decree;

c) The Ministry of Health shall organize the assessment and validation of the dossier and provide a written response on the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material within a maximum of 20 days from the date of receipt. In cases where the dossier has not yet met or fails to comply with Good Manufacturing Practices, the written response must clearly state the reasons;

d) Within a maximum of 15 days from the date of receiving the amended or supplemented dossier from the applying establishment, the Ministry of Health shall organize the assessment of the supplemented dossier and provide a written response on the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material. In cases where the dossier has not yet met or fails to comply with Good Manufacturing Practices, the written response must clearly state the reasons;

dd) Within a maximum of 15 days from the date of receiving the second amended or supplemented dossier from the applying establishment, the Ministry of Health shall organize the assessment of the second amended or supplemented dossier and provide a written response on the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material. In cases where the amended or supplemented dossier is not yet satisfactory or is unsatisfactory, the dossier-receiving authority shall send a written response that the dossier fails to comply with Good Manufacturing Practices and state the reasons;

e) Within 06 months from the date of receiving a written response from the Ministry of Health regarding the failure to comply with Good Manufacturing Practices, the applying establishment must submit an amended or supplemented dossier as required. After this time limit, if the establishment fails to submit the amended or supplemented dossier, the submitted dossier will no longer be valid;

g) Within 03 working days from the date of the assessment result concluding compliance with Good Manufacturing Practices, the Ministry of Health shall announce on the electronic portal of the Ministry of Health information about the assessed manufacturing establishment and the principles and standards of Good Manufacturing Practices that the establishment complies with.

4. The details of assessment:

a) Cross-checking the completeness of the dossier as prescribed in Clauses 1 and 2 of this Article and Article 97 of this Decree;

b) Cross-checking the scope of certification stated on the Certificate of Good Manufacturing Practices or the Good Manufacturing Practices inspection report or the manufacturing license with the announced scope;

c) Cross-checking the level of compliance with Good Manufacturing Practices of the manufacturing establishment, and the deficiencies in the manufacturing, testing, and storage of medicinal products and medicinal materials identified in the Good Manufacturing Practices inspection report;

d) Assessing the information about changes recorded in the Good Manufacturing Practices inspection report, the status of non-compliance with Good Manufacturing Practices, and the correction of such non-compliance (if any).

5. A foreign establishment manufacturing a medicinal product or medicinal material may maintain being assessed as compliant with Good Manufacturing Practices in one of the following cases:

a) It has submitted a dossier for assessment of maintenance of compliance with Good Manufacturing Practices as prescribed in Clauses 1 and 2 of this Article;

b) The establishment registering or manufacturing the medicinal product or medicinal material provides the results of a self-lookup of information on the website or in the English database of the competent authority for the assessment of compliance with Good Manufacturing Practices, or on the website operated by the competent authority of the host country or a competent regional authority, confirming that the manufacturing establishment maintains compliance with Good Manufacturing Practices. The lookup must be performed after the expiry date of the validity of the compliance with Good Manufacturing Practices that has been announced on the electronic portal of the Ministry of Health of Vietnam. The self-lookup results must be stamped with the confirmation seal of the establishment registering or manufacturing the medicinal product or medicinal material, enclosed with a document providing the lookup link;

c) The registering or manufacturing establishment shall take full accountability to the law for the legality and accuracy of these documents and information and the self-lookup results of the establishment. The agency or organization that uses the lookup information shall perform the lookup and verification using the link provided by the establishment registering or manufacturing the medicinal product or medicinal material.

Article 97. Specific regulations on documents in the dossier of application for assessment and maintenance assessment of compliance with Good Manufacturing Practices of an establishment manufacturing medicinal products or medicinal materials

1. Documents serving as the basis for assessment:

a) Principles and standards of Good Manufacturing Practices for medicinal products and medicinal materials promulgated or recognized for application by the Minister of Health;

b) Applicable regulations on registration and quality management of medicinal products and medicinal materials;

c) In cases where the principles and standards of Good Manufacturing Practices are not among the principles and standards promulgated or recognized for application by the Minister of Health as prescribed at Point a, Clause 1 of this Article, the Advisory Council for the issuance of marketing authorizations for medicinal products and medicinal materials shall assess the conformity of the principles and standards of the exporting country with the principles and standards promulgated or recognized for application by the Minister of Health. After a conformity assessment result is available, the Minister of Health shall issue a decision to recognize the conformity of the principles and standards of Good Manufacturing Practices of the exporting country to serve as a basis for assessing the manufacturing establishment.

2. A dossier of application for assessment or maintenance assessment of compliance with Good Manufacturing Practices of a manufacturing establishment shall be made into 01 set in English or Vietnamese, in which the documents must be clearly printed, with separators between sections, a cover page, and a table of contents.

3. Requirements for a Certificate of Good Manufacturing Practices or a manufacturing license:

a) It must be valid at the time of dossier receipt;

b) In cases where the validity period is not stated, these documents must have been issued within no more than 03 years from the date of dossier receipt;

c) In case of non-compliance with Points a and b of this Clause, the registering or manufacturing establishment shall provide a written explanation enclosed with documents proving the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material.

4. Requirements for a Good Manufacturing Practices inspection report:

a) The Good Manufacturing Practices inspection report must have been issued no more than 03 years prior to the date of dossier receipt;

b) In case of non-compliance with Point a of this Clause, the registering or manufacturing establishment shall provide a written explanation enclosed with supporting documents.

5. In cases where a foreign competent authority does not issue a Certificate of Good Manufacturing Practices, a manufacturing license, or a Good Manufacturing Practices inspection report, the establishment registering or manufacturing the medicinal product or medicinal material may substitute it with other legal papers issued by a foreign competent authority to prove the status of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material.

Particularly for the assessment of compliance with Good Manufacturing Practices through recognition or mutual recognition as prescribed in Article 94 of this Decree, it may also be substituted by a Certificate of Pharmaceutical Product enclosed with information on the status of registration of manufacturing operations or information on the most recent Good Manufacturing Practices inspection conducted by the competent authority of the host country.

6. The documents prescribed in Clauses 3, 4, and 5 of this Article must contain at least the name and address of the issuing authority; the reference number of the document; the applied principles and standards of Good Manufacturing Practices; the name and address of the manufacturing establishment; the scope of certification of compliance with Good Manufacturing Practices; the time of the assessment inspection; and the time of issuance.

7. The documents prescribed in Clauses 3, 4, and 5 of this Article must be granted a consular legalization as prescribed, unless:

a) They are provided directly in writing or via the email of the Ministry of Health from the competent authority of the issuing country;

b) They are published on the website or in the English database of the competent authority of the issuing country or a competent regional authority.

The registering or manufacturing establishment shall submit the self-lookup results, stamped with the confirmation seal of the establishment, enclosed with a document providing the lookup link, and shall take full accountability to the law for the legality and accuracy of the self-lookup results and the information provided by the establishment.

8. The technical procedure for assessing and maintaining the assessment of compliance with Good Manufacturing Practices of a foreign establishment manufacturing a medicinal product or medicinal material to announce the manufacturing establishment's compliance with Good Manufacturing Practices shall be in accordance with the regulations of the Minister of Health.

Article 98. Responsibilities of an establishment registering a medicinal product or medicinal material in the inspection and assessment of Good Manufacturing Practices of a foreign manufacturing establishment, and cases where the receipt of dossiers for issuance and renewal of marketing authorizations for medicinal products or medicinal materials from establishments registering or manufacturing medicinal products or medicinal materials shall be suspended

1. Specifically, an establishment registering a medicinal product or medicinal material in the inspection and assessment of Good Manufacturing Practices of a foreign manufacturing establishment shall:

a) Submit or coordinate with the establishment manufacturing the medicinal product or medicinal material to submit a dossier of application for assessment and maintenance assessment of compliance with Good Manufacturing Practices of the foreign establishment manufacturing the medicinal product or medicinal material as prescribed;

b) Take accountability for ensuring the completeness and accuracy of the dossier of application for assessment of compliance with Good Manufacturing Practices; provide supporting documents as requested by the Ministry of Health;

c) Coordinate with the establishment manufacturing the medicinal product or medicinal material to comply with the requirements of the Ministry of Health regarding the inspection and assessment of the manufacturing establishment;

d) Report to the Ministry of Health on the maintenance of compliance with Good Manufacturing Practices of the establishment manufacturing the medicinal product or medicinal material. In cases where the manufacturing establishment has its manufacturing license revoked or fails to comply with Good Manufacturing Practices according to a notice from the competent authority of the host country, or from the certifying authority that is a Stringent Regulatory Authority (SRA) or a pharmaceutical regulatory authority recognized by the Ministry of Health based on the classification of the World Health Organization, if it is a manufacturing establishment assessed in accordance with Clause 3, Article 95 of this Decree, the establishment must report within 15 days from the date of the notice from the competent authority;

dd) Bear the cost of assessing the manufacturing establishment as prescribed by law regulations.

2. The receipt of a dossier for issuance or renewal of a marketing authorization for a medicinal product or medicinal material shall be suspended if the establishment applying for the registration of, or the establishment manufacturing, the medicinal product or medicinal material commits one of the following violations:

a) Falling under the cases where a marketing authorization for a medicinal product or medicinal material shall be revoked, as prescribed at Points a, d, and dd, Clause 1, Article 58 of the Law on Pharmacy;

b) Manufacturing a medicinal product from a material of unknown origin or an expired medicinal material;

c) Having 02 or more batches of a medicinal product or medicinal material compulsorily recalled due to a Level 2 quality defect, or 03 or more batches of a medicinal product or medicinal material compulsorily recalled due to quality defect within 01 year, according to the conclusion of a competent state authority in Vietnam;

d) Providing information related to the technical dossier that is not based on the actual research or manufacturing of the manufacturing establishment;

dd) Failing to report to the Ministry of Health within 15 days from the date of the notice from the competent authority of the host country regarding the revocation of the manufacturing establishment's manufacturing license or its non-compliance with Good Manufacturing Practices, or a notice of non-compliance with Good Manufacturing Practices from a competent authority that is a Stringent Regulatory Authority (SRA) or a pharmaceutical regulatory authority recognized by the Ministry of Health based on the classification of the World Health Organization as prescribed at Point d, Clause 1 of this Article, unless the establishment voluntarily applies for the revocation of the manufacturing license for commercial reasons;

e) Altering or modifying the expiry date of a medicinal product, unless otherwise prescribed in Clause 3, Article 61 of the Law on Pharmacy;

g) Failing to report to the Ministry of Health within 15 days from the date of the notice from a competent regulatory authority in cases where the medicinal product or medicinal material registered by the establishment is recalled or has its marketing authorization withdrawn in any country in the world, unless the establishment voluntarily applies for the recall or withdrawal of the marketing authorization for commercial reasons;

h) Committing an act of forgery or unauthorized alteration of dossiers, documents, or legal papers of Vietnamese or foreign functional agencies; using a forged seal or forging the signature or seal of the establishment applying for the registration, the manufacturing establishment, or other relevant establishments in the medicinal product registration dossier.

3. The period of suspension of receipt of a dossier for issuance and renewal of a marketing authorization for a medicinal product or medicinal material, from the date of issuance of the written notice of the violation by a competent authority, is:

a) From 03 years to 05 years in the cases prescribed at Point d, Clause 1, Article 58 of the Law on Pharmacy and Point h, Clause 2 of this Article;

b) From 01 year to 02 years in the cases prescribed at Points a and dd, Clause 1, Article 58 of the Law on Pharmacy and Points b, c, d, dd, and e, Clause 2 of this Article;

c) From 06 months to 01 year in the cases prescribed at Point b, Clause 1, Article 58 of the Law on Pharmacy and Point g, Clause 2 of this Article.

4. A dossier of application for issuance or renewal of a marketing authorization for a medicinal product or medicinal material of an establishment that has committed a violation as prescribed at Points d and h, Clause 2 of this Article, submitted before the date of being sanctioned for the violation, will no longer be valid. Upon the expiry of the period of suspension of receipt of the dossier as prescribed in Clause 3 of this Article, if the establishment wishes to apply for registration of a medicinal product or medicinal material, it must submit a dossier in accordance with the Law on Pharmacy.

 

Chapter VI

COMPETENCE, FORMS, AND PROCEDURES FOR RECALL OF MEDICINAL MATERIALS, AND MEASURES FOR HANDLING RECALLED MEDICINAL MATERIALS

 

Article 99. Forms and scope of recall of medicinal materials

1. Forms of recall:

a) Compulsory recall means a recall carried out under a decision of a competent state authority;

b) Voluntary recall means a recall carried out voluntarily by the establishment applying for the registration of, the establishment manufacturing, or the establishment importing the medicinal material.

2. Scope of recall:

a) A medicinal material shall be recalled in its entirety from all establishments trading in and using such medicinal material, unless otherwise prescribed at Point b of this Clause;

b) In cases where a medicinal material fails to meet quality standards due to errors in storage, transport, or distribution, or is used for a wrong purpose, the recall shall only apply to the affected part of the material at the establishments trading in or using such medicinal material;

c) The scope of recall must be clearly stated in the recall decision of the competent authority or the recall notice of the establishment applying for the registration of, the establishment manufacturing, or the establishment importing the medicinal material that voluntarily recalls it.

Article 100. Competence and procedures for recall of medicinal materials

1. Competence to issue a recall decision:

a) The Ministry of Health shall conclude that a material falls under a case where a recall is required and shall issue a decision to recall the defective medicinal material in case of a compulsory recall;

b) A domestic establishment manufacturing a medicinal material or an establishment importing a medicinal material shall conclude that a material falls under a case where a recall is required and shall issue a decision to recall the medicinal material in case of a voluntary recall.

2. Procedures for recall of a medicinal material:

a) Within no more than 48 hours from the issuance of a conclusion on the recall of a material, the Ministry of Health shall issue a recall decision, or the establishment prescribed at Point b, Clause 1 of this Article shall issue a recall decision and report to the Ministry of Health on the recall of the defective medicinal material. The recall decision shall be sent to the domestic establishment manufacturing the medicinal material, the establishment importing the material, and the provincial-level People's Committee, and shall be announced on the electronic portal of the Ministry of Health in case of a compulsory recall;

b) Within no more than 05 working days from the date of the recall decision, the domestic establishment manufacturing the medicinal material or the establishment importing the material must notify the information about the recalled medicinal material to the manufacturing establishments and businesses that have purchased the material, and concurrently organize the recall and receipt of the recalled medicinal material returned by such manufacturing establishments and businesses;

c) The recall of the medicinal material must be completed within 30 days from the date of the recall decision;

d) Within no more than 10 days from the completion of the recall, the establishment responsible for the recall must send a report to the Ministry of Health on the recall results, enclosed with a copy, bearing the seal of the establishment, of the dossier for recall of the material. The recall dossier shall include documents showing the quantity of the material manufactured or imported, the recalled quantity, the time of manufacture, the date of import, a list of the establishments that have purchased the material, and evidence of the implementation of the recall at the establishments trading in or using it;

dd) The Ministry of Health shall review the reported recall results, organize an assessment of the recall effectiveness, or coordinate with the Ministry of Public Security and relevant units to enforce the recall in cases where the domestic establishment manufacturing the material or the establishment importing the material fails to carry out the recall as prescribed at Point b or c of this Clause.

Article 101. Responsibility for recall of medicinal materials

1. A domestic manufacturing establishment or an establishment importing a medicinal material, which is then recalled, shall:

a) Conclude that a material falls under a case requiring recall and issue a decision to recall the medicinal product in case of a voluntary recall;

b) Stop trading in the recalled medicinal material;

c) Assume the prime responsibility for, and coordinate with relevant organizations and individuals in, announcing information about the recalled medicinal material and organizing the recall and receipt of the recalled medicinal material;

d) Handle the recalled medicinal material;

dd) Pay the costs of the recall and handling of the recalled medicinal material (even in case of enforced recall) and pay compensation for damages as prescribed by law regulations;

e) Report to the Ministry of Health on the recall and the results of the recall of the medicinal material.

2. An establishment distributing a medicinal material, which is then recalled, shall:

a) Stop trading in and distributing the recalled medicinal material;

b) Notify and organize the recall and receipt of the recalled medicinal material returned by the establishments manufacturing and using it;

c) Return the recalled medicinal material to the establishment that supplied it;

d) Pay the costs of the recall and handling of the recalled medicinal material (even in case of enforced recall) and pay compensation for damages as prescribed by law regulations in case of fault.

3. An establishment manufacturing medicinal products that uses a medicinal material, which is then recalled, shall:

a) Stop using the recalled medicinal material;

b) Return the recalled medicinal material to the establishment that supplied it.

4. The Ministry of Health shall:

a) Conclude that a material falls under a case where a recall is required and shall issue a decision to recall the defective medicinal material in case of a compulsory recall;

b) Review the reports and results of the recall from the manufacturing establishments and businesses;

c) Direct the provincial-level People's Committees to inspect and supervise the organization and implementation of the recalls of medicinal materials and to impose penalties on violators within their localities;

d) Decide on the enforcement of the recall in cases where the domestic establishment manufacturing the material or the establishment importing the material fails to carry out the recall as requested;

dd) Publicly announce information about the recalled medicinal material on the electronic portal of the Ministry of Health in cases where the recalled medicinal material must be destroyed.

5. Provincial-level People's Committees shall:

a) Notify the manufacturing establishments and businesses in their localities of the information about the recalls of medicinal materials;

b) Inspect and supervise the organization and implementation of the recalls of medicinal materials in their localities and handle violators within their localities;

c) Report to the Ministry of Health on cases where they discover that manufacturing establishments and businesses failed to carry out or have not fully carried out the recalls of medicinal materials.

Article 102. Handling of recalled medicinal materials

1. A recalled medicinal material that is an herbal medicinal material or active pharmaceutical ingredient must be destroyed in the following cases:

a) The recalled medicinal material is a material manufactured for a purpose other than human use but is labelled as a medicinal material for human use;

b) The recalled medicinal material is a material for which the marketing authorization was granted based on a forged dossier;

c) The recalled medicinal material is a material of unknown origin;

d) It is an active pharmaceutical ingredient manufactured, presented, or labelled to counterfeit the manufacturer, country of manufacture, or country of origin;

dd) It is a counterfeit herbal medicinal material;

e) It is an herbal medicinal material for which a marketing authorization has not been granted or quality standards has not been announced as prescribed;

g) The recalled medicinal material is a material used to manufacture a medicinal product, which is then recommended by the World Health Organization as unsafe or ineffective for users.

2. A recalled medicinal material may be remedied and reused in the following cases:

a) The medicinal material is recalled due to non-compliance with the labelling requirements for medicinal products and medicinal materials as prescribed in Article 61 of the Law on Pharmacy or other relevant law regulations;

b) The medicinal material is recalled because it was not manufactured at the site stated in the medicinal product registration dossier but was manufactured by the same establishment at another site that has been licensed for manufacturing by a competent authority.

3. A recalled medicinal material, unless it is a psychotropic active pharmaceutical ingredient, a habit-forming substance, or a precursor used as a medicinal product, which is not prescribed in Clauses 1 and 2 of this Article may be reprocessed, if it is domestically manufactured, or re-exported, if it is imported.

A recalled medicinal material prescribed in this Clause, if not reprocessed or re-exported, must be destroyed.

The manufacturing establishment or importing establishment shall be responsible for reporting to the Ministry of Health on the implementation of the reprocessing, re-export, or destruction of the recalled medicinal material.

4. A reprocessed medicinal material shall only be placed on the market or used when it meets both of the following conditions:

a) The reprocessing is carried out at an establishment that complies with Good Manufacturing Practices;

b) The reprocessing method must be consistent with the manufacturing process approved in the dossier for registration of the medicinal product or the medicinal material;

c) It is concluded by a state-owned medicinal product and medicinal material testing agency to meet the quality standards approved or accepted by the Ministry of Health.

5. Procedures for the destruction of a medicinal material:

a) The head of the establishment that has a medicinal material to be destroyed shall issue a decision to establish a Medicinal Material Destruction Council. The Council must have at least 03 members, including the head of the establishment and the person professionally responsible for pharmacy of the establishment;

b) The destruction of a medicinal material must ensure long-term safety for humans and animals and prevent environmental pollution in accordance with the law on environmental protection;

c) The establishment trading in the medicinal material, which has committed the violation, shall bear the cost of destroying the medicinal material;

d) The destruction of a medicinal material subject to special control must comply with Article 36 of this Decree.

 

Chapter VII

MEDICINAL PRODUCT ADVERTISING CONTENT, DOSSIER, PROCEDURES FOR RECEIPT, APPRAISAL, AND CONFIRMATION OF MEDICINAL PRODUCT ADVERTISING CONTENT; RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS IMPLEMENTING AND PARTICIPATING IN MEDICINAL PRODUCT ADVERTISING

 

Article 103. Regulations on medicinal product advertising content

1. The advertising content for a medicinal product must be consistent with the following documents:

a) The current label sample and package insert/patient information leaflet of the medicinal product, approved by the Ministry of Health;

b) The monograph on the medicinal product in the Pharmacopoeia of Vietnam;

c) Professional documents and guidelines related to the medicinal product, issued or recognized by the Ministry of Health;

d) In cases where the information about the medicinal product in the documents prescribed at Points a, b, and c of this Clause is inconsistent, the advertising content for the medicinal product must be based on the current label sample and package insert/patient information leaflet of the medicinal product, approved by the Ministry of Health.

2. The advertising content for a medicinal product must include the following mandatory information:

a) Medicinal product name;

b) The active pharmaceutical ingredient(s) or herbal medicinal material(s) as stated in the approved package insert/patient information leaflet. For an herbal medicinal material, its Vietnamese name must be written; if a Vietnamese name is not available, its Latin name shall be used;

c) Indications;

d) Route of administration;

dd) Dosage;

e) Contraindications, and recommendations for special populations (pregnant women, breastfeeding women, children, the elderly, people with chronic diseases) (if information is available);

g) Precautions and things to avoid and be aware of when using the medicinal product;

h) Adverse reactions and undesirable effects of the medicinal product;

i) Name and address of the establishment manufacturing the medicinal product;

k) The instruction "Read the patient information leaflet carefully before use";

l) At the bottom of the first page of medicinal product advertising content, it must be clearly stated: Reference number of the written confirmation of medicinal product advertising content by ... (confirming authority): .../XNQC..., dated ... month ... year...;

m) For advertising content consisting of multiple pages, the pages must be numbered, and the first page must clearly state how many pages the document has, and on which page the detailed information about the product can be found;

n) The medicinal product advertising content must clearly cite the supporting documents and must also specify the part of the information cited in the supporting documents. The citation must ensure that the information is conveyed accurately, without any inference or truncation of information that could lead to a misunderstanding of the safety and efficacy of the medicinal product.

3. The medicinal product advertising content on radio and television must include all the information prescribed at Points a, b, c, e, i, and k, Clause 2 of this Article, in which the content prescribed at Points a, b, c, e, and k, Clause 2 of this Article must be read aloud and clearly. In cases where the medicinal product contains 03 or more active ingredients, each active ingredient must be read, or the general name of the groups of vitamins, minerals, and herbal medicinal materials must be read.

4. The advertising content on online newspapers, websites, electronic devices, specialized advertising screens, and other advertising media as prescribed by the law on advertising:

a) Advertising content with audio must be presented in the same way as radio and television advertising content as prescribed in Clause 3 of this Article;

b) Advertising content without audio must include all the information prescribed in Clause 2 of this Article.

In cases where the advertising content is an audio or video recording with multiple pages or advertising scenes, the pages or advertising scenes must appear consecutively and be paused long enough for the viewer to read all the information displayed; the page or scene with the product information must be static and not in motion so that the reader can carefully study the product information. The script of an advertisement with multiple pages must describe how the content pages appear.

Advertisements of this type must be presented individually, and multiple medicinal products must not be advertised in an overlapping or interspersed manner to avoid misunderstanding.

5. Outdoor advertising content for a medicinal product shall be displayed entirely on one side of the advertising medium and must include the information prescribed at Points a, b, i, k, and l, Clause 2 of this Article. In cases where the advertising content includes information related to the uses, effects, and indications of the medicinal product, all information as prescribed in Clause 2 of this Article must be provided.

6. The language spoken or written in the advertising content for a medicinal product must comply with the Law on Advertising.

7. The font size in the advertising content for medicinal product must be clear, legible, and recognizable, but not smaller than font size 12 of the VnTime or Times New Roman font on A4 paper.

8. The advertising script must clearly describe the visuals, voice-over, text, and music.

9. The advertising content for a medicinal product shall only provide information about the medicinal product and shall not include information unrelated to the medicinal product.

Article 104. Information and images not to be used in the medicinal product advertising content

1. Information and images prohibited in advertising as prescribed in the Law on Advertising.

2. Content that causes misunderstanding about the ingredients, effects, indications, or origin of the medicinal product.

3. Content that can be construed to mean that: This medicinal product is number one; this medicinal product is better than all others; using this medicinal product is the best measure; this medicinal product can be used without a physician's advice; this medicinal product is completely harmless; the medicinal product has no contraindications; the medicinal product has no undesirable effects; the medicinal product has no harmful effects.

4. Words, phrases, and images that are excessively inferential, leading to a misunderstanding of the effects, indications, or efficacy of the medicinal product, or that exaggerate the effects, indications, or efficacy of the medicinal product that have been approved.

5. Citing the effects of each ingredient in the medicinal product to advertise beyond the approved uses of the medicinal product or to cause confusion between the effects of each ingredient and the effects of the medicinal product.

6. The words and phrases: “điều trị tận gốc” (radical treatment), “tiệt trừ” (eradication), “chuyên trị” (special treatment), “hàng đầu” (leading), “đầu bảng” (top of the line), “đầu tay” (first choice), “lựa chọn” (choice), “chất lượng cao” (high quality), “đảm bảo 100%” (100% guaranteed), “an toàn” (safe), “dứt” (cured), “cắt đứt” (cut off), “chặn đứng” (stopped), “giảm ngay” (immediate relief), “giảm liền” (instant relief), “giảm tức thì” (instant relief), “khỏi ngay” (cured immediately), “khỏi hẳn” (completely cured), “yên tâm” (peace of mind), “không lo” (no worries), “khỏi lo” (no more worries), “khuyên dùng” (recommended), “hotline”, and other words and phrases with similar meanings.

7. The following indications shall not be included in the medicinal product advertising content:

a) Indications for the treatment of tuberculosis and leprosy;

b) Indications for the treatment of sexually transmitted diseases;

c) Indications for the treatment of insomnia;

d) Indications of an aphrodisiac nature;

dd) Indications for the treatment of cancer and tumours;

e) Indications for the treatment of medicinal product addiction withdrawal;

g) Indications for the treatment of diabetes or other similar metabolic disorders;

h) Indications for the treatment of viral hepatitis and other emerging dangerous diseases.

8. The results of quality control tests of medicinal products and medicinal materials.

9. The results of pre-clinical research.

10. The results of clinical research or bioequivalence trials that have not been recognized by the Ministry of Health.

11. The use of the name, status, reputation, correspondence, or letter of thanks of an organization or individual to advertise a medicinal product.

12. The abuse of the origin of the medicinal product or medicinal material to advertise the medicinal product.

13. The image, name, or symbol of a healthcare professional.

14. The image of an animal or plant on the list of endangered, precious, and rare species prioritized for protection.

15. Words and phrases of a hearsay or word-of-mouth nature to recommend the use of the medicinal product.

16. The use of an image of a patient to describe a pathological condition or the use of a medicinal product that is inconsistent with the documents related to the medicinal product and the professional guidelines issued or recognized by the Ministry of Health.

Article 105. Issuance, modification, and correction of a written confirmation of medicinal product advertising content

1. A written confirmation of medicinal product advertising content shall be issued in the following cases:

a) The written confirmation of the medicinal product advertising content is requested for the first time;

b) The written confirmation of the medicinal product advertising content has been issued but has a change not prescribed in Clause 2 of this Article.

2. A written confirmation of the medicinal product advertising content shall be modified in case the medicinal product advertising content has the following changes:

a) Information about the establishment registering or manufacturing the medicinal product;

b) Information about the name and address of the establishment named in the dossier of application for confirmation of medicinal product advertising content, but without a change in the establishment named in the dossier of application for confirmation of medicinal product advertising content;

c) Change of the establishment registering the medicinal product;

d) Information about the packaging specifications of the medicinal product; the logo without text of the establishment registering the medicinal product, the establishment named in the dossier of application for confirmation of medicinal product advertising content, or the establishment manufacturing the medicinal product;

dd) The logo with text, entirely protected as a trademark under the Certificate of Trademark Registration issued by a competent authority, of the establishment registering the medicinal product, the establishment named in the dossier of application for confirmation of medicinal product advertising content, or the establishment manufacturing the medicinal product.

3. A written confirmation of the medicinal product advertising content shall be corrected in cases where the information on the certificate is incorrect due to an error by the issuing authority.

Article 106. Dossier of application for a written confirmation of medicinal product advertising content

1. A dossier of application for a written confirmation of medicinal product advertising content, except for medicinal product advertising by means of seminars, conferences, and events to introduce medicinal products, shall comprise the following documents:

a) An application for confirmation of medicinal product advertising content, made using Form No. 01 in Appendix VI to this Decree;

b) The sample design of the medicinal product advertising content for which a written confirmation is applied; an audio or video recording of the advertising content on radio, television, or electronic devices, specialized advertising screens, and other advertising media as prescribed by the law on advertising with audio and animations;

c) The current label sample and package insert/patient information leaflet of the medicinal product, approved by the Ministry of Health;

d) Reference documents related to the medicinal product advertising content for which a written confirmation is applied for (if any);

dd) The Establishment License of the Representative Office of the foreign company in Vietnam, if it is a foreign establishment named in the application for confirmation of medicinal product advertising content, or the Certificate of Eligibility for Pharmaceutical Business, if it is a Vietnamese pharmaceutical business named in the application for confirmation of medicinal product advertising content. The submission of a Certificate of Eligibility for Pharmaceutical Business issued by the Ministry of Health is exempted if it is a Vietnamese pharmaceutical business named in the application for confirmation of medicinal product advertising content;

e) A power of attorney from the establishment registering the medicinal product to the establishment named in the dossier of application for confirmation of medicinal product advertising content, in case of authorization.

2. A dossier of application for a written confirmation of medicinal product advertising content by means of a seminar, conference, or event shall comprise the following documents:

a) An application for confirmation of medicinal product advertising content, made using Form No. 02 in Appendix VI to this Decree;

b) The medicinal product advertising content;

c) The current label sample and package insert/patient information leaflet of the medicinal product, approved by the Ministry of Health;

d) Reference documents related to the medicinal product advertising content for which a written confirmation is applied for (if any);

dd) The Establishment License of the Representative Office of the foreign company in Vietnam, if it is a foreign establishment named in the application for confirmation of medicinal product advertising content, or the Certificate of Eligibility for Pharmaceutical Business, if it is a Vietnamese pharmaceutical business named in the application for confirmation of medicinal product advertising content. The submission of a Certificate of Eligibility for Pharmaceutical Business issued by the Ministry of Health is exempted if it is a Vietnamese pharmaceutical business named in the application for confirmation of medicinal product advertising content;

e) A power of attorney from the establishment registering the medicinal product to the establishment named in the dossier of application for confirmation of medicinal product advertising content, in case of authorization;

g) The proposed agenda of the seminar, conference, or event to introduce the medicinal product.

3. The dossier quantity prescribed in Clauses 1 and 2 of this Article is 01 dossier.

Article 107. Requirements for a dossier of application for a written confirmation of medicinal product advertising content

1. The documents prescribed at Point c, Clause 1 and Point c, Clause 2, Article 106 of this Decree shall be copies.

2. The documents prescribed at Points d and dd, Clause 1 and Points d and dd, Clause 2, Article 106 of this Decree shall be copies bearing the seal of the establishment applying for confirmation of medicinal product advertising content if the documents are issued by the Ministry of Health, or certified true copies or copies presented with their originals for collation if the documents are not issued by the Ministry of Health.

3. The documents prescribed at Point e, Clause 1 and Point e, Clause 2, Article 106 of this Decree shall be the originals or certified true copies, or copies presented with their originals for collation.

4. The documents prescribed at Point b, Clause 1 and Point b, Clause 2, Article 106 of this Decree shall be the originals and each of them shall be made into 02 copies.

5. Each dossier of application for a written confirmation of medicinal product advertising content shall comprise:

a) 01 sample design or audio or video recording of the medicinal product advertising content if it is a dossier as prescribed in Clause 1, Article 106 of this Decree, or 01 medicinal product advertising content if it is a dossier as prescribed in Clause 2, Article 106 of this Decree for one medicinal product;

b) 01 sample design or audio or video recording of the medicinal product advertising content if it is a dossier as prescribed in Clause 1, Article 106 of this Decree, or 01 medicinal product advertising content if it is a dossier as prescribed in Clause 2, Article 106 of this Decree for two or more medicinal products with the same active substance and route of administration from the same manufacturer but with different strength or dosage forms.

6. The documents shall be printed on A4-sized paper. For large-format outdoor advertisements, the medicinal product advertising content may be presented on A3-sized paper with a clear indication of the scale ratio compared to the actual size. The seal of the establishment applying for confirmation of medicinal product advertising content must be stamped across the adjoining edges of the pages of all documents in the dossier. In cases where the design of the advertising object has a spatial structure, the dossier must include a description on A3-sized paper of the following mandatory details:

a) The spatial structure;

b) The sequential numbering of the faces and the dimensions of each face;

c) The scale ratio of the sample design compared to the actual sample.

7. An establishment that may be named in the dossier of application for confirmation of medicinal product advertising content includes:

a) The establishment registering the medicinal product in Vietnam;

b) The representative office in Vietnam of a foreign establishment that applies for registration of the medicinal product in Vietnam and is authorized by such establishment;

c) A Vietnamese pharmaceutical business authorized by the establishment prescribed at Point a of this Clause.

8. The establishment registering the medicinal product, even in case of authorizing the establishments prescribed at Points b and c, Clause 7 of this Article to be named in the application for confirmation of medicinal product advertising content, shall be responsible for the medicinal product advertising content.

Article 108. Procedures for receipt, appraisal, and confirmation of medicinal product advertising content

1. An establishment applying for confirmation of medicinal product advertising content shall submit a dossier either directly, via postal service, or online to the Ministry of Health.

2. Within 15 days from the date of receiving a complete dossier, the Ministry of Health shall organize an appraisal in accordance with this Decree and the law regulations on advertising and shall issue a written confirmation made using Form No. 03 or Form No. 04 in Appendix VI to this Decree. In cases where a written confirmation is not issued, the Ministry of Health must provide a written response stating the reasons for not issuing it.

3. In cases where amendment or supplementation to the dossier is required, within 15 days from the date of receiving a complete dossier, the Ministry of Health shall send a written request to the establishment for amendment or supplementation, and shall proceed as follows:

a) The written request for amendment or supplementation must specify in detail the documents and details to be amended and supplemented, along with the reasons;

b) Within 15 days from the date of receiving the amended or supplemented dossier as requested, the Ministry of Health shall organize an appraisal in accordance with this Decree and the law regulations on advertising and shall issue a written confirmation made using Form No. 03 or Form No. 04 in Appendix VI to this Decree, or provide a written response of non-issuance of the written confirmation, stating the reasons;

c) Within 90 days from the date the Ministry of Health sends a written notice of amendment or supplementation, the establishment must submit the amended or supplemented dossier as required. After the above time limit, the submitted dossier will no longer be valid.

4. During the processing of a submitted dossier, the Ministry of Health will temporarily suspend confirmation and will send a written notice stating the reasons if it discovers that the safety and efficacy information in the package insert/patient information leaflet of the medicinal product is inappropriate or has not been updated with the information required by a competent state regulatory authority or the professional documents and guidelines related to the medicinal product issued or recognized by the Ministry of Health. The temporary suspension of confirmation will last until the establishment resubmits the medicinal product advertising content that has been updated and amended to ensure safety for medicinal product users.

5. At least 03 working days before conducting medicinal product advertising by means of a seminar, conference, or event, the establishment that has been issued with a written confirmation of medicinal product advertising content must send a written notice to the provincial-level People's Committee of the locality where the medicinal product advertising is organized about the time and location, enclosed with a copy of the approved written confirmation of medicinal product advertising content.

In cases where there is a change in the location or time of organizing the medicinal product advertising that has been confirmed, the establishment must notify the provincial-level People's Committee of the locality where it is organized at least 01 working day before conducting the medicinal product advertising.

6. The receipt of new dossiers and the processing of any submitted dossier of an establishment applying for confirmation of medicinal product advertising content, even if it is an authorized establishment as prescribed at Points b and c, Clause 7, Article 107 of this Decree, shall be suspended if it commits one of the following violations:

a) Altering or forging legal papers of a competent state regulatory authority in the dossier of application for confirmation of medicinal product advertising content;

b) Advertising a medicinal product without the confirmation of the content by a competent state authority or not in accordance with the confirmed content;

c) Using a certification that has not been recognized by the Ministry of Health, using material benefits, taking advantage of the name of an organization or individual, or various types of symbols, images, status, reputation, correspondences, or letters of thanks to provide information or advertise a medicinal product;

d) Using the results of clinical research, pre-clinical research, testing, or bioequivalence trials that have not been recognized by the Ministry of Health to provide information or advertise a medicinal product.

7. The period of suspension of receipt of dossiers of application for confirmation of medicinal product advertising content, from the date of issuance of the written notice of the violation by a competent state authority, shall be as follows:

a) From 01 year to 02 years in the case prescribed at Point a, Clause 6 of this Article;

b) From 06 months to 12 months in the cases prescribed at Point b, c, or d, Clause 6 of this Article;

8. Within 03 working days from the date of issuing a written confirmation of medicinal product advertising content, the Ministry of Health shall upload the confirmed medicinal product advertising content on the electronic portal of the Ministry of Health.

Article 109. Regulations on the correction and modification of medicinal product advertising content that has been issued with a written confirmation

1. In cases where the information on a written confirmation of medicinal product advertising content is incorrect as prescribed in Clause 3, Article 105 of this Decree, the establishment named in the application for confirmation of medicinal product advertising content shall send a written notice to the authority that made the written confirmation, clearly stating the incorrect content to be corrected. Upon receiving the written notice, the authority that made the written confirmation shall issue the establishment a Dossier Receipt Note for the written notice of the medicinal product advertising content to be corrected, made using Form No. 05 in Appendix VI to this Decree. The establishment may proceed with the medicinal product advertising according to the corrected content and shall be responsible for the corrected content.

2. In cases where the medicinal product advertising content that has been issued with a written confirmation has a change as prescribed in Clause 2, Article 105 of this Decree, the establishment named in the application for confirmation of medicinal product advertising content shall send a written notice to the authority that made the written confirmation about the modified content. The establishment may automatically make the modification and shall be responsible for the modified medicinal product advertising content.

Article 110. Validity of a written confirmation of medicinal product advertising content

1. A written confirmation of medicinal product advertising content does not have a stated validity period and shall become invalid in the following cases:

a) The marketing authorization of the medicinal product expires;

b) The marketing authorization of the medicinal product is revoked;

c) There is a change in information that requires the issuance of a written confirmation of medicinal product advertising content as prescribed at Point b, Clause 1, Article 105 of this Decree;

d) There is a recommendation from a state regulatory authority in charge of pharmacy regarding the restricted use or use under the supervision of a medical examination and treatment practitioner;

dd) The medicinal product contains an active ingredient or herbal medicinal material that is removed from the list of over-the-counter medicinal products announced by the Minister of Health.

2. In cases where the marketing authorization of a medicinal product expires but may continue to be used as prescribed at Point c, Clause 8, Article 56 of the Law on Pharmacy or is renewed, the written confirmation of medicinal product advertising content will be automatically renewed for a period equal to the period of continued use or renewal of the marketing authorization of the medicinal product, provided that it does not fall under the cases of invalidity prescribed in Clause 1 of this Article.

Article 111. Responsibilities of organizations and individuals implementing and participating in medicinal product advertising

1. A medicinal product advertiser shall:

a) Perform the obligations prescribed in the Law on Advertising;

b) Ensure that the medicinal product advertising content complies with the law regulations on medicinal product advertising;

c) Take full accountability to the law for the medicinal product advertising content, even in case of authorizing medicinal product advertising;

d) Only provide the medicinal product advertising content that has been confirmed by a competent authority to a medicinal product advertising publisher or a medicinal product advertising service provider;

dd) Perform other responsibilities as prescribed by law regulations.

2. A medicinal product advertising service provider shall:

a) Perform the obligations prescribed in the Law on Advertising;

b) Provide documents related to the medicinal product advertising content if requested by a competent authority;

c) Only provide medicinal product advertising services for medicinal product advertising content that has been confirmed by a competent authority;

d) Be jointly liable in cases where the medicinal product advertising content does not comply with the law regulations on medicinal product advertising;

dd) Perform other responsibilities as prescribed by law regulations.

3. A medicinal product advertising publisher shall:

a) Perform the responsibilities prescribed at Points b, c, d, and dd, Clause 2 of this Article and the obligations prescribed in the Law on Advertising;

b) Not publish medicinal product advertising content enclosed with information about pathology, treatment measures, or health communication that could be construed to mean that this information is the cause, consequence, or result of using or not using such medicinal product;

c) Perform other responsibilities as prescribed by law regulations.

 

Chapter VIII

MEASURES FOR MANAGEMENT OF MEDICINAL PRODUCT PRICES

 

Section 1

ANNOUNCEMENT AND RE-ANNOUNCEMENT OF PROPOSED WHOLESALE PRICES OF PRESCRIPTION MEDICINAL PRODUCTS AND RECOMMENDATIONS ON ANNOUNCED AND RE-ANNOUNCED PROPOSED WHOLESALE PRICES OF MEDICINAL PRODUCTS

 

Article 112. Regulations on the forms of announcement and re-announcement of proposed wholesale prices of medicinal products

1. The form of announcement of the proposed wholesale prices of medicinal products imported into Vietnam and domestically manufactured medicinal products shall be made using Form No. 01 in Appendix VII to this Decree.

2. The form of re-announcement of the proposed wholesale prices of medicinal products imported into Vietnam and domestically manufactured medicinal products shall be made using Form No. 02 in Appendix VII to this Decree.

Article 113. Establishments making announcements and re-announcements of proposed wholesale prices of medicinal products

1. A domestic establishment manufacturing medicinal products shall announce and re-announce the proposed wholesale prices of domestically manufactured prescription medicinal products.

In cases where the medicinal product is manufactured in Vietnam through contract manufacturing, the establishment to make the announcement and re-announcement of the proposed wholesale price of such medicinal product shall be the establishment manufacturing such medicinal product or the contract giver.

2. An establishment importing medicinal products shall announce and re-announce the proposed wholesale prices of prescription medicinal products imported into Vietnam.

Article 114. Sequence and procedures for receiving announcements and re-announcements of proposed wholesale prices of medicinal products

1. After being granted a marketing authorization for a medicinal product or a license to import a medicinal product, the establishment as prescribed in Article 113 of this Decree shall announce the proposed wholesale price of the medicinal product before wholesaling the first batch of its medicinal product into the Vietnamese market. For subsequent batches or subsequent imported shipments, the establishment is not required to make any announcement if there is no adjustment to the price compared to the proposed wholesale price of the medicinal product previously announced by it.

2. When it needs to change the proposed wholesale price of a medicinal product that has been previously announced or re-announced and published on the electronic portal of the Ministry of Health, the establishment as prescribed in Article 113 of this Decree shall make a re-announcement.

3. When making an announcement or re-announcement, the establishment as prescribed in Article 113 of this Decree shall submit the form of announcement or re-announcement of the proposed wholesale price of the medicinal product, made using the form prescribed in Article 112 of this Decree, either directly, via postal service, or online to the Ministry of Health.

4. The Ministry of Health shall organize the receipt of the forms of announcement and re-announcement of proposed wholesale prices of medicinal products. In cases where the form of announcement or re-announcement of the proposed wholesale price of a medicinal product is made using the correct form, contains complete information, and the establishment has completed the payment of the fee as prescribed, within 01 working day, the Ministry of Health shall issue a Dossier Receipt Note made using Form No. 03 in Appendix VII to this Decree. In cases where the form of announcement or re-announcement of the proposed wholesale price of a medicinal product is not made using the correct form or does not contain complete information, within 01 working day, the Ministry of Health shall return such form to the establishment that has submitted it, and clearly state the reasons for the return.

5. Within 07 working days from the date of receiving a complete dossier, the Ministry of Health shall organize a review of the medicinal product information in the form of announcement or re-announcement of the proposed wholesale price of the medicinal product, based on the marketing authorization for the medicinal product or the license to import the medicinal product, and shall publish the proposed wholesale price of the medicinal product that has been announced or re-announced on the electronic portal of the Ministry of Health. In cases where the proposed wholesale price of the medicinal product that has been announced or re-announced is not published, the Ministry of Health shall provide a written response stating the reasons.

6. The establishment making the announcement or re-announcement of the proposed wholesale price of a medicinal product is responsible for fully complying with the regulations on the announcement and re-announcement of the proposed wholesale price of a medicinal product as prescribed in the Law on Pharmacy and this Decree; shall take full accountability to the law for the accuracy and truthfulness of the information in the form of announcement or re-announcement of the proposed wholesale price of the medicinal product; shall comply with reporting on the proposed wholesale price of the medicinal product that has been announced or re-announced at the request of the state regulatory authority in charge of medicinal product prices to serve the work of price stabilization, state management of prices, and inspection and examination; and shall comply with the inspection and examination of the competent state authority (if any).

Article 115. Medicinal products exempted from the announcement of proposed wholesale prices

Domestically manufactured or imported prescription medicinal products for non-commercial purposes are exempted from the announcement of proposed wholesale prices when they fall under one of the following cases:

1. Medicinal products and vaccines used free of charge for the people to serve urgent needs for national defence, security, overcoming the consequences of incidents, natural disasters, and catastrophes, and disease prevention and control.

2. Medicinal products for State health programs.

3. Aid and humanitarian aid medicinal products.

4. Medicinal products for clinical trials; bioequivalence trials, bioavailability assessment; samples for registration, samples for testing and scientific research; and display at exhibitions and fairs.

5. Medicinal products that meet the criteria prescribed in Clause 1, Article 60 of this Decree.

Article 116. Recommendations on the announced or re-announced proposed wholesale price of a medicinal product in cases where the proposed wholesale price of the medicinal product is higher than the highest price that has been announced and re-announced of a similar medicinal product for which there is no recommendation from the Ministry of Health

1. In cases where the announced or re-announced proposed wholesale price of a medicinal product has the same concentration or strength as a similar medicinal product that has been announced and re-announced, the Ministry of Health shall make a recommendation in one of the following cases:

a) The announced or re-announced proposed wholesale price of the medicinal product is higher than the highest announced or re-announced proposed wholesale price of a similar medicinal product manufactured on a production line that meets equivalent Good Manufacturing Practices principles and standards;

b) The announced or re-announced proposed wholesale price of a medicinal product manufactured in a country whose pharmaceutical regulatory authority is a Stringent Regulatory Authority is higher than the announced or re-announced proposed wholesale price of a brand-name medicinal product or a reference biological product;

c) The announced or re-announced proposed wholesale price of a medicinal product manufactured in a country whose pharmaceutical regulatory authority is not a Stringent Regulatory Authority is higher than the announced or re-announced proposed wholesale price of a medicinal product manufactured in a country with a Stringent Regulatory Authority, or higher than the announced or re-announced proposed wholesale price of a brand-name medicinal product or a reference biological product;

d) The announced or re-announced proposed wholesale price of a medicinal product domestically manufactured on a production line that meets the Good Manufacturing Practices principles and standards of the World Health Organization is higher than the announced or re-announced proposed wholesale price of a medicinal product domestically manufactured on a production line that meets the Good Manufacturing Practices principles and standards of the European Union or equivalent.

2. In cases where the announced or re-announced proposed wholesale price of a medicinal product has a different concentration or strength from a similar medicinal product that has been announced, the Ministry of Health shall make a recommendation in one of the following cases:

a) The announced or re-announced proposed wholesale price is higher than the announced or re-announced proposed wholesale price of a similar medicinal product from the same manufacturer with a higher strength or concentration;

b) The announced or re-announced proposed wholesale price is higher than the announced or re-announced proposed wholesale price of a similar medicinal product with the same strength or concentration and from the same manufacturer, but with a larger packaging volume.

Article 117. Recommendations on the announced or re-announced proposed wholesale price of a medicinal product in cases where the difference between the announced or re-announced proposed wholesale price and the winning bid price of the same medicinal product is higher than the prescribed maximum difference

1. The difference between the proposed wholesale price and the winning bid price of the same medicinal product (hereinafter referred to as the difference) is the percentage (%) of the monetary difference between the announced or re-announced proposed wholesale price and the highest winning bid price within 12 months from the time of the recommendation, and the announced or re-announced proposed wholesale price. The difference is calculated using the following formula:

2. The Ministry of Health shall make a recommendation when the difference between the announced or re-announced proposed wholesale price and the winning bid price of the same medicinal product is higher than the maximum difference as follows:

a) 35%, if it is a medicinal product with an announced or re-announced proposed wholesale price calculated on the smallest packaging unit of less than VND 1,000,000 (one million);

b) 15%, if it is a medicinal product with an announced or re-announced proposed wholesale price calculated on the smallest packaging unit of VND 1,000,000 (one million) or more.

Article 118. Recommendations on the announced or re-announced proposed wholesale price of a medicinal product in cases where there is no similar medicinal product being placed on the market in Vietnam and its announced or re-announced price is higher than the selling price in the country of origin or another country

The Ministry of Health shall make a recommendation for a medicinal product with an announced or re-announced proposed wholesale price, to which there is no similar medicinal product being placed on the market in Vietnam, when it discovers that the announced or re-announced proposed wholesale price is higher than the selling price in the country of origin or another country in the following cases:

1. The announced or re-announced proposed wholesale price is higher than the price in the country of origin or another country as in information provided by the establishment in the form of announcement of the proposed wholesale price of the medicinal product.

2. The announced or re-announced proposed wholesale price is higher than the price in the country of origin or another country as in information provided by a state agency of Vietnam or a foreign country.

3. The announced or re-announced proposed wholesale price is higher than the prices as in information found on the websites of the regulatory authorities in charge of medicinal product prices, the health insurance agencies, or the medicinal product procurement agencies of other countries, provided by a state agency of Vietnam or a foreign country.

Article 119. Sequence for implementing a recommendation on the announced or re-announced proposed wholesale price of a medicinal product

1. While a medicinal product is on the market, upon discovering that the announced or re-announced proposed wholesale price falls under one of the cases prescribed in Articles 116, 117, and 118 of this Decree, the Ministry of Health shall issue a written recommendation regarding the announced and re-announced proposed wholesale price. The written recommendation shall be sent to the establishment that made the announcement or re-announcement and shall be published on the electronic portal of the Ministry of Health.

2. After the Ministry of Health publishes the written recommendation, the establishment that made the announcement or re-announcement of the proposed wholesale price of the medicinal product is responsible for reporting or explaining the details as recommended. In cases where the reduction of the announced or re-announced proposed wholesale price is recommended, the establishment that made the announcement or re-announcement shall re-announce the proposed wholesale price of the medicinal product in accordance with Article 114 of this Decree.

3. In cases where the establishment that made the announcement or re-announcement provides a report and explanation on the details as recommended by the Ministry of Health, after considering the appropriateness of the fluctuation of the price-forming factors or the appropriateness of the difference between the proposed wholesale price and the updated winning bid price provided by the establishment that made the announcement or re-announcement, or the appropriateness of the information on the selling price of the medicinal product in the country of origin or another country provided by the establishment that made the announcement or re-announcement, the Ministry of Health shall remove the published written recommendation or publish the feedback of the Ministry of Health on the report and explanation of the establishment that made the announcement or re-announcement.

During the process of considering the report, explanation, and supporting documents of the establishment that made the announcement or re-announcement, the Ministry of Health shall coordinate with relevant agencies and organizations to consider the explanatory details of the establishment that made the announcement or re-announcement if deemed necessary.

 

Section 2

REGULATIONS ON RETAIL SURPLUS AT ESTABLISHMENTS RETAILING MEDICINAL PRODUCTS WITHIN THE PREMISES OF MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS AND PRICE MAINTENANCE AND REDUCTION POLICIES FOR NEW MEDICINAL PRODUCTS, BRAND-NAME MEDICINAL PRODUCTS, HIGH-TECH MEDICINAL PRODUCTS, VACCINES, AND ORPHAN MEDICINAL PRODUCTS FOR WHICH TECHNOLOGY TRANSFER FOR MANUFACTURING IN VIETNAM HAS OCCURRED

 

Article 120. Regulations on retail surplus and retail prices of medicinal products at establishments retailing medicinal products within the premises of medical examination and treatment establishments

1. The retail surplus means the monetary difference between the selling price and the purchase price of a medicinal product at an establishment retailing medicinal products within the premises of a medical examination and treatment establishment, calculated using the following formula:

Retail surplus = Selling price of the medicinal product - Purchase price of the medicinal product

2. The retail surplus rate means the percentage (%) of the retail surplus to the purchase price of a medicinal product at an establishment retailing the medicinal product within the premises of a medical examination and treatment establishment, calculated using the following formula:

3. The retail price of a medicinal product at an establishment retailing the medicinal product within the premises of a medical examination and treatment establishment is calculated using the following formula:

Retail price of the medicinal product = Purchase price of the medicinal product x (1 + Retail surplus rate)

4. The retail surplus rates of establishments retailing medicinal products within the premises of medical examination and treatment establishments shall not exceed the following maximum retail surplus rates:

a) For a medicinal product with a purchase price calculated on the smallest packaging unit of VND 1,000 (one thousand) or less, the maximum retail surplus rate is 15%;

b) For a medicinal product with a purchase price calculated on the smallest packaging unit of over VND 1,000 (one thousand) to VND 5,000 (five thousand), the maximum retail surplus rate is 10%;

c) For a medicinal product with a purchase price calculated on the smallest packaging unit of over VND 5,000 (five thousand) to VND 100,000 (one hundred thousand), the maximum retail surplus rate is 7%;

d) For a medicinal product with a purchase price calculated on the smallest packaging unit of over VND 100,000 (one hundred thousand) to VND 1,000,000 (one million), the maximum retail surplus rate is 5%;

dd) For a medicinal product with a purchase price calculated on the smallest packaging unit of over VND 1,000,000 (one million), the maximum retail surplus rate is 2.5%.

Article 121. Application of price maintenance and reduction policies for new medicinal products, brand-name medicinal products, high-tech medicinal products, vaccines, and orphan medicinal products for which technology transfer for manufacturing in Vietnam has occurred

1. A new medicinal product, brand-name medicinal product, high-tech medicinal product, vaccine, or orphan medicinal product for which technology transfer for manufacturing in Vietnam has occurred shall be subject to price maintenance and reduction policies in the price negotiation plan for bidding packages applying price negotiation when it meets one of the following requirements:

a) It is a medicinal product manufactured in Vietnam that has been granted a marketing authorization in the form of technology transfer or a contract-manufactured medicinal product with technology transfer;

b) It is a medicinal product manufactured abroad that has been granted a Certificate of Registration of Technology Transfer in accordance with the law on technology transfer, and has had a pilot batch manufactured on the production line with transferred technology in Vietnam in order to prepare the dossier of application for a marketing authorization for a technology-transferred medicinal product or a contract-manufactured medicinal product with technology transfer.

2. Principles for applying price maintenance and reduction policies:

a) The price of a brand-name medicinal product shall be maintained at the same level as the winning bid or the negotiated price for the medicinal product currently being supplied to the medical examination and treatment establishment when the price negotiation plan is developed, provided that at the time the price negotiation plan is developed, there are none or fewer than 03 valid marketing authorizations for medicinal products that are manufactured in countries of Stringent Regulatory Authorities and have the same active substance, concentration, strength, and dosage form;

b) The price of a new medicinal product, high-tech medicinal product, vaccine, or orphan medicinal product shall be maintained at the same level as the winning bid or the negotiated price for the medicinal product currently being supplied to the medical examination and treatment establishment when the price negotiation plan is developed, provided that at the time the price negotiation plan is developed, there are none or fewer than 03 valid marketing authorizations for medicinal products with the same active substance, concentration, strength, and dosage form;

c) A medicinal product not subject to the price maintenance policy as prescribed at Points a and b of this Clause shall be subject to a reduction of up to 50% in the discount rate compared to the discount rate under the price negotiation plan in the absence of technology transfer.

3. The duration of application of price maintenance and reduction policies:

a) A medicinal product that meets the requirement prescribed at Point a, Clause 1 of this Article shall be subject to the price maintenance or reduction policy once from the date of issuance of the marketing authorization;

b) A medicinal product, which meets the requirement prescribed at Point a, Clause 1 of this Article and of which all manufacturing stages in Vietnam have been completely transferred, shall be subject to the price maintenance or reduction policy for one more time in the next price negotiation;

c) A medicinal product that meets the requirement prescribed at Point b, Clause 1 of this Article shall be subject to the price maintenance or reduction policy once from the date of manufacturing the pilot batch on the line with transferred technology in Vietnam. The manufacturing of the pilot batch shall be proven by the pilot batch manufacturing record of the technology transferee or the contract manufacturer with technology transfer.

 

Chapter IX 

IMPLEMENTATION PROVISIONS

 

Article 122. Roadmap for the implementation of Good Practices for state-owned medicinal product and medicinal material testing establishments

1. From the effective date of this Decree, a state-owned medicinal product and medicinal material testing establishment that has not yet fully complied with Good Laboratory Practices shall only perform tests within the scope of certification of compliance with TCVN ISO/IEC 17025 general requirements for the competence of testing and calibration laboratories, which has been assessed and certified by a conformity assessment organization. By January 01, 2027, at the latest, a state-owned medicinal product and medicinal material testing establishment must fully comply with Good Laboratory Practices.

2. From the effective date of this Decree, a state-owned medicinal product and medicinal material testing establishment that first implements medicinal product and medicinal material testing operations or adds to its scope of testing operations must comply with Good Laboratory Practices.

Article 123. Roadmap for the implementation of the competence to issue export and licenses to import medicinal products and medicinal materials

1. Before July 01, 2027, the Ministry of Health shall:

a) Issue licenses to import medicinal products, active pharmaceutical ingredients, herbal medicinal materials, semi-finished medicinal products, semi-finished herbal medicinal materials, excipients, and capsules as prescribed in Articles 57, 58, 59, 65, 68, 70, and 72 of this Decree;

b) Issue licenses to export medicinal products, herbal medicinal materials, and herbal medicinal materials on the list of precious, rare, and endemic herb species and varieties subject to control as prescribed in Article 43; Article 44; Article 45; Points b and c, Clause 1, Article 46; Clause 1, Article 47; Article 48; and Clause 5, Article 82 of this Decree;

2. From July 01, 2027, the provincial-level People's Committee of the locality where an establishment is headquartered shall issue a license to export or import medicinal products, active pharmaceutical ingredients, herbal medicinal materials, semi-finished medicinal products, semi-finished herbal medicinal materials, excipients, and capsules in the cases prescribed in Clause 1 of this Article.

Import and export licenses issued by a provincial-level People's Committee shall be valid nationwide.

Article 124. Roadmap for the implementation of the receipt of reports and the form of reporting on the export, import, inventory, and use of medicinal products and medicinal materials

1. Before July 01, 2027, the Ministry of Health shall receive reports from establishments manufacturing, exporting, and importing medicinal products and medicinal materials as prescribed in Clause 1, Article 35 and Clause 2, Article 81 of this Decree.

2. From July 01, 2027, the cases to be reported as prescribed in Clause 1, Article 35 and Clause 2, Article 81 of this Decree shall be implemented as follows:

a) The provincial-level People's Committee shall receive reports on the import and export of medicinal products and medicinal materials as prescribed in Article 43; Article 44; Points b and c, Clause 1, Article 46; Clause 1, Article 47; and Articles 48, 57, 58, 59, and 65 of this Decree;

b) The Ministry of Health shall receive reports on the import of medicinal products and medicinal materials, unless otherwise prescribed at Point a of this Clause.

Article 125. Roadmap for the implementation of import control of medicinal products with marketing authorizations in Vietnam

1. The operations prescribed in Article 87 of this Decree shall be implemented from July 01, 2028.

2. The Ministry of Finance shall coordinate with the Ministry of Health to develop an online tool integrated into the National Single Window Portal to ensure the implementation of Clause 1 of this Article.

Article 126. Roadmap for the implementation of the announcement of proposed wholesale prices of prescription medicinal products

Within 30 days from the effective date of this Decree, for a prescription medicinal product whose first batch has been wholesaled to the market but for which the proposed wholesale price has not been published on the electronic portal of the Ministry of Health, or for a prescription medicinal product whose proposed wholesale price has changed compared to the immediately preceding announced or re-announced proposed wholesale price that was published on the electronic portal of the Ministry of Health before July 01, 2024, the establishment making the announcement of the proposed wholesale price is responsible for making an announcement or re-announcement in accordance with Section 1, Chapter VIII of this Decree.

Article 127. Transitional clauses

1. Dossiers for administrative procedures as prescribed in the Law No. 105/2016/QH13 on Pharmacy and relevant guiding documents that were submitted before the effective date of this Decree shall be handled in accordance with the Law No. 105/2016/QH13 on Pharmacy and relevant guiding documents; unless the establishment requests to apply the Law No. 44/2024/QH15 Amending and Supplementing a Number of Articles of the Law No. 105/2016/QH13 on Pharmacy or this Decree.

2. Licenses to export and import medicinal products and medicinal materials, export and import orders for medicinal products and medicinal materials, and related administrative procedures implemented in accordance with Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP, Decree No. 88/2023/ND-CP, and relevant documents shall remain valid until their expiry dates.

Medicinal products and medicinal materials exported and imported under the licenses and orders prescribed in this Clause shall be granted customs clearance if they comply with Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP, Decree No. 88/2023/ND-CP, and relevant documents, or this Decree, in a way that is convenient for enterprises, organizations, and individuals.

For a medicinal product used in a clinical trial that is not a medicinal product subject to special control, in cases where the license to import the medicinal product expires or where the import license is still valid but the information about the medicinal product has been updated in the form of announced information on imported medicinal products for use in clinical trials of the Ministry of Health, the importing establishment shall import the medicinal product according to the information announced by the Ministry of Health.

3. A medicinal product or active pharmaceutical ingredient on the list of substances banned from use in certain industries and fields that has been granted a marketing authorization in Vietnam; a medicinal material on the list of medicinal products and active pharmaceutical ingredients on the lists of substances banned from use in certain industries and fields that has been announced for the manufacture of a medicinal product according to a medicinal product registration dossier for which a marketing authorization in Vietnam has already been granted and is shipped from the port of departure of the exporting country before the effective date of the announcement of the list of medicinal products and active pharmaceutical ingredients on the lists of substances banned from use in certain industries and fields, shall be imported in accordance with the list of medicinal products and active pharmaceutical ingredients on the lists of substances banned from use in certain industries and fields in the guiding document that is effective at the time the goods are shipped from the port of departure of the exporting country.

4. A written confirmation of medicinal product information or a written confirmation of medicinal product advertising content issued before the effective date of this Decree shall remain valid until its expiry date.

5. By July 01, 2026, at the latest, the Ministry of Public Security is responsible for sharing with the authority that issues Pharmacy Practising Certificates the judicial record data of an applicant for a Pharmacy Practising Certificate, at the request of the authority that issues the Pharmacy Practising Certificate. The shared data shall include the information in the Judicial Record Card as prescribed by the Law on Judicial Records.

6. For a prescription medicinal product for which a price has been declared or re-declared in accordance with Clause 3, Article 107 of the Law on Pharmacy No. 105/2016/QH13, in cases where there is no change in the declared or re-declared price, the importing establishment or the manufacturing establishment is not required to make an announcement, and this declared price shall continue to be used and shall be considered the announced or re-announced proposed wholesale price of the medicinal product.

Article 128. Amending or supplementing the Government’s Decree No. 31/2021/ND-CP dated March 26, 2021 detailing and guiding the implementation of a number of articles of the Law on Investment

To add Clause 11 after Clause 10, Section IV, Part A. Special preferential investment sectors and trades of Appendix II - List of preferential investment sectors and trades, issued under the Government’s Decree No. 31/2021/ND-CP dated March 26, 2021, as follows:

“11. Research and development of technology, manufacturing, or technology transfer for the manufacture of herbal medicinal products, traditional medicinal products from domestic herbal medicinal material sources, active pharmaceutical ingredients, new medicinal products, brand-name medicinal products, orphan medicinal products, the first generic medicinal products manufactured in Vietnam, high-tech medicinal products, vaccines, and biologicals; cultivation of herbal medicinal materials in socio-economically disadvantaged areas, and extremely socio-economically disadvantaged areas; research for the conservation and development of precious, rare, and endemic domestic herbal gene sources; creation of new varieties from herbal gene sources with high economic value, with a new investment project (including the expansion of that new investment project) that meets the requirements prescribed in Clause 2, Article 8 of the Law on Pharmacy”.

Article 129. Effect

1. This Decree takes effect on July 01, 2025.

2. From the effective date of this Decree, the following Government’s Decrees and clauses shall cease to be effective:

a) Clause 10, Article 27 of the Government’s Decree No. 85/2024/ND-CP dated July 10, 2024 detailing a number of articles of the Law on Prices;

b) The Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy;

c) Chapter II and Clause 4, Article 21 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 amending and supplementing a number of regulations related to business investment conditions under the state management scope of the Ministry of Health;

d) The Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amending and supplementing a number of articles of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 detailing a number of articles and measures for the implementation of the Law on Pharmacy and the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 amending and supplementing a number of regulations related to investment and business conditions under the state management of the Ministry of Health;

dd) Article 3 of the Government’s Decree No. 181/2013/ND-CP dated November 14, 2013, detailing the implementation of a number of articles of the Law on Advertisement.

3. In cases where a legislative document or regulation referred to in this Decree is amended or replaced, the amendment or replacement shall apply.

Article 130. Responsibilities for implementation

1. The Minister of Health shall instruct and organize the implementation of this Decree.

2. The Chairperson of a provincial-level People's Committee shall organize the receipt of medicinal product price declarations in accordance with the Law on Prices and its guiding documents; shall have policies to provide incentives and support for the development of the medicinal product supply system and mobile medicinal product retailing establishments in ethnic minority-inhabited areas, mountainous areas, islands, socio-economically disadvantaged areas, and extremely socio-economically disadvantaged areas.

3. By July 01, 2027, at the latest, the Ministry of Health shall deploy a nationwide online management software system and database for the export and import of medicinal products and medicinal materials.

4. Periodically, before January 15 and before July 15 of each year, the Ministry of Finance is responsible for sharing information with the Ministry of Health on the data of medicinal products subject to special control that have been granted customs clearance for export and import, or for sharing information on the data of medicinal products subject to special control that have been granted customs clearance for export and import upon written request from the Ministry of Health, within 20 days from the date of receiving the written request from the Ministry of Health, to serve management work.

5. An organization or individual, when carrying out administrative procedures in the electronic environment, is responsible for complying with the following regulations:

a) Documents of which the originals or certified true copies are required for the administrative procedures prescribed in this Decree must be scanned copies in electronic form with complete and accurate details as the same as the originals in paper form;

b) He/she/it must comply with the regulations on carrying out administrative procedures in the electronic environment as prescribed in the Government's Decree No. 45/2020/ND-CP dated April 08, 2020 on implementation of administrative procedures in the electronic environment.

c) He/she/it must store the original or a certified true copy along with the entire submitted dossier to serve post-audit work and shall take accountability for the accuracy and legality of the submitted dossier.

6. Ministers, heads of ministerial-level agencies, heads of the Government-attached agencies, chairpersons of People's Committees of provinces and municipalities, and other relevant organizations and individuals shall be responsible for implementing this Decree./.

 

ON BEHALF OF THE GOVERNMENT FOR THE PRIME MINISTER DEPUTY PRIME MINISTER Le Thanh Long