Decree No. 54/2017/ND-CP dated May 08, 2017 of the Government on detailing a number of articles of and providing measures for implementing the Pharmacy Law

DECREE

Detailing a number of articles of and providing measures for implementing the Pharmacy Law[1]

Pursuant to the June 19, 2015 Law on Organization of the Government;

Pursuant to the April 6, 2016 Pharmacy Law;

At the proposal of the Minister of Health;

The Government promulgates the Decree detailing a number of articles of and providing measures for implementing the Pharmacy Law.

Chapter I

GENERAL PROVISIONS

Article 1.Scope of regulation and subjects of application

1. This Decree prescribes pharmacy practice certificates; pharmaceutical business; drug import and export; registration for circulation of drug materials, adjuvants and capsule shells; assessment of overseas drug manufacture establishments; competence, form and procedures for recall of drug materials and measures for disposing of recalled drug materials; dossiers, order, procedures and competence for grant of written certifications of drug information and advertising contents; and measures for management of drug prices.

2. This Decree applies to domestic and foreign organizations and individuals involved in pharmacy activities in Vietnam.

Article 2.Interpretation of terms

In this Decree, the terms and phrases below are construed as follows:

1. Drug information means the collection and provision of information relating to drugs, including indications, contraindications; dosage, use instructions, adverse drug reactions and other information relating to the quality, safety and efficacy of drugs, by a responsible establishment in order to meet information requirements of state management agencies in charge of pharmacy, medicine or pharmacy practicing organizations and individuals or drug users.

2. Drug introduction workshop means a drug introduction meeting or drug-related scientific discussion for medicine practitioners.

3. Semi-finished drug product means a drug product which has undergone one, several or all steps of the processing or manufacturing process, except the final step of packaging.

4. Import price means the customs value of an imported drug which is written on the customs value declaration at a Vietnamese port after customs clearance.

5. Whole cost of a domestically manufactured drug includes the direct material, fuel, tool, equipment and energy cost plus (+) direct labor cost plus (+) direct machine and equipment depreciation plus (+) general production cost plus (+) financing cost (if any) plus (+) selling cost plus (+) management cost minus (-) costs distributed to by-products (if any).

6. Wholesale price means the selling price applied between pharmaceutical business establishments or applied by a pharmaceutical business establishment to medical examination and treatment establishments.

7. Tentative wholesale price means the price declared by drug importers, drug manufacturers or establishments ordering drug processing (for drugs processing under orders) to competent state agencies.

8. Retail price is the selling price applied directly to drug buyers at drug retailing establishments.

9. Retail margin means the difference in money between the selling price and buying price of a drug retailing establishment.

10. Retail margin rate means the percentage between the retail margin and the buying price of a drug at a drug retailing establishment.

Chapter II

PHARMACY PRACTICE CERTIFICATES

Section 1

DOSSIERS AND PROCEDURES FOR GRANT, RE-GRANT, MODIFICATION AND REVOCATION OF PHARMACY PRACTICE CERTIFICATES

Article 3.Specific provisions on dossiers of application for pharmacy practice certificates

1. A dossier of application for a pharmacy practice certificate must comply with Article 24 of the Pharmacy Law and the following specific provisions:

a/ An application for a pharmacy practice certificate, made according to Form No. 2 in the Appendix to this Circular, enclosed with 2 white-background portrait photos of the applicant, of a size of 4 cm x 6 cm, taken within 6 months by the date of application;

b/ Certified copies of professional degrees. Degrees granted by foreign training institutions must be enclosed with certified copies of equivalence certificates issued by competent equivalence recognition agencies under Clause 2, Article 18 of this Decree;

c/ A health certificate or a certified copy of a health certificate issued by a medical examination and treatment establishment in accordance with the Law on Medical Examination and Treatment;

d/ A written certification of the period of practice, made according to Form No. 3 in the Appendix to this Decree. If the applicant has practiced at more than one establishment, the period of practice is the aggregate of periods of practice at these establishments, in this case, certificates issued by all these establishments are required;

dd/ In case of applying for a pharmacy practice certificate covering multiple operations which are subject to different requirements on period of practice and establishment of professional practice, the dossier must comprise one or some written certifications of the period and contents of practice issued by one or some establishments meeting the requirements applicable to each professional operation or working position. In case of applying for a pharmacy practice certificate covering multiple operations which are subject to the same requirements on period of practice or establishment of professional practice, it is not required to obtain a written certification for each operation;

e/ The original or a certified copy of the written certification of the examination result issued by an examination-organizing institution defined in Clause 2, Article 28 of this Decree, in case the practice certificate is granted on the basis of examination;

g/ For foreigners and overseas Vietnamese applying for pharmacy practice certificates on the basis of dossier consideration, a dossier of application must also comprise documents proving satisfaction of the language requirements prescribed in Clause 2, Article 14 of the Pharmacy Law.

2. Papers granted by foreign authorities must be consularly legalized under regulations and translated into Vietnamese; their Vietnamese translations must be notarized under regulations.

3. The dossier prescribed in this Article shall be made in 1 set.

Article 4.Specific provisions on dossiers of request for re-grant of pharmacy practice certificates

1. A dossier of request for re-grant of a pharmacy practice certificate must comply with Article 25 of the Pharmacy Law and the following specific provisions:

a/ A written request for re-grant of a pharmacy practice certificate, made according to Form No. 4 in the Appendix to this Circular, enclosed with 2 white-background portrait photos of the applicant, of a size of 4 cm x 6 cm, taken within 6 months by the date of request;

b/ A copy of the granted pharmacy practice certificate, unless the certificate is lost.

2. The dossier prescribed in this Article shall be made in 1 set.

Article 5.Specific provisions on dossiers of request for modification of pharmacy practice certificates

1. A dossier of request for modification of a pharmacy practice certificate must comply with Article 26 of the Pharmacy Law and the following specific provisions:

a/ A written request for modification of a pharmacy practice certificate, made according to Form No. 5 in the Appendix to this Decree, enclosed with 2 white-background portrait photos of the applicant, of a size of 4 cm x 6 cm, and taken within 6 months by the date of request;

b/ In case of change of personal information of a practitioner, there must be one of the following papers relating to the change: people’s identity card, passport, household registration book, citizen identity card or a written certification relating to the change granted by a competent agency in accordance with law;

c/ In case of change of scope of operation, there must be the following papers proving the change: relevant professional degrees and written certification of the period of practice at an appropriate establishment.

2. The papers specified at Points b and c, Clause 1 of this Article may be originals or certified copies.

3. In case the papers specified at Points b and c, Clause 1 of this Article are granted by competent foreign agencies, they must be consularly legalized under regulations and translated into Vietnamese; their Vietnamese translations must be notarized under regulations.

4. The dossier prescribed in this Article shall be made in 1 set.

Article 6.Specific provisions on procedures for grant, re-grant and modification of pharmacy practice certificates

1. A dossier of application for grant, or of request for re-grant or modification, of a pharmacy practice certificate shall be submitted directly or sent by post to:

a/ The Ministry of Health, for cases of applying for or requesting re-grant or modification of, pharmacy practice certificates on the basis of examination;

b/ The concerned provincial-level Health Department, for cases of applying for or requesting re-grant or modification of, pharmacy practice certificates on the basis of dossier consideration.

2. After receiving the dossier, the receiving agency shall issue the applicant or requester a dossier receipt slip made according to Form No. 1 in Appendix I to this Decree.

3. If the dossier does not need any modification or supplementation, the agency competent to grant, re-grant or modify pharmacy practice certificates shall:

a/ Grant a pharmacy practice certificate within 20 days from the date written on the dossier receipt slip; in case of refusal to grant a certificate, it shall issue a written reply clearly stating the reason;

b/ Grant a pharmacy practice certificate within 5 working days from the date written on the dossier receipt slip, in case the pharmacy practice certificate is revoked under Clause 3, Article 28 of the Pharmacy Law; in case of refusal to grant a certificate, it shall issue a written reply clearly stating the reason;

c/ Re-grant or modify the pharmacy practice certificate within 10 days from the date written on the dossier receipt slip; in case of refusal to re-grant or modify the certificate, it shall issue a written reply clearly stating the reason.

4. If the dossier needs any modification or supplementation, the dossier-receiving agency shall issue a notice of to-be-modified or -supplemented contents to the requester within:

a/ 10 days from the date written on the dossier receipt slip, for dossiers of application for pharmacy practice certificates;

b/ 5 working days from the date written on the dossier receipt slip, for dossiers of request for re-grant or modification of pharmacy practice certificates.

5. After receiving the modified or supplemented dossier, the dossier-receiving agency shall issue to the applicant or requester a dossier receipt slip, made according to Form No. 1 in Appendix I to this Decree.

a/ In case the modified or supplemented dossier is unsatisfactory, the dossier-receiving agency shall issue a notice to the applicant or requester under Clause 4 of this Article;

b/ In case the modified or supplemented dossier does not need any further modification or supplementation, the dossier-receiving agency shall comply with Clause 3 of this Article.

6. Within 6 months after the dossier-receiving agency issues a notice of modification or supplementation to the dossier, the applicant or requester shall submit the modified or supplemented dossier as requested. Past the above-said time limit, if the applicant or requester still fails to modify or supplement the dossier or after 12 months from the date of initial submission of the dossier, if the modified or supplemented dossier remains unsatisfactory, the submitted dossier shall become invalid.

7. Within 5 working days after granting, re-granting or modifying a pharmacy practice certificate, the dossier-receiving agency shall post and update on its portal the following information:

a/ Full name and date of birth of the person granted with a pharmacy practice certificate;

b/ Serial number of the certificate;

c/ Scope of professional operation.

8. A pharmacy practice certificate shall be made in 2 (two) copies, one to be issued to the applicant or requester and the other filed at the granting agency.

9. When receiving the re-granted or modified pharmacy practice certificate, the requester shall return the granted certificate.

In case the granted certificate is lost, a written request for re-grant of a pharmacy practice certificate made according to Form No. 4 in the Appendix to this Decree shall be submitted.

10. Forms of pharmacy practice certificates:

a/ Pharmacy practice certificates which are granted on the basis of dossier consideration must comply with Form No. 6 in Appendix I to this Decree;

b/ Pharmacy practice certificates which are granted on the basis of examination must comply with Form No. 7 in Appendix I to this Decree.

11. The Minister of Health shall prescribe the organization and operation of advisory councils for grant of pharmacy practice certificates.

12. In case of requesting re-grant of a pharmacy practice certificate under Clause 8, Article 24 of the Pharmacy Law, the requester is not required to pay any charge.

Article 7.Procedures for revocation of pharmacy practice certificates

1. Revocation of pharmacy practice certificates in the cases prescribed in Clauses 1, 4, 5, 6, 7, 8, 9, 10 and 11, Article 28 of the Pharmacy Law:

Within 5 working days after receiving inspection or examination conclusions proposing the revocation of a pharmacy practice certificate or when detecting a case prescribed in Clause 1, 4, 5, 6, 7, 8, 9, 10 or 11, Article 28 of the Pharmacy Law, the agency having granted the pharmacy practice certificate shall revoke the certificate; in case of refusal to revoke the certificate, it shall issue a written reply clearly stating the reason to the agency proposing the revocation.

2. Revocation of pharmacy practice certificates in the cases prescribed in Clauses 2 and 3, Article 28 of the Pharmacy Law:

Within 5 working days after detecting that a pharmacy practice certificate contains errors or receiving a proposal for revocation of a pharmacy practice certificate or receiving a pharmacy practice certificate holder’s petition on errors in his/her certificate, the agency having granted the pharmacy practice certificate shall revoke the certificate; in case of refusal to revoke the certificate, it shall issue a written reply clearly stating the reason to the proposing organization or individual.

3. Responsibilities of agencies granting and revoking pharmacy practice certificates:

a/ To issue decisions on revocation of pharmacy practice certificates;

b/ To publish on their portals and send to the Ministry of Health and provincial-level Health Departments nationwide decisions on revocation of pharmacy practice certificates;

c/ To update information on revocation of pharmacy practice certificates on their portals;

d/ Within 5 (five) working days after receiving a decision on revocation of a pharmacy practice certificate from a certificate-granting agency, the Ministry of Health and provincial-level Health Departments shall publish the revocation decision on their portals.

Section 2

PHARMACY KNOWLEDGE TRAINING AND UPDATING

Article 8.Programs, contents, forms, methods and durations of pharmacy knowledge training and updating

Institutions providing knowledge pharmacy training and updating shall develop training programs as follows:

1. Training contents must cover:

a/ Specialized knowledge;

b/ Pharmacy law and administration.

c/ Pharmacy practice skills and techniques.

2. The form and methods of teaching, learning and assessment of training outcomes must conform with the training program of each training subject, group of trainees and level of training.

3. The duration of pharmacy knowledge training and updating:

a/ Specialized knowledge: at least 6 hours, for university degree holders; at least 4 hours, for college, intermediate or elementary degree holders and holders of other degrees, diplomas or certificates;

b/ Pharmacy law and administration: at least 6 hours;

c/ Pharmacy practice skills and techniques: at least 6 hours.

Article 9.Requirements on institutions providing pharmacy knowledge training and updating for pharmacy practitioners

1. An institution providing pharmacy knowledge training and updating for pharmacy practitioners must meet the following requirements:

a/ Being a vocational education institution providing training in medicine or pharmacy; an educational institution providing training in health sciences; a research institute with the function of training in medicine or pharmacy; an establishment with the function of training health workers; or a pharmacy profession association;

b/ Having a pharmacy knowledge updating or training program as prescribed in Article 8 of this Decree;

c/ Having physical foundations and equipment meeting requirements of training programs;

d/ Having instructors and rapporteurs to participate in pharmacy knowledge training and updating (below referred to as instructors) who meet the following requirements:

- Instructors in pharmacy knowledge must possess one of the degrees prescribed in Articles 17 and 18 of this Decree at a level not lower than that of trainees and have at least 2 years’ experience in a field relevant to training contents;

- Instructors in pharmacy law and administration must possess at least 2 years’ experience of working at pharmacy management or inspection agencies or of teaching pharmacy management at pharmacy training institutions of intermediate or higher level;

- Instructors in pharmacy practice skills and techniques must have at least 3 years’ practical experiences relevant to training contents.

2. In case a pharmacy knowledge training and updating institution does not directly organize pharmacy practice skills and technique lessons, it shall sign contracts to outsource this work to pharmacy establishments meeting good practice requirements relevant to the contents of pharmacy practice skills and technique training.

Article 10.Dossiers of request for announcement or modification of announcement of eligibility to provide pharmacy knowledge training and updating

1. A dossier of request for announcement of eligibility to provide pharmacy knowledge training and updating must comprise:

a/ A request for announcement, made according to Form No. 8 in Appendix I to this Decree;

b/ A training program with the contents complying with Article 8 of this Decree, which must bear a seal on the cover page and on adjoining edges of its pages, in case it is a multiple-page document;

c/ A declaration of physical foundations to prove that the institution is capable of providing pharmacy knowledge training and updating as registered in the announcement prescribed at Point a of this Clause. The announcement must bear a seal on its cover page and on adjoining edges of its pages, in case it is a multiple-page document;

d/ A list of the institution’s instructors in charge of providing pharmacy knowledge training and updating, made according to Form No. 9 in Appendix I to this Decree, enclosed with their CVs and relevant professional diplomas;

dd/ A certified copy of the contract with a pharmacy establishment on cooperation in organizing pharmacy practice skills and techniques lessons, for the case prescribed in Clause 2, Article 9 of this Decree.

2. A dossier of request for modification of announcement of eligibility to provide pharmacy knowledge training and updating upon occurrence of a change in the contents of the dossier of announcement, except for the case prescribed at Point d, Clause 1 of this Article, must comprise:

a/ A request for modification of announcement of eligibility to provide pharmacy knowledge training and updating, made according to Form No. 10 in Appendix I to this Decree;

b/ A copy of the document on the change, which must bear the concerned institution’s seal on its cover page and adjoining edges of its pages, in case it is a multiple-page document.

3. In case of changing the list of instructors referred to at Point d, Clause 1 of this Article, the institution shall send a notice made according to Form No. 11 in Appendix I to this Decree.

4. A dossier shall be made in 1 set, enclosed with electronic files of all papers included therein.

Article 11.Order and procedures for announcement or modification of announcement of eligibility to provide knowledge pharmacy training and updating

1. An institution requesting announcement or modification of announcement of eligibility to provide pharmacy knowledge training and updating (below referred to as announcement or modification of eligibility) shall submit directly or send by post to the provincial-level Health Department of the locality where it is located 1 set of the dossier prescribed in Article 10 of this Decree.

2. After receiving the dossier of request for announcement or modification of announcement of eligibility, the provincial-level Health Department shall issue the dossier-submitting establishment a dossier receipt slip made according to Form No. 1 in Appendix I to this Decree.

3. If the dossier does not need any modification or supplementation, the provincial-level Health Department shall:

a/ Within 30 days from the date written on the dossier receipt slip, publish on its portal the list of institutions eligible to provide pharmacy knowledge training and updating, for cases of requesting announcement of eligibility;

b/ Within 10 working days from the date written on the dossier receipt slip, post on its portal information on modification of announcement of eligibility.

4. If the dossier needs any modification or supplementation, the provincial-level Health Department shall issue a written notice to the requesting institution to modify or supplement the dossier within:

a/ Fifteen days from the date written on the dossier receipt slip, for dossiers of request for announcement of eligibility;

b/ Five working days from the date written on the dossier receipt slip, for dossiers of request for modification of announcement of eligibility.

5. After receiving the modified or supplemented dossier, the provincial-level Health Department shall issue the institution a dossier receipt slip made according to Form No. 1 in Appendix I to this Decree.

a/ In case the modified or supplemented dossier remains unsatisfactory, the provincial-level Health Department shall issue a notice to the institution as prescribed in Clause 4 of this Article;

b/ In case the modified or supplemented dossier does not need any further modification or supplementation, the provincial-level Health Department shall approve the institution’s announcement or modification of announcement of eligibility under Clause 3 of this Article.

6. Within 6 months after the provincial-level Health Department issues a notice of modification or supplementation of the dossier, the institution requesting announcement or modification of announcement of eligibility shall submit a modified or supplemented dossier. Past the above-said time limit, if the institution still fails to submit a modified or supplemented dossier or after 12 months from the date of initial submission of the dossier, the modified or supplemented dossier remains unsatisfactory, the submitted dossier will become invalid.

7. Provincial-level Health Departments shall receive dossiers of request for announcement of eligibility to provide pharmacy knowledge training and updating from institutions subject to cancellation of announcement of eligibility under Clause 3, Article 12 of this Decree only after 12 months after the date of cancellation of announcement.

8. Provincial-level Health Departments shall post on their portals the following information:

a/ Names, addresses and telephone numbers of institutions providing pharmacy knowledge training and updating;

b/ Scope of pharmacy knowledge training and updating.

Article 12.Cases subject to cancellation or modification of announcement of eligibility to provision of pharmacy knowledge training and updating

1. Terminating pharmacy knowledge training and updating activities.

2. Failing to meet one of the requirements on pharmacy knowledge training and updating institutions prescribed in Article 9 of this Decree.

3. Falsifying papers in dossiers of announcement or modification of announcement of eligibility to provide pharmacy knowledge training and updating.

4. Stopping to carry out pharmacy knowledge training and updating activities in 12 consecutive months without notifying thereof to concerned provincial-level Health Departments.

Article 13.Order and procedures for cancelation of announcement or modification of announcement of eligibility for provision of pharmacy knowledge training and updating

1. Within 5 working days after receiving inspection or examination conclusions or competent agencies’ conclusions proposing cancellation of an establishment’s announcement or modification of announcement of eligibility in one of the cases prescribed in Article 12 of this Decree, the concerned provincial-level Health Department shall cancel the announcement or modification of announcement of eligibility according to its competence; if deciding not to cancel the announcement, it shall issue a written reply clearly stating the reason to the agency proposing the cancellation.

2. Within 5 working days after issuing a decision on cancellation of an establishment’s announcement or modification of announcement of eligibility, the concerned provincial-level Health Department shall:

a/ Post on its portal and send to the Ministry of Health and other provincial-level Health Departments nationwide the decision on cancellation of the establishment’s announcement or modification of announcement of eligibility;

b/ Update on its portal information on cancellation of the establishments’ announcement or modification of announcement of eligibility.

3. Within 5 working days after receiving the decision on cancellation of an establishment’s announcement or modification of announcement of eligibility, the Ministry of Health and provincial-level Health Departments shall publish such decision on their portals.

Article 14.Responsibilities of pharmacy knowledge training and updating institutions

1. To carry out pharmacy knowledge training and updating activities only after the announcement of eligibility is posted on the portals of provincial-level Health Departments and carry out these activities in accordance with training and updating programs already announced.

2. To assess and grant certificates of completion of pharmacy knowledge training or updating programs according to Form No. 12 in Appendix I to this Decree.

3. To annually report on the list of persons having completed pharmacy knowledge training or updating programs to provincial-level Health Departments of the localities where they are located according to Form No. 13 in Appendix I to this Decree.

4. To notify in writing provincial-level Health Departments of their termination or resumption of operation.

Article 15.Responsibilities of pharmacy administration agencies

1. The Ministry of Health shall:

a/ Examine and supervise pharmacy knowledge training and updating institutions under Article 9 of this Decree;

b/ Request provincial-level Health Departments to make periodical and extraordinary reports on management of pharmacy knowledge training and updating institutions.

2. Provincial-level Health Departments shall:

a/ Examine, supervise and coordinate with pharmacy knowledge training and updating institutions as prescribed in Article 9 of this Decree in their localities in organizing pharmacy knowledge training and updating activities;

b/ Update on their portals the list of persons having completed pharmacy knowledge training and updating programs at training institutions in their localities;

c/ Post on their portals information relating to the operation of pharmacy knowledge training and updating institutions in their localities.

Article 16.Expenses for pharmacy knowledge training and updating

Persons provided with pharmacy knowledge training and updating shall pay expenses therefor under regulations.

Section 3

IDENTIFICATION OF PROFESSIONAL DEGREES AND TITLES SERVING THE GRANT OF PHARMACY PRACTICE CERTIFICATES

Article 17.Professional degrees and titles eligible for grant of pharmacy practice certificates

1. University degree in pharmacy, which is a university-level degree in pharmacy granted by a domestic educational institution and printed with the title of “Dược sĩ” (Pharmacist), “Dược sĩ đại học”(University-degree pharmacist) or “Dược sĩ cao cấp” (Senior pharmacist).

2. University degree in general medicine, which is a university-level degree in general medicine granted by a domestic educational institution and printed with the title of “Bác sĩ” (Physician) or “Bác sĩ đa khoa”(General Physician).

3. University degree in traditional medicine or traditional pharmacy, which is a university-level degree in traditional medicine or traditional pharmacy granted by a domestic educational institution.

4. University degree in biology, which is a university-level degree in biology granted by a domestic educational institution.

5. University degree in chemistry, which is a university-level degree in chemistry granted by a domestic educational institution.

6. College degree in pharmacy, which is a college-level degree in pharmacy granted by a domestic educational institution.

7. Intermediate degree in pharmacy, which is an intermediate-level degree in pharmacy granted by a domestic educational institution and printed with the title of “Dược sĩtrung cấp” (Intermediate-level Pharmacist) or “Dược sĩtrung học”(Secondary-level pharmacist).

8. College or intermediate degree in medicine, which is a college- or intermediate-level degree in medicine granted by a domestic educational institution.

9. Intermediate degree in traditional medicine or traditional pharmacy, which is an intermediate-level degree in traditional medicine or traditional pharmacy granted by a domestic educational institution.

10. Elementary degree or certificate in pharmacy, which is a written certification or certificate granted by a domestic educational institution and printed with the title “Dược tá”or “Sơ cấpdược”(Elementary-level Pharmacist).

Article 18.Determination of scope of practice under uncategorized professional degrees and titles

1. The scope of practice under degrees and certificates granted by domestic educational institutions and printed with professional titles other than those prescribed in Clauses 1, 2, 7 and 10, Article 17 of this Decree, shall be considered and determined by agencies competent to grant pharmacy practice certificates on the basis of opinions of advisory councils for grant of pharmacy practice certificates.

2. Degrees and certificates granted by foreign training institutions shall be recognized under the Minister of Education and Training’s regulations. The determination of the scope of practice under degrees and certificates granted by foreign training institutions must comply with Clause 1 of this Article.

Section 4

PROFESSIONAL PHARMACY PRACTICE

Article 19.Professional practice establishments

1. Professional practice establishments are those prescribed in Clause 2, Article 13 of the Pharmacy Law, including: pharmaceutical business establishments, pharmacy sections of medical examination and treatment establishments, professional pharmacy training schools, pharmacy research institutions, drug and drug material testing establishments, pharmacy administration agencies or representative offices of foreign traders engaged in pharmacy in Vietnam (below collectively referred to as pharmacy establishments), and medical examination and treatment establishments suitable to specialties of practitioners.

2. Appropriate professional practice establishments are those defined in Clause 1 of this Article the operations of which are suitable to the contents of professional practice of practitioners prescribed in Article 20 of this Decree.

3. Professional practice establishments shall make written certifications of the period of professional practice for those who practice at their establishments according to Form No. 3 in Appendix I to this Decree and shall take responsibility for contents of their certifications.

4. For drug retailing establishments:

a/ In addition to complying with Clause 3 of this Article, before providing professional practice instructions to those who register to practice at his/her establishment, the head of a professional practice establishment shall send a list of persons registering to practice at the establishment, made according to Form No. 14 in Appendix I to this Decree, to the provincial-level Health Department of the locality where the establishment is located. Such list must specify the name and address of the professional practice establishment; full names of persons registering to practice at the establishment; contents of practice; time of commencement of practice; names of persons assigned to instruct the practice;

b/ Within 5 (five) working days after receiving the list of persons registering to practice at an establishment, the provincial-level Health Department shall post the information prescribed at Point a of this Clause on its portal.

Article 20.Contents of professional practice

1. For persons responsible for professional pharmacy activities at establishments manufacturing drugs, adjuvants and capsule shells:

a/ A person responsible for professional pharmacy activities at a drug manufacturing establishment, except the cases prescribed at Points c and d of this Clause, shall practice one of the following professional operations: drug manufacture; drug testing; drug product research and development; and pharmacy administration at pharmacy administration agencies;

b/ A person responsible for professional pharmacy activities at an establishment manufacturing drug materials being pharmaceutical ingredients, adjuvants and capsule shells shall practice one of the following professional operations: drug manufacture; drug testing; drug product and drug material research and development; drug material and chemical manufacture; and pharmacy administration at pharmacy administration agencies;

c/ A person responsible for professional pharmacy activities at an establishment manufacturing vaccines or biological products shall practice one of the following professional operations: vaccine and biological product manufacture; vaccine and biological product testing; vaccine and biological product research and development; and pharmacy administration at pharmacy administration agencies;

d/ A person responsible for professional pharmacy activities at an establishment manufacturing traditional drugs shall practice one of the following professional operations: traditional drug manufacture and processing; traditional drug testing; traditional drug product quality assurance and traditional drug product research and development; and traditional pharmacy or medicine administration at pharmacy administration agencies.

2. For persons in charge of quality assurance at establishments manufacturing drugs, pharmaceutical ingredients, adjuvants and capsule shells:

a/ A person in charge of quality assurance at a drug manufacturing establishment, except the case prescribed at Point c of this Clause, shall practice one of the following professional operations: manufacture, testing, quality assurance, and product research and development at drug manufacturing or testing establishments;

b/ A person in charge of quality assurance at an establishments manufacturing drug materials being pharmaceutical ingredients, adjuvants or capsule shells shall practice one of the following professional operations: manufacture, testing, quality assurance and, product research and development at drug or drug material manufacturing establishments or drug testing establishments;

c/ A person in charge of quality assurance at an establishment manufacturing vaccines, biological products and vaccine and biological product materials shall practice one of the following professional operations: manufacture, testing, quality assurance, and product research and development at vaccine and biological product manufacturing or testing establishments.

3. For persons responsible for professional pharmacy activities and persons in charge of quality assurance at establishments manufacturing medicinal materials

a/ A person responsible for professional pharmacy activities or in charge of quality assurance at an establishment manufacturing medicinal materials shall practice one of the following professional operations: manufacture, preparation and processing of drugs from medicinal materials, traditional drugs and medicinal materials; drug testing; and quality assurance in drug material  manufacture and traditional drug preparation and processing; and pharmacy administration or traditional medicine and pharmacy administration at pharmacy administration agencies;

b/ A person responsible for professional pharmacy activities or a person in charge of quality assurance at a household or cooperative manufacturing medicinal materials shall practice one of the following professional operations: drug material manufacture; drug testing; quality assurance in manufacture; medicinal material and traditional medicine research; traditional drug preparation and processing; and pharmacy administration or traditional medicine and pharmacy administration at pharmacy administration agencies.

4. For persons responsible for professional pharmacy activities at drug or drug material wholesaling establishments

a/ A person responsible for professional pharmacy activities at a drug wholesaling establishment, except the cases prescribed at Point c and d of this Clause, shall practice one of the following professional operations: drug and drug material wholesale; and pharmacy administration at pharmacy administration agencies;

b/ A person responsible for professional pharmacy activities at a drug material wholesaling establishment shall practice one of the following professional operations: drug material manufacture; chemical manufacture; drug and drug material testing; chemical or pharmaceutical technology research; drug wholesale; drug import and export; drug and drug material storage; and pharmacy administration or traditional medicine and pharmacy administration at pharmacy administration agencies;

c/ A person responsible for professional pharmacy activities at a vaccine and biological product wholesaling establishment shall practice one of the following professional operations: vaccine and biological product manufacture, wholesale, storage and testing; vaccine and biological product research; and pharmacy administration at pharmacy administration agencies;

d/ A person responsible for professional pharmacy activities at an establishment wholesaling medicinal materials, drugs from medicinal materials and traditional drugs shall practice one of the following professional operations: drug and medicinal material wholesale; storage of drugs and medicinal materials for drug manufacture; medicinal material manufacture; drug and drug material testing; traditional medicine; medicinal material and traditional medicine research; pharmacy administration or traditional medicine or pharmacy administration at pharmacy administration agencies.

5. For persons responsible for professional pharmacy activities at drug and drug material import and export establishments

a/ A person responsible for professional pharmacy activities at a drug or drug material import and export establishment, except the cases prescribed at Points b and c of this Clause, shall practice one of the following professional operations: drug wholesale; drug import and export; drug manufacture; drug and drug material testing; good storage practice; pharmacy administration regarding drug circulation and drug and drug material import, export and wholesale; and pharmacy administration at pharmacy administration agencies;

b/ A person responsible for professional pharmacy activities at an establishment importing and exporting vaccines and biological products shall practice one of the following professional operations: vaccine and biological product manufacture, wholesale, storage, testing, or research; vaccine and biological product management; vaccine and biological product use; and pharmacy administration at pharmacy administration agencies;

c/ A person responsible for professional pharmacy activities at an establishment importing and exporting medicinal materials, drugs from medicinal materials and traditional drugs shall practice one of the following professional operations: drug and drug material wholesale, storage or manufacture; drug, drug material and traditional drug testing; medicinal material and traditional medicine research; and pharmacy administration or traditional medicine or pharmacy administration at pharmacy administration agencies.

6. For persons responsible for professional pharmacy activities at drug retailing establishments

a/ A person responsible for professional pharmacy activities at a drugstore, drug dispensary or medicine cabinet of a commune health station shall practice one of the following professional operations: drug wholesale or retail; drug import and export; clinical pharmacy, drug supply within medical examination and treatment establishments; drug manufacture; drug and drug material testing; pharmacy research; drug storage; drug distribution; or pharmacy administration at pharmacy administration agencies;

b/ A person responsible for professional pharmacy activities at an establishment retailing medicinal materials, drugs from medicinal materials and traditional drugs, except the case prescribed at Point c, Clause 2, Article 13 of the Pharmacy Law shall practice one of the professional operations concerning manufacture, research, trading and medical examination and treatment in the traditional medicine sector; or pharmacy administration or traditional medicine or pharmacy administration at pharmacy administration agencies.

7. For persons responsible for professional pharmacy activities at an establishment providing the service of drug and drug material testing

a/ A person responsible for professional pharmacy activities at an establishment providing the service of drug and drug material testing, except the case prescribed at Point b of this Clause, shall practice one of the following professional operations: drug and drug material testing; research related to drug and drug material manufacture, testing or analysis; and pharmacy administration at pharmacy administration agencies;

b/ A person responsible for professional pharmacy activities at an establishment providing the service of vaccine and biological product testing shall practice one of the following professional operations: drug or drug material testing; vaccine or biological product testing; research related to vaccine or biological product manufacture or testing; drug storage covering vaccines and biological products; and pharmacy administration at pharmacy administration agencies.

8. Persons responsible for professional pharmacy activities at establishments providing the service of clinical trial of drugs or bioequivalence trial of drugs shall practice one of the following professional operations: bioequivalence trial of drugs; clinical trial of drugs; drug and drug material testing; pharmacological research; clinical pharmacy; and pharmacy administration or traditional medicine and pharmacy administration at pharmacy administration agencies.

9. Persons responsible for clinical pharmacy work at medical examination and treatment establishments

a/ A person responsible for clinical pharmacy work at a medical examination and treatment establishment shall practice one of the following professional operations:  bioequivalence trial of drugs; clinical trial of drugs; pharmacological research; clinical pharmacy; pharmacovigilance at drug information centers; and adverse drug reaction monitoring;

b/ A person responsible for clinical pharmacy work at a traditional medical examination and treatment establishment shall practice one of the following professional operations:  clinical trial of drugs; pharmacological research; clinical pharmacy; pharmacovigilance at drug information centers; and adverse drug reaction monitoring with regard to traditional drugs.

10. For persons responsible for professional pharmacy activities at establishments providing the service of drug and drug material storage

a/ A person responsible for professional pharmacy activities shall practice one of the following professional operations: drug storage; pharmacy administration or traditional medicine and pharmacy administration at pharmacy administration agencies;

b/ A person responsible for professional pharmacy activities at an establishment providing the service of vaccine and biological product storage shall practice one of the following professional operations: drug storage covering vaccines and biological products; vaccine and biological product manufacture; vaccine and biological product testing; and pharmacy administration at pharmacy administration agencies.

Article 21.Requirements on the period of practice for persons with postgraduate qualifications

1. Persons with postgraduate qualifications are those who have one of the following degrees:

a/ Master’s degree in pharmacy, medicine, traditional medicine, chemistry or biology (below collectively referred to as master’s degree);

b/ Doctor’s degree in pharmacy, medicine, traditional medicine, chemistry or biology (below collectively referred to as doctor’s degree);

c/ Grade-I or -II medical specialist’s degree in accordance with the Ministry of Health’s regulations on the system of postgraduate specialty training.

2. The period of practice for a person with a postgraduate qualification shall be determined correspondingly to the scope of his/her professional practice as follows:

a/ If possessing a postgraduate qualification in drug preparation, pharmacy industry or drug testing, a person who is responsible for professional pharmacy activities, or in charge of drug quality at a drug or drug material manufacturing establishment, or responsible for professional activities at an establishment providing the drug or drug material testing service is entitled to a reduction of the period of practice which is:

- Six months, for holders of master’s or grade-I medical specialist’s degree;

- One year, for holders of doctor’s or grade-II medical specialist’s degree.

b/ If possessing a postgraduate qualification in pharmacology or clinical pharmacy, a person who is responsible for professional pharmacy activities at an establishment providing the service of bioequivalence trial, establishment providing the service of clinical trial of drugs or drug retailing establishment, or in charge of clinical pharmacy work at a medical examination and treatment establishment is entitled to a reduction of the period of practice which is:

- Six months, for holders of master’s or grade-I medical specialist’s degree;

- One year, for holders of doctor’s or grade-II medical specialist’s degree.

c/ If possessing a postgraduate qualification in medicinal materials, traditional pharmacy or traditional medicine, a person who is responsible for professional pharmacy activities at an establishment trading in medicinal materials and traditional drugs or in charge of clinical pharmacy work at a traditional medical examination and treatment establishment is entitled to a reduction of the period of practice which is:

- Six months, for holders of master’s or grade-I medical specialist’s degree;

- One year, for holders of doctor’s or grade-II medical specialist’s degree.

d/ If possessing a postgraduate qualification in infection, microbiology or preventive medicine, a person who is responsible for professional pharmacy activities at an establishment wholesaling, or providing the service of storage of, vaccines and biological products is entitled to a reduction of the period of practice which is:

- Six months, for holders of master’s or grade-I medical specialist’s degree;

- One year, for holders of doctor’s or grade-II medical specialist’s degree.

dd/ If possessing a postgraduate qualification in pharmacy economics or pharmacy administration, a person who is responsible for professional pharmacy activities at a drug wholesaling or retailing establishment (except medicine cabinets of commune health stations) or an establishment providing drug storage services is entitled to a reduction of the period of practice which is:

- Six months, for holders of master’s or grade-I medical specialist’s degree;

- One year, for holders of doctor’s or grade-II medical specialist’s degree.

e/ If possessing a postgraduate qualification in pharmacy economics or pharmacy administration, a person who is responsible for professional pharmacy activities at an establishment retailing drugs from medicinal materials, traditional drugs and medical materials or at the medicine cabinet of a commune health station is entitled to a reduction of the period of practice which is:

- Three months, for holders of master’s or grade-I medical specialist’s degree;

- Six months, for holders of doctor’s or grade-II medical specialist’s degree.

Section V

EXAMINATION FOR GRANT OF PHARMACY PRACTICE CERTIFICATES

Article 22.Examination forms, contents and programs

1. Examination forms: sitting examinations at an examination-organizing institution or online examinations.

2. Examination contents:

a/ General knowledge for pharmacy practitioners;

b/ Specialized knowledge suitable to each working position requiring a pharmacy practice certificate prescribed in Article 11 of the Pharmacy Law.

3. The Minister of Health shall stipulate in detail regulations and contents of examinations, exam question banks and scores for grant of pharmacy practice certificates.

Article 23.Requirements on institutions organizing examinations for grant of pharmacy practice certificates

1. Being institutions providing university degree training in pharmacy or traditional medicine and pharmacy.

2. Having a plan on organization of examinations for grant of pharmacy practice certificates, made according to Form No. 15 in Appendix I to this Decree.

Article 24.Dossiers of request for announcement or modification of announcement of an institution’s eligibility to organize examinations for grant of pharmacy practice certificates

1. A dossier of request for announcement of an institution’s eligibility to organize examinations for grant of pharmacy practice certificates must comprise:

a/ A request for announcement of an institution’s eligibility to organize examinations for grant of pharmacy practice certificates, made according to Form No. 16 in Appendix I to this Decree;

b/ A plan on organization of examinations for grant of pharmacy practice certificates, made according to Clause 2, Article 23 of this Decree;

c/ A certified copy of the institution’s establishment decision or operation license.

2. A dossier of request for modification of announcement of an institution’s eligibility to organize examinations for grant of pharmacy practice certificates in case change in information on the name and address of an examination-organizing institution:

a/ A request for modification of announcement of an institution’s eligibility to organize examinations for grant of pharmacy practice certificates, made according to Form No. 17 in Appendix I to this Decree;

b/ A plan on organization of examinations for grant of pharmacy practice certificates, made according to Clause 2, Article 23 of this Decree.

3. A dossier of request for modification of announcement of an institution’s eligibility to organize examinations in case of change in the scope of examination must comprise:

a/ A request for modification of announcement of an institution’s eligibility to organize examinations for grant of pharmacy practice certificates, made according to Form No. 17 in Appendix I to this Decree;

b/ A plan on organization of examinations for grant of pharmacy practice certificates, made according to Clause 2, Article 23 of this Decree.

4. A dossier shall be made in one set, enclosed with electronic files of all documents included therein.

Article 25.Procedures for requesting announcement or modification of announcement of an institution’s eligibility to organize examinations for grant of pharmacy practice certificates

1. An institution requesting announcement or modification of announcement of its eligibility to organize examinations for grant of pharmacy practice certificates (below referred to as announcement of eligibility to organize examinations) shall submit directly or send by post to the Ministry of Health a dossier set prescribed in Article 24 of this Decree.

2. After receiving the dossier, the Ministry of Health shall issue the submitting institution a dossier receipt slip made according to Form No. 1 in Appendix I to this Decree.

3. If the dossier does not need any modification or supplementation, the Ministry of Health shall:

a/ Post on its portal the list of institutions eligible to organize examinations for grant of pharmacy practice certificates within 30 days from the date written on the dossier receipt slip, for cases of request for announcement or modification of the announcement of the scope of examination; in case of disapproval of the announcement or modification of the announcement, it shall issue a written reply clearly stating the reason;

b/ Modify the examination-organizing institution’s announcement of eligibility to organize examinations for grant of pharmacy practice certificates within 10 working days from the date written on the dossier receipt slip, for cases of request for modification of information on names and address of examination-organizing institutions.

4. If the dossier needs any modification or supplementation, the Ministry of Health shall issue a written notice to the institution requesting announcement of eligibility to organize examinations for the latter to modify or supplement the dossier within:

a/ Fifteen days from the date written on the dossier receipt slip, for dossiers of request for announcement or modification of the announcement of the scope of examination;

b/ Five working days from the date written on the dossier receipt slip, for dossiers of request for modification of announcement regarding names and addresses of examination-organizing institutions.

5. After receiving the modified or supplemented dossier, the Ministry of Health shall issue the institution a dossier receipt slip made according to Form No. 1 in the Appendix to this Decree.

a/ In case the modified or supplemented dossier is unsatisfactory, the Ministry of Health shall issue a notice to the institution as prescribed in Clause 4 of this Article;

b/ In case the modified or supplemented dossier does not need further modification or supplementation, the Ministry of Health shall approve the institution’s announcement or modification of announcement of eligibility to organize examinations under Clause 3 of this Article.

6. Within 6 months after the Ministry of Health issue a notice of modification or supplementation of the dossier, the establishment requesting announcement or modification of announcement of eligibility to organize examinations shall submit a modified or supplemented dossier. Past the above-said time limit, if the institution still fails to submit the modified or supplemented dossier or after 12 months from the date of initial submission of the dossier, the modified or supplemented dossier remains unsatisfactory, the submitted dossier will become invalid.

7. The Ministry of Health shall receive dossiers of request for announcement of eligibility to organize examinations from institutions that have their announcement of eligibility cancelled under Clause 3, Article 26 of this Decree only after 12 months after the date of the cancellation.

8. The Ministry of Health shall post on its portal the following information:

a/ Names, addresses and telephone numbers of institutions eligible to organize examinations for grant of pharmacy practice certificates;

b/ Scope of examination.

Article 26.Cases subject to cancellation of announcement or modification of announcement of eligibility to organize examinations for grant of pharmacy practice certificates

1. Terminating activities of organizing examinations for grant of pharmacy practice certificates.

2. Failing to meet one of the requirements prescribed in Article 23 of this Decree.

3. Falsifying papers in the dossier of announcement or modification of announcement of eligibility to organize examinations for grant of pharmacy practice certificates.

Article 27.Order and procedures for cancelation of announcement or modification of announcement of eligibility to organize examinations for grant of pharmacy practice certificates

1. Within 5 working days after receiving inspection or examination conclusions or competent agencies’ conclusions proposing cancellation of an institution’s announcement or modification of announcement of eligibility to organize examinations in one of the cases prescribed in Article 26 of this Decree, the Ministry of Health shall cancel the announcement or modification of announcement of eligibility according to its competence; if deciding not to cancel the announcement or modification of announcement, it shall issue a written reply clearly stating the reason to the agency proposing the cancellation.

2. Within 5 working days after issuing a decision on cancellation of an institution’s announcement or modification of announcement of eligibility to organize examinations, the Ministry of Health shall:

a/ Post on its portal and send to provincial-level Health Departments nationwide the decision on cancellation of the institution’s announcement or modification of announcement of eligibility to organize examinations;

b/ Update on its portal information on cancellation of the institution’s announcement or modification of announcement of eligibility to organize examinations.

3. Within 5 working days after receiving the decision on cancellation of an institution’s announcement or modification of announcement of eligibility to organize examinations from the Ministry of Health, provincial-level Health Departments shall publish such decision on their portals.

Article 28.Organization of examinations for grant of pharmacy practice certificates

1. Institutions may organize examinations only after the announcement of eligibility to organize examination is posted on the portal of the Ministry of Health and shall ensure that the organization of examinations:

a/ Conform with the plan announced by the Ministry of Health;

b/ Conform with examination regulations issued by the Ministry of Health.

2. Within 5 working days after examination results are available, an examination-organizing institution shall issue a written certification of examination results of examinees according to Form No. 18 in Appendix I to this Decree and notify the list of persons with satisfactory results for grant of pharmacy practice certificates to the Ministry of Health.

3. In case no institution is announced as eligible to organize examinations, the Ministry of Health shall designate institutions meeting the conditions prescribed in Article 23 of this Decree to organize examinations for grant of pharmacy practice certificates.

Article 29.Priorities in professional practice for holders of pharmacy practice certificates granted on the basis of examination

Those who possess pharmacy practice certificates granted on the basis of examination shall be given with priority in recruitment and employment at public non-business health establishments as follows:

1. Priority in recruitment if obtaining “Pass with distinction” result and having a university or postgraduate degree of distinction level.

2. Exemption from probation after being recruited.

3. Priority in consideration for participation in training, retraining and professional capacity building courses at home and abroad.

Article 30.Expenses

Those who sit examinations for grant of pharmacy practice certificates shall pay examination expenses in accordance with law.

Chapter III

PHARMACEUTICAL BUSINESS

Section 1

CERTIFICATES OF ELIGIBILITY FOR PHARMACEUTICAL BUSINESS

Article 31.Conditions for traditional drug business

1. An establishment manufacturing traditional drugs for circulation nationwide must satisfy the conditions specified at Points a, c and d, Clause 2, Article 69 of the Pharmacy Law.

2. An establishment importing traditional drugs must have its location, warehouse for drug storage, storage equipment, vehicles, quality management system, professional and technical documents, and employees that meet the requirements on good storage practices for traditional drugs. The person responsible for professional pharmacy activities at an establishment exporting and importing traditional drugs must satisfy the conditions specified in Clause 3, Article 17 of the Pharmacy Law.

3. An establishment providing the service of storing traditional drugs must have its location, warehouse for drug storage, storage equipment, vehicles, quality management system, professional and technical documents, and employees that meet the requirements on good storage practices for traditional drugs. The person responsible for professional pharmacy activities at an establishment providing the service of storing traditional drugs must satisfy the conditions specified in Clause 1, Article 22 of the Pharmacy Law.

4. An establishment wholesaling traditional drugs must have its location, warehouse for drug storage, storage equipment, vehicles, quality management system, professional and technical documents, and employees that meet the requirements on good distribution practices for traditional drugs. The person responsible for professional pharmacy activities at an establishment wholesaling traditional drugs must satisfy the conditions specified in Clause 3, Article 16 of the Pharmacy Law.

5. Conditions on an establishment retailing medicinal materials, drugs from medicinal materials or traditional drugs:

a/ The establishment’s person responsible for professional pharmacy activities must satisfy the conditions specified in Clause 4, Article 18 of the Pharmacy Law;

b/ The establishment must have a fixed and separate location; be firmly built; have an area suitable to its business scale; and be built in a high and dry, well-ventilated and safe place which is far from polluting sources, meeting the fire and explosion prevention and fighting requirements;

c/ The establishment must have a storage place and storage equipment meeting the storage requirements written on product labels.

Drugs from medicinal materials and traditional drugs shall be stored separately from medicinal materials and traditional medicaments.

Toxic medicinal materials (if any) shall be displayed for sale and stored in separate places; if being displayed for sale and stored in the same place with that for other medicinal materials, toxic medicinal materials shall be separately placed and marked with the words “Toxic medicinal materials” to avoid confusion.

Prescription drugs from medicinal materials and traditional drugs (if any) shall be displayed for sale and stored in separate places; if being displayed for sale and stored in the same place with that for non-prescription drugs, prescription drugs from medicinal materials and traditional drugs shall be separately placed and marked with the words “Prescription drugs” to avoid confusion.

An establishment retailing drugs from medicinal materials and traditional drugs or retailing medicinal materials is only required to have an appropriate place for storage of drugs from medicinal materials and traditional drugs or for storage of medicinal materials and traditional medicaments;

d/ Instruments in direct contact with or primary packages of drugs from medicinal materials, traditional drugs or medicinal materials must not affect the quality of such drugs or materials;

dd/ The establishment must keep books for recording or take appropriate measures to store information on output and input activities and origin tracing;

e/ A retailer of medicinal materials, drugs from medicinal materials or traditional drugs must possess one of the degrees prescribed at Points a, c, e, g, i and l, Clause 1, Article 13 of the Pharmacy Law.

For toxic medicinal materials, prescription drugs from medicinal materials or prescription traditional drugs, a person directly retailing such materials or drugs to and providing counseling for buyers must be the person responsible for professional activities of the retailing establishment;

g/ If a retailing establishment also trades in other commodities under law, these commodities shall be displayed for sale and stored in separate places and must not affect medicinal materials, drugs from medicinal materials or traditional drugs.

Article 32.Detailed provisions on dossiers for grant, re-grant and modification of certificates of eligibility for pharmaceutical business

A dossier for grant, re-grant or modification of a certificate of eligibility for pharmaceutical business must comply with Article 38 of the Pharmacy Law, and is specified as follows:

1. An application for, or written request for re-grant or modification of, a certificate of eligibility for pharmaceutical business shall be made according to Form No. 19, 20 or 21 in Appendix I to this Decree.

2. Technical documents prescribed at Point b, Clause 1, and Point b, Clause 2, Article 38 of the Pharmacy Law include a certificate of eligibility for pharmaceutical business or a certificate of good practices at the business place (if any) and the following technical documents:

a/ For an establishment manufacturing drugs and drug materials: documents on the establishment’s location, manufacturing workshop, testing laboratory, warehouse for storage of drugs and drug materials, auxiliary system, equipment and machinery for drug manufacture, testing and storage, quality management system, professional and technical documents, and employees meeting the requirements of good manufacturing practices for drugs and drug materials.

An establishment applying for a certificate of eligibility for pharmaceutical business that manufactures drugs and sells drugs or drug materials to retailing establishments or medical examination and treatment establishments is also required to have professional and technical documents and employees meeting the requirements of good distribution practices for drugs and drug materials;

b/ For an establishment importing drugs and drug materials, an establishment exporting drugs and drug materials or an establishment providing the service of storing drugs and drug materials: documents on its location, warehouse for storage of drugs and drug materials, storage equipment, vehicles, quality management system, professional and technical documents and employees meeting the requirements of good storage practices for drugs and drug materials.

An establishment applying for a certificate of eligibility for pharmaceutical business that exports and imports drugs and drug materials and sells them to retailing establishments or health establishments is also required to have professional and technical documents and employees meeting the requirements of good distribution practices for drugs and drug materials;

c/ For an establishment wholesaling drugs and drug materials: documents on its location, warehouse for storage of drugs and drug materials, storage equipment, vehicles, quality management system, professional and technical documents and employees meeting the requirements of good distribution practices for drugs and drug materials;

d/ For a drug retailing establishment: documents on its location, storage place, storage equipment, professional and technical documents and employees meeting the requirements of good retail practices for drugs.

For an establishment retailing medicinal materials, drugs from medicinal materials and traditional drugs: documents proving its satisfaction of the conditions specified in Clause 5, Article 31 of this Decree under the Minister of Health’s regulations;

dd/ For an establishment providing the service of testing drugs and drug materials: documents on its location, laboratory for chemical, microbiological or biological testing, auxiliary system, testing equipment, chemicals, reagents, quality management system, professional and technical documents and employees satisfying the requirements of good laboratory practices for drug quality inspection;

e/ For an establishment providing the service of clinical trial of drugs: documents on its location, clinical trial laboratory, laboratory and equipment for bio-chemical testing, quality management system, professional and technical documents and employees satisfying the requirements of good practices of clinical trial of drugs;

g/ For an establishment providing the service of bioequivalence trial of drugs: documents on its location, laboratory for biofluid analysis, experiment equipment for biofluid analysis, place for accommodation and monitoring of drug users to serve the assessment of bioequivalence, quality management system, professional and technical documents and employees satisfying the requirements of good laboratory practices for the stage of biofluid analysis and of good practices of clinical trial of drugs for the stage of clinical research.

If an establishment providing the service of bioequivalence trial signs a contract or cooperates with an establishment providing the service of clinical trial of drugs that satisfies the requirements of good practices of clinical trial of drugs to conduct the stage of clinical research in bioequivalence trial of drugs, technical documents are not required to include documents on the establishment’s location, laboratory for biofluid analysis, testing equipment for biofluid analysis, place for accommodation and monitoring of drug users to serve the assessment of bioequivalence, quality management system, professional and technical documents and employees satisfying the requirements of good practices of clinical trial of drugs.

3. Every document referred to in Clause 2 of this Article must have the establishment’s seal appended on the cover page and on adjoining edges of all other pages. If the establishment has no seal, its at-law representative’s signature is required.

Article 33.Order of grant of certificates of eligibility for pharmaceutical business

1. An establishment applying for a certificate of eligibility for pharmaceutical business shall submit directly or send by post a dossier to:

a/ The Ministry of Health, if applying for a certificate of eligibility for pharmaceutical business in one of the cases specified at Points a, b, c, e, g and h, Clause 2, Article 32 of the Pharmacy Law;

b/ The provincial-level Health Department of the locality where the establishment is located, if applying for a certificate of eligibility for pharmaceutical business in one of the cases specified at Points d and dd, Clause 2, Article 32 of the Pharmacy Law;

2. After receiving the dossier, the dossier-receiving agency shall issue the applicant a dossier receipt slip made according to Form No. 01 in Appendix I to this Decree.

3. If requesting no modification or supplementation to the dossier, the agency in charge of granting certificates of eligibility for pharmaceutical business shall:

a/ Grant a certificate of eligibility for pharmaceutical business within 30 days from the date written on the dossier receipt slip if after inspection, the applicant’s physical and technical foundations and employees have been assessed as satisfying the requirements of good practices as suitable to its business scope and no field assessment at the applicant is required;

b/ Conduct a field assessment at the applicant within 20 days from the date written on the dossier receipt slip.

4. If requesting any modification or supplementation to the dossier, the dossier-receiving agency shall, within 10 working days from the date written on the dossier receipt slip, send a written request to the applicant, specifying the documents and contents to be modified and supplemented.

5. After receiving the modified or supplemented dossier, the dossier-receiving agency shall issue the applicant a dossier receipt slip made according to Form No. 01 in Appendix I to this Decree.

a/ If the modified or supplemented dossier remains unsatisfactory, the dossier-receiving agency shall issue a written notice to the applicant under Clause 4 of this Article;

b/ If requesting no further modification or supplementation to the modified dossier, the dossier-receiving agency shall comply with Clause 3 of this Article.

6. After conducting a field assessment at the applicant, the agency in charge of granting certificates of eligibility for pharmaceutical business shall:

a/ Grant a certificate of eligibility for pharmaceutical business within 10 working days from the date of completion of the field assessment, if requiring no remediation or improvement;

b/ Issue a written notice of the items to be remedied or improved, if any, within 5 working days from the date of completion of the field assessment.

7. Within 20 days after receiving a written notice and documents proving completion of the remediation or improvement from the applicant, the agency in charge of granting certificates of eligibility for pharmaceutical business shall grant such a certificate or state the reason for its refusal to grant the certificate.

8. Within 6 months from the date the dossier-receiving agency issues a written request for dossier modification or supplementation, the applicant shall submit a modified or supplemented dossier. Past this time limit, if the establishment fails to modify or supplement the dossier, or after 12 months from the date of initial submission of the dossier, if the modified or supplemented dossier remains unsatisfactory, the submitted dossier will become invalid.

9. Within 5 working days from the date of grant of a certificate of eligibility for pharmaceutical business, the dossier-receiving agency shall post and update on its portal the following information:

a/ Name and address of the establishment that has been granted a certificate of eligibility for pharmaceutical business;

b/ Full name of the person responsible for professional pharmacy activities and serial number of his/her pharmacy practice certificate;

c/ Serial number of the certificate of eligibility for pharmaceutical business.

10. For the case of grant of a certificate of eligibility for pharmaceutical business specified at Point b, Clause 1, Article 36 of the Pharmacy Law, the applicant shall return the old certificate of eligibility for pharmaceutical business, unless it is lost.

11. A certificate of eligibility for pharmaceutical business shall be made in 2 copies according to Form No. 22 in Appendix I to this Decree: 1 copy shall be issued to the applicant and the other kept at the agency in charge of granting certificates of eligibility for pharmaceutical business.

12. If the applicant has been assessed as satisfying the requirements of good practices, the agency in charge of granting certificates of eligibility for pharmaceutical business shall grant a certificate of satisfaction of the requirements of good practices if the establishment so wishes.

Article 34.Order of re-grant and modification of certificates of eligibility for pharmaceutical business

1. An establishment that requests re-grant or modification of a certificate of eligibility for pharmaceutical business shall submit a dossier directly or by post to:

a/ The Ministry of Health, if requesting re-grant or modification of a certificate of eligibility for pharmaceutical business in one of the cases specified at Points a, b, c, e, g and h, Clause 2, Article 32 of the Pharmacy Law;

b/ The provincial-level Health Department of the locality where the establishment is located, if requesting re-grant or modification of a certificate of eligibility for pharmaceutical business in one of the cases specified at Points d and dd, Clause 2, Article 32 of the Pharmacy Law.

2. After receiving the dossier, the dossier-receiving agency shall issue the applicant a dossier receipt slip made according to Form No. 01 in Appendix I to this Decree.

3. If requesting no modification or supplementation to the dossier, the agency in charge of re-granting or modifying certificates of eligibility for pharmaceutical business shall:

a/ Re-grant or modify a certificate of eligibility for pharmaceutical business within 20 days from the date written on the dossier receipt slip, for the cases specified at Point a, Clause 2, and Clause 3, Article 36 of the Pharmacy Law;

b/ Re-grant or modify a certificate of eligibility for pharmaceutical business within 7 working days from the date written on the dossier receipt slip, for the case specified at Point b, Clause 2, Article 36 of the Pharmacy Law.

4. If requesting modification or supplementation to the dossier, the dossier-receiving agency shall, within 5 working days from the date written on the dossier receipt slip, send a written request for dossier modification or supplementation to the applicant.

5. After receiving the modified or supplemented dossier, the dossier-receiving agency shall issue the applicant a dossier receipt slip made according to Form No. 01 in Appendix I to this Decree.

a/ If the modified or supplemented dossier is unsatisfactory, the dossier-receiving agency shall issue a written notice to the applicant under Clause 4 of this Article;

b/ If requesting no modification or supplementation to the dossier, the dossier-receiving agency shall re-grant or modify a certificate of eligibility for pharmaceutical business under Clause 3 of this Article.

6. Within 6 months from the date the dossier-receiving agency issues a written notice of dossier modification or supplementation, the applicant shall submit a modified or supplemented dossier. Past this time limit, if the establishment fails to modify or supplement the dossier, or after 12 months from the date of initial submission of the dossier, if the modified or supplemented dossier remains unsatisfactory, the submitted dossier will become invalid.

7. Within 5 working days from the date of re-grant or modification of a certificate of eligibility for pharmaceutical business, the dossier-receiving agency shall post and update on its portal the following information:

a/ Name and address of the establishment having its certificate of eligibility for pharmaceutical business re-granted or modified;

b/ Full name of the person responsible for professional pharmacy activities and serial number of his/her pharmacy practice certificate;

c/ Serial number of the certificate of eligibility for pharmaceutical business.

8. Upon receiving a new certificate of eligibility for pharmaceutical business, the establishment shall return the old certificate of eligibility for pharmaceutical business, unless it is lost.

9. A certificate of eligibility for pharmaceutical business shall be made in 2 copies according to Form No. 22 in Appendix I to this Decree: 1 (one) copy shall be handed over to the applicant and the other kept at the agency in charge of re-granting and modifying certificates of eligibility for pharmaceutical business.

Article 35.Procedures for revocation of certificates of eligibility for pharmaceutical business

1. Within 5 working days after receiving the inspection or examination conclusion, including the proposal to revoke a certificate of eligibility for pharmaceutical business, or when detecting one of the cases specified in Article 40 of the Pharmacy Law, the agency in charge of granting certificates of eligibility for pharmaceutical business shall revoke the certificate of eligibility for pharmaceutical business under its management; if not revoking such certificate, this agency shall issue a written reply to the agency proposing the revocation, stating the reason.

2. Within 5 working days after issuing a decision to revoke a certificate of eligibility for pharmaceutical business, the decision-issuing agency shall:

a/ Publish this decision on its portal and send it to the Ministry of Health and provincial-level Health Departments nationwide;

b/ Update the information on revocation of the certificate on its portal.

3. Within 5 working days after receiving a decision to revoke a certificate of eligibility for pharmaceutical business, the Ministry of Health and provincial-level Health Departments shall post this decision on their portals.

Section 2

GEOGRAPHICAL AREAS AND SCOPE OF BUSINESS OPERATION OF RETAILING ESTABLISHMENTS BEING DISPENSARIES OR MEDICINE CABINETS

Article 36.Geographical areas for establishment of dispensaries or medicine cabinets of commune health stations

1. Geographical areas for establishment of dispensaries:

a/ Communes and townships;

b/ Wards newly transformed from communes or townships; if there is no drug retail establishment to serve 2,000 inhabitants, such a ward may establish a new dispensary which shall be allowed to operate for not more than 3 years from the date of transformation;

c/ Dispensaries located outside the geographical areas referred to at Point a of this Clause and having certificates of eligibility for drug trading granted before the effective date of this Decree may operate until the expiry date of these certificates. If such a certificate does not specify its expiry date, these dispensaries may operate for not more than 3 years from the effective date of this Decree.

2. Geographical areas for establishment of medicine cabinets:

a/ Commune health stations;

b/ Health stations of townships in ethnic minority, mountainous and island areas and areas with extremely difficult socio-economic conditions.

Article 37.Business scope of dispensaries and medicine cabinets of commune health stations

1. The business scope of dispensaries must comply with Point b, Clause 1, Article 48 of the Pharmacy Law.

2. The business scope of medicine cabinets of commune health stations must comply with Point b, Clause 1, Article 49 of the Pharmacy Law.

Section 3

ORGANIZATION OF MOBILE DRUG RETAIL

Article 38.Conditions for mobile drug retail

1. Mobile drug retail establishments include:

a/ Drug manufacturing establishments;

b/ Drug wholesaling establishments;

c/ Drug retailing establishments;

d/ Health establishments of people’s armed forces that supply drugs in ethnic minority, mountainous and island areas and areas with extremely difficult socio-economic conditions.

2. Mobile drug retailers must be staff members of the establishments defined in Clause 1 of this Article and possess one of the professional degrees prescribed at Points a, b, c, e, g, h, i and k, Clause 1, Article 13 of the Pharmacy Law.

3. Drugs for mobile retail must have a remaining shelf life of at least 6 months and shall be stored in hygienic devices and equipment and kept away from rain or sun.

4. A place for mobile drug retail must have a signboard indicating the name and address of the mobile drug retailing establishment, full name of the seller, and geographical area of operation of the establishment.

5. An establishment may organize mobile drug retail only after obtaining a receipt of the written notice of mobile drug retail from the provincial-level Health Department, and shall manage information relating to mobile drug retail. The establishment shall operate in the notified geographical area and sell drugs on the list announced by the provincial-level Health Department.

Article 39.Lists of drugs for mobile retail and geographical areas for mobile drug retail

1. A list of drugs for mobile retail includes drugs that meet the following criteria:

a/ Being on the list of non-prescription drugs;

b/ Being required to be stored under normal conditions only;

c/ Meeting the normal use demands of local people.

2. Based on the criteria specified in Clause 1 of this Article, directors of provincial-level Health Departments shall announce lists of drugs for mobile retail and geographical areas for mobile drug retail in localities.

Article 40.Procedures for notification of mobile drug retail activities

1. Before organizing mobile drug retail, a mobile drug retailing establishment shall send a written notice, made according to Form No. 23 in Appendix I to this Decree, to the provincial-level Health Department of the locality where it expects to organize mobile drug retail.

2. After receiving the written notice of the mobile drug retailing establishment, the provincial-level Health Department shall issue a notice receipt slip made according to Form No. 01 in Appendix I to this Decree. The date written on this slip is the date of receipt of the notice.

3. Within 5 (five) working days from the date written on the notice receipt slip, the provincial-level Health Department shall post on its portal information on the mobile drug retailing establishment and notify such to the district-level Health Division for supervision and inspection.

Section 4

SECURITY MEASURES TO AVOID LOSS OF DRUGS AND DRUG MATERIALS UNDER SPECIAL CONTROL, ORDER AND PROCEDURES FOR LICENSING THE TRADING IN DRUGS UNDER SPECIAL CONTROL, AND DRUGS RESTRICTED FROM RETAIL

Article 41.List of radioactive substances for medical use and issuance of the list of drugs and pharmaceutical materials banned from use in a number of sectors and fields

1. To issue the list of radioactive substances for medical use in Appendix IV to this Decree.

2. To issue the list of drugs and pharmaceutical ingredients banned from use in a number of sectors and fields:

a/ Ministries and ministerial-level agencies shall send to the Ministry of Health lists of substances banned from use in the sectors and fields under their respective management upon issuance or modification of these lists;

b/ After receiving the notices from ministries and ministerial-level agencies, the Minister of Health shall take appropriate management measures and, based on the risk of abuse or improper use of drugs or drug materials, the Ministry of Health shall issue the list of drugs and pharmaceutical ingredients banned from use in a number of sectors and fields.

Article 42.Conditions for doing business in drugs under special control

1. An establishment doing business in drugs under special control must satisfy the following conditions:

a/ Fully satisfying the conditions specified in Article 33 of the Pharmacy Law as suitable to the establishment;

b/ Satisfying specific requirements on security measures specified in Articles 43 thru 48 of this Decree;

c/ For radioactive drugs, the establishment must, in addition to the conditions specified at Points a and b of this Clause, satisfy the conditions specified in the Law on Atomic Energy and relevant legal documents.

2. If there is no establishment doing business in drugs under special control in a province or centrally run city, the provincial-level Health Department shall designate a wholesale establishment in the locality that satisfies the conditions specified in Clause 1 of this Article to trade in these drugs in order to ensure the supply of sufficient drugs for patients.

3. The Ministry of Health and provincial-level Health Departments shall once every 3 years or extraordinarily conduct inspections and assessments of the satisfaction of requirements on security measures specified in Section 4, Chapter III of this Decree by establishments doing business in drugs under special control in accordance with the Minister of Health’s regulations or treaties to which the Socialist Republic of Vietnam is a contracting party.

Article 43.Provisions on physical foundations of establishments doing business in drugs under special control

1. For an establishment manufacturing habit-forming drugs, psychotropic drugs, precursor drugs, or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs:

a/ Having a separate warehouse or a separate place satisfying the principles of good storage practices for storage of habit-forming drugs, psychotropic drugs, precursor drugs, or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs. This warehouse or place must have walls and ceilings made of solid materials and have secure doors and locks;

b/ Having a camera system for monitoring every stage of the process of drug manufacture and storage;

c/ Having records and books for management and monitoring under the Minister of Health’s regulations;

d/ Having a software system for monitoring and managing the output, input and inventory of habit-forming drugs, psychotropic drugs and precursor drugs, and output, input, inventory and use of materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs.

2. For an establishment manufacturing combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients or combination drugs containing precursors:

a/ Having a separate warehouse or a separate place satisfying the principles of good storage practices for storage of drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs. This warehouse or place must have walls and ceilings made of solid materials and have secure doors and locks;

b/ Having a separate place for storage of combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients or combination drugs containing precursors;

c/ Having a camera system for monitoring every stage of the process of drug manufacture and storage;

d/ Having records and books for management and monitoring under the Minister of Health’s regulations;

dd/ Having a software system for monitoring and managing output, input, inventory and use of drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs, and output, input and inventory of combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients or combination drugs containing precursors.

3. For an establishment manufacturing radioactive drugs:

a/ Having a separate warehouse or a separate place satisfying the principles of good storage practices for storage of radioactive drugs;

b/ Possessing a license for performing radiation jobs suitable to the establishment’s scope of operation;

c/ Having a software system for monitoring and managing the output, input and inventory of radioactive drugs;

d/ Having records and books for management and monitoring under the Minister of Health’s regulations;

dd/ Having a camera system in the place for drug manufacture and storage.

4. For an establishment exporting and importing, or an establishment providing the service of storing, habit-forming drugs, psychotropic drugs, precursor drugs, or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs:

a/ Having a separate warehouse satisfying the principles of good storage practices for storage of habit-forming drugs, psychotropic drugs, precursor drugs, or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs. This warehouse shall be isolated from warehouses for storage of other drugs and must have walls and ceilings made of solid materials and have secure doors and locks;

b/ Having a camera system in the warehouse for storage of drugs and drug materials;

c/ Having records and books for management and monitoring under the Minister of Health’s regulations;

d/ Having a software system for monitoring and managing the output, input and inventory of habit-forming drugs, psychotropic drugs, precursor drugs and drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs.

5. For an establishment exporting and importing, an establishment wholesaling, or an establishment providing the service of storing, combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients or combination drugs containing precursors:

a/ Having a separate warehouse or a separate place satisfying the principles of good storage practices for storage of combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients or combination drugs containing precursors. This warehouse must have walls and ceilings made of solid materials and have secure doors and locks;

b/ Having records and books for management and monitoring under the Minister of Health’s regulations;

c/ Having a software system for monitoring and managing the output, input and inventory of combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients or combination drugs containing precursors.

6. An establishment exporting, importing and wholesaling radioactive drugs must have a software system for monitoring and managing the output, input and inventory of radioactive drugs and must have records and books for management and monitoring under the Minister of Health’s regulations.

7. For an establishment wholesaling habit-forming drugs, psychotropic drugs and precursor drugs:

a/ Having a separate warehouse or a separate place satisfying the principles of good storage practices for storage of habit-forming drugs, psychotropic drugs and precursor drugs. This warehouse must have walls and ceilings made of solid materials and have secure doors and locks;

b/ Having a camera system in the drug storage place;

c/ Having files and books for management and monitoring under the Minister of Health’s regulations;

d/ Having a software system for monitoring and managing the output, input and inventory of habit-forming drugs, psychotropic drugs and precursor drugs.

8. For an establishment retailing habit-forming drugs, psychotropic drugs and precursor drugs:

a/ Having a separate warehouse or a separate place for storage of habit-forming drugs, psychotropic drugs and precursor drugs. This warehouse or place must have firm doors and locks. If no separate warehouse or separate place is available, habit-forming drugs, psychotropic drugs and precursor drugs shall be stored in separate cabinets or separate drawers with secure locks;

b/ Having records and books for management and monitoring under the Minister of Health’s regulations.

9. An establishment retailing combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients or combination drugs containing precursors must have a software system or records and books for monitoring under the Minister of Health’s regulations.

10. For an establishment retailing radioactive drugs:

a/ Having a separate place for storage of radioactive drugs;

b/ Possessing a license for performing radiation jobs suitable to the establishment’s scope of operation;

c/ Having files and books for management and monitoring under the Minister of Health’s regulations;

d/ Having a software system for monitoring and managing the output, input and inventory of radioactive drugs.

11. For an establishment providing the service of clinical trial of drugs, the service of bioequivalence trial of drugs, the testing service, or the service of storing radioactive drugs:

a/ Having a separate warehouse or a separate place satisfying the principles of good storage practices for storage of radioactive drugs;

b/ Possessing a license for performing radiation jobs suitable to the establishment’s scope of operation;

c/ Having a software system for monitoring and managing the output, input and inventory of radioactive drugs;

d/ Having records and books for management and monitoring under the Minister of Health’s regulations;

dd/ Having a camera system, for an establishment providing the service of storing radioactive drugs.

12. An establishment providing the service of clinical trial of drugs, the service of bioequivalence trial of drugs or the service of testing drugs subject to special control, except the cases specified in Clause 11 of this Article, shall store habit-forming drugs, psychotropic drugs, precursor drugs, drugs materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs, combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients or combination drugs containing precursors in separate places with secure locks. If no separate places are available, these drugs and materials shall be stored in separate cabinets or separate drawers with secure locks.

13. An establishment doing business in toxic drugs and toxic drug materials, or drugs and pharmaceutical materials banned from use in a number of sectors and fields must have a software system or records and books for monitoring the whole process of output, input and inventory under the Minister of Health’s regulations.

Article 44.Provisions on employees of establishments doing business in drugs subject to special control

1. For an establishment manufacturing habit-forming drugs, psychotropic drugs, precursor drugs, or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs:

a/ The keeper of the warehouse for storage of habit-forming drugs or drug materials being habit-forming pharmaceutical ingredients must possess a university or higher degree in pharmacy and have practiced for at least 2 years at a pharmaceutical business establishment;

b/ The keeper of the warehouse for storage of psychotropic drugs, precursor drugs and drug materials being psychotropic pharmaceutical ingredients or precursors used as drugs must possess an intermediate or higher degree in pharmacy and have practiced for at least 2 years at a pharmaceutical business establishment;

c/ The person in charge of taking notes and making reports must possess an intermediate or higher degree in pharmacy.

2. For an establishment manufacturing combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients or combination drugs containing precursors:

a/ The keeper of the warehouse for storage of drug materials being habit-forming pharmaceutical ingredients must possess a university or higher degree in pharmacy and have practiced for at least 2 years at a pharmaceutical business establishment;

b/ The keeper of the warehouse for storage of drug materials being psychotropic pharmaceutical ingredients or precursors used as drugs must possess an intermediate or higher degree in pharmacy and have practiced for at least 2 years at a pharmaceutical business establishment;

c/ The person in charge of taking notes and making reports must possess an intermediate or higher degree in pharmacy.

3. For an establishment manufacturing radioactive drugs:

a/ The keeper of the warehouse for storage of radioactive drugs must possess an intermediate or higher degree in pharmacy or a bachelor or higher degree in radiation chemistry or a bachelor or higher degree in radiation medicine or nuclear medicine;

b/ The person in charge of taking notes and making reports must possess an intermediate or higher degree in pharmacy or an intermediate or higher degree in radiation chemistry, analytical chemistry, radiation pharmaceutical chemistry or nuclear physics;

c/ The person in charge of supervising the research, manufacture, analysis and testing process must possess a bachelor or higher degree in radiation chemistry or a bachelor or higher degree in radiation medicine or nuclear medicine or a university or higher degree in pharmacy.

4. For an establishment exporting and importing habit-forming drugs, psychotropic drugs, precursor drugs, or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs:

a/ The keeper of the warehouse for storage of habit-forming drugs, psychotropic drugs, precursor drugs, or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs must possess a university or higher degree in pharmacy and have practiced for at least 2 years at a pharmaceutical business establishment;

b/ The person in charge of taking notes and making reports must possess an intermediate or higher degree in pharmacy.

5. For an establishment exporting and importing radioactive drugs: The person in charge of taking notes and making reports must possess an intermediate or higher degree in pharmacy or an intermediate or higher degree in radiation chemistry, analytical chemistry, radiation pharmaceutical chemistry or nuclear physics.

6. For an establishment wholesaling habit-forming drugs, psychotropic drugs and precursor drugs:

a/ The keeper of the warehouse for storage of habit-forming drugs must possess a university or higher degree in pharmacy and have practiced for at least 2 years at a pharmaceutical business establishment;

b/ The keeper of the warehouse for storage of psychotropic drugs and precursor drugs must possess an intermediate or higher degree in pharmacy and have practiced for at least 2 years at a pharmaceutical business establishment;

c/ The person in charge of taking notes and making reports must possess an intermediate or higher degree in pharmacy.

7. For an establishment wholesaling radioactive drugs: The person in charge of taking notes and making reports must possess an intermediate or higher degree in pharmacy or an intermediate or higher degree in radiation chemistry, analytical chemistry, radiation pharmaceutical chemistry, or nuclear physics.

8. For an establishment retailing habit-forming drugs, psychotropic drugs and precursor drugs:

a/ The person in charge of retailing habit-forming drugs must possess a university or higher degree in pharmacy;

b/ The person in charge of retailing psychotropic drugs and precursor drugs must possess an intermediate or higher degree in pharmacy.

9. For an establishment retailing radioactive drugs: The persons in charge of retailing radioactive drugs and taking notes and making reports must possess an intermediate or higher degree in pharmacy.

10. For an establishment providing the service of storing habit-forming drugs, psychotropic drugs and precursor drugs or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs: The keeper of the warehouse for storage of habit-forming drugs, psychotropic drugs and precursor drugs or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs must possess a university or higher degree in pharmacy and have practiced for at least 2 years at a pharmaceutical business establishment.

11. For an establishment providing the service of clinical trial of drugs, the service of bioequivalence trial of drugs or the service of testing habit-forming drugs, psychotropic drugs and precursor drugs or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs: The person in charge of monitoring and managing habit-forming drugs, psychotropic drugs, precursor drugs or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs must possess an intermediate or higher degree in pharmacy.

12. For an establishment providing the service of clinical trial of drugs, the service of bioequivalence trial of drugs, the testing service or the service of storing radioactive drugs:

a/ The keeper of the warehouse for storage of drugs must possess an intermediate or higher degree in pharmacy or a bachelor or higher degree in radiation chemistry or a bachelor or higher degree in radiation medicine or nuclear medicine;

b/ The person in charge of taking notes and making reports must possess an intermediate or higher degree in pharmacy or an intermediate or higher degree in radiation chemistry, analytical chemistry, radiation pharmaceutical chemistry or nuclear physics;

c/ The person in charge of supervising the research, manufacture, analysis and testing process must possess a bachelor or higher degree in radiation chemistry or a bachelor or higher degree in radiation medicine or nuclear medicine or a university or higher degree in pharmacy.

Article 45.Provisions on delivery, receipt and transportation for establishments doing business in drugs under special control

1. The persons delivering and receiving drugs and drug materials subject to special control must possess an intermediate or higher degree in pharmacy; for radioactive drugs, these persons must also possess a radiation safety certificate under regulations of the Ministry of Science and Technology.

2. The person transporting habit-forming drugs, psychotropic drugs and precursor drugs or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs shall, while on duty, carry along the task assignment document issued by his/her head, his/her valid personal identification papers, and sale invoice or drug delivery note. For radioactive drugs, this person shall also carry along a radiation safety certificate.

3. Upon delivering and receiving habit-forming drugs, psychotropic drugs and precursor drugs or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs, a delivery and receipt written record shall be made according to Form No. 01 in Appendix II to this Decree.

4. Security must be ensured in the course of transportation of drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs, or habit-forming drugs, psychotropic drugs and precursor drugs to avoid loss. In case of transportation of radioactive drugs, radiation safety shall be ensured under the Minister of Science and Technology-issued guidelines on safe transportation of radioactive materials.

5. An establishment engaged in the delivery and receipt of radioactive drugs must possess a license for performing radiation jobs for transportation of radioactive sources under regulations of the Ministry of Science and Technology.

Article 46.Provisions on purchase and sale of drugs under special control

1. For drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients and precursors used as drugs:

a/ Drug manufacturers may only import materials to serve their own manufacture operations;

b/ Importers may only sell imported materials to manufacturers of habit-forming drugs, psychotropic drugs, precursor drugs and combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients and combination drugs containing precursors; medical examination and treatment establishments; research and assay establishments, compulsory detoxification establishments, establishments treating opium substance addiction with replacement drugs, medical and pharmacy training institutions for research and assay nationwide; and drugstores for preparation of prescription drugs;

c/ Drug manufacturers that have not used up materials purchased for manufacture and wish to sell them to drug manufacturers and importers eligible for doing business in drugs under special control shall obtain the Ministry of Health’s written permission.

2. For habit-forming drugs, psychotropic drugs, precursor drugs and combination drugs containing precursors:

a/ Manufacturers may only sell their own drugs to establishments concurrently having certificates of eligibility for pharmaceutical business covering drug import, export and wholesale, medical examination and treatment establishments, research and assay establishments, compulsory detoxification establishments, establishment treating opium substance addiction with replacement drugs, medical and pharmacy training institutions nationwide, and select 1 wholesaler in 1 province for sale of all products they manufacture;

b/ Importers may sell their own imported drugs to medical examination and treatment establishments, research and assay establishments, compulsory detoxification establishments, establishment treating opium substance addiction with replacement drugs, medical and pharmacy training institutions nationwide, and select 1 wholesaler in 1 province for sale of all of their imported products;

c/ Establishments concurrently having certificates of eligibility for pharmaceutical business covering drug import, export and wholesale may only sell drugs to other establishments concurrently having certificates of eligibility for pharmaceutical business covering drug import, export and wholesale, medical examination and treatment establishments, research and assay establishments, compulsory detoxification establishments, establishment treating opium substance addiction with replacement drugs, medical and pharmacy training institutions nationwide, drugstores located in provinces where the establishments are headquartered and select 1 wholesaler in 1 province for sale of all products they trade in;

d/ Drug wholesalers may only sell drugs to medical examination and treatment establishments, research and assay establishments, compulsory detoxification establishments, establishment treating opium substance addiction with replacement drugs, medical and pharmacy training institutions and drugstores based in provinces where the wholesalers are located;

dd/ Medical examination and treatment establishments, compulsory detoxification establishments, and establishment treating opium substance addiction with replacement drugs may purchase drugs at the establishments prescribed at Points a, b, c and d of this Clause according to their bid winning results.

3. Drug traders’ combination drugs containing habit-forming substances, combination drugs containing psychotropic pharmaceutical ingredients, radioactive drugs, toxic drugs, toxic drug materials, drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields shall be purchased and sold in accordance with Chapter IV of the Pharmacy Law

Article 47.Provisions on reporting applicable to establishments doing business in drugs under special control

1. Import or export report:

a/ Within 10 days after its import or export of habit-forming drugs, psychotropic drugs, precursor drugs or drug materials containing habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs, an establishment shall make a report on such import or export according to Form No. 02 or 03 in Appendix II to this Decree and send it to the Ministry of Health and Ministry of Public Security;

b/ Within 10 days after its import or export of radioactive drugs, an establishment shall make a report on such import or export according to Form No. 04 or 05 in Appendix II to this Decree and send it to  the Ministry of Health;

c/ On January 15 of the subsequent year at the latest, an establishment shall make an annual report on import or export of combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing precursors, or radioactive drugs according to Form No. 06, 07 or 08 in Appendix II to this Decree and send it to the Ministry of Health.

2. Before July 15 and January 15 every year, a manufacturer, an exporter or an importer shall make a biannual report and an annual report respectively on the input, output, inventory and use of habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs according to Forms No. 09 and No. 10 in Appendix II to this Decree and send them to the Ministry of Health.

3. Before July 15 and January 15 every year, a manufacturer, an exporter or an importer shall make a biannual report and an annual report respectively on the input, output, inventory and use of radioactive drugs, combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients or combination drugs containing precursors according to Forms No. 11 and No. 12  in Appendix II to this Decree and send them to the Ministry of Health.

4. Before July 15 and January 15 every year, a wholesaler or retailer shall make a biannual report and an annual report respectively on the input, output, inventory and use of radioactive drugs, habit-forming drugs, psychotropic drugs, precursor drugs, combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients or combination drugs containing precursors according to Forms No. 11, No. 12 and No. 13 in Appendix II to this Decree and send them to the provincial-level Department of Health of the locality where it is located.

5. Before January 15 every year, a manufacturer, an exporter or an importer shall make a report on the input, output, inventory and use of drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields and send it to the Ministry of Health. A wholesaler shall make a report on the input, output, inventory and use of drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields and send it to the provincial-level Department of Health. The report shall be made according to Form No. 09 in Appendix II to this Decree.

6. Within 48 hours after detecting a mistake in or loss of radioactive drugs, habit-forming drugs, psychotropic drugs, precursor drugs or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or drug precursors, a manufacturer, an exporter or an importer, or a provider of the drug storage, clinical drug testing or drug bioequivalence trial or assay service shall make a report and send it to the Ministry of Health; and a wholesaler or retailer shall make and send a report to the provincial-level Department of Health. The report shall be made according to Form No. 14 in Appendix II to this Decree.

7. Before January 15 every year, provincial-level Departments of Health shall report to the Ministry of Health on the list of wholesalers of habit-forming drugs, psychotropic drugs, precursor drugs and combination drugs containing precursors in their provinces according to Form No. 15 in Appendix II to this Decree.

Article 48.Provisions on destruction of drugs under special control

1. An establishment requesting destruction of habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs shall make a written request for destruction, clearly stating the drug name, materials, concentration or content and quantity, reason for destruction, and destruction method.

2. Procedures for permitting destruction of habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs shall be carried out as follows:

a/ The requesting establishment shall submit directly or send by post its dossier to the Ministry of Health, for manufacturers, exporters and importers, or to the provincial-level Department of Health of the locality where it is headquartered, for pharmaceutical trading establishments other than manufacturers, exporters and importers;

b/ After receiving a dossier, the receiving agency shall issue the requesting establishment a dossier receipt slip made according to Form No. 01 in Appendix I to this Decree;

c/ If having no request for modification or supplementation of the dossier, within 30 days after the date written on the dossier receipt slip, the dossier- receiving agency shall issue a written permission for the destruction;

d/ If requesting any modification or supplementation to the dossier, within 30 days after the date written on the dossier receipt slip, the dossier-receiving agency shall issue a written request for such modification or supplementation;

dd/ After the establishment submits a modified or supplemented dossier, the dossier-receiving agency shall issue the former a receipt slip of the modified or supplemented dossier according to Form No. 01 in Appendix I to this Decree. If no further modification or supplementation is required, the receiving agency shall issue a written permission for the destruction under Point c of this Clause. In case the modified or supplemented dossier remains unsatisfactory, the receiving agency shall issue a notice thereof to the establishment under Point d of this Clause.

3. Habit-forming drugs, psychotropic drugs, precursor drugs or drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs may only be destroyed after written permission is issued by the Ministry of Health or the provincial-level Department Health of the locality where the requesting establishment is located.

4. Habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs shall be destroyed as follows:

a/ The head of an establishment shall establish a drug destruction council of at least 3 members, including the person in charge of professional operations of the establishment. The council shall organize the destruction, decide on the destruction method and supervise the destruction;

b/ Drugs and drug materials shall be destroyed in the presence of a representative of the provincial-level Department of Health and the destruction shall be recorded in writing according to Form No. 16 in Appendix II to this Decree;

c/ Within 10 days after completing the destruction of drugs or drug materials, the establishment shall send to the Ministry of Health or the provincial-level Department of Health a report on drug destruction according to Form No. 17 in Appendix II to this Decree together with the drug destruction record.

5. Radioactive drugs and packages in direct contact with radioactive drugs which are no longer used shall be temporarily stored prior to destruction in accordance with the law on atomic energy.

6. Waste originated from radioactive drugs shall be managed in accordance with the law on atomic energy.

7. When destructing redundant or defective products containing habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drug in the manufacture process; combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing precursors and packages in direct contact with habit-forming drugs, psychotropic drugs, precursor drugs, habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients and precursors used as drugs which are no longer used, toxic drugs, toxic drug materials, and drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields at drug trading establishments, establishments shall gather and destroy them under Point a, Clause 4 of this Article, and keep destruction dossiers at their establishments.

Article 49.Dossiers of application for business licenses for drugs under special control

An establishment applying for a business license for drugs under special control, shall, in addition to the documents prescribed in Article 32 of this Decree, submit the following documents:

1. A document in Vietnamese proving the establishment’s satisfaction of requirements on security measures to avoid loss of drugs under special control, made on A4-size paper according to Form No. 18 in Appendix II to this Decree.

2. The original or a certified copy of the license for performing radiation jobs granted by a competent agency, for establishments applying for a business license for radioactive drugs.

3. A list of drugs and the process of drug preparation, for retailers being drugstores which organize preparation of prescription drugs under special control.

4. The number of sets of the dossier prescribed in this Article is 1.

Article 50.Order and procedures for grant of certificates of eligibility for pharmaceutical business to establishments to do business in habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, drug precursors and radioactive drugs; and establishments to manufacture combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients and combination drugs containing precursors

1. An establishment applying for a certificate of eligibility for pharmaceutical business shall submit directly or send by post a dossier to:

a/ The Ministry of Health, for manufacture, export, import or provision of the drug storage, clinical drug testing, drug bioequivalence trial or drug assay service;

b/ The provincial-level Department of Health of the locality where the establishment is located, for wholesale and retail of drugs.

2. After receiving a dossier, the receiving agency shall issue a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree, to the applicant.

3. If requiring no modification or supplementation to the dossier, within 15 days after the date written on the dossier receipt slip, the dossier-receiving agency shall submit the dossier to the advisory council for consideration.

4. If requesting any modification or supplementation to the dossier, within 20 days after the date written on the dossier receipt slip, the dossier-receiving agency shall send to the establishment a written request specifying documents and contents to be modified or supplemented.

5. After the establishment submits a modified or supplemented dossier, the dossier-receiving agency shall issue the former a receipt slip of the modified or supplemented dossier, made according to Form No. 01 in Appendix I to this Decree.

a/ In case the modified or supplemented dossier remains unsatisfactory, the dossier-receiving agency shall notify such to the establishment under Clause 4 of this Article;

b/ In case no further modification or supplementation is required, the dossier-receiving agency shall comply with Clause 3 of this Article.

6. The dossier-receiving agency shall consider the dossier on the basis of the advisory council’s opinions.

a/ If no modification or supplementation to the dossier is required, the dossier-receiving agency shall organize a team to conduct a field assessment at the establishment within 60 days after the date written on the dossier receipt slip;

b/ If requesting any modification or supplementation to the dossier, the dossier-receiving agency shall send a notice to the establishment under Clause 4 of this Article.

7. After completing the field assessment at the establishment and on the basis of the advisory council’s opinions, the dossier-receiving agency shall:

a/ Grant a certificate of eligibility for pharmaceutical business within 20 days after completing the field assessment, in case no remediation or improvement is required;

b/ Issue a notice of contents to be remedied or improved within 15 working days after completing the field assessment, in case remediation or improvement is required;

c/ Within 6 months after the dossier-receiving agency makes a written request for remediation or improvement, if the applicant fails to accomplish such remediation or improvement, the submitted dossier will become invalid.

8. Within 20 days after receiving a notice and documents proving the applicant’s accomplishment of remediation or improvement, the dossier-receiving agency shall grant a certificate of eligibility for pharmaceutical business or give a reply stating the reason for not granting the certificate.

9. Within 6 months after the dossier-receiving agency issues a request for dossier modification or supplementation, the applicant for a certificate of eligibility for pharmaceutical business shall submit a modified or supplemented dossier as requested. After this time limit, if the establishment fails to modify or supplement the dossier or 12 months after submitting the initial dossier, the modified or supplemented dossier remains unsatisfactory, the submitted dossier will become invalid.

10. Within 5 working days after granting a certificate of eligibility for pharmaceutical business, the dossier-receiving agency shall post and update on its portal the following information:

a/ Name and address the establishment obtaining the certificate of eligibility for pharmaceutical business;

b/ Full name and number of the pharmacy practice certificate of the person in charge of professional pharmacy activities;

c/ Serial number of the certificate of eligibility for pharmaceutical business;

d/ Scope of operation of the establishment.

11. Competent agencies shall conduct field assessments of only contents which have not been examined and assessed to satisfy good practice requirements.

Article 51.Order and procedures for grant of certificates of eligibility for pharmaceutical business to establishments doing business in combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing precursors (except manufacturers prescribed in Article 50 of this Decree); establishments doing business in toxic drugs and toxic drug materials; and in drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields

1. An establishment applying for a certificate of eligibility for pharmaceutical business shall submit directly or send by post a dossier to:

a/ The Ministry of Health, for drug manufacture, export or import or provision of the drug storage, clinical drug testing, drug bioequivalence trial or drug assay service;

b/ The provincial-level Department of Health of the locality where the establishment is located, for drug wholesale and retail.

2. After receiving a dossier of application for a certificate of eligibility for pharmaceutical business, the receiving agency shall issue the applicant a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree.

3. If no modification or supplementation to the dossier is required, the agency granting certificates of eligibility for pharmaceutical business shall:

a/ Within 30 days after the date written on the dossier receipt slip, grant a certificate of eligibility for pharmaceutical business added with the scope of business in drugs under special control, for establishments having had a certificate of eligibility for pharmaceutical business and meeting good practice requirements for the requested scope of business;

b/ Within 30 days after the date written on the dossier receipt slip, organize a field assessment, for establishments applying for a certificate of eligibility for pharmaceutical business for the first time or establishments having had a certificate of eligibility for pharmaceutical business but not yet met good practice requirements for the requested scope of business.

4. If requesting any modification or supplementation to the dossier, within 30 days after the date written on the dossier receipt slip, the dossier-receiving agency shall send to the establishment a written request specifying documents and contents to be modified or supplemented.

5. After the establishment submits a modified or supplemented dossier, the dossier-receiving agency shall issue the former a receipt slip of the modified or supplemented dossier, made according to Form No. 01 in Appendix I to this Decree.

a/ In case the modified or supplemented dossier remains unsatisfactory, the dossier-receiving agency shall notify such to the establishment under Clause 4 of this Article;

b/ In case no further modification or supplementation is required, the dossier-receiving agency shall comply with Clause 3 of this Article.

6. After completing a field assessment at the establishment, the agency granting certificates of eligibility for pharmaceutical business shall:

a/ Grant a certificate of eligibility for pharmaceutical business within 20 days after completing the field assessment, in case no remediation or improvement is required;

b/ Issue a notice of contents to be remedied or improved within 15 days after completing the field assessment, in case remediation or improvement is required.

7. Within 20 days after receiving a notice together documents proving the completion of remediation or improvement from the applicant, the agency granting certificates of eligibility for pharmaceutical business shall grant a certificate or give a reply stating the reason for not granting the certificate.

8. Within 6 months after the dossier-receiving agency issues a request for dossier modification or supplementation, the applicant shall submit a modified or supplemented dossier as requested. After this time limit, if the establishment fails to modify or supplement the dossier or 12 months after submitting the dossier, the modified or supplemented dossier remains unsatisfactory, the initially submitted dossier will become invalid.

9. Within 5 working days after granting a certificate of eligibility for pharmaceutical business, the certificate-granting agency shall post and update on its portal the following information:

a/ Name and address of the establishment obtaining the certificate of eligibility for pharmaceutical business;

b/ Full name of the person in charge of professional pharmacy activities and serial number of his/her pharmacy practice certificate;

c/ Serial number of the certificate of eligibility for pharmaceutical business;

d/ Scope of operation of the establishment.

Article 52.Advisory councils for grant of business licenses for habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients and precursors used as drugs, and radioactive drugs

1. Membership of the advisory council at the Ministry of Health

The Minister of Health shall establish an advisory council with at least 5 members to advise on the grant of business licenses for the above drugs, composed of:

a/ The Ministry of Health’s representative as the council chairperson;

b/ The Ministry of Public Security’s representative, for consideration of applications for business licenses for drug materials containing habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, drug precursors, habit-forming drugs, psychotropic drugs, and precursor drugs;

c/ The Ministry of Science and Technology’s representative, for consideration of applications for business licenses for radioactive drugs;

d/ Related organizations’ representatives and related persons (if necessary).

2. Membership of the advisory council at a provincial-level Department of Health

The director of a provincial-level Department of Health shall establish an advisory council with at least 3 members to advise on grant of business licenses for the above drugs, composed of:

a/ The provincial-level Department of Health’s representative;

b/ Related organizations’ representatives and related persons (if necessary).

3. The Minister of Health shall prescribe the organization and operation of advisory councils.

Article 53.Dossiers of request for purchase of habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients and precursors used as drugs; dossiers of request for resale of drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients and precursors used as drugs

1. A dossier of request for purchase of habit-forming drugs, psychotropic drugs or precursor drugs must comprise:

a/ Three purchase orders of habit-forming drugs, psychotropic drugs or precursor drugs, made according to Form No. 19 in Appendix II to this Decree;

b/ A report on business results of habit-forming drugs, psychotropic drugs or precursor drugs, made according to Form No. 20 in Appendix II to this Decree;

c/ A written explanation, if the quantity of drugs requested for purchase exceeds 150% of the previously used quantity.

2. A dossier of request for purchase of drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or drug precursors must comprise:

a/ Three purchase orders of drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or drug precursors, made according to Form No. 19 in Appendix II to this Decree;

b/ A report on use of drug materials, made according to Form No. 10 in Appendix II to this Decree;

c/ A report on business results of drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or drug precursors, made according to Form No. 20 in Appendix II to this Decree;

d/ A drug manufacture plan involving the use of the materials requested for purchase;

dd/ A written explanation, if the quantity of drug materials requested for purchase exceeds 150% of the previously used quantity.

3. A dossier of request for resale of drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or drug precursors must comprise:

a/ The selling establishment’s request for resale of drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or drug precursors, made according to Form No. 21 in Appendix II to this Decree;

b/ Three purchase orders of drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or drug precursors, made according to Form No. 19 in Appendix II to this Decree;

c/ A report on business results, and a report on use, of drug materials, made according to Forms No. 10 and No. 20 in Appendix II to this Decree.

4. The number of sets of the dossiers prescribed in Clauses 1, 2 and 3 of this Article is 1.

Article 54.Order and procedures for permitting purchase of habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients and precursors for use as drugs; and resale of drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients and drug precursors

1. An establishment requesting purchase of drugs or drug materials or resale of drug materials shall submit directly or send by post a dossier to:

a/ The Ministry of Health, for manufacturers; establishments concurrently having certificates of eligibility for pharmaceutical business covering drug import, export and wholesale; medical examination and treatment establishments; research and assay establishments, compulsory detoxification establishments, establishments treating opium substance addiction with replacement drugs; medical and pharmacy training institutions purchasing drug materials for research and assay;

b/ The provincial-level Department of Health of the locality where the establishment is located, for research and assay establishments, medical and pharmacy training institutions, drug wholesalers and retailers, compulsory detoxification establishments, establishments treating opium substance addiction with replacement drugs (for drugs for which bidding is not required).

2. The dossier-receiving agency shall issue the establishment a receipt slip of the dossier of request for purchase or resale of habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or drug precursors, made according to Form No. 01 in Appendix I to this Decree.

3. If no modification or supplementation to the dossier is required, within 30 days after the date written on the dossier receipt slip, the dossier-receiving agency shall sign for approval the purchase order or issue a written permission for the establishment’s resale.

4. If requesting modification or supplementation to the dossier of request for drug purchase or resale, within 30 days after the date written on the dossier receipt slip, the dossier-receiving agency shall send to the establishment a written request specifying documents and contents to be modified or supplemented.

5. After the establishment submits a modified or supplemented dossier, the dossier-receiving agency shall issue the former a receipt slip of the modified or supplemented dossier, made according to Form No. 01 in Appendix I to this Decree.

a/ In case the modified or supplemented dossier remains unsatisfactory, the dossier-receiving agency shall notify such to the establishment under Clause 4 of this Article;

b/ In case no further modification or supplementation is required, the dossier-receiving agency shall comply with Clause 3 of this Article.

6. Within 6 months after the dossier-receiving agency issues a request for dossier modification or supplementation, the applicant shall submit a modified or supplemented dossier as requested. After this time limit, if the establishment fails to modify or supplement the dossier or 12 months after submitting the dossier, the modified or supplemented dossier remains unsatisfactory, the initially submitted dossier will become invalid.

Article 55.Dossiers and procedures for permitting retail of drugs on the list of drugs restricted from retail

1. For establishments having no certificate of eligibility for pharmaceutical business covering drug retail:

a/ A dossier must comprise a written request for retail of drugs on the list of drugs restricted from retail, made according to Form No. 22 in Appendix II to this Decree, and the documents prescribed at Point d, Clause 2, Article 32 of this Decree;

b/ Licensing procedures and time must comply with Article 33 of this Decree.

2. For establishments having obtained a certificate of eligibility for pharmaceutical business covering drug retail:

a/ A dossier must comprise a written request for retail of drugs on the list of drugs restricted from retail, made according to Form No. 23 in Appendix II to this Decree;

b/ Licensing procedures and time:

- A retailer shall submit directly or send by post a dossier to the provincial-level Department of Health of the locality where it is located;

- After receiving the dossier, the provincial-level Department of Health shall issue the retailer a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree;

- If no modification or supplementation to the dossier is required, within 7 working days after the date written on the dossier receipt slip, the provincial-level Department of Health shall issue a written permission for retail of drugs on the list of drugs restricted from retail;

- If requesting any modification or supplementation to the dossier, within 5 working days after the date written on the dossier receipt slip, the provincial-level Department of Health shall send a written request for dossier modification or supplementation to the retailer;

- After receiving the modified or supplemented dossier, the provincial-level Department of Health shall issue the retailer a receipt slip of the modified or supplemented dossier, made according to Form No. 01 in Appendix I to this Decree. In case the modified or supplemented dossier remains unsatisfactory, the provincial-level Department of Health shall issue a notice thereof to the retailer within 5 working days after the date written on the dossier receipt slip. If having no request for further modification or supplementation to the modified or supplemented dossier, within 7 working days after the date written on the dossier receipt slip, the provincial-level Department of Health shall issue a written permission for retail of drugs on the list of drugs restricted from retail;

- Within 6 months after the provincial-level Department of Health issues a request for dossier modification or supplementation, the retailer shall submit a modified or supplemented dossier as requested. After this time limit, if the retailer fails to modify or supplement the dossier or 12 months after submitting the dossier, the modified or supplemented dossier remains unsatisfactory, the initially submitted dossier will become invalid.

3. Within 5 working days after the date of issuing its permission, the provincial-level Department of Health shall post on its portal information on the retailer and the list of drugs permitted for retail at the establishment.

Article 56.Responsibilities of competent agencies for observance of reporting regulations by traders of drugs under special control

1. For an establishment doing business in drugs under special control failing to observe reporting regulations prescribed in Article 47 of this Decree, a competent agency shall issue an official letter on suspension of the receipt and consideration of all of the establishment’s dossiers of request for purchase of domestic drugs and drug materials and for import and export of drugs and drug materials.

2. Dossiers of the drug trader may be considered only after it fully makes reports under regulations.

Chapter IV

EXPORT AND IMPORT OF DRUGS AND DRUG MATERIALS

Section 1

EXPORT OF DRUGS UNDER SPECIAL CONTROL, MEDICINAL MATERIALS ON THE LIST OF PRECIOUS, RARE OR ENDEMIC MEDICINAL MATERIAL SPECIES AND VARIETIES UNDER CONTROL

Article 57.Criteria and dossiers of application for export licenses for habit-forming drugs, psychotropic drugs, precursor drugs, combination drugs containing a habit-forming pharmaceutical ingredient, combination drugs containing a psychotropic pharmaceutical ingredient ingredient, combination drugs containing a precursor, drug materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients and precursors used as drugs

1. A drug may only be permitted for export when satisfying one of the following criteria:

a/ Being manufactured in Vietnam and having a registration for circulation in Vietnam and an import license granted by a competent management agency of the importing country;

b/ Being manufactured overseas, permitted for circulation in Vietnam and having an import license granted by a competent management agency of the importing country.

2. A drug material may only be permitted for export when satisfying one of the following criteria:

a/ Being manufactured in Vietnam with or without a registration for circulation in Vietnam and having an import license granted by a competent management agency of the importing country;

b/ Being manufactured overseas, permitted for circulation in Vietnam and having an import license granted a competent management agency of the importing country.

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

a/ One original export order, made according to Form No. 01 or 02 in Appendix III to this Decree;

b/ A report on quantity and origin of the drug or drug material, made according to Form No. 03 in Appendix III to this Decree;

c/ The original import license for the drug or drug material which is granted by a competent management agency of the importing country and remains valid. In case an import license is presented in neither Vietnamese nor English, a notarized Vietnamese or English translation of such permit is required. Import licenses shall be consularly legalized in accordance with the law on consular legalization, except those exempted from consular legalization as prescribed by law.

4. A dossier prescribed in this Article shall be made in one set.

Article 58.Criteria and dossiers of application for export licenses for radioactive drugs, drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields, toxic drugs and toxic drug materials

1. A drug or drug material may only be permitted for export when satisfying one of the following criteria:

a/ Being manufactured in Vietnam, with or without a registration for circulation in Vietnam;

b/ Being manufactured overseas and permitted for circulation in Vietnam.

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

a/ Three originals of the export order, made according to Form No. 04 or 05 in Appendix III to this Decree;

b/ A report on quantity and origin of the drug or drug material, made according to Form No. 03 in Appendix III to this Decree, except toxic drugs, toxic drug materials and radioactive drugs;

c/ A copy of the license to perform the radiation job of the exporting establishment which is authenticated or bears the seal of the establishment in case of export of a radioactive drug. In case of submitting a copy bearing the seal of the establishment, the original license shall be produced for comparison upon submission of the dossier.

3. A dossier prescribed in this Article shall be made in one set.

Article 59.Criteria and dossiers of application for export licenses for medicinal materials on the list of precious, rare or endemic medicinal material species and varieties under control

1. A medicinal material on the list of precious, rare or endemic medicinal material species and varieties under control may only be permitted for export when it is not naturally exploited and not on the list of medicinal materials banned from export issued by the Minister of Health. In case it is exported for non-commercial purpose, it must comply with the law on biodiversity.

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

a/ Three original export orders, made according to Form No. 06 in Appendix III to this Decree;

b/ A copy of the certificate of eligibility for pharmaceutical business which is authenticated or bears the seal of the exporting establishment. In case of submitting a copy bearing the seal of the establishment, the original certificate shall be produced for comparison upon submission of the dossier;

c/ A copy of the written certification by the commune-level People’s Committee of the origin of the planted medicinal material which is authenticated or bears the seal of the exporting establishment. In case of submitting a copy bearing the seal of the establishment, the original certification shall be produced for comparison upon submission of the dossier;

d/ A copy of the contract on purchase of medicinal material which is authenticated or bears the seal of the exporting establishment. In case of submitting a copy bearing the seal of the establishment, the original contract shall be produced for comparison upon submission of the dossier;

dd/ In case the medicinal material is exported for non-commercial purpose, the documents specified at Points c and d of this Clause are not required.

3. A dossier prescribed in this Article shall be made in one set.

Article 60.Grant of export licenses for drugs under special control for non-commercial purpose

1. A drug under special control that may be exported for non-commercial purpose must be the one permitted for circulation in Vietnam and fall into one of the following cases:

a/ It is part of the personal luggage consigned by an organization or individual on exit together a bill of lading, or of the hand luggage of an individual who is on exit for his/her own medical treatment and is not a drug material under special control;

b/ It is exported as aid or humanitarian aid;

c/ It has been licensed for import for use in humanitarian health care but not used up.

2. An export license shall be granted for a drug before its export, except the  drugs specified at Point a, Clause 1 of this Article which are exported in a quantity which can be used:

a/ For  7 days at most, for habit-forming drugs according to the dosage stated in the accompanying prescription;

b/ For 10 days at most, for psychotropic drugs and precursor drugs according to the dosage stated in the accompanying prescription;

c/ For 30 days at most, for combination drugs containing a habit-forming pharmaceutical ingredient, combination drugs containing a psychotropic pharmaceutical ingredient ingredient, combination drugs containing a precursor, toxic drugs, drugs on the list of drugs and pharmaceutical ingredients banned from use in a number of fields and sectors, according to the dosage stated in the accompanying prescription.

3. A dossier of application for an export license for the drugs specified at Point a, Clause 1 of this Article must comprise:

a/ An application for a drug export license, made according to Form No. 07 in Appendix III to this Decree;

b/ Copies of the prescription and medical report book for monitoring the out-patient treatment bearing the certification, signature or seal of the applicant. These papers must fully have the following details: name and age of the patient; name, content or concentration and volume of the drug; quantity of the drug (or number of use days); dosage; full name and signature of the physician; address of the hospital or clinic where the physician works.

In case of submitting copies bearing the signature or seal of the applicant, their originals shall be produced for comparison upon submission of the dossier;

c/ A copy of one of the following papers: people’s or citizen identity card or passport of the applicant which is certified or bears his/her signature.

In case of submitting a copy bearing the signature of the applicant, the original shall be produced for comparison upon submission of the dossier;

d/ If the papers specified at Points b and c of this Clause are presented  in neither Vietnamese nor English, their notarized Vietnamese or English translations are required.

4. A dossier of application for an export license for the drugs specified at Point b, Clause 1 of this Article must comprise:

a/ An official letter of the exporter applying for an export license, written in Vietnamese or English;

b/ Three original orders, made according to Form No. 01 or 04 in Appendix III to this Decree;

c/ The original or a certified copy of the written approval of the use of drugs for aid or humanitarian aid purpose, issued by a competent management agency of the importing country;

d/ The original import license granted by a competent management agency of the importing country and still valid for habit-forming drugs, psychotropic drugs, precursor drugs, combination drugs containing a habit-forming pharmaceutical ingredient, combination drugs containing a psychotropic pharmaceutical ingredient or combination drugs containing a precursor;

dd/ If the papers specified at Points c and d of this Clause are presented in neither Vietnamese nor English, their notarized Vietnamese or English translations are required. These papers shall be consularly legalized in accordance with the law on consular legalization, except those exempted from consular legalization as prescribed by law.

5. A dossier of application for an export license for the drugs specified at Point c, Clause 1 of this Article must comprise:

a/ An official letter of the exporter applying for an export license, written in Vietnamese or English;

b/ Three original orders, made according to Form No. 01 or 04 in Appendix III to this Decree;

c/ A report on drug volumes used for humanitarian health care, made according to Form No. 08 in Appendix III to this Decree.

6. A dossier prescribed in Clause 3, 4 or 5 of this Article shall be made in one set.

Article 61.Criteria and dossiers for export of drugs under special control for display at exhibitions or trade fairs

1. A habit-forming drug, psychotropic drug, precursor drug, habit-forming pharmaceutical, psychotropic pharmaceutical, precursor used as a drug, combination drug containing a habit-forming pharmaceutical ingredient, combination drug containing a psychotropic pharmaceutical ingredient ingredient or combination drug containing a precursor may only be permitted for export when satisfying one of the following criteria:

a/ Being manufactured in Vietnam, with or without a registration for circulation in Vietnam, and having an import license granted by a competent management agency of the importing country;

b/ Being manufactured overseas, permitted for circulation in Vietnam and having an import license granted by a competent management agency of the importing country.

2. A dossier of application for an export license for a habit-forming drug, psychotropic drug, precursor drug, habit-forming pharmaceutical, psychotropic pharmaceutical, precursor used as a drug, combination drug containing a habit-forming pharmaceutical ingredient, combination drug containing a psychotropic pharmaceutical ingredient ingredient or combination drug containing a precursor must comprise:

a/ One original export order, made according to Form No. 01 or 02 in Appendix III to this Decree;

b/ The original import license granted by a competent management agency of the importing country and still valid for drugs and drug materials. If such import license is presented in neither Vietnamese nor English, its notarized Vietnamese or English translation is required. Such import license shall be consularly legalized in accordance with the law on consular legalization, except those exempted from consular legalization as prescribed by law;

c/ A dossier prescribed in this Clause shall be made in one set.

3. The export of radioactive drugs, toxic drugs, toxic drug materials, drugs and pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields for display at exhibitions or trade fairs must comply with the regulations on temporary export of goods for re-import.

Article 62.Criteria and dossiers for export of drugs under special control for clinical trial, bioequivalence trial, bioavailability assessment, use as testing samples, for scientific research or as registration samples

1. A habit-forming drug, psychotropic drug, precursor drug, habit-forming pharmaceutical, psychotropic pharmaceutical, precursor used as a drug, combination drug containing a habit-forming pharmaceutical ingredient, combination drug containing a psychotropic pharmaceutical ingredient ingredient or combination drug containing a precursor may only be permitted for export when satisfying one of the following criteria:

a/ Being manufactured in Vietnam, with or without a registration for circulation in Vietnam, and having an import license granted by a competent management agency of the importing country;

b/ Being manufactured overseas, permitted for circulation in Vietnam and having an import license granted by a competent management agency of the importing country.

2. A dossier of application for an export license for a habit-forming drug, psychotropic drug, precursor drug, habit-forming pharmaceutical, psychotropic pharmaceutical, precursor used as a drug, combination drug containing a habit-forming pharmaceutical ingredient, combination drug containing a psychotropic pharmaceutical ingredient or combination drug containing a precursor must comprise:

a/ One original export order, made according to Form No. 01 or 02 in Appendix III to this Decree;

b/ The original import license granted by a competent management agency of the importing country and still valid for drugs and drug materials. If such import license is presented in neither Vietnamese nor English, its notarized Vietnamese or English translation is required. Such import license shall be consularly legalized in accordance with the law on consular legalization, except those exempted from consular legalization as prescribed by law;

c/ The original written certification of the import purpose and imported volume by the establishment using the drugs for clinical trial, bioequivalence trial, bioavailability assessment, use as testing samples, for scientific research or as registration samples in the importing country. If such certification is written in neither Vietnamese nor English, its notarized Vietnamese or English translation is required;

d/ A dossier prescribed in this Clause shall be made in one set.

3. A radioactive drug, toxic drug, toxic drug material, drug or pharmaceutical on the list of substances banned from use in a number of sectors and fields may only be permitted for export when satisfying one of the following criteria:

a/ Being manufactured in Vietnam, with or without a registration for circulation in Vietnam;

b/ Being manufactured overseas and permitted for circulation in Vietnam.

4. A dossier of application for an export license for a radioactive drug, toxic drug, toxic drug material, drug or pharmaceutical on the list of substances banned from use in a number of sectors and fields must comprise:

a/ One original export order, made according to Form No. 04 or 05 in Appendix III to this Decree;

b/ The original written certification of the import purpose and imported volume by the establishment using the drugs for clinical trial, bioequivalence trial, bioavailability assessment, use as testing samples, for scientific research or as registration samples in the importing country. If such certification is written in neither Vietnamese nor English, its notarized Vietnamese or English translation is required.

Article 63.Procedures and time limit for grant of export license for drugs under special control or medicinal materials on the list of precious, rare or endemic medicinal material species and varieties under control

1. Procedures and time limit for grant of an export license for a drug under special control or medicinal material on the list of precious, rare or endemic medicinal material species and varieties under control are prescribed in Articles 57, 58 and 59; at Points b and c, Clause 1, Article 60; in Clause 1, Article 61, and Article 62, of this Decree:

a/ The export license applicant shall submit directly or send by post its dossier to the Ministry of Health;

b/ After receiving a dossier, the Ministry of Health shall issue a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree, to the applicant;

c/ If the dossier does not need any modification or supplementation, the Ministry of Health shall grant an export license within 10 working days from the date stated in the dossier receipt slip;

d/ If the dossier needs any modification or supplementation, the Ministry of Health shall send a written request to the applicant for dossier modification or supplementation within 7 working days from the date stated in the dossier receipt slip;

dd/ After receiving the modified or supplemented dossier, the Ministry of Health shall issue a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree, to the applicant. If the modified or supplemented dossier remains unsatisfactory, the Ministry of Health shall notify such in writing to the applicant under Point d of this Clause. If the modified or supplemented dossier does not need any further modification or supplementation, the Ministry of Health shall grant an export license under Point c of this Clause;

e/ Within 6 months after the Ministry of Health sends a written request for dossier modification or supplementation, the export license applicant shall submit the modified or supplemented dossier as requested. Past that time limit, if the applicant fails to modify or supplement the dossier or past 12 months from the date of initial submission of the dossier, if the modified or supplemented dossier remains unsatisfactory, the submitted dossier will become invalid.

2. Procedures and time limit for grant of an export license for a drug specified at Point a, Clause 1, Article 60 of this Decree:

a/ An export license applicant shall submit directly or send by post its dossier to the provincial-level Department of Health of the locality of the border gate where the exit procedures are carried out or where the patient is lawfully residing or temporarily residing or the organization is located;

b/ After receiving a dossier, the provincial-level Department of Health shall issue a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree, to the applicant;

c/ If the dossier does not need any modification or supplementation, the provincial-level Department of Health shall grant an export license within 7 working days from the date stated in the dossier receipt slip;

d/ If the dossier needs any modification or supplementation, the provincial-level Department of Health shall send a written request to the applicant for dossier modification or supplementation within 5 working days from the date stated in the dossier receipt slip;

dd/ After receiving the modified or supplemented dossier, the provincial-level Health Department shall issue a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree, to the applicant. If the modified or supplemented dossier remains unsatisfactory, the provincial-level Department of Health shall notify such in writing to the applicant under Point d of this Clause. If the modified or supplemented dossier does not need any further modification or supplementation, the provincial-level Health Department shall grant an export license under Point c of this Clause;

e/ Within 3 months after the provincial-level Health Department issues a written request for dossier modification or supplementation, the export license applicant shall submit its modified or supplemented dossier as requested. Past that time limit, if the applicant fails to modify or supplement its dossier or past 4 months from the date of initial dossier submission, if the modified or supplemented dossier remains unsatisfactory, the submitted dossier will become invalid.

3. Within 20 days after an export license is granted, the Ministry of Health shall announce on its portal information on the medicinal material on the list of precious, rare or endemic medicinal material species and varieties under control for which the export license is granted.

4. Export licenses and official letters permitting export shall be made according to Form No. 09, 10, 11, 12 or 13 in Appendix III to this Decree.

Article 64.Management of export of drugs and drug materials

1. An export license for a habit-forming drug, psychotropic drug, precursor drug, combination drug containing a habit-forming pharmaceutical ingredient, combination drug containing a psychotropic pharmaceutical ingredient, combination drug containing a precursor, drug material being a habit-forming pharmaceutical ingredient, psychotropic pharmaceutical, or precursor used as a drug shall be granted for each importation; the drug or drug material volume permitted for export must not exceed that stated in the import license granted by a competent management agency of the importing country.

2. An export license for a medicinal material on the list of precious, rare or endemic medicinal material species and varieties under control shall be granted for each exportation.

3. Habit-forming drugs, psychotropic drugs, precursor drugs, radioactive drugs, combination drugs containing a habit-forming pharmaceutical ingredient, combination drugs containing a psychotropic pharmaceutical ingredient, combination drugs containing a precursor, drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, precursors used as drugs, and medicinal materials on the list of precious, rare or endemic medicinal material species and varieties under control may only be exported through international border gates, except those specified at Point a, Clause 1, Article 60 of this Decree.

4. Establishments manufacturing habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients or psychotropic pharmaceutical ingredients, and precursors used as drugs may export drugs and drug materials which they manufacture.

5. Establishments importing or exporting habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients or psychotropic pharmaceutical ingredients, and precursors used as drugs may export drugs and drug materials which they trade in.

6. Individuals and organizations that wish to export drugs under special control for non-commercial purpose under Point a, Clause 1, Article 60 of this Decree shall take responsibility for the origin, quality, safety and efficacy of exported drugs and satisfy requirements set by importing countries.

7. Exporters shall re-import all habit-forming drugs, psychotropic drugs, precursor drugs, drug materials being habit-forming pharmaceutical ingredients or psychotropic pharmaceutical ingredients, precursors  used as drugs, combination drugs containing a habit-forming pharmaceutical ingredient, combination drugs containing a psychotropic pharmaceutical ingredient, and combination drugs containing a precursor that have been temporarily exported for display at exhibitions or trade fairs.

8. For drugs and drug materials that may be exported without export license of the Ministry of Health under Clause 5, Article 60 of the Pharmacy Law for which establishments need to apply for export licenses:

a/ A dossier of application for an export license must comprise 3 original export orders, made according to Form No. 14 in Appendix III to this Decree, and a copy of the certificate of eligibility for pharmaceutical business of the exporter which is authenticated by or bears the seal of the exporter;

b/ The procedures for grant of export licenses comply with Clause 1, Article 63 of this Decree.

Section 2

IMPORT OF DRUGS WITHOUT REGISTRATION FOR CIRCULATION IN VIETNAM

Article 65.Criteria and dossiers of application for import licenses for drugs containing pharmaceutical ingredients without circulation registration and drugs containing medicinal materials used for the first time in Vietnam

1. Such a drug may only be permitted for import when satisfying the following criteria:

a/ Being permitted for circulation in one of the following countries: country of manufacture, reference country being a member state to the International Council for Harmonization of Technical Requirements for pharmaceutical ingredients for Human Use - ICH) or Australia;

b/ Being used to treat very dangerous diseases, social diseases, dangerous and newly emerging diseases and epidemics announced by the Minister of Health;

c/ Having sufficient clinical data on drug safety and efficacy under the Minister of Health’s regulations on drug registration. For vaccines, there must be also results of clinical trial of the drug in Vietnam under the Minister of Health’s regulations on drug registration.

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

a/ Three original import orders, made according to Form No. 15, 16 or 17 in Appendix III to this Decree;

b/ The original or a certified copy of the pharmaceutical product certificate;

c/ Copies of the drug’s quality standards and testing method of the manufacturer bearing the seal of the importer;

d/ The original set of specimen labels and use instruction sheets of the drug actually circulated in the country that has granted the pharmaceutical product certificate, unless these specimen labels and use instruction sheets are enclosed with the pharmaceutical product certificate;

dd/ Two sets of specimen labels expected to be circulated in Vietnam enclosed with use instruction sheets in Vietnamese bearing the seal of the importer;

e/ Clinical data on the drug’s safety and efficacy under the Minister of Health’s regulations on drug registration. For vaccines, there must be also results of clinical trial of the drug in Vietnam under the Minister of Health’s regulations on drug registration.

g/ A report on the drug’s trading results in case the imported drug is a habit-forming drug, psychotropic drug, precursor drug, combination drug containing a habit-forming pharmaceutical ingredient, combination drug containing a psychotropic pharmaceutical ingredient, combination drug containing a precursor, drug on the list of drugs and pharmaceutical ingredients banned from use in a number of sectors and fields, made according to Form No. 18 in Appendix III to this Decree;

h/ The original or a certified copy of the certificate of good manufacturing practices of all establishments participating in the manufacture of the drug to be imported in case such drug is manufactured jointly by more than one establishment;

i/ A certified copy or a copy of the importer’s license for performance of radiation jobs bearing the seal of the importer, for case of import of a radioactive drug. In case of submitting a copy bearing the seal of the importer, the original shall be produced for comparison.

3. A dossier prescribed in this Article shall be made in one set.

Article 66.Criteria and dossiers of application for import licenses for drugs containing pharmaceutical ingredients already having a registration for circulation in Vietnam but not yet fully meeting treatment needs and drugs containing medicinal materials once used as drugs in Vietnam but not yet fully meeting treatment needs

1. A drug may only be permitted for import when satisfying the following criteria:

a/ Being on the list of drugs not yet fully meeting treatment needs announced by the Minister of Health;

b/ Being permitted for circulation in one of the following countries: country of manufacture, reference country being an ICH member state or Australia.

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

a/ Three original import orders, made according to Form No. 15, 16 or 17 in Appendix III to this Decree;

b/ The original or a certified copy of the pharmaceutical product certificate;

c/ The quality dossier under the Minister of Health’s regulations on application of the ASEAN Common Technical Dossier (ACTD) in drug registration;

d/ The original set of specimen labels and use instruction sheets of the drug actually circulated in the country that has granted the pharmaceutical product certificate, unless such specimen labels and use instruction sheets are enclosed with the pharmaceutical product certificate;

dd/ Two sets of specimen labels expected to be circulated in Vietnam enclosed with use instruction sheets in Vietnamese bearing the seal of the importer;

e/ Clinical dossier, for drugs required to have clinical dossiers under the Minister of Health’s regulations on application of ACTD in drug registration;

g/ For traditional drugs involving a new combination of medicinal materials once used as drugs in Vietnam, there must be an adequate clinical dossier proving the drug’s safety and efficacy under Article 89 of the Pharmacy Law and documents describing the processing, preparing or mixing methods according to traditional medicine theories;

h/ A report on the drug’s trading results in case the imported drug is a habit-forming drug, psychotropic drug, precursor drug, combination drug containing a habit-forming pharmaceutical ingredient, combination drug containing a psychotropic pharmaceutical ingredient, combination drug containing a precursor, drug on the list of drugs and pharmaceutical ingredients banned from use in a number of sectors and fields, made according to Form No. 18 in Appendix III to this Decree;

i/ The original or a certified copy of the certificate of good manufacturing practices of all establishments involved in the manufacture of the drug to be imported in case such drug is manufactured jointly by more than one establishment;

k/ A certified copy or a copy of the importer’s license for performance of radiation jobs bearing the seal of the importer, for case of import of a radioactive drug. In case of submitting a copy bearing the seal of the importer, the original shall be produced for comparison.

3. A dossier prescribed in this Article shall be made in one set.

Article 67.Criteria and dossiers of application for import licenses for drugs to meet urgent needs for national defense, security, prevention and control of diseases and epidemics and remediation of natural disaster and calamity consequences

1. A drug may only be permitted for import into Vietnam when it has been permitted for circulation in at least another country in the world and falls into one of the following cases:

a/ Its import is requested by the Ministry of National Defense to meet urgent needs for national defense;

b/ Its import is requested by the Ministry of Public Security to meet urgent needs for security;

c/ Its import is approved by the Ministry of Health to meet urgent needs for prevention and control of diseases and epidemics or remediation of natural disaster and calamity consequences.

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

a/ Three original import orders, made according to Form No. 15, 16 or 17 in Appendix III to this Decree;

b/ The original or a certified copy of the pharmaceutical product certificate or certification by a competent management agency of the exporting country of the drug’s circulation in at least one country in the world;

c/ The original or a copy bearing the seal of a competent agency of the written request or approval of the competent agency specified at Point a, b or c, Clause 1 of this Article, which states ingredients for pharmacochemical drugs, or names of medicinal materials, for drugs from medicinal materials and traditional drugs, form of preparation, concentration or content of pharmaceutical ingredients, for pharmacochemical drugs, or volume of medicinal materials, for drugs from medicinal materials and traditional drugs, packaging specifications, manufacturer and country of manufacture of the drug.

3. A dossier prescribed in this Article shall be made in one set.

Article 68.Criteria and dossiers of application for import licenses for drugs to meet special treatment needs

1. A drug may only be permitted for import when satisfying one of the following criteria:

a/ Having a superior efficacy in medical treatment compared to drugs currently in circulation in Vietnam or there is no substitute for it, having been circulated in the country of manufacture or reference country being an ICH member state or Australia, having sufficient clinical data on its safety and efficacy under the Minister of Health’s regulations on drug registration, and being recommended for use by the advisory council for grant of drug and drug material circulation registrations;

b/ Being used for first-aid or detoxification purposes and having ingredients and routes of administration different from those of drugs currently in circulation in Vietnam;

c/ Being a vaccine for use in some special cases with a limited dosage as decided by the Minister of Health based on the data on its satisfaction of quality, efficacy and safety requirements.

2. A dossier of application for an import license for a drug specified at Point a, Clause 1 of this Article must comprise:

a/ Three original import orders, made according to Form No. 15, 16 or 17 in Appendix III to this Decree;

b/ Clinical data on drug safety and efficacy under the Minister of Health’s regulations on drug registration. For vaccines, there must be also results of drug clinical trial in Vietnam under the Minister of Health’s regulations on drug registration;

c/ The original or a certified copy of the pharmaceutical product certificate;

d/ Copies of the drug quality standards and testing method of the manufacturer, bearing the seal of the importer;

dd/ The original set of specimen labels and use instruction sheets of the drug actually circulated in the country that has issued the pharmaceutical product certificate, unless the specimen labels and use instruction sheets are enclosed with the pharmaceutical product certificate;

e/ Two sets of specimen labels expected to be circulated in Vietnam enclosed with use instruction sheets in Vietnamese bearing the seal of the importer;

g/ A report on the drug’s trading results in case the imported drug is a habit-forming drug, psychotropic drug, precursor drug, combination drug containing a habit-forming pharmaceutical ingredient, combination drug containing a psychotropic pharmaceutical ingredient, combination drug containing a precursor, drug on the list of drugs and pharmaceutical ingredients banned from use in a number of sectors and fields, made according to Form No. 18 in Appendix III to this Decree;

h/ The original or a certified copy of the certificate of good manufacturing practices of all establishments involved in the manufacture of the drug to be imported in case such drug is manufactured jointly by more than one establishment;

i/ A certified copy or a copy of the importer’s license for performance of radiation jobs bearing the seal of the importer, for case of import of a radioactive drug. In case of submitting a copy bearing the seal of the importer, the original shall be produced for comparison.

3. A dossier of application for an import license for a drug specified at Point b or c, Clause 1 of this Article must comprise:

a/ Three original import orders, made according to Form No. 15, 16 or 17 in Appendix III to this Decree;

b/ Documents proving the quality, safety and efficacy of the vaccine requested to be imported;

c/ The original request bearing the signature and seal of the head of the medical examination and treatment establishment for the drug’s import, clearly stating the reason for the drug’s import, estimated number of patients that need to use the drug, corresponding needs for the drug and commitment to assume total responsibility for the use of the drug. Such request shall be enclosed with the original or a copy of the minutes of the drug and treatment council’s meeting on the drug’s import need, bearing the seal of the medical examination and treatment establishment. In case a vaccination establishment has no drug and treatment council, no meeting minutes is required;

d/ A list of drugs requested to be imported by the medical examination and treatment establishment, made according to Form No. 19, 20 or 21 in Appendix III to this Decree;

dd/ A report of the medical examination and treatment establishment on the drug requested to be imported, including the following information: the used volume, treatment efficacy (except vaccines) and safety of the drug, made according to Form No. 22 in Appendix III to this Decree;

e/ The original commitment of the foreign drug manufacturer and supplier to guaranteeing the quality, safety and efficacy of vaccines and biological products supplied to Vietnam, made according to Form No. 23 in Appendix III to this Decree;

g/ A copy of the power of attorney or sale permit or certificate of partnership relation, bearing a certification seal of the importer. Contents of such document are specified at Point dd, Clause 15, Article 91 of this Decree.

In case the importer cannot produce such a copy, it shall send a document clearly stating the reason to the Minister of Health for consideration.

4. A dossier prescribed in Clause 2 or 3 this Article shall be made in one set.

Article 69.Criteria and dossiers of application for import licenses for orphan drugs

1. A drug may only be permitted for import when satisfying one of the following criteria:

a/ It is on the list of orphan drugs;

b/ It is permitted for circulation in at least one country in the world.

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

a/ Three original import orders, made according to Form No. 15, 16 or 17 in Appendix III to this Decree;

b/ The original or a certified copy of the pharmaceutical product certificate;

c/ Copies of the drug quality standards and testing method of the manufacturer, bearing the seal of the importer;

d/ The original set of specimen labels and use instruction sheets of the drug actually circulated in the country that has issued the pharmaceutical product certificate, unless the specimen labels and use instruction sheets are enclosed with the pharmaceutical product certificate;

dd/ Two sets of specimen labels expected to be circulated in Vietnam enclosed with use instruction sheets in Vietnamese bearing the seal of the importer;

e/ A report on the drug’s trading results in case the imported drug is a habit-forming drug, psychotropic drug, precursor drug, combination drug containing a habit-forming pharmaceutical ingredient, combination drug containing a psychotropic pharmaceutical ingredient, combination drug containing a precursor, or drug on the list of drugs and pharmaceutical ingredients banned from use in a number of sectors and fields, made according to Form No. 18 in Appendix III to this Decree;

g/ The original or a certified copy of the certificate of good manufacturing practices of all establishments involved in the manufacture of the drug to be imported in case such drug is manufactured jointly by more than one establishment, unless it is certified in the pharmaceutical product certificate that all of these establishments have complied with the good manufacturing practices rules and standards;

h/ A certified copy or a copy of the importer’s license for performance of radiation jobs. bearing the seal of the importer, for case of import of a radioactive drug. In case of submitting a copy bearing the seal of the importer, the original shall be produced for comparison.

3. A dossier prescribed in this Article shall be made in one set.

Article 70.Criteria and dossiers of application for import licenses for drugs that have the same trade names, active ingredients, content or concentration, or form of preparation as those of brand name specifics that have a registration of circulation in Vietnam or have been manufactured by the manufacturers of those brand name specifics or by authorized manufacturers, and whose prices are lower than those of brand name specifics circulated in Vietnam

1. A drug may only be permitted for import when satisfying one of the following criteria:

a/ It is specified at Point dd, Clause 2, Article 60 of the Pharmacy Law;

b/ Its tentative wholesale price is at least 20% lower than the bid-winning price of the brand name specific having a registration for circulation in Vietnam;

c/ It is permitted for circulation in and export to Vietnam from the country of manufacture or reference country being an ICH member state or Australia;

d/ It is not a radioactive drug, vaccine or biological product.

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

a/ Three original import orders, made according to Form No. 15, 16 or 17 in Appendix III to this Decree;

b/ The importer’s commitment on the drug’s quality and notice of tentative wholesale price of the drug;

c/ A document proving that the drug is lawfully sold in the country of manufacture or reference country;

d/ One set of specimen labels and use instruction sheets of the drug actually circulated in the exporting country bearing the seal of the importer;

dd/ Two sets of specimen secondary labels enclosed with use instruction sheets in Vietnamese bearing the seal of the importer. Contents of use instructions sheets in Vietnamese must be consistent with contents approved by the Ministry of Health for brand name specifics having a registration for circulation in Vietnam.

3. A dossier prescribed in this Article shall be made in one set.

Article 71.Criteria and dossiers of application for import licenses for drugs to serve health programs of the State

1. A drug may only be permitted for import when satisfying the following criteria:

a/ It is approved by the competent state management agency to serve health programs of the State;

b/ It is permitted for free sale in one of the following countries: country of manufacture, reference country being an ICH member state or Australia.

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

a/ Three original import orders, made according to Form No. 15, 16 or 17 in Appendix III to this Decree;

b/ The original or a certified copy of the pharmaceutical product certificate;

c/ A quality dossier under the Minister of Health’s regulations on application of ACTD dossiers in drug registration;

d/ A clinical dossier, for drugs required to have clinical dossiers under the Minister of Health’s regulations on application of ACTD dossiers in drug registration;

dd/ The original set of specimen labels and use instruction sheets of the drug actually circulated in the country that has issued the pharmaceutical product certificate, unless the specimen labels and use instruction sheets are enclosed with the pharmaceutical product certificate;

e/ Two sets of specimen labels expected to be circulated in Vietnam enclosed with use instruction sheets in Vietnamese bearing the seal of the importer;

g/ The original or a certified copy of a competent state management agency’s written approval of use of the drug to serve health programs of the State;

h/ The original or a certified copy of the certificate of good manufacturing practices of all establishments involved in the manufacture of the drug to be imported in case such drug is manufactured jointly by more than one establishment;

i/ A certified copy or a copy of the importer’s license for performance of radiation jobs bearing the seal of the importer, for case of import of a radioactive drug. In case of submitting a copy bearing the seal of the importer, the original shall be produced for comparison.

3. A dossier prescribed in this Article shall be made in one set.

Article 72.Criteria and dossiers of application for import licenses for drugs for use for aid or humanitarian aid purpose

1. A drug may only be permitted for import when satisfying one of the following criteria:

a/ It is permitted for free sale in one of the following countries: country of manufacture, reference country being an ICH member state or Australia;

b/ It satisfies the actual need of aid recipients;

c/ It is not a habit-forming drug, radioactive drug or vaccine.

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

a/ An application for an import license, made by the importer enclosed with a list of drugs for use for aid or humanitarian aid purpose, made according to Form No. 24, 25 or 26 in Appendix III to this Decree;

b/ The original document of the aid or humanitarian aid recipient, clearly stating the quantity of each drug and its commitment to using the drug for proper purposes and eligible users;

c/ The original or a certified copy of the competent state agency’s written approval of use of the drug for health programs of the State, for foreign drugs provided through programs or projects;

d/ The original or a certified copy of the pharmaceutical product certificate;

dd/ A quality dossier under the Minister of Health’s regulations on application of ACTD dossiers in drug registration;

e/ A clinical dossier, for drugs required to have clinical dossiers under the Minister of Health’s regulations on application of ACTD dossiers in drug registration;

g/ The original set of specimen labels and use instruction sheets of the drug actually circulated in the country that has issued the pharmaceutical product certificate, unless the specimen labels and use instruction sheets are enclosed with the pharmaceutical product certificate;

h/ Two sets of specimen secondary labels enclosed with the use instruction sheets in Vietnamese bearing the seal of the importer;

i/ The original or a certified copy of the certificate of good manufacturing practices of all establishments involved in the manufacture of the drug to be imported in case such drug is manufactured jointly by more than one establishment;

k/ A certified copy or a copy of the importer’s license for performance of radiation jobs bearing the seal of the importer, for case of import of a radioactive drug. In case of submitting a copy bearing the seal of the importer, the original shall be produced for comparison.

3. A dossier prescribed in this Article shall be made in one set.

Article 73.Criteria and dossiers of application for import licenses for drugs for use for clinical trial, bioequivalence trial, bioavailability assessment or scientific research purpose or as testing samples

1. A drug may only be permitted for import when:

a/ It is used for research involving clinical trial with a research proposal approved by the Ministry of Health under Clause 1, Article 94 of the Pharmacy Law;

b/ It is used as a test drug in bioequivalence trial or bioavailability assessment in Vietnam under an approved proposal under Clause 1, Article 100 of the Pharmacy Law;

c/ It is used as a control drug in bioequivalence trial. In case the control drug is a new drug, it may only be used in research under an approved proposal under Clause 1, Article 100 of the Pharmacy Law;

d/ It is used in testing or inspection at drug manufacturing, testing or inspecting establishments; or,

dd/ It is used in scientific researches other than the cases specified at Points a, b and c of this Clause.

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

a/ Three original import orders, made according to Form No. 15, 16 or 17 in Appendix III to this Decree;

b/ The original or a certified copy of the competent agency or organization’s written approval, for drugs specified at Points a, b and dd, Clause 1 of this Article;

c/ The original or a certified copy of the written approval of the bioequivalence trial proposal under Article 100 of the Pharmacy Law, for new drugs specified at Point c, Clause 1 of this Article;

d/ The explanatory document bearing the seal of the importer on the import purpose and quantity and the importer’s commitment to using the drug for proper purposes;

dd/ A certified copy or a copy of the importer’s license for performance of radiation jobs bearing the seal of the importer, for case of import of a radioactive drug. In case of submitting a copy bearing the seal of the importer, the original shall be produced for comparison.

3. A dossier prescribed in this Article shall be made in one set.

Article 74.Criteria and dossiers of application for import licenses for drugs for display at exhibitions or trade fairs

1. A dossier of application for an import license for a combination drug containing a habit-forming pharmaceutical ingredient, combination drug containing a psychotropic pharmaceutical ingredient or combination drug containing a precursor for display at a medical, pharmaceutical or medical equipment exhibition or trade fair must comprise:

a/ One original import order, made according to Form No. 16 or 17 in Appendix III to this Decree;

b/ A written commitment of the importer to re-exporting the whole imported quantity of the drug after the closure of the exhibition or trade fair.

2. A dossier prescribed in Clause 1 of this Article shall be made in one set.

3. Drugs other than those specified in Clause 1 of this Article may only be permitted for import when fully satisfying the following criteria:

a/ They are used for display at medical, pharmaceutical or medical equipment exhibitions or trade fairs;

b/ They are not habit-forming drugs, psychotropic drugs, precursor drugs or radioactive drugs.

4. The import of drugs specified in Clause 3 of this Article must comply with the regulations on temporary import of goods for re-export.

Article 75.Criteria and dossiers of application for import licenses for drugs for non-commercial purpose under Point i, Clause 2, Article 60 of the Pharmacy Law

1. A drug may only be permitted for import for non-commercial purpose when falling into one of the following cases:

a/ It is part of the personal luggage of a person on entry consigned with a bill of lading or of the hand luggage of a person on entry for his/her own medical treatment;

b/ It is not a habit-forming drug, psychotropic drug or precursor drug and is a belonging of a diplomatic mission, consular office or representative office of an international organization in Vietnam or a Vietnamese diplomatic mission in a foreign country, or of a person working at such agency or organization or at an organization introduced by an overseas Vietnamese diplomatic mission.

2. An import license is required for a drug specified in Clause 1 of this Article, except the following cases:

a/ Drugs imported in a quantity for use for 7 days at most, for habit-forming drugs, or for 10 days at most, for psychotropic or precursor drugs, according to the dosage stated in the accompanying prescription;

b/ Drugs other than habit-forming drugs, psychotropic drugs or precursor drugs imported with a total customs value of up to USD 200 (two hundred) (at the interbank exchange rate applied at the time of customs clearance) at a time, provided that the importer receives the imported drugs no more than 3 times a year.

For drugs used for patients suffering diseases on the list of fatal diseases promulgated together with the Government’s Decree No. 134/2016/ND-CP of September 1, 2016, detailing a number of articles of and providing measures to implement the Law on Import Duty and Export Duty, the permitted total customs value must not exceed VND 10,000,000 (ten million) at a time, provided that the importer receives the imported drugs no more than 4 times a year.

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

a/ An application for an import license, made according to Form No. 27 in Appendix III to this Decree;

b/ The applicant’s commitment to taking responsibility for the origin and quality of the to-be-imported drug;

c/ Certified copies or copies of the prescription and medical report book for monitoring out-patient treatment bearing the signature or seal of the applicant. These papers must fully have the following details: name and age of the patient; name, concentration or content and volume of the drug; drug quantity (or number of days of use); dosage; full name and signature of the physician; address of the hospital or clinic where the physician works.

In case of submitting copies of papers bearing the signature or seal of the applicant, the originals of such papers shall be produced for comparison.

For the drugs specified at Point b, Clause 1 of this Article, the papers specified at this Point are not required.

d/ A certified copy or copy bearing the signature of the applicant of one of the following papers: people’s identity card, citizen identification card or passport of the applicant who is an individual.

In case of submitting copies bearing the signature of the applicant, the originals shall be produced for comparison.

4. A dossier prescribed in this Article shall be made in one set.

Article 76.Specific provisions on papers in dossiers of application for import licenses for drugs

1. For drugs imported under Articles 65, 66, 69, 71, 72 and Point a, Clause 1, Article 68, of this Decree, separate import orders for each drug shall be made, unless such drugs share all the following features:

a/ Name;

b/ Form of preparation and route of administration;

c/ Concentration or content of pharmaceutical ingredients, for drugs in liquid or semi-solid form;

d/ Quality standards;

dd/ Date of expiry;

e/ Name and address of the manufacturer.

2. If papers in a dossier of application for an import license are presented in neither Vietnamese nor English, the dossier must also contain notarized Vietnamese or English translations of such papers.

3. The following papers shall be consularly legalized in accordance with the law on consular legalization, unless they are exempted in accordance with law:

a/ Pharmaceutical product certificate;

b/ Documents proving the drug is eligible for free sale in the country of manufacture or reference country;

c/ Certificate of drug good manufacturing practices;

d/ Label and use instruction sheet of a drug actually circulated in the country that has granted the pharmaceutical product certificate.

4. Requirements on pharmaceutical product certificate, except drugs imported to meet urgent needs of national defense, security, prevention and control of diseases and epidemics, or remediation of natural disaster and calamity consequences under Article 67 of this Decree:

a/ Satisfying the conditions prescribed in Clauses 2, 3 and 6 of this Article;

b/ Bearing the signature and showing the name and position title of the signatory, date of grant and bearing the seal of the state agency competent to grant pharmaceutical product certificates of the country of origin;

c/ Containing full certification of the contents related to the signature, name and position title of the signatory and seal of the state agency competent to grant pharmaceutical product certificates of the country of origin by the diplomatic mission, consular office or another mission or office authorized to perform the consular function of the country of origin;

d/ The pharmaceutical product certificate used for consular legalization must be the original;

dd/ Having a certification that the drug is permitted for sale and actually sold in the country that has granted the pharmaceutical product certificate;

e/ Clearly showing the name, address and role of each of the establishments involved in the drug’s manufacture;

g/ Being presented according to the form set by the World Health Organization applicable to the system of quality certification of pharmaceutical products eligible for sale in international trade.

5. Requirements on certification of specimen labels and use instruction sheets of drugs currently in circulation in countries that have granted pharmaceutical product certificates, except drugs that have the same trade name, active ingredients, concentration or content, form of preparation with a brand name specific having a registration for circulation in Vietnam, have been manufactured by the very manufacturer of such brand name specific or an authorized manufacturer, and have a price lower than that of the brand name specific circulated in Vietnam imported under Article 70 of this Decree:

a/ Satisfying the conditions prescribed in Clause 3 of this Article;

b/ Bearing the seal of the state agency competent to grant pharmaceutical product certificates of the country of origin;

c/ Specimen labels and use instruction sheets used for consular legalization must be originals.

6. Legal papers in a dossier must remain effective at the time of receipt of the dossier stated in its receipt slip.

Article 77.Procedures and time limit for grant of import licenses for drugs without registration for circulation in Vietnam

1. For the cases of grant of a drug import license under Articles 65, 66, 69, 71 and 72 and Point a, Clause 1, Article 68 of this Decree:

a/ An import license applicant shall submit directly or send by post its dossier to the Ministry of Health;

b/ After receiving a dossier, the Ministry of Health shall issue to the applicant a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree;

c/ In case the dossier does not need any modification or supplementation, within 60 days for dossiers not requiring clinical data or documents proving similarity to reference biological products, or 90 days for dossiers requiring clinical data or documents proving similarity to reference biological products, from the date stated in the dossier receipt slip, the Ministry of Health shall grant an import license after examining the dossier and consulting the advisory council for grant of drug and drug material circulation registration certificates;

d/ In case the dossier needs any modification or supplementation, within 60 days for dossiers not requiring clinical data or documents proving similarity to reference biological products or 90 days for dossiers requiring clinical data or documents proving similarity to reference biological products from the date stated in the dossier receipt slip, the Ministry of Health shall send a written request to the applicant for dossier modification or supplementation;

dd/ After receiving a modified or supplemented dossier, the Ministry of Health shall issue to the applicant a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree. In case the modified or supplemented dossier remains unsatisfactory, the Ministry of Health shall notify such in writing to the applicant under Point d of this Clause. In case the modified or supplemented dossier does not need any further modification or supplementation, the Ministry of Health shall grant an import license under Point c of this Clause;

e/ Within 6 months after the Ministry of Health issues a written request for dossier modification or supplementation, the import license applicant shall submit the modified or supplemented dossier as requested. Past that time limit, if the applicant fails to modify or supplement the dossier or after 12 months from the date of initial submission of the dossier, if the supplemented dossier remains unsatisfactory, the submitted dossier will become invalid;

g/ For drugs imported to serve humanitarian health care as approved by a competent state agency, if the paper specified at Point d, dd, e, g or i, Clause 2, Article 72 of this Decree cannot be provided but the drugs are needed for freatment, the Minister of Health shall consider and decide to grant an import license after consulting the advisory council for grant of drug circulation registration certificates.

2. For the case of grant of a drug import license under Article 67 of this Decree:

a/ An import license applicant shall submit directly or send by post its dossier to the Ministry of Health;

b/ After receiving a dossier, the Ministry of Health shall issue to the applicant a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree;

c/ In case the dossier does not need any modification or supplementation, within 3 working days from the date stated in the dossier receipt slip, the Ministry of Health shall grant an import license;

d/ In case the dossier needs any modification or supplementation, within 3 working days from the date stated in the dossier receipt slip, the Ministry of Health shall send a written request to the applicant for dossier modification or supplementation;

dd/ After receiving a modified or supplemented dossier, the Ministry of Health shall issue to the applicant a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree. In case the modified or supplemented dossier remains unsatisfactory, the Ministry of Health shall notify such in writing to the applicant under Point d of this Clause. In case the modified or supplemented dossier does not need any further modification or supplementation, the Ministry of Health shall grant an import license under Point c of this Clause;

e/ In case the importer cannot provide the paper specified at Point b, Clause 2, Article 67 of this Decree but the drug is needed for disease prevention and control, the Minister of Health shall consider and decide to grant an import license based on commitments of related ministries.

3. For the cases of drug import specified in Articles 70 and 73; Clause 1, Article 74; and Points b and c, Clause 1, Article 68, of this Decree:

a/ An import license applicant shall submit directly or send by post its dossier to the Ministry of Health;

b/ After receiving a dossier, the Ministry of Health shall issue to the applicant a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree;

c/ In case the dossier does not need any modification or supplementation, within 15 days from the date stated in the dossier receipt slip, the Ministry of Health shall grant an import license;

d/ In case the dossier needs any modification or supplementation, within 15 days from the date stated in the dossier receipt slip, the Ministry of Health shall send a written request to the applicant for dossier modification or supplementation;

dd/ After receiving a modified or supplemented dossier, the Ministry of Health shall issue to the applicant a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree. In case the modified or supplemented dossier remains unsatisfactory, the Ministry of Health shall notify such in writing to the applicant under Point d of this Clause. In case the modified or supplemented dossier does not need any further modification or supplementation, the Ministry of Health shall grant an import license under Point c of this Clause;

e/ Within 6 months after the Ministry of Health issues a written request for dossier modification or supplementation, the import license applicant shall submit the modified or supplemented dossier as requested. Past that time limit, if the applicant fails to modify or supplement the dossier or after 12 months from the date of initial submission of the dossier, if the supplemented dossier remains unsatisfactory, the submitted dossier will become invalid.

4. For the case of drug import specified in Article 75 of this Decree:

a/ An import license applicant shall submit directly or send by post its dossier to the provincial-level Health Department of the locality of the border gate of entry or where the applicant being a patient lives or lawfully temporarily resides or where the applicant being an organization is located;

b/ After receiving a dossier, the provincial-level Health Department shall issue to the applicant a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree;

c/ In case the dossier does not need any modification or supplementation, within 7 working days from the date stated in the dossier receipt slip, the provincial-level Health Department shall grant an import license;

d/ In case the dossier needs any modification or supplementation, within 7 working days from the date stated in the dossier receipt slip, the provincial-level Health Department shall send a written request to the applicant for dossier modification or supplementation;

dd/ After receiving a modified or supplemented dossier, the provincial-level Health Department shall issue to the applicant a dossier receipt slip, made according to Form No. 01 in Appendix I to this Decree. In case the modified or supplemented dossier remains unsatisfactory, the provincial-level Health Department shall notify such in writing to the applicant under Point d of this Clause. In case the modified or supplemented dossier does not need any further modification or supplementation, the provincial-level Health Department shall grant an import license under Point c of this Clause;

e/ Within 3 months after the provincial-level Health Department issues a written request for dossier modification or supplementation, the import license applicant shall submit the modified or supplemented dossier as requested. Past that time limit, if the applicant fails to modify or supplement the dossier or after 4 months from the date of initial submission of the dossier, if the supplemented dossier remains unsatisfactory, the submitted dossier will become invalid.

5. Within 10 working days after a drug import license is granted under Article 65, 66, 67, 68 or 69 of this Decree, the Ministry of Health shall announce it on its portal under Clause 6, Article 60 of the Pharmacy Law.

6. The Ministry of Health shall announce on its portal information relating to drugs for use for first-aid or detoxification purpose and vaccines for use in some special cases in limited dosages for which an import license has been granted under Point b or c, Clause 1, Article 68 of this Decree, including the importer, manufacturer, permitted drug quantity, drug name, form of preparation, route of administration, concentration or content of pharmaceutical ingredients, serial number of import license, date of grant, medical examination and treatment establishment, and vaccination establishment in need of the drug.

7. Drug import licenses and official letters permitting import shall be made according to Form No. 28, 29, 30, 31 or 32 in Appendix III to this Decree.

Article 78.Management of import of drugs without registration for circulation in Vietnam

1. Drugs containing pharmaceutical ingredients without registration for circulation in Vietnam, drugs containing medicinal materials used for the first time in Vietnam, and orphan drugs for which import licenses are granted under Articles 65 and 69 of this Decree may only be supplied to medical examination and treatment establishments.

2. The Minister of Health shall base himself/herself on requests of medical examination and treatment establishments and opinions of the advisory council for grant of drug and drug material circulation registration certificates to identify drugs that satisfy the criteria prescribed at Point a, Clause 1, Article 68 of this Decree.

3. For drugs for use for first-aid or detoxification purpose and vaccines for use in special cases in limited dosages for which import licenses are granted under Point b or c, Clause 1, Article 68 of this Decree:

a/ They may only be supplied to medical examination and treatment establishments and vaccination establishments that request their import. These establishments shall notify drug users, patients or families of patients of the grant of import licenses for these drugs although legal and technical dossiers of these drugs cannot be fully provided. These drugs may only be used with the consent of users, patients or families of patients;

b/ Drug importers and users specified at Point a of this Clause may sell or transfer drugs to other medical examination and treatment establishments and vaccination establishments. Transferees of these drugs must have all the papers specified at Points c and d, Clause 3, Article 68 of this Decree and have the responsibility prescribed at Point a of this Clause.

4. Before being circulated in the market, a drug lot that has the same trade name, active ingredients, concentration or content and form of preparation with a brand name specific having a registration for circulation in Vietnam, is manufactured by the very manufacturer of such brand name specific or an authorized manufacturer, and has a price lower than that of such brand name specific and is imported under Article 70 of this Decree shall be subject to quality inspection by a state agency in charge of testing drugs and drug materials whether to meet the quality standards of brand name specifics having a registration for circulation in Vietnam.

5. Drugs imported to serve the State’s health programs or for use for clinical trial, research, testing or inspection purpose shall be used for proper purposes and eligible subjects.

6. If drugs under special control that have been imported for humanitarian health care are not yet used up for such programs, they shall be exported under Clause 5, Article 60 of this Decree and may not be used for other purposes.

7. Drugs imported for display at medical, pharmaceutical or medical equipment exhibitions or trade fairs under Article 74 of this Decree shall be wholly re-exported after the closure of such exhibitions or trade fairs and may be neither used nor circulated in Vietnam.

8. Applicants for import licenses for drugs for use for non-commercial purpose under Article 75 of this Decree shall assume responsibility for the origin and quality of imported drugs.

Section 3

IMPORT OF DRUGS UNDER SPECIAL CONTROL WHICH HAVE CERTIFICATES OF REGISTRATION FOR CIRCULATION IN VIETNAM, DRUG MATERIALS UNDER SPECIAL CONTROL

Article 79.Dossiers of application for licenses to import drugs under special control which have certificates of registration for circulation in Vietnam

A dossier of application for a license to import habit-forming drugs, psychotropic drugs, precursor drugs, combination drugs containing a habit-forming pharmaceutical ingredient, combination drugs containing a psychotropic pharmaceutical ingredient, combination drugs containing a precursor, radioactive drugs, toxic drugs and drugs that are on the list of drugs and pharmaceutical ingredients banned from use in a number of sectors and fields which have valid certificates of registration for circulation in Vietnam must comprise:

1. The original import order, made according to Form No. 33 or 34 in Appendix III to this Decree.

2. A report on imported drug trading results, made according to Form No. 18 in Appendix III to this Decree, except toxic drugs.

3. A certified copy or a copy bearing a seal of the importer of the license for performance of radiation jobs in case of import of radioactive drugs. In case the copy bears the seal of the importer, the original is required for comparison when submitting the dossier.

4. A dossier specified in this Article shall be made in 1 set.

Article 80.Dossiers and provisions on grant of licenses for import of drug materials under special control.

1. A dossier of application for a license for import of drug materials under special control must comprise:

a/ The original import order, made according to Form No. 35 or 36 in Appendix III to this Decree;

b/ A copy of the manufacturer’s declaration of quality standards and testing methods of drug materials bearing a seal of the importer;

c/ A certified copy of the production license granted by a foreign competent management agency to the material manufacturer, which must be consularly legalized under the law on consular legalization, except cases exempt from consular legalization in accordance with law;

d/ A report on the use of drug materials, made according to Form No. 37 in Appendix III to this Decree, except the case of import of toxic materials for manufacture of drugs, a report on drug material trading results, made according to Form No. 38 in Appendix III to this Decree, except toxic materials for manufacturing drugs;

dd/ A plan on production and use of the materials requested for import and a tentative business plan for finished products to be manufactured from the materials requested for import, except the case of import of toxic materials to manufacture drugs;

e/ For materials imported for testing and research; drug materials which have certificates of free sale in Vietnam or on the list of pharmaceutical ingredients, adjuvants and semi-finished drug products for drug manufacture according to the drug registration dossier which has a certificate of registration for circulation in Vietnam, papers specified at Points b and c of this Clause are not required;

g/ The original of the importer’s written explanation of the purpose and quantity of imported materials and commitment on use of imported materials for proper purposes in case of importing drug materials for testing and research;

h/ In case of import of drug materials under special control which have certificates of free sale in Vietnam or outside the list of pharmaceutical ingredients, adjuvants and semi-finished products for manufacture of drugs according to the drug registration dossier which has a certificate of registration for circulation in Vietnam for preparation of prescription drugs at drugstores and medical examination and treatment establishments for disease and epidemic prevention and control, the dossier must contain a written request of the drug preparation establishment, made according to Form No. 39 in Appendix III to this Decree.

2. If the papers specified at Points b and c, Clause 1 of this Article are not made in Vietnamese or English, their notarized Vietnamese or English translations are required.

3.  A dossier specified specified in Clauses 1 and 2 of this Clause shall be made in 1 set.

4. Drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients or precursors used as drugs may not be granted import licenses for display at exhibitions and trade fairs.

5. Toxic materials used for manufacturing drugs, pharmaceutical ingredients on the list of drugs and pharmaceutical ingredients banned from use in a number of sectors and fields imported for display at exhibitions and trade fairs must comply with Article 83 of this Decree.

Article 81.Procedures and time limit for grant of licenses for import of drugs under special control which have certificates of registration for circulation in Vietnam that remain valid and drug materials under special control

1. An establishment applying for an import license shall submit directly or by post its dossier to the Ministry of Health.

2. After receiving a dossier, the Ministry of Health shall issue to the applicant a dossier receipt slip, made according to Form No. 1 in Appendix I to this Decree.

3. In case no modification or supplementation of the dossier is required, within 15 days from the date stated in the dossier receipt slip, the Ministry of Health shall issue an import license.

4. In case modification or supplementation of the dossier is required, within 15 days from the date stated in the dossier receipt slip, the Ministry of Health shall send a written request to the applicant for modification or supplementation.

5. After receiving a modified or supplemented dossier, the Ministry of Health shall issue a modified or supplemented dossier receipt slip, made according to Form No. 1 in Appendix I to this Decree. In case the modified or supplemented dossier is unsatisfactory, the Ministry of Health shall issue a written notice to the applicant as prescribed in Clause 4 of this Article. In case no further modification or supplementation of the modified or supplemented dossier is required, the Ministry of Health shall grant an import license as prescribed in Clause 3 of this Article.

6. Within 6 months from the date the Ministry of Health issues a written notice of the modification or supplementation of the dossier, the applicant shall submit the modified or supplemented dossier as requested. Past this time limit, if no modification or supplementation is made or after 12 months from the date of initial submission of the dossier if the supplemented dossier remains unsatisfactory, the submitted dossier will become invalid.

7. The import license and official letter licensing the import of drugs and drug materials shall be made according to Form No. 28, 29, 30, 40 or 44 in Appendix III to this Decree.

Section 4

IMPORT OF DRUG MATERIALS WHICH HAVE NO CERTIFICATES OF REGISTRATION FOR CIRCULATION IN VIETNAM, EXCEPT FOR DRUG MATERIALS UNDER SPECIAL CONTROL; IMPORT OF STANDARD SUBSTANCES AND PRIMARY PACKAGES OF DRUGS

Article 82.Criteria and dossiers of application for licenses to import pharmaceutical ingredients, medicinal materials, semi-finished drug products, semi-finished medicinal material products for use as samples for testing or research

1. Pharmaceutical ingredients, medicinal materials, semi-finished drug products, and semi-finished products for manufacturing drugs, that are derived from medicinal materials, in the form of paste, granule, powder, extract, oil, resin, gum or jelly (below referred to as semi-finished medicinal material products) which have no certificate of registration for circulation in Vietnam may be licensed for import in one of the following cases:

a/ For use in testing or research at drug or drug material manufacturers or testing or research establishments;

b/ For use in scientific research as approved by competent authorities.

2. A dossier must comprise:

a/ Three original import orders, made according to Form No. 36 or 41 in Appendix III to this Decree;

b/ The importer’s written explanation of the purpose and quantity of to-be-used pharmaceutical ingredients and medicinal materials and commitment on use for proper purposes;

c/ The original or a certified copy of the competent authority’s written approval, for the case specified at Point b, Clause 1 of this Article.

3. A dossier specified in this Article shall be made in 1 set.

Article 83.Provisions on import of pharmaceutical ingredients, semi-finished drug products, medicinal materials, semi-finished medicinal material products for display at exhibitions and trade fairs

1. Drug materials may be licensed for import for display at medical, pharmaceutical and medical equipment exhibitions and trade fairs.

2. The import of drug materials for display at exhibitions and trade fairs must comply with the law on temporary import for re-export.

3. Drug materials licensed for import under this Article may not be circulated in Vietnam and shall be wholly re-exported after exhibitions or trade fairs are concluded.

Article 84.Dossiers of application for licenses to import pharmaceutical ingredients, semi-finished drugs, medicinal materials and semi-finished medicinal material products for manufacture of drugs for export

1. A dossier must comprise:

a/ Three original import orders, made according to Form No. 36 or 41 in Appendix III to this Decree;

b/ A copy of the manufacturer’s declaration of quality standards and testing methods of drug materials bearing the seal of the importer. If such paper is not made in Vietnamese or English, its notarized Vietnamese or English translation is required;

c/ A written commitment to using drug materials for proper purposes and finished drugs for export, not for circulation in Vietnam.

2. A dossier specified in this Article shall be made in 1 set.

Article 85.Criteria and dossiers of application for licenses to import pharmaceutical ingredients, semi-finished drugs, medicinal materials and semi-finished medicinal materials for manufacture of drugs for national defense and security, disease and epidemic prevention and control or remediation of consequences of natural disasters or catastrophes

1. Drug materials may be licensed for import for drug manufacture in one of the following cases:

a/ Drugs to serve  national defense;

b/ Drugs to serve security;

c/ Drugs to serve  disease and epidemic prevention and control, remediation of consequences of natural disasters or catastrophes, including prescription drugs prepared at drugstores or medical examination and treatment establishments. Medicinal materials imported for preparation at drugstore or medical examination and treatment establishments must comply with Article 87 of this Decree.

2. A dossier must comprise:

a/ Three original import orders, made according to Form No. 36 or 41 in Appendix III to this Decree;

b/ In case drug materials are imported to manufacture drugs to serve national defense or security, the dossier must also comprise the original written request of the Ministry of National Defense or Ministry of Public Security, which must contain at least information on drug name, manufacturer name, active ingredients, concentration or content, form of preparation, packaging specifications, route of administration and indications;

c/ In case drug materials are imported to manufacture drugs for disease and epidemic prevention and control, remediation of consequences of natural disasters or catastrophes, the dossier must also comprise a written approval of the list of drugs by the Ministry of Health, which must contain at least information on drug name, manufacturer name, active ingredients, concentration or content, form of preparation, packaging specifications, route of administration and indications;

d/ In case drug materials are imported to manufacture and prepare prescription drugs at drug stores or drugs manufactured or prepared at medical examination and treatment establishments, the dossier must contain written requests of the manufacturer and drug preparation establishment, made according to Form No. 42 in Appendix III to this Decree;

dd/ A written commitment of import and use of drug materials for proper purposes of drug material importer and user;

e/ A copy of the manufacturer’s declaration of quality standards and testing methods of drug materials bearing the seal of the importer;

g/ A certified copy of the production license granted by a foreign competent management agency to the drug material manufacturer. The production license must be consularly legalized in accordance with the law on consular legalization, except cases exempt from consular legalization in accordance with law;

h/ If the papers specified at Points e and g of this Clause are not made in Vietnamese or English, their notarized Vietnamese or English translations are required.

3. A dossier specified in this Article shall be made in 1 set.

Article 86.Dossiers of application for licenses to import adjuvants, capsules and primary packages for drugs, standard substances

1. A dossier of application for an import license must comprise:

a/ Three original import orders, made according to Form No. 43 in Appendix III to this Decree;

b/ A copy of the manufacturer’s declaration of quality standards and testing methods of adjuvants, capsules and primary packages for drugs bearing the seal of the importer. If such paper is not made in Vietnamese or English, its notarized Vietnamese or English translations are required.

2. A dossier specified in this Article shall be made in 1 set.

Article 87.Dossiers of application for licenses to import medicinal materials  not in the cases specified in Articles 82, 83, 84 and 85 of this Decree

1. A dossier of application for an import license must comprise:

a/ Three original import orders, made according to Form No. 41 in Appendix III to this Decree;

b/ The text of the quality standard applicable to medicinal materials in conformity with relevant national technical regulations on medicinal materials stated in the Pharmacopoeia of Vietnam or a foreign pharmacopoeia recognized by the Ministry of Health;

In case relevant national technical regulations on medicinal materials are not included in the Pharmacopoeia of Vietnam or any foreign pharmacopoeias recognized by the Ministry of Health, the establishment shall supply the text of the quality standard, including testing methods, which is formulated by the establishment itself and appraised by a state drug and drug material testing establishment;

c/ A certified copy of the certificate of establishment of representative office in Vietnam of a foreign supplier of medicinal materials to Vietnam or a drug and drug material trading license of a foreign enterprise in Vietnam covering the trading of medicinal materials and preliminarily processed and processed medicinal materials;

d/ A certified copy of a business license covering export of medicinal materials granted by a competent agency of the host country to a foreign supplier of medicinal materials to Vietnam;

dd/ A certified copy of the good manufacturing practices certificate in the field of manufacturing medicinal materials granted by a competent agency of the host country to the manufacturer;

e/ A copy bearing the seal of the importer, a written authorization of the medicinal material manufacturer for a foreign drug supplier, unless the manufacturer is also the supplier. The written authorization must comply with Point dd, Clause 15, Article 91 of this Decree.

2. A dossier specified in this Article shall be made in 1 set.

Article 88.Procedures and time limit for grant of licenses for import of drug materials which have no certificate of registration for circulation in Vietnam, excluding drug materials under special control; primary packages for drugs, standard substances

1. Procedures and time limit for grant of licenses for import of drug materials, primary packages for drugs and standard substances specified in Articles 82, 84, 86 and 87 of this Decree:

a/ An establishment applying for an import license shall submit directly or by post its dossier to the Ministry of Health;

b/ After receiving a dossier, the Ministry of Health shall issue to the applicant a dossier receipt slip, made according to Form No. 1 in Appendix I to this Decree;

c/ In case no modification or supplementation of the dossier is required, within 15 days from the date stated in the dossier receipt slip, the Ministry of Health shall issue an import license;

d/ In case modification or supplementation of the dossier is required, within 15 days from the date stated in the dossier receipt slip, the Ministry of Health shall send a written request to the applicant for modification or supplementation;

dd/ After receiving the modified or supplemented dossier, the Ministry of Health shall issue the modified or supplemented dossier receipt slip, made according to Form No. 1 in Appendix I to this Decree. In case the modified or supplemented dossier is unsatisfactory, the Ministry of Health shall issue a written notice to the applicant as prescribed at Point d of this Clause. In case no further modification or supplementation of the modified or supplemented dossier is required, the Ministry of Health shall issue an import license under Point c of this Clause;

e/ Within 6 months after the Ministry of Health issues a written notice of the modification or supplementation of the dossier, the applicant shall submit the modified or supplemented dossier as requested. Past this time limit, if no modification or supplementation is made or after 12 months from the date the dossier if the supplemented dossier remains unsatisfactory, the submitted dossier will become invalid.

2. For cases of import of drug materials specified in Article 85 of this Decree:

a/ An establishment applying for an import license shall submit directly or by post its dossier to the Ministry of Health;

b/ After receiving a dossier, the Ministry of Health shall issue to the applicant a dossier receipt slip, made according to Form No. 1 in Appendix I to this Decree;

c/ In case no modification or supplementation of the dossier is required, within 3 working days from the date stated in the dossier receipt slip, the Ministry of Health shall grant an import license;

d/ In case modification or supplementation of the dossier is required, within 3 working days from the date stated in the dossier receipt slip, the Ministry of Health shall send a written request to the applicant for modification or supplementation;

dd/ After receiving the modified or supplemented dossier, the Ministry of Health shall issue the modified or supplemented dossier receipt slip, made according to Form No. 1 in Appendix I to this Decree. In case the modified or supplemented dossier is unsatisfactory, the Ministry of Health shall issue a written notice to the applicant as prescribed at Point d of this Clause. In case no further modification or supplementation of the modified or supplemented dossier is required, the Ministry of Health shall issue an import license under Point c of this Clause.

3. An import license and official letter licensing the import of drug materials, made according to Form No. 44 or 45 in Appendix III to this Decree.

Section 5

PROVISIONS ON EXPORT AND IMPORT OF DRUGS AND DRUG MATERIALS

Article 89.Provisions on validity duration of licenses and official letters licensing the export and import of drugs and drug materials

1. A license or an official letter licensing the export of drugs and drug materials is valid:

a/ For a maximum of 1 year, for drugs and drug materials licensed for export under Articles 57, 59, 60, 62 and Clause 1, Article 61 of this Decree;

b/ For a maximum of 2 years, for drugs and drug materials licensed for export under Article 58 and Clause 8, Article 64 of this Decree;

2. An import license or an official letter licensing the import of drugs and drug materials is valid:

a/ For a maximum of 1 year, for an import license or an official letter licensing the import of drugs;

b/ For a maximum of 1 year and for one importation, for a license to import habit-forming drugs, psychotropic drugs, precursor drugs and drug materials being habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients and precursors used as drugs;

c/ For a maximum of 2 years, for an import license or an official letter licensing the import of drug materials, except for drug materials specified at Point b of this Clause;

3. The validity duration of the import license or an official letter must be stated in such papers.

Article 90.Provisions on the remaining shelf life of imported drugs and drug materials at the time of customs clearance

1. At the time of customs clearance, pharmacochemical drugs, drugs from medicinal materials, traditional drugs and drug materials, excluding drugs and drug materials specified in Clause 3 of this Article, imported into Vietnam must have a minimum remaining shelf life of:

a/ Eighteen months, for drugs and drug materials with a shelf life of over 24 months;

b/ Half of the shelf life, for drugs and drug materials with a shelf life equal to or under 24 months.

2. At the time of customs clearance, vaccines and biological products imported into Vietnam, except the cases specified in Clause 3 of this Article, must have a remaining shelf life equal to at least half of the shelf life time.

3. Drugs and drug materials imported under Articles 67, 73, 74, 75, 82, 83, 84, 85, 86 and Point b, Clause 1 of Article 68 of this Decree must be in their shelf life at the time of customs clearance.

4. The Minister of Health shall decide to license the import of drugs and drug materials that have the remaining shelf life at the time of customs clearance shorter than that specified in Clause 1 or 2 of this Article but are necessary for use in manufacture, disease and epidemic prevention and control.

5. A dossier of application for a license to import drugs and drug materials specified in Clause 4 of this Article must comprise:

a/ An application of the importer containing information on drug/drug material name, remaining shelf life at the time of customs clearance, reasons for drug/drug material having the remaining shelf life at the time of customs clearance shorter than that specified in Clause 1 or 2 of this Article;

b/ Papers proving the lot of drugs/drug materials having the remaining shelf life at the time of customs clearance shorter than that specified in Clause 1 or 2 of this Article.

6. Order and procedures for licensing the import of drugs and drug materials specified in Clause 4 of this Article:

a/ An establishment applying for an import license shall submit directly or by post its dossier to the Ministry of Health;

b/ After receiving a dossier, the Ministry of Health shall issue to the applicant a dossier receipt slip, made according to Form No. 1 in Appendix I to this Decree;

c/ In case no modification or supplementation of the dossier is required, within 15 days from the date stated in the dossier receipt slip, the Ministry of Health shall grant an import license;

d/ In case modification or supplementation of the dossier is required, within 15 days from the date stated in the dossier receipt slip, the Ministry of Health shall send a written request to the applicant for modification or supplementation;

dd/ After receiving the modified or supplemented dossier, the Ministry of Health shall issue a modified or supplemented dossier receipt slip, made according to Form No. 1 in Appendix I to this Decree. In case the modified or supplemented dossier is unsatisfactory, the Ministry of Health shall issue a written notice to the applicant as prescribed at Point d of this Clause. In case no further modification or supplementation of the modified or supplemented dossier is required, the Ministry of Health shall grant an import license under Point c of this Clause;

e/ Within 3 months after the Ministry of Health issues a written notice of the modification or supplementation of the dossier, the applicant shall submit the modified or supplemented dossier as requested. Past this time limit, if no modification or supplementation is made or after 4 months from the date of the submission of the dossier, if the supplemented dossier remains unsatisfactory, the submitted dossier will become invalid.

Article 91.Provisions on import of drugs and drug materials

1. Drug materials being pharmaceutical ingredients, adjuvants or semi-finished drug products, excluding semi-finished medicinal material products, for manufacture of drugs under the drug registration dossier with a certificate of registration for circulation in Vietnam, shall be announced by the Minister of Health, according to Form No. 46 in Appendix III to this Decree within 15 days after the grant or extension of the certificate. An import license is not required for drug materials being pharmaceutical ingredients, adjuvants and semi-finished drug products on the list of those licensed for import, excluding drug materials under special control.

2. The list of drugs and drug materials banned from import or manufacture is provided in Appendix V to this Decree.

3. Drug materials that have certificates of registration for circulation in Vietnam, including medicinal materials, semi-finished medicinal material products, adjuvants, capsules, semi-finished drug products, excluding semi-finished drug products under special control, may be imported without applying for an import license.

4. Medical and pharmaceutical training institutions, drug research or testing establishments may be licensed to import drugs, drug materials and standard substances to serve their own training, research or testing activities.

5. Vietnam-based representative offices of manufacturers, registrants and establishments having licenses for circulation of drugs for clinical trial, bioavailability assessment and bioequivalence trial; and establishments conducting clinical trial of drugs, bioavailability assessment and bioequivalence trial may import drugs and drug materials and standard substances for clinical trial, bioavailability assessment and bioequivalence trial.

6. Traders may import primary packages for drugs.

7. Drugs and drug materials, excluding drugs licensed for import for non-commercial purposes specified in Article 75 of this Decree, shall only be imported through international border gates.

8. The Minister of Health shall decide on quantity of drugs and drug materials licensed for import as follows:

a/ Quantity of to-be-imported drugs containing pharmaceutical ingredients that have no certificates of registration for circulation and drugs containing medicinal materials that are used for the first time in Vietnam under Article 65 of this Decree shall be decided based on scope and developments of fatal diseases, social diseases, dangerous and newly emerging diseases and epidemics;

b/ Quantity of to-be-imported drugs containing pharmaceutical ingredients that have certificates of registration for circulation in Vietnam but still insufficient to meet treatment needs, drugs containing medicinal materials that have previously been used in Vietnam but still insufficient to meet treatment needs, drugs meeting special treatment needs prescribed in Articles 66 and 68 of this Decree shall be decided based on practical needs of medical examination and treatment establishments;

c/ Quantity of to-be-imported drugs to meet urgent needs of national defense, security, disease and epidemic prevention and control, remediation of consequences of natural disasters or catastrophes specified in Article 67 of this Decree shall be decided based on needs of national defense, security, disease and epidemic prevention and control, remediation of consequences of natural disasters or catastrophes;

d/ Quantity of to-be-imported orphan drugs prescribed in Article 69 of this Decree shall be decided based on trading needs of the importer;

dd/ Quantity of to-be-imported drugs having the same trade names, active ingredients, content or concentration, or form of preparation as those of brand name specifics that have certificates of registration for circulation in Vietnam, manufactured by the manufacturers of those brand name specifics or by authorized manufacturers, and whose prices are lower than those of brand name specifics circulated in Vietnam under Article 70 of this Decree shall be decided based on their ability to meet the objective of stabilizing prices;

e/ Quantity of to-be-imported drugs to serve the State’s health programs under Article 71 of this Decree shall be decided based on needs of such programs;

g/ Quantity of to-be-imported drugs donated as aid or humanitarian aid under Article 72 of this Decree shall be decided based on practical needs of aid recipients;

h/ Quantity of to-be-imported drugs used for clinical trial, bioequivalence trial, bioavailability assessment, as samples for testing and scientific research specified in Article 73 of this Decree shall be decided based on approved research outlines or needs for testing and research of the establishment;

i/ Quantity of to-be-imported drugs for non-commercial purposes specified in Article 75 of this Decree shall be decided based on practical needs for treatment of organizations and individuals;

k/ Quantity of to-be-imported drugs under special control prescribed in Articles 79 and 80 of this Decree shall be decided based on the establishments’ practical trading needs;

l/ Quantity of to-be-imported standard substances, primary packages of drugs and drug materials that have no certificate of registration for circulation in Vietnam prescribed in Articles 82, 84, 85, 86 and 87 of this Decree shall be decided based on needs for materials for practical manufacture and trading of the establishments, excluding drug materials under special control.

9. Drugs and drug materials imported under the Pharmacy Law and this Decree are not required to go through procedures for chemical declaration.

10. Establishments eligible for import but ineligible for distribution of drugs and drug materials in Vietnam may not carry out activities directly relating to the distribution of drugs and drug materials in Vietnam, excluding drugs and drug materials manufactured by themselves in Vietnam, including:

a/ Selling or delivering drugs and drug materials to medical examination and treatment establishments, retailers and organizations and individuals other than drug and drug material wholesalers;

b/ Taking orders and payments for drugs and drug materials from medical examination and treatment establishments, retailers and organizations and individuals other than drug and drug material wholesalers;

c/ Transporting and storing drugs and drug materials;

d/ Determining and fixing selling prices of drugs and drug materials distributed by other pharmaceutical traders;

dd/ Making decisions on distribution strategies and business policies for drugs and drug materials distributed by other pharmaceutical traders;

e/ Formulating plans to supply drugs and drug materials for medical examination and treatment establishments in Vietnam;

g/ Providing financial support in any forms to direct drug and drug material buyers in order to manipulate the distribution of imported drugs and drug materials;

h/ Taking other acts relating to drug distribution in accordance with law.

11. Wholesalers that buy drugs or drug materials imported by the importers but are ineligible for distribution of drugs and drug materials in Vietnam must have enough capacity and ability to directly distribute drugs and drug materials to medical examination and treatment establishments and pharmaceutical traders without being imposed, controlled or regulated by establishments ineligible for distribution drugs and drug materials in Vietnam in the activities specified in Clause 10 of this Article.

12. An establishment eligible for import but ineligible for distribution of drugs and drug materials in Vietnam shall send to the Ministry of Health a written notice of the sale or termination of the sale of drugs to the wholesalers that distribute its imported drugs and drug materials.

Within 3 working days after receiving the establishment’s notice (the date stated on the incoming-mail stamp), the Ministry of Health shall make public on its portal information on drug wholesalers purchasing drugs and drug materials from importers but ineligible for distribution of drugs and drug materials in Vietnam.

13. The import of medicinal materials being samples of species on the list of endangered, precious and rare species prioritized for protection for use as samples of drug testing or research must comply with the law on biodiversity.

14. Provisions on a testing slip of a lot of imported drugs and drug materials:

a/  A testing slip shall be made in Vietnamese or English. If a testing slip has not been made in Vietnamese or English, its notarized Vietnamese or English translation is required;

b/ In case 2 drugs in a lot of imported drugs and drug materials is manufactured by 2 or more establishments, a testing slip of the manufacturer or final packaging establishment or establishment in charge of ex-workshop is required;

c/ A testing slip must contain administration information (name and address of the manufacturer, the serial number of the testing slip, name and signature of the assigned person, the date of issuance of the testing slip) and information on the sample of drugs and drug materials (product name, lot number, expiry date, the applied quality standard, quality norms and requirements, testing results, conclusions on the lot quality).

15. A supplier of drugs and drug materials being a foreign establishment shall sign a sale and purchase contract with the importer. A supplier of drugs and drug materials must be one of the following establishments:

a/ An establishment manufacturing imported drugs and drug materials;

b/ An establishment possessing products or a certificate of registration for circulation of imported drugs and drug materials stated in the pharmaceutical product certificate for drugs that have certificates of free sale in accordance with the Pharmacy Law and drugs that have no certificate of registration for circulation in Vietnam;

c/ A foreign establishment undersigned to register drugs and drug materials having a certificate of free sale in Vietnam which remains valid at the time of customs clearance but not the one specified at Point a or b of this Clause;

d/ A foreign enterprise’s establishment that has been granted a license for operation in drugs and drug materials in Vietnam or a foreign company’s establishment that has been granted a license for operation in vaccines, biological products and materials for manufacturing vaccines and biological products in Vietnam;

dd/ A supplier being the establishment specified at Point c or d of this Clause must be authorized in writing by the establishment specified at Point a or b of this Clause to supply drugs to Vietnam.

A written authorization may be an authorization letter or sale license or partnership relation certificate. A written authorization must be made in Vietnamese or English and contain at least have information on the names and addresses of the authorizer and authorized establishment; the scope of authorization for supply of drugs and drug materials to Vietnam; the duration of authorization or sale license; responsibilities of related parties for ensuring the quality and origin of drugs and drug materials supplied to Vietnam; and signatures of related parties;

e/ Suppliers of drugs imported under Articles 67 and 73 and Clause 1, Article 74 of this Decree are not required to comply with this Clause.

g/ Suppliers of drugs imported under Article 70 of this Decree are not required to comply with Point dd of this Clause.

16. Suppliers of adjuvants, capsules, primary packages of drugs and standard substances are not required to comply with Clause 15 of this Article.

17. A drug import license shall be revoked in the following cases:

a/ Imported drugs are recalled for a level-1 violation under Point a, Clause 2, Article 63 of the Pharmacy Law;

b/ Imported drugs have their certificates of registration for circulation revoked by the competent agency of the country of manufacture or a member state of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) or Australia;

c/ A competent agency concluded that papers in the approved dossier of application for an import license are forged papers;

d/ Imported drugs are manufactured at locations other than those stated in the approved dossier of application for a license to import drugs;

dd/ Drugs containing pharmaceutical ingredients or medicinal materials are unsafe and ineffective for users as recommended by the World Health Organization or the competent management agency of Vietnam or the country of origin of the drugs;

e/ The manufacturer or importer requests the revocation of import license for drugs and drug materials;

g/ There is a notice from the foreign pharmacy administration authority to recall the lot of imported drugs.

18. A drug material import license shall be revoked in the following cases:

a/ Drug materials are recalled under Point a, b, d, dd, or e, Clause 2, Article 62 of the Law on Pharmacy;

b/ Imported pharmaceutical ingredients and medicinal materials are unsafe and inefficient for users as recommended by the World Health Organization or the competent management agency of Vietnam or the country of origin of the pharmaceutical ingredients and medicinal materials.

19. Cases subject to suspension from submission of dossiers of application for a license to import drugs and drug materials for between 1 and 2 years or grant of a license for import of drugs and drug materials for between 1 and 2 years for drug and drug material importers:

a/ Committing the violations specified at Points a, c and d, Clause 17 of this Article;

b/ Having 2 or more lots of imported drugs subject to compulsory recall for a level-2 violation under Point b, Clause 2, Article 63 of the Pharmacy Law or 3 or more lots of imported drugs detected as violating quality regulations within 12 months;

c/ Providing information in the dossiers of application for an import license not based on research outcomes or actual production activities of manufacturers;

d/ Failing to update drug efficacy and safety information on labels and use instruction sheets of imported drugs which are circulated in Vietnam at the request of the Ministry of Health.

20. A drug and drug material manufacturing establishment shall be suspended from import of drugs and drug materials if falling into one of the following cases:

a/ Committing a serious violation of principles of good manufacturing practices as prescribed by the Ministry of Health;

b/ Having 2 or more lots of drugs and drug materials involved in a level-1 violation prescribed at Point a, Clause 2, Article 63 of the Pharmacy Law with respect to the quality of drugs and drug materials within 12 months.

c/ Having 3 or more of lots of drugs and drug materials involved in a level-2 violation prescribed at Point b, Clause 2, Article 63 of the Pharmacy Law or 4 or more lots of drugs and drug materials violating quality regulations within 12 months;

d/ The import suspension period shall be between 1 year and 2 years for the cases specified at Points a and b of this Clause and between 6 months and 1 years for the case specified at Point c of this Clause.

21. Provisions on reporting on the import and export of drugs and drug materials under special control

a/ An establishment importing vaccines which have a certificate of registration for circulation in Vietnam or drugs which have not yet had a certificate of registration for circulation in Vietnam shall send a report on the import of each imported goods lot, made according to Form No. 47 or 48 in Appendix III to this Decree, to the Ministry of Heath and concurrently to the National Institute for Control of Vaccines and Biologicals, for vaccines, within 10 days from the date of importation;

b/ Before July 15 or January 15 every year, the importer shall send to the Ministry of Health biannual and annual reports on import and export of drugs and drug materials, made according to Form No. 49 or 50 in Appendix III to this Decree.

Article 92.Provisions on specialized papers to be produced and submitted upon customs clearance for import or export of drugs and drug materials

In addition to papers to be produced and submitted under the law on customs, upon the customs clearance for import or export of drugs and drug materials, a pharmaceutical business establishment, an organization or individual shall produce and submit the following papers:

1. For customs clearance for export of drugs and drug materials:

a/ To produce the original or a certified copy and submit a copy of the exporter’s certificate of eligibility for pharmaceutical business bearing the exporter’s certification seal, in case the exporter is a pharmaceutical business establishments;

b/ To submit a copy bearing the exporter’s certification seal of the export license and produce the original or a certified copy for comparison in case of export of medicinal materials on the list of precious, rare or endemic medicinal material species and varieties under control or drugs under special control, except those specified at Point c of this Clause;

c/ To submit certified copies of prescriptions and medical records for outpatient treatment or a copy bearing the signature of the individual applicant for an export license or a copy bearing the seal of the institutional applicant for an export license and produce the originals for comparison  in case drugs under special control are in personal luggage of the organization or individual on exit sent together with the bill of lading, hand luggage carried by the organization or individual on exit for its/his/her own treatment with the export quantity not exceeding the quantity to be used for maximum 7 days, for habit-forming drugs, 10 days, for psychotropic and precursor drugs or 30 days, for combination drugs containing a habit-forming pharmaceutical ingredient, combination drugs containing a psychotropic pharmaceutical ingredient, combination drugs containing a precursor, toxic drugs, drugs on the list of drugs and pharmaceutical ingredients banned from use in a number of sectors and fields according to the dosage stated in accompanying prescriptions.

2. For customs clearance for import of drugs and drug materials that have certificates of registration for circulation in Vietnam, drug materials on the list of pharmaceutical ingredients, adjuvants, semi-finished drugs for manufacturing drugs that have certificates of registration for circulation in Vietnam according to the drug registration dossier, except medicinal materials:

a/ To produce the original or a certified copy and submit a copy bearing the importer’s certification seal of the importer’s certificate of eligibility for pharmaceutical trading in case the importer is a pharmaceutical trader;

b/ To submit a copy bearing the importer’s certification seal of the import license and produce the original or a certified copy for comparison in case of import of drugs under special control;

c/ To submit the original or a copy bearing the importer’s certification seal of the testing slip for each lot of imported drugs and drug materials; in case of submission of the copy, the original is required for comparison upon customs clearance;

d/ To submit a copy of the authorization letter or sale license or the partnership relation certificate bearing the importer’s certification seal as prescribed at Point dd, Clause 15, Article 91 of this Decree, except cases of import of adjuvants or capsules;

dd/ For drugs and drug materials that are imported under Point dd, Clause 1, Article 59 of the Pharmacy Law, the importer shall produce the bill of lading for the lot of drugs and drug materials indicating that the goods are exported from the port of departure of the country of exportation before the certificate of free sale expires.

3. For customs clearance for import of medicinal materials and semi-finished medicinal material products that have or do not have a certificate of free sale in Vietnam:

a/ To submit a copy bearing a certification seal of the importer of the certificate of eligibility for pharmaceutical trading and produce the original or a certified copy for comparison in case the importer is a pharmaceutical trader;

b/ For medicinal materials and semi-finished medicinal material products that have a certificate of free sale in Vietnam, to submit a copy bearing a seal of the importer of the certificate of free sale and produce the original or a certified copy for comparison;

c/ For medicinal materials and semi-finished medicinal material products that have no certificate of free sale in Vietnam, to submit a copy bearing a seal of the importer of the medicinal material import license and produce the original or a certified copy for comparison;

d/ A copy bearing the importer’s seal of a written authorization of the manufacturer of medicinal materials and semi-finished medicinal material products for a foreign supplier, except where the manufacturer is the supplier. The written authorization must comply with Point dd, Clause 15, Article 91 of this Decree;

dd/ To submit the original or a copy bearing the importer’s seal of the manufacturer’s testing slip for each lot of medicinal materials and semi-finished medicinal material products; in case of submission of a copy, the original is required for comparison upon customs clearance;

e/ For import of medicinal materials and semi-finished medicinal material products under Point dd, Clause 1, Article 59 of the Pharmacy Law, the importer shall produce the bill of lading of the lot of medicinal materials and semi-finished medicinal material products indicating that the goods are exported from the port of departure of the country of exportation before the certificate of free sale expires.

g/ For import of medicinal materials and semi-finished medicinal material products under Articles 82 and 83 of this Decree, the papers specified at Points b, d, dd and e of this Clause are not required.

4. For customs clearance for import of drugs and drug materials that have no certificate of free sale in Vietnam, except medicinal materials:

a/ To produce the original or a certified copy and submit a copy bearing a certification seal of the importer of the certificate of eligibility for pharmaceutical trading in case of importer is a pharmaceutical trader;

b/ To submit a copy bearing a certification seal of the importer of the license to import drugs and drug materials and produce the original or a certified copy for comparison;

c/ To submit the original or a copy bearing a certification seal of the importer of the testing slip for each lot of imported drugs and drug materials in case drugs and drug materials are imported under Articles 65, 66, 69, 71, 72, 79, 80, 84, 85, 86 and Points a and c, Clause 1, Article 68 of this Decree; in case of submission of a copy, the original is required for comparison upon customs clearance;

d/ To submit certified copies of prescriptions and medical records for outpatient treatment bearing a signature of the person on entry or a copy bearing a seal of the importer with the quantity of imported drugs as follows:

Not exceeding the quantity needed to be used for a maximum of 7 days for habit-forming drugs or 10 days for psychotropic and precursor drugs according to the dosage stated in accompanying prescriptions;

Imported drugs that are not habit-forming drugs, psychotropic drugs or precursor drugs must have a total customs value of no more than USD 200 (two hundred) (according to the inter-bank foreign exchange rate at the time of customs clearance) for each time of import and one organization or person may only receive imported drugs for no more than 3 times a year. For drugs used for patients suffering diseases on the list of fatal diseases provided in the Government’s Decree No. 134/2016/ND-CP of September 1, 2016, detailing a number of articles of, and measures to implement, the Law on Import Duty and Export Duty, drugs must have a total customs value of no more than VND 10,000,000 (ten million) for each time of import and one person may only receive imported drugs for no more than 4 times a year.

In case of submission of a copy bearing a signature of the person on entry or a copy bearing the seal of the importer, such organization or person shall produce the original of his/her/its prescription and medical records for outpatient treatment for comparison upon customs clearance.

dd/ To submit a copy of the power of attorney or sale license or partnership relation certificate bearing a certification seal of the importer under Point dd, Clause 15, Article 91 of this Decree, except the case of import of drugs under Articles 67, 70 and 73, and Clause 1, Article 74, of this Decree, of primary packages of drugs, standard substances or drug materials permitted for import under Articles 82, 83 and 86 of this Decree, or of drug materials under special control imported for testing or research.

Chapter V

CIRCULATION REGISTRATION OF MEDICINAL MATERIALS, ADJUVANTS AND CAPSULE SHELLS AND ASSESSMENT OF FOREIGN DRUG MANUFACTURERS

Section 1

CIRCULATION REGISTRATION OF MEDICINAL MATERIALS, ADJUVANTS AND CAPSULE SHELLS

Article 93.Subjects and requirements of circulation registration of medicinal materials, adjuvants and capsule shells

1. In one of the following cases, a medicinal material shall be registered before being circulated in Vietnam:

a/ It is on the list of toxic medicinal materials;

b/ It is used as a drug for the first time in Vietnam;

c/ It can easily be confused with another medicinal material or counterfeited;

d/ It contains a pharmaceutical ingredient the quality of which can easily be affected in the course of manufacture, processing or circulation;

dd/ It is on the list of medicinal materials domestically planted or collected to meet the treatment demand and be supplied at a reasonable price;

e/ It is a semi-finished product, unless it has been manufactured by the manufacturer for manufacturing a finished product.

The Minister of Health shall specify the list of medicinal materials subject to circulation registration.

2. Medicinal materials not specified in Clause 1 of this Article are subject to standard declaration under Clause 2, Article 68 of the Pharmacy Law. Any establishment wishing to register medicinal materials for circulation shall comply with Section 1, Chapter V of this Decree.

3. Adjuvants used for manufacturing drugs with standards elaborated by their manufacturers and neither applying nor being included in the Pharmacopoeia of Vietnam, nor applying national standards or regulations on drugs or foreign pharmacopoeias in Vietnam under the Minister of Health’s regulations are subject to circulation registration, except those used for manufacturing drugs for which circulation registration is still valid in Vietnam. Any establishment wishing to register adjuvants for circulation shall comply with Section 1, Chapter V of this Decree.

4. Capsule shell used for manufacturing drugs are subject to circulation registration, except those used for manufacturing drugs for which circulation registration is still valid in Vietnam. Any establishment wishing to register capsule shells for circulation shall comply with Section 1, Chapter V of this Decree.

5. Establishments that may register in their names medicinal materials, adjuvants and capsule shells include:

a/ Establishments specified in Clause 3, Article 54 of the Pharmacy Law;

b/ Establishments specified at Point c, Clause 1, Article 35 of the Pharmacy Law, which may register in their names medicinal materials.

6. Forms of registration, and rights and responsibilities of establishments registering medicinal materials, adjuvants and capsule shells must comply with Articles 55 and 57 of the Pharmacy Law.

Article 94.Competence, dossiers, procedures and time limit for grant, extension, modification, supplementation and revocation of circulation registrations for medicinal materials, adjuvants and capsule shells

The competence, dossiers, procedures and time limit for grant, extension, modification, supplementation and revocation of circulation registrations for medicinal materials, adjuvants and capsule shells must comply with Articles 56 and 58 of the Pharmacy Law, except provisions on time limit for grant and the following provisions:

1. An establishment planting or collecting medicinal materials without a certificate of eligibility for pharmaceutical business shall submit a certified copy of its enterprise registration certificate upon submitting its dossier for medicinal material circulation registration.

2. The time limit for grant of a circulation registration for a medicinal material, an adjuvant or a capsule shell is 6 months from the date of receipt of a complete dossier.

Section 2

ASSESSMENT OF SATISFACTION OF GOOD MANUFACTURING PRACTICES BY FOREIGN DRUG AND DRUG MATERIAL MANUFACTURERS WHEN REGISTERING DRUG CIRCULATION IN VIETNAM

Article 95.Cases of submission of dossiers of request for assessment of foreign drug and drug material manufacturers when registering drug circulation in Vietnam

1. For a drug or drug material without circulation registration, upon submission of a dossier of application for a drug or drug material circulation registration, a foreign registering establishment shall submit a dossier of request for assessment of a manufacturer satisfying good manufacturing practices in the following cases:

a/ The establishment is a foreign manufacturer registering a drug for circulation for the first time in Vietnam;

b/ The drug is manufactured on a line not yet assessed by the Ministry of Health;

c/ The drug material is a pharmaceutical ingredient registered for circulation for the first time in Vietnam;

d/ The establishment is a foreign manufacturer registering a medicinal material for circulation for the first time in Vietnam.

2. For a drug or drug material with circulation registration granted before the effective date of this Decree, of which the manufacturer has not yet been assessed by the Ministry of Health, a registering establishment shall submit a dossier of request for assessment of a manufacturer satisfying good manufacturing practices when:

a/ Submitting a dossier of request for extension of its drug or drug material circulation registration under Clause 4, Article 55 of the Pharmacy Law;

b/ Submitting a dossier of application for drug or drug material circulation registration due to its relocation under Point b or c, Clause 2, Article 55 of the Pharmacy Law.

3. In case a drug or drug material is manufactured in different stages at different manufacturing establishments, the registering establishment shall submit a dossier of request for assessment of all establishments involved in the manufacture of such drug or drug material.

Article 96.Forms of assessment

1. Appraisal of dossiers related to satisfaction of the manufacturing conditions is applied to manufacturers not specified in Clause 2 and at Point b, Clause 3 of this Article.

2. Recognition of results of inspection and examination by the state management agency in charge of pharmacy of the requirements on satisfaction of good manufacturing practices is applied to:

a/ Manufacturers in the countries announced by the Ministry of Health in the list of countries with which Vietnam has concluded treaties on mutual recognition of results of inspection of good manufacturing practices, except the cases specified in Clause 3 of this Article;

b/ Manufacturers in the ICH member states and Australia that are inspected and assessed by the US Food and Drug Administration (USFDA), European Union, European Medicines Agency (EMA), Australia’s Therapeutic Goods Administration (TGA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) or Health Canada as having satisfied the good manufacturing practices, except the cases specified in Clause 3 of this Article.

3. Physical inspection at manufacturers is applied to:

a/ Manufacturers having a drug or drug material registration dossier showing signs of being tampered with or containing suspicious information and data;

b/ Manufacturers having drugs involved in level-1 quality violations as concluded by the Ministry of Health;

c/ Manufacturers having a dossier of request for assessment of satisfaction of the manufacturing conditions which is concluded by the Ministry of Health as having insufficient evidence of their satisfaction of good manufacturing practices.

Article 97.Contents of assessment of foreign manufacturers’ satisfaction of good manufacturing practices

1. Grounds for assessment:

a/ Standards of good drug and drug material manufacturing practices promulgated by the Ministry of Health;

b/ Current regulations on drug and drug material registration and quality management.

2. Contents of assessment in the form of appraisal of dossiers related to the satisfaction of the manufacturing conditions:

a/ Lawfulness of the certificate of good manufacturing practices, manufacturing license or report on inspection of good manufacturing practices;

b/ Conformity of the scope of certification stated in the certificate of good manufacturing practices or report on inspection of good manufacturing practices or manufacturing license with the form of preparation of the registered drugs or drug materials;

c/ Conformity of the conditions on workshops including arrangement of workshops and manufacturing line, building materials, manufacturing environment,  passageways of employees, materials, semi-finished products, finished products, equipment for manufacturing, testing and storing drugs or drug materials;

d/ Setting up and operation of the quality management system of the manufacturer;

dd/ Assessment by the pharmaceutical management agency of the host country or pharmaceutical management agencies of other countries, problems detected and preventive and remedial activities of the manufacturer.

3. Contents of assessment in the form of recognition or mutual recognition of results of inspection and examination of good manufacturing practices by foreign pharmaceutical management agencies:

a/ Lawfulness of the certificate of good manufacturing practices, manufacturing license or report on inspection of good manufacturing practices;

b/ Conformity of the scope of certification stated in the certificate of good manufacturing practices or report on inspection of good manufacturing practices or manufacturing license with the form of preparation of the registered drugs or drug materials.

4. Contents of assessment in the form of physical inspection at manufacturers:

a/ Lawfulness of the certificate of good manufacturing practices, manufacturing license or report on inspection of good manufacturing practices;

b/ Actual state of workshops, including arrangement of workshops and manufacturing lines, building materials, manufacturing environment, passageways of employees, materials, semi-finished products, finished products, equipment for manufacturing, testing and storing drugs or drug materials;

c/ Actual manufacturing process of the lines of manufacturing the registered drugs or drug materials;

d/ Setting up and operation of the quality management system of the manufacturer;

dd/ Actual state of the application and satisfaction of good manufacturing practices in all activities of manufacturing, testing and storing drugs or drug materials at the manufacturer.

Article 98.Dossiers of request for assessment of satisfaction of good manufacturing practices

1. For manufacturers of drugs or drug materials being pharmaceutical ingredients in the cases specified in Clause 2, Article 96 of this Decree, a dossier of request for assessment of a manufacturer must comprise:

a/ A certificate of good manufacturing practices or report on inspection of good manufacturing practices or manufacturing license containing sufficient information on the form of preparation of the drug or drug material granted by a competent agency of the host country;

b/ A general dossier of the manufacturer made according to the guidelines on general dossiers of manufacturers provided by the European Union (EU) or the Pharmaceutical Inspection Cooperation Scheme (PIC/S) or the World Health Organization.

2. For manufacturers of drugs or drug materials being pharmaceutical ingredients in the cases specified in Clauses 1 and 3, Article 96 of this Decree, a dossier of request for assessment of a manufacturer must comprise:

a/ A certificate of good manufacturing practices or report on inspection of good manufacturing practices or manufacturing license containing sufficient information on the form of preparation of the drug or drug material granted by a competent agency of the host country; a certificate of good manufacturing practices or report on inspection of good manufacturing practices granted by the pharmaceutical management agency of a member state of the European Union (EU) or the Pharmaceutical Inspection Cooperation Scheme (PIC/S);

b/ A general dossier of the manufacturer made according to the guidelines on general dossiers of manufacturers provided by the European Union (EU) or the Pharmaceutical Inspection Cooperation Scheme (PIC/S) or the World Health Organization;

c/ A list of inspections of goods manufacturing practices carried out by the pharmaceutical management agency of the host country or another country within 3 years from the date of submission of the dossier and the report on inspection of good manufacturing practices of the last inspection covering the registered drugs or drug materials or forms of preparation of the registered drugs;

d/ A list of drugs accompanied by their forms of preparation and drug materials already supplied or expected to be supplied into Vietnam;

dd/ An ex-workshop process of drugs or drug materials expected to be registered for circulation in Vietnam;

e/ A periodical quality review report with regard to sterile drugs or drug materials registered for circulation.

3. For manufacturers of drug materials being adjuvants or capsule shells, a dossier of request for assessment of a manufacturer must comprise:

a/ A certificate of good manufacturing practices or report on inspection of good manufacturing practices or manufacturing license containing sufficient information on manufacturing materials granted by a competent agency of the host country with regard to adjuvants or capsule shells;

b/ A quality handbook of the manufacturer, made under the guidelines in ISO/TR 10013:2001 or its updated version, or a general dossier of the manufacturer, made under the guidelines on general dossiers of manufacturers provided by the European Union (EU) or the Pharmaceutical Inspection Cooperation Scheme (PIC/S) or the World Health Organization;

c/ A manufacturer of drug materials being adjuvants or capsule shells in the case specified in Clause 2, Article 96 of this Decree shall submit only the paper specified at Point a of this Clause.

4. For manufacturers of drug materials being medicinal materials, a dossier of request for assessment of a manufacturer must comprise :

a/ A certificate of good manufacturing practices or report on inspection of good manufacturing practices;

b/ A quality handbook of the manufacturer, made under the guidelines in ISO/TR 10013:2001 or its updated version, or a general dossier of the manufacturer, made under the guidelines on general dossiers of manufacturers provided by the European Union (EU) or the Pharmaceutical Inspection Cooperation Scheme (PIC/S) or the World Health Organization;

c/ A list of medicinal materials already supplied or expected to be supplied into Vietnam;

d/ Documents and information on areas where medicinal materials already supplied or expected to be supplied into Vietnam are planted or collected;

dd/ A manufacturer of drug materials being medicinal materials in the case specified in Clause 2, Article 96 of this Decree shall submit only the papers specified at Points a, c and d of this Clause.

5. Requirements on dossiers of request for assessment of manufacturers satisfying good manufacturing practices:

a/ A dossier of request for assessment of a manufacturer shall be made in one set in English or Vietnamese, comprising documents clearly printed and arranged in the order specified in Clauses 1, 2, 3 and 4 of this Article, with dividers between them, covers and a checklist;

b/ A certificate of good manufacturing practices or report on inspection of good manufacturing practices specified in Clauses 1, 2, 3 and 4 of this Article, or a manufacturing license specified in Clauses 1, 2 and 3 of this Article must be the original or a certified copy which is still valid at the time of submission of the dossier. In case no validity duration is stated, such a paper must have been granted or made for no more than 3 years.

Article 99.Order, procedures and competence to receive dossiers and assess manufacturers

1. The Ministry of Health shall receive dossiers of request for assessment and organize the assessment of satisfaction of good manufacturing practices by foreign manufacturers; make an assessment report and notify assessment results within:

a/ Thirty days after receiving a complete dossier, for the case of assessment in the form of recognition of results of inspection and examination of satisfaction of good manufacturing practices by the state management agency in charge of pharmaceuticals;

b/ Sixty days after receiving a complete dossier, for the case of assessment in the form of appraisal of dossiers related to manufacturing conditions;

c/ Ninety days after receiving a complete dossier, for the case specified at Point b, Clause 3, Article 96 of this Decree, or from the date of notification of results of the appraisal of a drug registration dossier or dossier of request for assessment of a manufacturer satisfying good manufacturing practices and a plan on physical inspection and assessment at the manufacturer, for the cases specified at Points a and c, Clause 3, Article 96 of this Decree.

2. In case a manufacturer requests a change in the tentative plan on physical assessment, the time limit prescribed at Point c, Clause 1 of this Article shall be counted from the date of receipt of such request.

3. In case a certificate of good manufacturing practices or manufacturing license expires at the time of appraisal or a report on inspection of good manufacturing practices is made more than 3 years from the date of inspection or a general dossier of the manufacturer does not have sufficient contents as required, the Ministry of Health shall request in writing the manufacturer to supplement its dossier.

a/ A registering establishment shall submit its supplemented dossier within 90 days, for general dossiers of manufacturers; or within 6 months, for certificates of good manufacturing practices or manufacturing licenses or reports on inspection of good manufacturing practices;

b/ Within 30 days after receiving a supplemented dossier, the Ministry of Health shall notify assessment results.

4. Within 10 working days after obtaining assessment results, the Ministry of Health shall post information on manufacturers recognized or assessed on its portal.

Article 100.Responsibilities of foreign drug or drug material registrants for inspecting and assessing good manufacturing practices of foreign manufacturers and cases of suspension of receipt of dossiers for grant or extension of drug or drug material circulation registrations of drug or drug material registrants or manufacturers

1. Specific responsibilities of a drug or drug material registrant for inspecting and assessing good manufacturing practices of a foreign manufacturer:

a/ To submit a dossier of request for assessment of the manufacturer’s satisfaction of good manufacturing practices as prescribed;

b/ To ensure the adequacy and accuracy of documents in the dossier of request of assessment; to additionally provide evidencing documents at the request of the Ministry of Health;

c/ To coordinate with the manufacturer in fulfilling requirements set by the Ministry of Health regarding the inspection and assessment of the manufacturer;

d/ To provide the Ministry of Health with updated information on the state of satisfaction of good manufacturing practices by the manufacturer. In case the manufacturer has its manufacturing license revoked or fails to satisfy good drug or drug material manufacturing practices in the host country, it shall report such within 15 days after the competent management agency of the host country issues a notice;

dd/ To bear expenses for the assessment as prescribed by law.

2. The receipt of dossiers for grant or extension of drug or drug material circulation registrations shall be suspended when a drug or drug material registrant or manufacturer commits any of the following violations:

a/ Any of the violations subject to revocation of drug or drug material circulation registration specified at Points a, b, d and dd, Clause 1, Article 58 of the Pharmacy Law;

b/ Manufacturing drugs from materials of unclear origin or expired materials;

c/ Having at least 2 drug or drug material lots of level-2 inferior quality or at least 3 drug or drug material lots of inferior quality within 1 year as concluded by a competent state agency;

d/ Providing information relating to technical dossiers not obtained from any research or its actual manufacturing operation;

dd/ Failing to report to the Ministry of Health within 15 days after a competent management agency of the host country issues a notice that the manufacturer has its manufacturing license revoked or fails to satisfy good drug or drug material manufacturing practices;

e/ Changing the expiry date of drugs, except the case specified in Clause 3, Article 61 of the Pharmacy Law;

g/ Failing to report to the Ministry of Health within 15 days after a competent management agency issues a notice of recall of a drug or drug material registered by the registrant or of revocation of the circulation registration in any country in the world;

h/ Failing to update information on labels or use instruction sheets or to summarize product properties of drugs currently in circulation in Vietnam at the request of the Ministry of Health.

3. The suspension of receipt of dossiers for grant or extension of drug or drug material registrations from the date of issuance of a competent agency’s notice of violation may last:

a/ Between 3 and 5 years, for the cases specified at Point d, Clause 1, Article 58 of the Pharmacy Law;

b/ Between 1 year and 2 years, for the cases specified at Points a and dd, Clause 1, Article 58 of the Pharmacy Law, and Points b, c, d, dd and e, Clause 2 of this Article;

c/ Between 6 months and 1 year, for the cases specified at Point b, Clause 1, Article 58 of the Pharmacy Law and Points g and h, Clause 2 of this Article.

4. Dossiers for grant or extension of drug or drug material circulation registrations of establishments committing violations specified at Points a, b, c, d, dd and e, Clause 2 of this Article submitted before their violations are handled will become invalid. Upon the expiration of the duration of suspension of receipt of dossiers prescribed in Clause 3 of this Article, establishments wishing to register their drugs or drug materials shall submit their dossiers as prescribed in the Pharmacy Law.

Chapter VI

COMPETENCE, FORMS AND PROCEDURES FOR RECALLING DRUG MATERIALS, MEASURES TO HANDLE RECALLED DRUG MATERIALS

Article 101.Form and scope of recall of drug materials

1. Forms of recall:

a/ Compulsory recall, which is made under a decision of a competent state agency;

b/ Voluntary recall, which is made on a voluntary basis by an establishment that registers, manufactures or imports drug materials.

2. Scope of recall:

a/ All drug materials at their trading or manufacturing establishments shall be recalled, except the case specified at Point b of this Clause;

b/ For drug materials that fail to satisfy quality standards due to mistakes during the storage, transportation or distribution thereof or that are used for an improper purpose, only those that are affected at their trading or using establishment shall be recalled;

c/ The scope of recall shall be specified in the recall decision of the competent agency or in the recall notice of the registering, manufacturing or importing establishment that voluntarily recalls the materials.

Article 102.Competence and procedures for recalling drug materials

1. Competence to issue recall decisions:

a/ The Ministry of Health shall make conclusions on drug materials subject to recall and issue decisions to recall drug materials subject to compulsory recall;

b/ Establishments domestically manufacturing drug materials and establishments importing drug materials shall make conclusions on drug materials subject to recall and issue decisions to recall drug materials, for cases of voluntary recall.

2. Procedures for recalling drug materials:

a/ Within 48 hours after making a conclusion to recall drug materials, the Ministry of Health shall issue a decision to recall violating drug materials or the establishment referred to at Point b, Clause 1 of this Article shall issue a decision to recall violating drug materials and report it to the Ministry of Health. Such a recall decision shall be sent to the domestic drug material manufacturing establishment or drug material importing establishment and provincial-level Departments of Health, and, for cases of compulsory recall, posted on the Ministry of Health’s portal;

b/ Within 5 working days from the date of issuance of a recall decision, the domestic drug material manufacturing establishment or drug material importing establishment shall notify such recall to manufacturing and trading establishments that have bought the drug materials and concurrently organize the recall and receipt of drug materials returned by the manufacturing and trading establishments;

c/ The recall of drug materials shall be completed within 30 days from the date of issuance of the recall decision;

d/ Within 10 days after completing the recall, the establishment responsible for the recall shall send to the Ministry of Health a report on the recall result enclosed with copies of recall documents which are affixed with the seal of the establishment. Recall documents include those showing the quantity of manufactured or imported materials, quantity of recalled materials, date of manufacture or import, list of establishments that have bought the materials, and evidence of the recall at the trading or using establishments;

dd/ The Ministry of Health shall examine the report on the recall result and evaluate the recall or enforce the recall in case the domestic drug material manufacturing or drug material importing establishment fails to recall the materials under Point b or c of this Clause.

Article 103.Responsibility to recall drug materials

1. Responsibilities of the establishment that domestically manufactures or imports drug materials subject to recall:

a/ To conclude on drug materials subject to recall and issue decisions to recall drug materials, for cases of voluntary recall;

b/ To stop trading in drug materials that are recalled;

c/ To assume the prime responsibility for, and coordinate with related organizations and individuals in, announcing drug materials subject to recall and organize the recall and receipt thereof;

d/ To dispose of recalled drug materials;

dd/ To pay expenses for the recall and disposal of drug materials (including those subject to coercive recall) and damages in accordance with law;

e/ To report to the Ministry of Health on the recall of drug materials and its results.

2. Responsibilities of the establishment that distributes drug materials subject to recall:

a/ To stop trading in and distributing drug materials that are recalled;

b/ To announce and organize the recall and receipt of drug materials returned by manufacturing or using establishments;

c/ To return drug materials subject to recall to their supplier;

d/ To pay expenses for the recall and receipt of drug materials subject to recall (including those subject to coercive recall) and damages in accordance with law if it is at fault.

3. Responsibilities of the drug manufacturing establishment that uses drug materials subject to recall:

a/ To stop using drug materials that are recalled;

b/ To return drug materials subject to recall to their supplier.

4. Responsibilities of the Ministry of Health:

a/ To conclude on recall of drug materials and issue decisions to recall violating drug materials subject to compulsory recall;

b/ To examine recall reports and results and give opinions on proposals of manufacturing and trading establishments on disposal or reprocessing of recalled drug materials;

c/ To examine and supervise the recall of drug materials and handle violating establishments in accordance with law;

d/ To direct provincial-level Departments of Health in examining and supervising the recall of drug materials and handle violating establishments in their localities;

dd/ To decide on coercive recall in case domestic drug material manufacturing establishments or drug material importing establishments fail to recall their drug materials as requested;

e/ To announce information on recalled drug materials subject to destruction on its portal.

5. Responsibility of a provincial-level Department of Health:

a/ To notify information about recall of drug materials to manufacturing and trading establishments operating in its locality;

b/ To examine and supervise the recall of drug materials and handle violating establishments in its locality;

c/ To report to the Ministry of Health when detecting manufacturing or trading establishments that fail to recall or fully recall drug materials.

Article 104.Disposal of recalled drug materials

1. Recalled drug materials being medicinal materials and pharmaceutical ingredients shall be destroyed in the following cases:

a/ Recalled drug materials are manufactured not for human use but are labeled for human use;

b/ Recalled drug materials have their certificates of free sale granted based on forged documents;

c/ Recalled drug materials are of unclear origin;

d/ Pharmaceutical ingredients are manufactured, presented or labeled in the name of another manufacturer, country of manufacture or country of origin;

dd/ Fake medicinal materials;

e/ Medicinal materials have no certificate of free sale or whose quality standards are not announced as prescribed;

g/ Recalled drug materials are used for manufacturing drugs which are recommended by the World Health Organization to be unsafe and ineffective for their users.

2. Recalled drug materials may have their violations remedied and be reused in the following cases:

a/ Drug materials are recalled for failing to satisfy requirements on labeling of drugs and drug materials set out in Article 61 of the Pharmacy Law or other relevant laws;

b/ Drug materials are recalled because they are manufactured at a place other than that declared in the drug registration dossier but still by the establishment that has been licensed by a competent agency.

3. Drug materials, excluding psychotropics, habit-forming substances and precursors used as drugs, which are recalled in the cases not prescribed in Clauses 1 and 2 of this Article, may be re-processed, if they are domestically made, or re-exported, if they are imported, or used for another purpose according to the procedures prescribed in Clause 4 of this Article.

Recalled drug materials prescribed in this Clause shall be destroyed if they are not re-processed or re-exported or used for another purpose.

4. Procedures for remedying violations of, re-processing, re-exporting, or changing the use purpose of, drug materials:

a/ An establishment that has drug materials recalled and wishes to change the use purpose of, remedy violations of, re-process or re-export such drug materials shall send a written request specifying the new use purpose, remedial measure or re-processing process to the Ministry of Health;

b/ The remediation of violations, or re-processing or re-export of drug materials may be carried out only after it is so agreed in writing by the Ministry of Health;

c/ Within 3 months after receiving a written request of an establishment, the Ministry of Health shall issue a written reply. For re-export of imported drug materials, the Ministry of Health shall notify it to the competent authority of the country to which such drug materials will be exported for information and coordinated management.

5. Procedures for destroying drug materials:

a/ The head of the establishment that has drug materials to be destroyed shall issue a decision to form a council for destruction of drug materials, which shall be composed of at least 3 (three) members including the head and the person responsible for professional pharmacy activities of the establishment;

b/ The destruction of drug materials must ensure long-term safety for people and animals and not pollute the environment in accordance with the law on environmental protection;

c/ The establishment that trades in violating drug materials shall bear all expenses for the destruction thereof;

d/ The destruction of drug materials under special control must comply with the provisions of Article 48 of this Decree.

Chapter VII

DOSSIERS, ORDER, PROCEDURES AND COMPETENCE TO CERTIFY DRUG INFORMATION AND ADVERTISEMENT CONTENTS

Section 1

CERTIFICATION OF DRUG INFORMATION

Article 105.Forms of provision of drug information

Drug information for medicine practitioners shall be provided in the following forms:

1. By drug introducers.

2. Distribution of drug information documents.

3. Drug introduction workshops.

Article 106.Establishments undersigning dossiers of request for certification of drug information

1. Establishments that are eligible to undersign dossiers of request for certification of drug information include:

a/ Drug-registering establishments in Vietnam;

b/ Vietnam-based representative offices of foreign establishments registering drugs in Vietnam when authorized by these establishments;

c/ Vietnamese pharmaceutical business establishments when authorized by establishments referred to at Point a, Clause 1 of this Article;

d/ Vietnamese drug-importing establishments may provide drug information only in the form specified in Clause 3, Article 105 of this Decree for drugs imported by these establishments which have no certificates of free sale yet.

2. Drug-registering establishments, even when authorizing other establishments referred to at Point b or c, Clause 1 of this Article, and Vietnamese drug-importing establishments which undersign dossiers of request for certification of drug information shall assume responsibility for drug information.

Article 107.Cases of grant or re-grant of certificates of drug information and adjustment of certified drug information

1. Certificates of drug information shall be granted in the following cases:

a/ First-time application for certification of drug information;

b/ Certified drug information sees changes in drug-registering establishment, drug name, ingredients, concentration or content, form of preparation, indications, contraindications, dosage, usage on special users, and information relating to warnings and drug safety.

2. Certificates of drug information already granted under this Decree may be re-granted in one of the following cases:

a/ The certificate of drug information is lost or damaged;

b/ Information written on the certificate is incorrect due to the fault of the granting agency.

3.  Adjustment of certified drug information may be made in case of changes other than those specified at Point b, Clause 1 of this Article.

Article 108.Dossiers of application for certificates of drug information

1. A dossier of application for a certificate of drug information to be provided in the form prescribed in Clause 2, Article 105 of this Decree must comprise:

a/ An application for certification of drug information, made according to Form No. 01 in Appendix VI to this Decree;

b/ A specimen design of drug information;

c/ Samples of the drug’s label and use instruction sheet already approved by the Ministry of Health;

d/ Reference documents (if any) relating to the drug information requested for certification;

dd/ The certificate of free sale of the drug;

e/ The establishment license of the representative office of the foreign company in Vietnam, for foreign establishments requesting certification of drug information, or the certificate of eligibility for pharmaceutical business, for Vietnamese pharmaceutical business establishments requesting certification of drug information;

g/ A power of attorney issued by the drug-registering establishment to the establishment undersigning the dossier of application, for cases of authorized application.

2. A dossier of application for a certificate of drug information to be provided in the form prescribed in Clause 3, Article 105 of this Decree must comprise:

a/ An application for certification of drug information, made according to Form No. 02 in Appendix VI to this Decree;

b/ Drug information;

c/ Samples of the drug’s label and use instruction sheet already approved by the Ministry of Health;

d/ Reference documents (if any) relating to the drug information requested for certification;

dd/ The certificate of free sale or import license of the drug;

e/ The establishment license of the representative office of the foreign company in Vietnam, for foreign establishments requesting certification of drug information, or the certificate of eligibility for pharmaceutical business, for Vietnamese pharmaceutical business establishments requesting certification of drug information;

g/ A power of attorney issued by the drug-registering establishment to the establishment undersigning the dossier of application, for cases of authorized application;

h/ The program of the workshop to introduce the drug.

Article 109.Dossier of request for re-grant of certificates of drug information

1. A written request for re-grant of a certificate of drug information, made according to Form No. 03 in Appendix VI to this Decree.

2. The specimen design of drug information or drug information requested for re-certification.

3. The certificate of drug information containing incorrect information due to the mistake of the granting agency, for the case referred to at Point b, Clause 2, Article 107 of this Decree.

Article 110.Dossier of request for adjustment of certified drug information

1. A written request for adjustment of certified drug information, made according to Form No. 04 in Appendix VI to this Decree, specifying the contents to be adjusted and reasons for adjustment.

2. Documents justifying the adjustment.

Article 111.Requirements on documents in dossiers of application for or request for re-grant of certificates of drug information or adjustment of certified drug information

1. Documents specified at Points c and dd, Clause 1, and Points c and dd, Clause 2, Article 108 of this Decree are copies.

2. Documents specified at Points d and e, Clause 1, and Points d and e, Clause 2, Article 108, and in Clause 2, Article 110, of this Decree are copies affixed with the seal of the establishment requesting certification of drug information, for documents issued by the Ministry of Health, or are certified copies, for documents not issued by the Ministry of Health.

3. Documents specified at Point g, Clause 1, and Point g, Clause 2, Article 108 of this Decree are originals or certified copies.

4. Documents specified in Clause 3, Article 109 of this Decree are originals.

5. Documents specified at Point b, Clause 1, and Point b, Clause 2, Article 108, and in Clause 2, Article 109, of this Decree are originals, each having two originals.

6. A dossier of application for, or request for re-grant of, a certificate of drug information must comprise:

a/ One specimen design, for the dossier prescribed in Clause 1, Article 108 of this Decree, or 1 document on drug information contents, for the dossier prescribed in Clause 2, Article 108 of this Decree, for each drug;

b/ One specimen design, for the dossier prescribed in Clause 1, Article 108 of this Decree, or 1 drug information document, for the dossier prescribed in Clause 2, Article 108 of this Decree, for two or more drugs manufactured by the same manufacturer with the same active ingredient and route of administration but with different contents or forms of preparation.

7. Documents shall be printed on A4-size paper. Every document in a dossier must be affixed with the seal of the establishment requesting certification of drug information on adjoining edges of its pages.

Article 112.Provisions on method of writing drug information

1. Drug information must satisfy the following requirements:

a/ Containing full contents as prescribed at Point a, Clause 5, Article 76 of the Pharmacy Law; containing no information and images not directly related to the drug or drug usage and similar information and images prescribed in Article 126 of this Decree;

b/ Clearly specifying proof documents and information quoted therefrom. The quotation must present the information accurately without arbitrary inference or addition or omission that may cause misunderstanding about the safety and effectiveness of drugs;

c/ Being presented in Vietnamese, except information which cannot be translated into Vietnamese or which makes no sense in Vietnamese;

d/ Being presented in a conspicuous and readable size not small than 12-point size of VnTime or Times New Roman font on A4-size paper.

2. On the top of every page of drug information documents must be printed with the words “Drug information document”. A multiple-page document must be paginated, with the first page clearly indicating specific numbers of pages containing detailed information on the drug and the serial number of the certificate of drug information issued by the Ministry of Health: …/XNTT/… date… month… year.

3. For drugs introduced at workshops, drug information documents must also specify the name and academic title of the introducer who must possess a medicine or pharmacy qualification relevant to the introduced drug.

Article 113.Procedures for grant of certificates of drug information

1. An establishment requesting certification of drug information shall send a dossier to a competent agency defined in Article 116 of this Decree.

2. Within 15 days after receiving a complete dossier, the dossier-receiving agency shall issue a certificate according to Form No. 05 or 06 in Appendix VI to this Decree. If refusing to grant, the dossier-receiving agency shall issue a written reply clearly stating the reason.

3. If requesting any modifications and supplementations to the dossier, within 15 days after receiving it, the dossier-receiving agency shall make a written request for the establishment to modify and supplement the dossier as follows:

a/ The written request must specify the documents and details to be modified and/or supplemented;

b/ Within 15 days after receiving the modified and supplemented dossier as requested, the dossier-receiving agency shall issue a certificate according to Form No. 05 or 06 in  Appendix VI to this Decree. If refusing to grant, the dossier-receiving agency shall issue a written reply clearly stating the reason;

c/ Within 90 days after the dossier-receiving agency makes a written request for modification and supplementation, the establishment shall submit the modified and supplemented dossier as requested. Past this time limit, the submitted dossier will become invalid.

4. During the processing of a submitted dossier, the dossier-receiving agency may suspend the certification and notify in writing the reason for such suspension when detecting the information on safety and effectiveness in the drug’s use instruction sheet is improper or has not been updated with information as requested by competent state management agencies or according to technical documents and guidelines related to the drug issued or recognized by the Ministry of Health. The suspension period will end when the establishment re-submits updated or modified drug information in order to ensure safety for drug users.

5. At least 3 working days before introducing a drug in the form specified in Clause 3, Article 105 of this Decree, an establishment that has been granted a certificate of drug information shall issue a written notice of the time and venue of the introduction to the provincial-level Department of Health of the place where the drug will be introduced, enclosed with a copy of the approved certificate of drug information.

If there is any change in the time and venue of drug introduction already certified, the establishment shall notify it at least one working day in advance to the provincial-level Department of Health of the place where the drug will be introduced.

6. To suspend receipt of new dossiers and stop processing of submitted dossiers of an establishment requesting certification of drug information, including an establishment authorized under Point b or c, Clause 1, Article 106 of this Decree, when any of the following violations is committed:

a/ Tampering with and forging regulatory documents of competent state management agencies in dossiers of request for certification of drug information or advertisement;

b/ Disseminating information about or advertising a drug when the drug’s information or advertisement has not been certified by competent state agencies or not according to certified contents;

c/ Using a certificate not yet recognized by the Ministry of Health, using material benefits, abusing the names of organizations or individuals, or using logos, images, social status, reputation, correspondence, letters of thank to introduce or advertising a drug;

d/ Using clinical research results, pre-clinical research results, testing results, or bioequivalence trial results not yet recognized by the Ministry of Health for introducing or advertising a drug;

dd/ Disseminating information about or advertising a drug after making a change subject to certification of drug information or advertisement prescribed at Point b, Clause 1, Article 107, or Point b, Clause 1, Article 120, of this Decree.

7. The period of suspension of receipt of dossiers of request for certification of drug information or advertisement starting from the date of issuance by a competent state agency of a written notice of a violation is prescribed as follows:

a/ Between 1 year and 2 years, for violations prescribed at Point a, Clause 6 of this Article;

b/ Between 6 months and 12 months, for violations prescribed at Point b, c or d, Clause 6 of this Article;

c/ Between 3 and 6 months, for violations prescribed at Point dd, Clause 6 of this Article.

Article 114.Procedures for re-grant of certificates of drug information

1. An establishment requesting re-grant of a certificate of drug information shall submit a dossier to a competent agency as prescribed in Article 116 of this Decree.

2. Within 10 working days after receiving a complete dossier, the dossier-receiving agency shall re-grant a certificate according for Form No. 05 or 06 in Appendix VI to this Decree.

Article 115.Procedures for adjustment of certified drug information

1. An establishment requesting adjustment of certified drug information shall submit a dossier to a competent agency defined in Article 116 of this Decree.

2. Within 7 working days after receiving a written request for adjustment, if the dossier-receiving agency issues no reply, the requesting establishment may effect the adjustment. If disagreeing with the adjustment, the dossier-receiving agency shall issue a written reply clearly stating the reason.

Article 116.Competence to grant or re-grant certificates of drug information and adjust certified drug information

1. The Ministry of Health may grant or re-grant certificates of drug information and adjust certified drug information, for the form of provision of drug information prescribed in Clause 2, Article 105 of this Decree.

2. Provincial-level Departments of Health may grant or re-grant certificates of drug information and adjust certified drug information, for the form of provision of drug information prescribed in Clause 3, Article 105 of this Decree.

Article 117.Validity of certificates of drug information

1. Certificates of drug information are valid nationwide.

2. A certificate of drug information does not specify its expiration date but will expire in the following cases:

a/ The drug has its certificate of free sale or import license revoked;

b/ There is any change in information subject to re-grant of a certificate as prescribed at Point b, Clause 1, Article 107 of this Decree.

Section 2

CERTIFICATION OF DRUG ADVERTISEMENT CONTENTS

Article 118.Drug advertising media

Drugs may be advertised to the public in the media prescribed by the advertising law.

Article 119.Establishments undersigning dossiers of request for certification of drug advertisement contents

1. Establishments that may undersign dossiers of request for certification of drug advertisement contents include:

a/ Drug-registering establishments in Vietnam;

b/ Vietnam-based representative offices of foreign establishments registering drugs in Vietnam as authorized by the latter;

c/ Vietnamese pharmaceutical business establishments authorized by establishments referred to at Point a, Clause 1 of this Article.

2. Drug-registering establishments, even in case of authorizing establishments referred to at Point b or c, Clause 1 of this Article, undersigning dossiers of request for certification of drug advertisement contents shall take responsibility for advertisement contents.

Article 120.Cases of grant and re-grant of certificates of drug advertisement contents and adjustment of certified drug advertisement contents

1. Certificates of drug advertisement contents shall be granted in the following cases:

a/ First-time application for certification of drug advertisement contents;

b/ Certified drug advertisement contents see any changes in drug-registering establishment, drug name, ingredients, concentration or content, form of preparation, indications, contraindications, dosage, usage on special users, and information relating to drug warnings and safety.

2. Certificates of drug advertisement contents may be re-granted in the following cases:

a/ The certificate of drug advertisement contents is lost or damaged;

b/ Information written on the certificate is incorrect due to the fault of the granting agency.

3.  Adjustment of certified drug advertisement contents may be made with regard to changes in contents other than those specified at Point b, Clause 1 of this Article.

Article 121.Dossiers of application for certificates of drug advertisement contents

1. A dossier of application for a certificate of drug advertisement contents, except the case of drug advertisement through workshops or events, must comprise:

a/ An application for certification of drug advertisement contents, made according to Form No. 01 in Appendix VI to this Decree;

b/ A specimen design of the drug advertisement requested for certification; an audio or video recording of advertisement contents on radio or television or an electronic medium, specialized advertisement screens and other advertising media in accordance with the advertising law with sounds and moving images;

c/ Samples of the drug’s label and use instruction sheet already approved by the Ministry of Health;

d/ Reference documents (if any) relating to the drug advertisement contents requested for certification;

dd/ The certificate of free sale of the drug;

e/ The establishment license of the representative office of the foreign company in Vietnam, for foreign establishments requesting certification of drug advertisement contents, or the certificate of eligibility for pharmaceutical business, for Vietnamese pharmaceutical business establishments requesting certification of drug advertisement contents;

g/ A power of attorney issued by the establishment undersigning the dossier of application, for cases of authorized application.

2. A dossier of application for a certificate of drug advertisement contents through workshops or events must comprise:

a/ A written request for certification of drug advertisement contents, made according to Form No. 02 in Appendix VI to this Decree;

b/ Drug advertisement contents;

c/ Samples of the drug’s label and drug use instruction sheet already approved by the Ministry of Health;

d/ Reference documents (if any) relating to the drug advertisement contents requested for certification;

dd/ The certificate of free sale of the drug;

e/ The establishment license of the representative office of the foreign company in Vietnam, for foreign establishments requesting certification of drug advertisement contents, or the certificate of eligibility for pharmaceutical business, for Vietnamese pharmaceutical business establishments requesting certification of drug advertisement contents;

g/ A power of attorney issued by the drug-registering establishment to the establishment undersigning the dossier of request, for cases of authorized application;

h/ The tentative program of the workshop or event to introduce the drug.

Article 122.Dossier of request for re-grant of certificates of drug advertisement contents

1. A written request for re-grant of a certificate of drug advertisement contents, made according to Form No. 03 in Appendix VI to this Decree.

2. The specimen design, audio or video recording of drug advertisement contents, or drug advertisement contents requested for re-certification.

3. The certificate of drug advertisement contents containing incorrect information due to the mistake of the granting agency, for the case prescribed at Point b, Clause 2, Article 120 of this Decree.

Article 123.Dossier of request for adjustment of certified drug advertisement contents

1. A written request for adjustment of certified drug advertisement contents, made according to Form No. 04 in Appendix VI to this Decree, specifying the contents to be adjusted and reasons for adjustment.

2. Documents justifying the adjustment.

Article 124.Requirements on dossiers of application for, request for re-grant of certificates of drug advertisement contents, and adjustment of certified drug advertisement contents

1. Documents specified at Points c and dd, Clause 1, and Points c and dd, Clause 2, Article 121 of this Decree are copies.

2. Documents specified at Points d and e, Clause 1, and Points d and e, Clause 2, Article 121, and in Clause 2, Article 123, of this Decree are copies affixed with the seal of the establishment requesting certification of drug advertisement contents, for documents issued by the Ministry of Health, or are certified copies, for documents not issued by the Ministry of Health.

3. Documents specified at Point g, Clause 1, and Point g, Clause 2, Article 121 of this Decree are originals or certified copies.

4. Documents specified in Clause 3, Article 122 of this Decree are originals.

5. Documents specified at Point b, Clause 1, and Point b, Clause 2, Article 121, and in Clause 2, Article 122, of this Decree are originals, each having two originals.

6. A dossier of application for, or request for re-grant of, a certificate of drug advertisement contents must comprise:

a/ One specimen design or audio or video recording of drug advertisement contents, for the dossier prescribed in Clause 1, Article 121 of this Decree, or 1 document on drug advertisement contents, for the dossier prescribed in Clause 2, Article 121 of this Decree, for each drug;

b/ One specimen design or audio or video recording of drug advertisement contents, for the dossier prescribed in Clause 1, Article 121 of this Decree, or 1 document on drug advertisement contents, for the dossier prescribed in Clause 2, Article 121 of this Decree, for two or more drugs manufactured by the same manufacturer with the same active ingredient and route of administration but with different contents or forms of preparation.

7. Documents shall be printed on A4-size paper. For large-size outdoor advertisements, drug advertisement contents may be presented on A3-size paper and the proportion to the actual size shall be specified. Every document in a dossier must be affixed with a seal of the establishment requesting certification of drug advertisement contents on adjoining edges of its pages. If the content design of an advertising object has a spatial structure, the dossier must comprise a written description presented on A3-size paper of the following compulsory contents:

a/ Spatial structure;

b/ Serial numbers of dimensions and sizes;

c/ The proportion of the size of the specimen design to that of the actual object.

Article 125.Requirements on drug advertisement contents

1. Drug advertisement contents must conform with the following documents:

a/ The specimen label and drug use instruction sheet approved by the Ministry of Health;

b/ Specialized information on the drug written in the Vietnamese National Drug Formulary;

c/ Professional documents and instructions concerning the drug issued or recognized by the Ministry of Health.

2. Drug advertisement contents must include the following compulsory information:

a/ Drug name;

b/ Pharmaceutical ingredients or medicinal materials written in the approved use instruction sheet of the drug. For medicinal materials, their Vietnamese names shall be used; if the Vietnamese name is unavailable, the Latin name may be used;

c/ Indications;

d/ Usage;

dd/ Dosage;

e/ Contraindications or warnings for special users (pregnant women, breastfeeding women, children, elderly people and patients with chronic diseases);

g/ Cautions and recommendations when using the drug;

h/ Side effects and adverse reactions;

i/ Name and address of drug manufacturer;

k/ The phrase “Read instructions carefully before use”;

l/ At the bottom of the first page of drug advertisement contents must be printed with the serial number of the certificate of drug advertisement contents issued by the Ministry of Health: …/XNQC/… date… month… year;

m/ A multiple-page drug advertisement document must be paginated, with the first page clearly indicating the number of pages of the document and the pages containing detailed information on the drug;

n/ Drug advertisement contents must specify proof documents and information quoted therefrom. The quotation must accurately present the information without arbitrary inference or addition or omission that may cause misunderstanding about the safety and effectiveness of the drug.

3. Drug advertisements on radio or television must fully contain the information details specified at Points a, b, c, e, i and k, Clause 2 of this Article, with the details specified at Points a, b, c, e and k, Clause 2 of this Article clearly and loudly read out. For a drug containing 3 or more active ingredients, its advertisement must have the name of each active ingredient or the common names of vitamin, mineral and medicinal material groups read out.

4. Drug advertisements on e-newspapers, websites, electronic devices and specialized advertisement screens and other advertising media must comply with the advertising law:

a/ Audio advertisements must have their contents presented like advertisements on radio or television specified in Clause 3 of this Article;

b/ Silent advertisements must fully contain the information details specified in Clause 2 of this Article.

If an audio advertisement or a video advertisement consists of multiple pages or scenes, these pages or scenes must appear consecutively and pause for a sufficient time for viewers can read through all information shown; the pages or scenes showing information on the product must be still so that viewers can thoroughly read and well understand the product information. For advertisements with multiple pages, their scripts must describe the way of appearance of the content pages.

Drug advertisements in this form must be shown separately; advertisements of different drugs may not be shown in an overlapping or alternate manner at a time in order to avoid misunderstanding.

5. Drug advertisement contents of a single drug on an outdoor advertising medium shall be displayed on the same side of the medium and contain information details specified at Points a, b, i, k and l, Clause 2 of this Article. For advertisement contents on the uses, effects and indications of a drug, all information details specified in Clause 2 of this Article shall be displayed.

6. The spoken and written languages used in drug advertisements must comply with the Law on Advertising.

7.  Drug advertisements must be presented in a conspicuous, readable and noticeable size not small than 12-point size of VnTime or Times New Roman font on A4-size paper.

8. The script of an advertisement must clearly describe images, words to be read out, words to be displayed and music.

9. Drug advertisements must contain information about drugs only, but not any information irrelevant to drugs.

Article 126.Information and images banned from use in drug advertisements

1.  Information and images prescribed in the Law on Advertising.

2. Contents causing misunderstanding about ingredients, effects, indications and origin of drugs.

3. Contents that lead to an understanding that: This drug is number one; this drug is the best; using this drug is the best measure; use this drug without physician’s advice; this drug is totally harmless; this drug has no contraindication; this drug has no undesirable effect; or this drug has no harmful effect.

4. Sentences, words and images which are excessively deductive leading to a misunderstanding about or an overestimation of the approved effects, indications and efficacy of a drug.

5. The effect of each ingredient of the drug in order to over-advertise the uses of the drug or cause confusion between the effect of a single ingredient and the effect of the drug.

6. Words and phrases: “điềutrị tận gốc” (treat to the root), “tiệt trừ” (eliminate), “chuyên trị” (exclusively treat), “hàngđầu” (leading), “đầubảng” (top), “đầutay” (first), “lựa chọn” (selected), “chất lượng cao” (high quality), “đảmbảo 100%”(100% guaranteed), “an toàn” (safe), “dứt” (thoroughly), “cắtđứt” (thoroughly end), “chặnđứng” (stop), “giảm ngay”(promptly reduce), “giảm liền”, “giảm tức thì” (reduce at once), “khỏi ngay” (immediately relieve or recover), “khỏi hẳn” (completely relieve or recover), “yên tâm”(feel at ease), “không lo”(do not worry), “khỏi lo” (no longer worry), “khuyên dùng” (advise), “hotline”, “điệnthoại tư vấn” (call for counseling) and those with similar meanings.

7. Indications prohibited from inclusion in drug advertisements:

a/ Treatment of tuberculosis or leprosy;

b/ Treatment of sexually transmitted diseases;

c/ Treatment of insomnia;

d/ Indication of aphrodisiac nature;

dd/ Treatment of cancer or tumor;

e/ Treatment of drug addiction fits;

g/ Treatment of diabetes or similar metabolic disorders;

h/ Treatment of viral hepatitis or emerging dangerous diseases.

8. Results of quality tests of drugs and drug materials.

9. Results of pre-clinical researches.

10. Results of clinical researches or bioequivalence trials not yet recognized by the Ministry of Health.

11. Use of name, status, reputation, correspondence or letters of thank of organizations and individuals to advertise a drug.

12. Abuse of the origin of a drug or drug materials to advertise the drug.

13. Images, names and symbols of health workers.

14. Images of animals and plants on the list of endangered, precious and rare species prioritized for protection.

15. Sentences and words being pieces of advice passed down orally on use of a drug.

16. Images of patients to describe the pathological status or uses of a drug unsuitable to relevant documents of the drug and professional instructions issued or recognized by the Ministry of Health.

Article 127.Order and procedures for grant and re-grant of certificates of drug advertisement contents and adjustment of certified drug advertisement contents

1. An establishment applying for or requesting re-grant of a certificate of drug advertisement contents or adjustment of certified drug advertisement contents shall submit a dossier to the Ministry of Health.

2. The order and procedures for grant and re-grant of certificates of drug advertisement contents and adjustment of certified drug advertisement contents are similar to those prescribed in Articles 113, 114 and 115 of this Decree.

Article 128.Competence to grant or re-grant certificates of drug advertisement contents and adjust certified drug advertisement contents

The Ministry of Health shall grant or re-grant certificates of drug advertisement contents and adjust certified drug advertisement contents.

Article 129.Validity of certificates of drug advertisement contents

1. A certificate of drug advertisement contents does not specify its expiration date but will expire in the following cases:

a/ The certificate of free sale of the drug expires;

b/ The certificate of free sale of the drug is revoked;

c/ There is a change in information subject to grant of a certificate as prescribed at Point b, Clause 1, Article 120 of this Decree;

d/ There is a recommendation of a state management agency in charge of pharmaceutical ingredients on restricted use or use under physician’s supervision;

dd/ The drug contains an active ingredient or medicinal material which is removed from the list of non-prescription drugs issued by the Minister of Health.

2. In case a certificate of free sale of a drug is extended, the certificate of contents of advertisement of the drug will be automatically extended for the same extended period of the certificate of free sale.

Chapter VIII

MEASURES TO MANAGE DRUG PRICES

Section 1

DECLARATION OR RE-DECLARATION OF DRUG PRICES

Article 130.Dossiers of declaration or re-declaration of drug prices

1. A dossier of declaration of drug prices:

a/ A declaration of prices of foreign drugs imported into Vietnam, made according to Form No. 01 in Appendix VII to this Decree;

b/ A declaration of prices of domestically manufactured drugs, made according to Form No. 02 in Appendix VII to this Decree.

2. A dossier of re-declaration of drug prices:

a/ A re-declaration of prices of foreign drugs imported into Vietnam, made according to Form No. 03 in Appendix VII to this Decree;

b/ A re-declaration of prices of domestically manufactured drugs, made according to Form No. 04 in Appendix VII to this Decree.

3. A dossier of declaration of drug prices for cases of change of certificates of free sale must comply with Clause 1 of this Article.

4. A dossier of request for addition or change of announced information of a drug whose price has been declared or re-declared in case this price does not change (except the case specified in Clause 3 of this Article):

a/ A written request for change or addition of announced information of drugs whose prices have been declared or re-declared, made according to Form No. 05 in Appendix VII to this Decree;

b/ A copy of the document already approved by a competent state management agency on the changed information of the drug.

5. A dossier shall be made in 2 sets, one to be sent to the Ministry of Health or to the provincial-level People’s Committee for re-declaration of domestically manufactured drugs, and the other to be filed at the requesting establishment.

6. The declared or re-declared price of a drug shall be set in Vietnam dong, inclusive of value-added tax, and per smallest packaging unit. For an imported drug, the declaration or re-declaration of its price must provide the exchange rate used for converting the used foreign currency into Vietnam dong at the time of price declaration or re-declaration. Such exchange rate is the one actually used by the drug business establishment for making payments to the bank from which it borrows or buys the foreign currency; for a drug business establishment that has not yet made any payment to the bank, the selling rate applied by the commercial bank from which it borrows or buys the foreign currency at the time of calculation of drug prices shall be provided.

Article 131.Order, procedures and competence to receive dossiers of declaration or re-declaration of drug prices, change and addition of information of drugs whose prices have been declared or re-declared and to examine and announce declared or re-declared drug prices

1. For foreign drugs imported into Vietnam:

a/ Drug-importing establishments shall declare tentative wholesale prices and retail prices (if wishing to declare retail prices) before putting the first lot of drugs they have imported into circulation on the Vietnamese market. For subsequent imported lots, no declaration is required if the declared tentative wholesale and retail prices do not change;

b/ Drug-importing establishments shall re-declare tentative wholesale prices and retail prices when they wish to increase such prices after they have been declared or re-declared and announced on the Ministry of Health’s portal;

c/ When there is any change in the certificate of free sale and before putting the first lot of drugs into circulation on the Vietnamese market, an establishment shall submit a dossier of declaration of drug prices;

d/ In the course of business, a drug-importing establishment that wishes to reduce tentative wholesale prices and retail prices already declared or re-declared shall re-declare the reduced prices.

2. For domestically manufactured drugs:

a/ Drug-manufacturing establishments or drug processing-ordering establishments (for drugs manufactured under processing contracts) shall declare tentative wholesale prices and retail prices (if wishing to declare retail prices) before putting the first lot of drugs into circulation on the Vietnamese market. For subsequent lots, no declaration is required if the declared tentative wholesale and retail prices do not change;

b/ Drug-manufacturing establishments or drug processing-ordering establishments (for drugs manufactured under processing contracts) shall re-declare tentative wholesale prices and retail prices when they wish to increase such prices after they have been declared or re-declared and announced on the Ministry of Health’s portal;

c/ When there is any change in the certificate of free sale and before putting the first lot of drugs into circulation on the Vietnamese market, an establishment shall submit a dossier of declaration of drug prices;

d/ In the course of business, a drug-manufacturing establishment or drug processing-ordering establishment (for drugs manufactured under processing contracts) that wishes to reduce tentative wholesale prices and retail prices already declared or re-declared shall re-declare the reduced prices.

3. Competence to receive dossiers of declaration or re-declaration of drug prices:

a/ The Ministry of Health shall receive and examine dossiers of declaration or re-declaration of prices of foreign drugs imported into Vietnam; dossiers of declaration of prices of domestically manufactured drugs; and dossiers of request for addition or change of information of drugs whose prices have been declared or re-declared;

b/ Provincial-level People’s Committees shall receive and examine dossiers of re-declaration of prices of domestically manufactured drugs of establishments whose manufacturing facilities are located in their provinces or cities.

4. Receipt, examination and announcement of declared or re-declared drug prices:

a/ Drug-importing establishments, drug-manufacturing establishments or drug processing-ordering establishments (for drugs manufactured under processing contracts) shall submit dossiers as prescribed in Clauses 1, 2, 3 and 4, Article 130 of this Decree to competent state management agencies defined in Clause 3 of this Article;

b/ State management agencies competent to receive dossiers of declaration or re-declaration of drug prices shall issue receipt slips of dossiers of declaration or re-declaration of drug prices or dossiers of request for addition or change of information of drugs whose prices have been declared or re-declared, made according to Form No. 06 of Appendix VII to this Decree, if the Ministry of Health receives the dossiers, or according to Form No. 07 of Appendix VII to this Decree, if provincial-level People’s Committees  receive the dossiers, to the dossier-submitting establishments upon receiving complete dossiers;

c/ Within 45 days for cases of declaration of drug prices; 30 days for cases of re-declaration of prices of imported drugs; or 15 days for cases of request for addition or change of information of drugs whose prices have been declared or re-declared, from the date of receiving complete dossiers as prescribed, the Ministry of Health shall examine and announce declared or re-declared drug prices, and added or changed information of drugs on its portal if such declared or re-declared prices are reasonable or dossiers of request for addition or change of information of drugs comply with regulations. If a declared or re-declared drug price is unreasonable or a dossier of request for addition or change of information of drugs does not comply with regulations, within the time limit prescribed at this Point, the Ministry of Health shall send a written notice stating the reason to the price-declaring establishment for re-considering the declared or re-declared price or modifying or supplementing the dossier;

d/ For dossiers of re-declaration of prices of domestically manufactured drugs, within 25 days from the date of receiving complete dossiers as prescribed, provincial-level People’s Committees shall examine  and report on drugs whose prices are re-declared to the Ministry of Health, if such re-declared prices are reasonable, according to Form No. 08 of Appendix VII to this Decree. If a declared or re-declared price is unreasonable, within the time limit prescribed at this Point, a provincial-level People’s Committee shall issue a written notice stating the reason to the price-declaring establishment for re-considering the declared or re-declared price;

Within 5 working days after receiving a report from a provincial-level People’s Committee, the Ministry of Health shall summarize it and announce relevant information on its portal.

dd/ Within 6 months from the date the competent state management agency issues written opinions on declared or re-declared prices or requests any modification and supplementation, the declaring establishment shall give a written reply enclosed with relevant documents explaining the reasonability of declared prices, or adjust declared or re-declared prices to reasonable levels, or clarify modified and supplemented contents. After that time limit, if the declaring establishment issues no written reply, its dossier will become invalid;

e/ For dossiers of declaration or re-declaration of prices of foreign drugs imported into Vietnam, within 25 days after receiving a written reply from the declaring establishment, if the establishment manages to explain or prove that the declared prices are reasonable or adjusts the prices to reasonable levels, the Ministry of Health shall examine and announce declared or re-declared drug prices on its portal. If the establishment fails to explain or prove that the declared or re-declared prices are reasonable or adjust the prices to reasonable levels, within the time limit prescribed at this Point, the Ministry of Health shall issue a written notice stating the reason to the establishment for re-considering the declared or re-declared prices;

g/ For dossiers of re-declaration of prices of domestically manufactured drugs, within 20 days after receiving a written reply from the declaring establishment, if the establishment manages to explain or prove that the declared prices are reasonable or adjusts the prices to reasonable levels, a provincial-level People’s Committee shall examine and report to the Ministry of Health on re-declared prices according to Form No. 08 in Appendix VII to this Decree. If the declared or re-declared prices are unreasonable, within the time limit prescribed at this Point, the provincial-level People’s Committee shall issue a written notice stating the reason to the establishment for re-considering the declared or re-declared prices.

Within 5 working days after receiving a report from a provincial-level People’s Committee, the Ministry of Health shall summarize it and announce relevant information on its portal.

Article 132.Responsibilities of state management agencies in charge of drug prices in the implementation of regulations on declaration and re-declaration of drug prices

1. During the examination and control of drug prices, if detecting that the declared or re-declared price which has been announced is unreasonable at the time of examination, a competent state management agency prescribed in Clause 3, Article 131 of this Decree shall issue a written notice stating the reason for the price-declaring establishment to re-consider the declared or re-declared price.

2. During the examination and control of drug prices, if state management agencies in charge of drug prices and competent persons detect a drug trading establishment that violates regulations on management of drug prices, they may handle the establishment or report the violations to a competent agency for handling in accordance with law in the following cases:

a/ Failing to declare or re-declare or to fully declare drug prices under regulations;

b/ Failing to re-consider and adjust declared prices after receiving written opinions of a state management agency in charge of drug prices;

c/ Selling drugs at prices higher than their declared or re-declared prices which remain effective.

3. For pharmaceutical business establishments which have committed violations two or more times or have two or more violative drugs within 1 year, state management agencies in charge of drug prices shall consider applying the following measures:

a/ Suspending receipt of dossiers of request for certification of drug information or advertisement contents;

b/ Suspending receipt of dossiers of request for permission to import drugs without certificates of free sale in Vietnam;

c/ Suspend receipt of dossiers of application for, or request for extension of, certificates of free sale of drugs or drug materials.

4. The suspension of receipt of dossiers prescribed in Clause 3 of this Article may last between 3 and 12 months from the date a competent agency issues a written notice of violations.

Article 133.Responsibilities of trading establishments in the implementation of regulations on declaration and re-declaration of drug prices

1. Pharmaceutical business establishments shall fully comply with regulations on declaration and re-declaration of drug prices and other regulations on management of drug prices in this Decree and relevant laws, and take responsibility before law for their declared or re-declared prices and the accuracy of data, reports and information they provide.

2. Pharmaceutical business establishments may not sell drugs which have no prices declared or re-declared by establishments manufacturing, ordering the processing of, or importing these drugs and announced on the Ministry of Health’s portal.

3. Pharmaceutical business establishments may not wholesale or retail drugs at prices higher than their prices announced on the Ministry of Health’s portal which are declared or re-declared by establishments manufacturing, ordering the processing of, or importing these drugs.

4. In case a competent state management agency issues a written notice to a pharmaceutical business establishment for re-considering the price of a drug declared or re-declared by the latter and announced on the Ministry of Health’s portal, within 60 days after receiving the notice, the establishment shall give a written reply enclosed with relevant documents explaining the reasonability of the declared price or adjust declared or re-declared price to a reasonable level. After this time limit, if the establishment issues no written reply, the declared or re-declared price announced on the Ministry of Health’s portal will become invalid and be removed from the portal.

Article 134.Principles of examination and announcement of declared or re-declared prices

1. The examination and determination of reasonability of drug prices declared or re-declared by drug trading establishments shall be based on the following factors:

a/ The domestic market prices of similar drugs with the same technical specifications or prices of similar drugs in other countries in case such similar drugs are unavailable on the domestic market;

In case the declared price of a drug is higher than the domestic price of similar drugs with the same technical specifications or the average price of similar drugs in other countries, a competent agency shall consider and examine such declared price on the basis of documents supplied by the declaring establishment proving the efficacy of the drug, comparison in terms of the efficacy and cost of the drug, the manufacturing technology and techniques and explaining the price structure of the drug, using Forms No. 09 and 10 in Appendix VII to this Decree, and other relevant documents explaining the reasonability of the declared price.

b/ Fluctuations in the input factors such as materials, fuel, exchange rate, wage and other related costs in case of increasing the price of a drug. A competent agency shall consider and examine the re-declared price of a drug on the basis of documents supplied by the declaring establishment on the input factors such as materials, fuel, exchange rate, labor cost and other related costs to explain the increase of the price and the proposed increase rate, which must not be higher than the fluctuation rate of the input costs;

c/ The import price or total cost prices of the drug;

d/ The supply-demand relationship on the market, competitiveness and factors of drug quality, drug with bioequivalence proof and other factors affecting the price of the drug and the assurance of the supply of the drug.

2. The reasonable declared price of a drug shall be posted on the Ministry of Health’s portal when conforming with the following principles:

a/ Being not higher than the declared price of this drug or another drug with a different trade name but with the same active ingredient, concentration or content and form of preparation of the same manufacturer already posted on the Ministry of Health’s portal;

b/ Being not higher than the highest declared price with the same active ingredient, concentration or content and form of preparation and in the same group of technical specifications within the last three years already posted on the Ministry of Health’s portal, taking into account the price inflation rate announced by the General Statistics Office since the price declaration or re-declaration of the drug with the highest price;

c/ For a drug which has no drug of the same type with the same active ingredient, concentration, content and form of preparation on the Vietnamese market, its declared import price or wholesale price must not be higher than the average import price or wholesale price in the ASEAN countries in which the drug is imported and sold;

d/ The declared price of a foreign drug imported into Vietnam must be the actual import price written on the customs declaration at the time of declaration.

3. The declared increased price of a drug shall be announced if it complies with the provisions of Points b and d, Clause 1 of this Article. The declared reduced price of a drug shall be considered and posted on the Ministry of Health’s portal.

4. In case the declared or re-declared price of a drug is unreasonable and has not yet been posted on the Ministry of Health’s portal and the declaring or re-declaring establishment provides written explanations, the examination and posting of such price must comply with the following principles:

a/ If the declaring or re-declaring establishment adjusts the price to a level conformable with the provisions of Clause 2 of this Article, it shall be posted on the Ministry of Health’s portal;

b/ If the declaring or re-declaring establishment provides written explanations for the declared or re-declared price which is not conformable with the provisions of Clause 2 of this Article, such price shall be appraised on the basis of the documents provided by the establishment and its explanations prescribed in Clause 1 of this Article; if such price is reasonable, it shall be posted on the Ministry of Health’s portal.

5. The state management agency in charge of drug prices shall establish a team of drug price experts to examine the reasonability of a dug price declaration or re-declaration dossier.

6. The Minister of Health shall establish an interdisciplinary council for drug prices, composed of representatives of the Ministry of Health, Ministry of Finance, Vietnam Social Security and related agencies and units to give advice to the Minister of Health on the examination of drug prices and decision on the reasonability of declared or re-declared prices of drugs in the following cases:

a/ The drug with the declared price has a concentration or content different from that of the drugs already posted on the portal of the Ministry of Health;

b/ The drug has a form of preparation different from that of the drugs already posted on the portal of the Ministry of Health and a price higher than the highest price of the drug with the same active ingredient, concentration or content and the same technical standards within the last 3 years already posted on the portal of the Ministry of Health;

c/ New drugs;

d/ Drugs on the list of drugs subject to price negotiation, brand name specifics, drugs manufactured on chains satisfying EU-GMP or PIC/S-GMP standards at manufacturing establishments in an ICH member country or Australia or drugs manufactured on chains satisfying WHO-GMP standards which have certificates granted by the Vietnamese Ministry of Health and sale licenses issued by competent national authorities in an ICH member country or Australia, of which the re-declared prices see an increase of:

- Over 10%, for drugs whose price per smallest packaging unit is between over VND 5,000 (five thousand) and VND 100,000 (one hundred thousand).

- Over 7%, for drugs whose price per smallest packaging unit is between over VND 100,000 (one hundred thousand) and VND 1,000,000 (one million).

- Over 5%, for drugs whose price per smallest packaging unit is over VND 1,000,000 (one million).

7. The Minister of Health shall regulate in detail the organization and operation of the interdisciplinary council for drug prices.

Section 2

DISPLAY OF DRUG PRICES, PROVISIONS ON RETAIL MARGINS OF DRUG RETAILLING ESTABLISHMENTS LOCATED WITHIN MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 135.Display of drug prices

1. Responsibility to display drug prices:

a/ Drug wholesaling establishments shall display wholesale prices of drugs at their transaction places or drug sale places;

b/ Drug retailing establishments shall display retail prices of drugs at their establishments;

c/ Drug wholesaling and retailing establishments may not sell drugs at prices higher than displayed ones.

2. Requirements on display of drug prices:

a/ Wholesale prices shall be displayed on boards or paper or in other appropriate forms easy to be seen by customers and competent state agencies;

b/ Retail prices shall be printed or written on or affixed to direct or external packages of drugs or displayed on boards, paper or in other appropriate forms easy to be seen by customers and competent state agencies, without hiding compulsory drug labels;

c/ Prices shall be displayed in Vietnam dong;

d/ Displayed prices are inclusive of tax, charge and fee (if any).

Article 136.Provisions on retail margins of drug retailing establishments located within medical examination and treatment establishments

1. The retail price of a drug of a drug retailing establishment is the invoiced buying price plus a retail margin calculated by multiplying the retail margin rate by the buying price. Specifically:

Retail price = Buying price + Retail margin rate (%) x Buying price.

2. Drug retailing establishments located within medical examination and treatment establishments may only buy drugs procured through bidding by their medical examination and treatment establishments and drugs procured through bidding announced on the Ministry of Health’s portal within 12 months before the time of buying the drugs at the prices prescribed below:

a/ Not higher than the prices of drugs procured through bidding at the same point of time, for drugs on the list of drugs procured through bidding by the medical examination and treatment establishment;

b/ Not higher than the prices of drugs procured through bidding announced on the Ministry of Health’s portal within 12 months before the time of buying the drugs, for drugs outside the list of drugs procured through bidding by the medical examination and treatment establishment.

3. The retail margin rate for a drug retailing establishment located within a medical examination and treatment establishment must not higher than the maximum retail margin rate below:

a/ 15%, for drugs with buying prices of VND 1,000 (one thousand) or lower per smallest packaging unit;

b/ 10%, for drugs with buying prices of between VND 1,000 (one thousand) and VND 5,000 (five thousand) per smallest packaging unit;

c/ 7%, for drugs with buying prices of between VND 5,000 (five thousand) and VND 100,000 (one hundred thousand) per smallest packaging unit;

d/ 5%, for drugs with buying prices of between VND 100,000 (one hundred thousand) and VND 1,000,000 (one million) per smallest packaging unit;

dd/ 2%, for drugs with buying prices of over VND 1,000,000 (one million) per smallest packaging unit.

4. The smallest packaging unit used for calculating retail margin is prescribed below:

a/ Tablet, for the form of preparation being tablet;

b/ Ampoule, bottle, sachet or pre-filled syringe, for the form of preparation being liquid;

c/ Ampoule, bottle, sachet or pre-filled syringe, for the form of preparation being powder for solution for injection;

d/ Pack, bottle or sachet, for the form of preparation being powder or granules for solution for oral administration;

dd/ Bottle or tube, for the form of preparation being cream, ointment and gel for external use;

e/ Plaster pad, for the form of preparation being adhesive plaster;

g/ Spray bottle or bottle used for aerosol machines, for the form of preparation being spray or aerosol;

h/ Kit, for the form of preparation being kit.

Section 3

BIDDING TO PROCURE DRUGS, DRUG PRICE NEGOTIATION AND DRUG PRICE STABILIZATION MEASURES

Article 137.Bidding to procure drugs

1. Bidding to procure drugs with state funds, health insurance fund, revenues from medical examination and treatment services and funds from other lawful sources of public healthcare establishments must comply with the bidding law and the principles prescribed in Clause 4, Article 7, and Clause 6, Article 107, of the Pharmacy Law.

2. Criteria for determining reasonable prices as the basis for promulgation of the list of medicinal materials which are farmed and harvested in the country and satisfying treatment and supply and reasonable price requirements:

a/ Winning prices at bidding and actual selling prices on the markets of domestic and imported medicinal materials;

b/ Priority shall be given to medicinal materials satisfying the following technical criteria: being farmed and harvested in the country and satisfying good agricultural and collection practices; being locally manufactured at establishments satisfying good manufacturing practices for traditional drugs and drugs from medicinal materials; and being locally manufactured with clearly identified active ingredients and their concentration or content.

3. The Minister of Health shall issue detailed guidance on the bidding of drugs specified in Clauses 1 and 2 of this Article; announce the list of brand name specifics; and prescribe the purchase of brand name specifics not on the list of drugs and medicinal materials eligible to price negotiation referred to in Article 138 of this Decree in the form of selection of contractors in accordance with the bidding law.

Article 138.Lists of drugs and medicinal materials eligible for price negotiation

The Minister of Health shall issue the list of drugs and medicinal materials eligible for price negotiation as prescribed in Clause 6, Article 107 of the Pharmacy Law on the basis of the proposal of the National Advisory Council for Drug Bidding.

Article 139.Stabilization of drug prices

Cases of stabilization of drug prices, measures to stabilize drug prices and competence and responsibility to decide to apply, and organize the implementation of, drug price stabilization measures must comply with the Law on Price and its guiding documents.

Chapter IX

IMPLEMENTATION PROVISIONS

Article 140.Roadmap for satisfaction of the requirement on pharmacy practice certificate

1.  No later than January 1, 2019, persons responsible for professional pharmacy activities and persons in charge of drug quality assurance of establishments manufacturing pharmaceutical ingredients, except sterile pharmaceutical ingredients, must have pharmacy practice certificates. No later than January 1, 2021, persons responsible for professional pharmacy activities and persons in charge of drug quality assurance of establishments manufacturing adjuvants or capsule shells and establishments manufacturing and processing medicinal materials and traditional drugs must have pharmacy practice certificates.

2. No later than July 1, 2018, persons in charge of quality assurance of establishments manufacturing pharmacochemical drugs, drugs from medicinal materials and traditional drugs, except establishments manufacturing traditional medicaments, vaccines or biological products must have pharmacy practice certificates.

3. No later than January 1, 2021, persons in charge of clinical pharmacy of hospitals prescribed in Clause 3, Article 116 of the Pharmacy Law must have pharmacy practice certificates.

4. Since the effective date of this Decree, persons responsible for professional pharmacy activities of pharmaceutical business establishments and persons in charge of drug quality assurance of establishments manufacturing drugs or drug materials must have practice certificates, except the cases prescribed in Clauses 1 and 2 of this Article.

5. Persons responsible for professional pharmacy activities of pharmaceutical business establishments and owners of drug retailing establishments which have been granted certificates of eligibility for pharmaceutical business under Law No. 34/2005/QH11 on Pharmacy may continue working as persons responsible for professional pharmacy activities of pharmaceutical business establishments.

Article 141.Roadmap for application of good practices at pharmaceutical business establishments

1. Since the effective date of this Decree, establishments manufacturing pharmacochemical drugs, drugs from medicinal materials, vaccines or biological products, importing and exporting establishments, wholesaling establishments, retailing establishments that are drugstores or dispensaries, establishments providing the testing service, establishments providing the storage service, establishments providing the bioequivalence trial service, establishments providing the clinical drug trial service and establishments manufacturing drug materials being sterile pharmaceutical ingredients shall apply good practices required for their respective operations, except the cases prescribed in Clauses 2 and 5 of this Article.

2. No later than January 1, 2019, establishments manufacturing drug materials being pharmaceutical ingredients, except sterile pharmaceutical ingredients, prescribed in Clause 1 of this Article, shall apply good manufacturing practices.

3. Since the effective date of this Decree, retailing establishments that are drug cabinets, when applying for a certificate of eligibility for pharmaceutical business, shall apply good retail practices required for their respective operations.

No later than July 1, 2019, retailing establishments that are drug cabinets which have their certificates of eligibility for pharmaceutical business granted before the effective date of this Decree shall apply good retail practices required for their respective operations. Before this deadline, these establishments shall fully maintain the business conditions for which they have been granted these certificates.

4. Since the effective date of this Decree, establishments manufacturing traditional drugs, when applying for a certificate of eligibility for pharmaceutical business, shall apply good practices of manufacturing traditional drugs, except establishments manufacturing traditional medicaments.

No later than July 1, 2019, establishments manufacturing oriental medicaments which have their certificates of eligibility for pharmaceutical business granted before the effective date of this Decree shall apply good practices of manufacturing traditional drugs. Before this deadline, these establishments shall fully maintain the business conditions for which they have been granted these certificates.

5. No later than January 1, 2021, establishments manufacturing adjuvants and capsule shells and establishments manufacturing or processing medicinal materials or traditional medicaments shall apply good drug or drug material manufacturing practices corresponding to their respective products.

Article 142.Roadmap for application of good practices at establishments engaged in pharmacy activities for non-commercial purpose

1. Since the effective date of this Decree, establishments currently engaged in pharmacy activities for non-commercial purpose referred to at Point a, Clause 1, Article 35 of the Pharmacy Law but failing to fully apply good practices may only carry out these activities within the scope suitable to the level of good practices they are applying, and shall apply good practices corresponding to their scope of operation according to the following roadmap:

a/ No later than July 1, 2019, establishments storing, stockpiling and supplying vaccines shall fully apply good practices corresponding to their scope of operation;

b/ No later than January 1, 2021, establishments engaged in pharmacy activities for non-commercial purpose, except the case prescribed at Point a of this Clause, shall fully apply good practices corresponding to their scope of operation.

2. Since the effective date of this Decree, establishments that are engaged in pharmacy activities for non-commercial purpose referred to at Point a, Clause 1, Article 35 of the Pharmacy Law for the first time or that expand the scope of their pharmacy activities shall apply good practices required for their respective operations.

Article 143.Transitional articles and clauses

1. Dossiers for implementing administrative procedures prescribed in Pharmacy Law No. 34/2005/QH11 and relevant guiding documents outside the cases prescribed in Clause 2, Article 115 of Pharmacy Law No. 105/2016/QH13 and submitted before the effective date of this Decree shall be compiled in accordance with Pharmacy Law No. 34/2005/QH11 and relevant guiding documents, unless establishments wish to apply the provisions of Pharmacy Law No. 105/2016/QH13.

2. No later than July 1, 2018, when submitting dossiers of request for extension of certificates of free sale of imported drugs, establishments that have registered such drugs shall submit dossiers of request for assessment of establishments satisfying good manufacturing practice standards.

3. Import or export licenses for drugs and drug materials and import and export orders for drugs and drug materials granted under Pharmacy Law No. 34/2005/QH11 and relevant guiding documents may be used until they expire.

For drugs and drug materials referred to in this Clause that are imported into or exported from Vietnam and cleared from customs procedures before January 1, 2018, their customs clearance dossiers shall be compiled in accordance with either Pharmacy Law No. 34/2005/QH11 and relevant guiding documents or this Decree since its effective date.

4.  For drugs and drug materials which are granted circulation registration numbers or announced before the effective date of this Decree and imported into Vietnam and cleared from customs procedures before January 1, 2018, their customs clearance dossiers shall be compiled either in accordance with Pharmacy Law No. 34/2005/QH11 and relevant guiding documents or this Decree since its effective date.

5. For establishments trading in drugs under special control shall comply with the following provisions:

a/ Establishments that are trading in drugs under special control prescribed at Points a and b, Clause 26, Article 2 of the Pharmacy Law may continue operating until June 30, 2018. After this date, those establishments that wish to continue operating must have a certificate of eligibility for pharmacy business covering trading in drugs under special control suitable to their operation scope prescribed in Section 4, Chapter III of this Decree;

b/ Establishments that are trading in drugs under special control prescribed at Points c and d, Clause 26, Article 2 of the Pharmacy Law may continue operating until their certificates of eligibility for pharmacy business expire or their certificates of good practices expire in case their certificates of eligibility for pharmacy business have no expiry date. After this date, those establishments that wish to continue operating must have a certificate of eligibility for pharmacy business covering trading in drugs under special control suitable to their operation scope prescribed in Section 4, Chapter III of this Decree.

6.  No later than July 1, 2018, establishments that are retailing drugs on the list of drugs restricted from retail shall comply with the provisions in Clause 2, Article 55 of this Decree.

7. No later than March 1, 2018, medicinal materials must have a certificate of free sale or have their standards announced in accordance with Clauses 1 and 2, Article 93 of this Decree before being put into circulation in Vietnam.

8. No later than January 1, 2019, capsule shells must have a certificate of free sale in accordance with Clause 4, Article 93 of this Decree before being put into circulation in Vietnam. No later than January 1, 2021, adjuvants must have a certificate of free sale in accordance with Clause 3, Article 93 of this Decree before being put into circulation in Vietnam.

9. No later than January 1, 2018, drug retailing establishments located within medical examination and treatment establishments must comply with the provisions in Article 136 of this Decree.

10. Receipt slips of drug information and certificates of drug advertisement contents granted before the effective date of this Decree may be used until they expire.

11. Establishments that have been granted operation licenses of foreign enterprises related to drugs and drug materials in Vietnam, operation licenses of foreign enterprises related to vaccines, medical biological products and vaccine and medical biological materials in Vietnam which expire after December 31, 2016, may continue supplying drugs into Vietnam until the effective date of this Decree and may continue supplying drug materials until January 1, 2018.

12. Since January 1, 2021, drug materials being adjuvants used for drug manufacturing under drug registration dossiers and having been granted a certificate of registration of drug sale in Vietnam may be imported according to the list already announced under regulations of the Minister of Health without requiring an import license.

Article 144.Effect

1. This Decree takes effect on July 1, 2017.

2. To annul:

a/ The provisions on drug advertisement in Article 3 of the Government’s Decree No. 181/2013/ND-CP of November 14, 2013, detailing a number of articles of the Law on Advertising;

b/ The Government’s Decree No. 79/2006/ND-CP of August 9, 2006, detailing a number of articles of the Pharmacy Law;

c/ The Government’s Decree No. 89/2012/ND-CP of October 24, 2012, amending and supplementing a number of articles of the Government’s Decree No. 79/2006/ND-CP of August 9, 2006, detailing a number of articles of the Pharmacy Law;

d/ The Government’s Decree No. 102/2016/ND-CP of July 1, 2016, prescribing drug business conditions.

3. In case the legal documents and provisions referred to in this Decree are amended, supplemented or replaced, the new legal documents will apply.

Article 145.Organization of implementation

1. The Minister of Health shall guide and organize the implementation of this Decree.

2. Chairpersons of provincial-level People’s Committees shall assign provincial-level Departments of Health to organize the receipt and examination of dossiers of re-declaration of prices of drugs manufactured by establishments in their respective localities.

3. The online announcement, registration and application for licenses shall be implemented according to the roadmap set by the Minister of Health.

4. Ministers, heads of ministerial-level agencies, heads of government-attached agencies and chairpersons of provincial-level People’s Committees shall implement this Decree.-

On behalf of the Government
Prime Minister
NGUYEN XUAN PHUC

* All appendices to this Decree are not translated.