Circular 08/2022/TT-BYT marketing authorization of drugs and medicinal ingredients

CIRCULAR

On marketing authorization of drugs and medicinal ingredients

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Pursuant to the Law No. 105/2016/QH13 dated April 06, 2016 on Pharmacy;

Pursuant to 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 Law on Pharmacy;

Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government on amending and supplementing a number of regulations related to business conditions under state management of the Ministry of Health;

At the proposal of the Director of the Drug Administration of Vietnam.

The Minister of Health promulgates Circular on marketing authorization of drugs and medicinal ingredients.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Circular provides for:

a) Application dossiers and procedures for marketing authorization of pharmaceuticals, vaccines, biologicals, herbal drugs and medicinal ingredients (active ingredients, semi-finished herbal ingredients, excipients, capsule shells) for human use in Vietnam, and renewal, revision and revocation thereof;

b) Requirements on clinical data for assurance of safety and efficacy in any application dossier for marketing authorization of drugs;

c) Criteria for exemption from clinical trial or certain stages thereof in Vietnam; drugs that have to undergo Stage 4 clinical trial;

d) Principles of peer review of application dossiers for marketing authorization of drugs/medicinal ingredients, renewal and revision thereof;

dd) Principles of peer review of application dossiers for import licensing of drugs that are yet to be approved for marketing authorization in the cases specified at Point a, Clause 43, Article 5 of Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government on amending and supplementing a number of regulations related to business conditions under state management of the Ministry of Health (hereinafter referred to as Decree No. 155/2018/ND-CP);

e) Rules for organization and operation of Marketing Authorization Advisory Committee (hereinafter referred to as the Committee);

g) Procedures for validating application dossiers for marketing authorization of drugs, medicinal ingredients, or renewal or revision thereof; procedures for validating application dossiers for licenses to import drugs that are yet to be approved for marketing authorization.

2. This Circular is not compulsorily applicable to the cases specified at Points a and b, Clause 2, Article 54 of the Law on Pharmacy, and semi-finished herbal ingredients manufactured by the authorization holder itself in order to manufacture finished drug products as specified at Point e, Clause 1, Article 93 of 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 Law on Pharmacy (hereinafter referred to as Decree No. 54/2017/ND-CP), unless the authorization holders voluntarily apply.

Article 2. Interpretation of terms

In this Circular, the terms below are construed as follows:

1. ASEAN Common Technical Dossier (ACTD) means a guideline for the preparation of application dossiers for drug marketing authorizations that satisfy the Association of Southeast Asian Nations (ASEAN) Common Technical Requirements, which are specified in Appendix I hereof.

2. ICH Common Technical Document (ICH-CTD) means the common technical document provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

3. Major variation means a variation to a drug that may affect significantly and directly the quality, safety, and efficacy thereof specified in Appendix II hereof.

4. Minor variation means a variation to a drug that do not affect or barely affect the quality, safety, and efficacy thereof specified in Appendix II hereof.

5. Marketing authorization applicant means any entity that applies for the grant, renewal or revision of the marketing authorization of drugs, medicinal ingredients.

6. Drug manufacturer means any entity that is engaged in any or some or all steps of the production of drugs or in the release of a batch of finished drug.

7. Medicinal ingredient manufacturer means any entity that is engaged in the production or the release of batches of medicinal ingredients.

8. Certificate of Pharmaceutical Product (CPP) means a certificate issued in the format recommended by the World Health Organization (WHO) according to WHO Certification scheme on the quality of pharmaceutical products moving in international commerce.

9. European Medicines Agency (EMA) and Stringent Regulatory Authorities (SRA) refer to:

a) European Medicines Agency (EMA);

b) Stringent Regulatory Authorities (SRA) mean drug regulatory authorities that are considered SRA by the World Health Organization (WHO). A SRA is:

- A member of ICH before October 23, 2015, including: U.S. Food and Drug Administration (US-FDA), drug regulatory authorities of European Union, the UK Medicines and Healthcare products Regulatory Agency (MHRA), and Japan’s Pharmaceuticals Medical Devices Agency (PMDA);

- An ICH observer before October 23, 2015, including: drug regulatory authorities of European Free Trade Association (EFTA), with representatives from Swissmedic and Health Canada;

- A regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement before October 23, 2015, including: Australia, Iceland, Liechtenstein, and Norway.

10. Product license holder/Marketing authorization holder means any entity that holds an authorization to market a drug stated on the Certificate of Pharmaceutical Product (CPP) issued in the format recommended by WHO.

11. Semi-finished herbal ingredient means any of medicinal ingredients derived from herbs in the form of glue, granule, powder, extract, essential oil, resin, gum, jelly.

Article 3. Responsibilities of every marketing authorization applicant

1. Take full accountability before the law for the legitimacy and accuracy of every document in the application dossier. Coordinate with any domestic/foreign competent authority and manufacturer in responding to written inquiries of the Drug Administration of Vietnam regarding the authenticity of relevant legal documents in the application dossier.

2. Apply for revision according to Clause 4, Article 27; Clause 3, Article 30; Clause 3, Article 32; and Article 38 of this Circular during the validity period of the marketing authorization.

3. Take responsibility for the revision to the label or package insert made strictly under the written request for update of the Drug Administration of Vietnam during the validity period of the marketing authorization without compulsory submission of an application dossier for revision.

4. Ensure the quality, safety and efficacy of the drug/medicinal ingredients as declared in the application dossier.

5. Send a written notice to Drug Administration of Vietnam within 30 days from the day on which the marketing authorization is revoked in any country if the marketing authorization for the drug/medicinal ingredients has been granted in Vietnam, and specify the reason for such revocation.

6. At the request of any competent authority, cooperate with the manufacturer in studying or providing additional information about the to-be-marketed drug when there is information or evidence about the safety and efficacy of the drug during the validity period of its market authorization.

7. Coordinate with the manufacturers, importers and distributors in following up, monitoring, collecting and summarizing information of evaluating post-vaccination reactions and adverse drug reactions as specified in Clause 5, Article 77 of the Law on Pharmacy, national guidelines for pharmacovigilance issued by the Ministry of Health and relevant regulations and submit reports thereon to the National Centre of Drug Information and Adverse Drug Reactions Monitoring (National DI&ADR Center).

8. Maintain the marketing authorization applicant’s eligibility for pharmaceutical business throughout the validity period of the marketing authorization. In the case where the authorization applicant is no longer eligible for operation, it shall follow procedures for changing the authorization applicant as specified in Clause 4, Article 27; Clause 3, Article 30; Clause 3, Article 32; and Article 38 of this Circular within 30 days from the day on which the marketing authorization holder no longer qualifies for operation.

9. Take responsibility for issues relevant to intellectual property rights of the drugs/medicinal ingredients of which the applicant applies for the authorization of marketing in Vietnam.

10. Coordinate with the manufacturers in updating quality standards of drug/medicinal ingredients in accordance with Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Minister of Health on quality of drugs and medicinal ingredients (hereinafter referred to as Circular No. 11/2018/TT-BYT) and Circular No. 38/2021/TT-BYT dated December 31, 2021 of the Minister of Health on quality of herbal ingredients, traditional medicinal materials and traditional drugs (hereinafter referred to as Circular No. 38/2021/TT-BYT).

11. Implement the approved risk management plan in the application dossier for marketing authorization or vaccines, or renewal thereof.

12. Take responsibility as specified in Clause 2, Article 57 of the Law on Pharmacy and provisions of this Article for the drugs/medicinal ingredients of which the applicant applies for the authorization of marketing from the day on which the Drug Administration of Vietnam signs the written permission for substituting the marketing authorization applicant, including any drugs/medicinal ingredients approved for marketing authorization before such permission is signed by the Drug Administration of Vietnam.

13. Coordinate with the manufacturers in providing any of the documents specified in Clause 11, Article 22 of this Circular to any competent regulatory authority upon its request.

14. Assume other responsibilities specified in this Circular and relevant law provisions.

Article 4. Responsibilities of every manufacturer of drugs/medicinal ingredients

1. Drugs and medicinal ingredients must be actually manufactured by the manufacturer that has a drug manufacturing license/certificate of eligibility for pharmaceutical business issued by any competent regulatory authority, under which the manufacture of the drugs/medicinal ingredients is permitted.

2. Take full accountability before the law for the accuracy, lawfulness and truthfulness of all documents related to the drugs/medicinal ingredients supplied by the manufacturer to the applicants for marketing authorization in Vietnam.

3. Coordinate with the marketing authorization applicant in:

a) Complying with the provisions of Clauses 2, 3 and 4, Article 3 of this Circular;

b) Fulfilling any competent authority’s request for inspection or evaluation of the manufacturer.

4. Send a written request made using Form No. 1/TT enclosed herewith for revocation of the marketing authorization of the drug/medicinal ingredients that it has manufactured in the cases such drugs/medicinal ingredients have any problem in terms of quality, safety or efficacy that may affect its users’ health.

5. Maintain the operating conditions of the manufacturer throughout the validity period of the marketing authorization.

6. In the case where the applicants for marketing authorization of the drug/medicinal ingredients is not eligible for operation as mentioned in a notice of any competent regulatory authority, the manufacturer may initiate the procedures for substitution of the marketing authorization applicant within 30 days from the day on which the said notice is received.

7. Update quality standards of the drugs/medicinal ingredients in accordance with Circular No. 11/2018/TT-BYT and Circular No. 38/2021/TT-BYT.

8. Take responsibility for assessing and ensuring that the manufacturer of medicinal ingredients adopts the Good Manufacturing Practice for medicinal ingredients, stores and provides any of the specified in Clause 11, Article 22 of this Circular to the competent regulatory authority upon request.

Article 5. Regulations regarding reports on safety and efficacy follow-up and evaluation

1. Pharmaceutical-trading establishments and health facilities shall follow up, monitor, collect and summarize information of, evaluate post-vaccination reactions and adverse drug reactions as specified in Article 77 and Article 78 of the Law on Pharmacy, national guidelines for pharmacovigilance issued by the Ministry of Health and relevant regulations and submit reports thereon to competent authorities.

2. The authorization applicants for drugs shall submit reports on safety and efficacy follow-up and evaluation of the drugs as specified in Clause 2, Article 8 of this Circular, using Form No. 2A/TT (for drugs) or Form No. 2B/TT (for vaccines):

a) To the National DI&ADR Center every 06 months throughout the validity period of the marketing authorization;

b) When submitting an application dossier for renewal of the marketing authorization at the Drug Administration of Vietnam.

3. Health facilities using the drugs specified in Clause 2, Article 8 of this Circular shall submit their reports on the use of drugs made according to Form No. 2C/TT enclosed herewith to the National DI&ADR Center every 06 months throughout the validity period of the marketing authorization.

4. Every 6 months, the National DI & ADR Center shall evaluate and summarize the aforementioned reports and send a summary report to the Drug Administration of Vietnam.

Article 6. Language, format, and quantity of documents included in the application dossiers.

1. Language of documents included in a marketing authorization application dossier

Every document included in the marketing authorization application dossier shall be written in Vietnamese or English. Nevertheless, the package insert and summary of product characteristics shall be written in Vietnamese.

2. Every document included in the marketing authorization application dossier shall be made in A4 papers, which shall be firmly fixed together. The application dossier shall have a cover (Form No. 3/TT) and be arranged in the order specified in the Table of Contents (Form No. 4/TT), and different sections thereof shall be separated from each other. The separated sections shall be numbered and each bear a seal of the applicant or the manufacturer of the drug/medicinal ingredients on the first page throughout the dossier (for any foreign drug, the seal of a representative office is acceptable). This provision is not applicable to online submissions.

The following documents shall be bound separately and enclosed with 01 application:

a) Bioequivalence study documents;

b) Pre-clinical and clinical documents;

c) Documents serving GMP evaluation as specified in Article 95 and Article 98 of Decree No. 54/2017/ND-CP and Clause 53, Article 4; Clause 51, Article 5 of Decree 155/2018/ND-CP, in case of any foreign manufacturer that applies for marketing authorization of its drugs/medicinal ingredients in Vietnam.

3. Different drugs may be included in the same marketing authorization application dossier if the following elements are the same: Drug name, dosage form, route of administration, quality standards; manufacturer’s name and address, formula in which: the content of active ingredient per unit dose with respect to metered-dose solid drugs, or the content or concentration of active ingredient with respect to non-metered solid drugs, liquid drugs or semi-solid drugs; and the concentration or content of active ingredient and material of the primary package with respect to parenteral or intravenous drugs is the same.

4. Quantity of mandatory documents to be included in an application dossier for issuance or renewal of the marketing authorization:

a) 01 (one) set of all documents specified in Clauses 1, 2, 3, 5, Article 27 of this Circular with respect to pharmaceuticals, vaccines, and biologicals; or all documents specified in Clause 1 and Clause 2, Article 30; Clause 1 and Clause 2, Article 32 of this Circular with respect to herbal drugs and medicinal ingredients;

b) 01 (one) set of copies of all documents with respect to vaccines; 02 (two) sets of copies of the application, the quality standards, the method of drug/medicinal ingredient testing with respect to others;

c) 02 (two) sets of samples of labels of the drugs/medicinal ingredients to be marketed and the package insert thereof bearing the seal of the applicant (or seal of a representative office for foreign drugs) or the manufacturer. The said labels shall be attached to or presented on appropriately sized papers which shall not be smaller than A4 papers. In case of online submissions, the applicant shall submit only 01 set of samples of labels of the drugs/medicinal ingredients and the package insert.

5. Quantity of mandatory documents to be included in an application dossier for revision of the marketing authorization:

a) 01 (one) set of all documents specified in Clause 4, Article 27 of this Circular with respect to pharmaceuticals, vaccines, and biological and those specified in Clause 3, Article 30 and Clause 3, Article 32 of this Circular with respect to herbal drugs and medicinal ingredients;

b) 02 (two) sets of samples of the labels of the drugs/medicinal ingredients and the package insert bearing the seal of the applicant (or seal of a representative office for foreign drugs) or the manufacturer in case of revision to the labels or package insert. The said labels shall be attached to or presented on appropriately sized papers which shall not be smaller than A4 papers. In case of online submissions, the applicant shall submit only 01 set of samples of labels of the drug/medicinal ingredients and the package insert.

6. Regulations regarding online application:

a) Quantity and composition of an application dossier to be submitted online: 01 (one) set of all documents specified in this Circular (except the cover page); regarding parts of the dossier that shall be kept confidential the applicant shall submit them in person to the Drug Administration of Vietnam in accordance with Circular No. 05/2010/TT-BYT dated March 1, 2010 of the Minister of Health guiding the keeping of confidentiality of trial data in drug marketing authorization (hereinafter referred to as Circular No. 05/2010/TT-BYT);

b) The online application roadmap shall be announced by the Ministry of Health. From the day on which it is made compulsory for all application dossiers to be submitted online, the applicants shall make their online submissions in accordance with Point a of this Clause. In the case where the paper copy of an application dossier is required for consideration and comparison, the Drug Administration of Vietnam shall serve a notice in writing.

Article 7. Marketing authorization charges

Applicants shall pay the charges for issuance of the marketing authorization in accordance with applicable law provisions on fees and charges.

Article 8. Validity and symbols of the marketing authorization of any drug/medicinal ingredient and deadline for submission of an application dossier for renewal; quantity of marketing authorizations that can be granted for drugs that have the same active ingredients or herbal ingredients, dosage form, route of administration, content or concentration per dose unit.

1. The validity period of a marketing authorization is 05 (five) years from the issuance date or renewal date, except for the case specified in Clause 2 of this Article.

2. The validity period of the marketing authorization for the following drugs is 03 (three) years:

a) New drugs and vaccines that apply for the marketing authorization for the first time, reference biologicals and similar biologicals that apply for the marketing authorization in Vietnam for the first time;

b) Drugs having the same active ingredients, concentration, content or dosage form as that of the new drug which has not been granted a marketing authorization with the validity period of 05 (five) years;

c) Drugs of which the safe and efficacy shall be followed up as recommended by the Committee;

d) Any drug mentioned at Points a, b, and c of this Clause, of which a report on safety and efficacy is not submitted at the time the application dossier for renewal of the marketing authorization is submitted because the drug has yet been marketed in reality or the quantity of drug used, quantity of patients or use duration thereof is insufficient in the Committee’s opinions, or the health facility recommends extension of safety and efficacy follow-up of such drug;

3. Any drug or medicinal ingredient approved for marketing authorization shall have an authorization number as specified in Appendix VI hereof.

4. Deadline for submission of an application dossier for renewal: Within 12 months before the expiration date of the marketing authorization, its holder shall submit an application dossier for renewal.

5. In the case where any of the administrative documents included in the application dossier for renewal is substituted or otherwise changed, after 12 months from the day on which the Decision on renewal of the marketing authorization is issued, the applicant shall carry out the approved changes in the renewal application dossier.

6. Quantity of marketing authorizations that can be granted for drugs of the same manufacturer that have the same active ingredients or herbal ingredients; dosage form; route of administration; content or concentration per dose unit: 01 marketing authorization under the brand name of each and 01 marketing authorization under an international non-proprietary. This clause is not applicable to drug products processed by outsource manufacturing and drugs manufactured exclusively for export.

Article 9. Criteria for drugs to be classified, and cases where drugs are declared, as proprietary drugs and reference biologicals

1. Criteria for drugs to be classified as proprietary drugs and reference biologicals

a) Drugs approved for marketing authorization in Vietnam has been granted shall be classified as proprietary drugs or reference biologicals when they satisfy all following criteria:

- The clinical data on safety and efficacy is sufficient as prescribed in Article 13 of this Circular;

Particularly, to be classified as reference biologicals, the documents and pre-clinical and clinical data on quality are sufficient, on which the biological must be originally developed, not a biosimilar;

- The drug is approved for marketing authorization by any of the regulatory authorities mentioned in Clause 9, Article 2 of this Circular, except for new drugs that are manufactured in Vietnam.

b) In the case where any drug is declared by the Ministry of Health as proprietary drug or reference biological, and then processed by outsource manufacturing or any or some or all of the manufacturing processes thereof is transferred to manufacturers in Vietnam, such declared proprietary drug or reference biological and the drug products processed by outsourced manufacturing in Vietnam or manufactured with manufacturing processes transferred to Vietnam must satisfy all of the following criteria:

- The formulae are the same;

- The manufacturing processes are the same;

- The material quality standards are the same;

- The finished drug product quality standards are the same;

In the case where there are changes in any of the criteria specified at this Point or otherwise related to the quality of the drug, such changes must be approved by the drug regulatory authority of the country of origin or any regulatory authority specified in Clause 9, Article 2 of this Circular which has granted the marketing authorization for such drug, or the applicant must provide data proving that the drug products manufactured in Vietnam is equivalent in quality to the proprietary drug or reference biological before outsource manufacturing or transfer of manufacturing processes.

c) In the case where the manufacturer of a drug that is declared a proprietary drug or reference biological is changed, the drug granted the new marketing authorization of the new manufacturer will also be classified as a proprietary drug or reference biological if such manufacturer makes a written request and all of the following criteria are satisfied:

- The drug is approved for market authorization by any of the regulatory authorities mentioned in Clause 9, Article 2 of this Circular;

- The drug satisfies all the criteria specified at Point b, Clause 1 of this Article.

In the case where there are changes in any of the criteria specified at Point b, Clause 1 of this Article or otherwise related to the quality of the drug, such changes must be approved by the drug regulatory authority of the country of origin or any regulatory authority specified in Clause 9, Article 2 of this Circular which has granted the marketing authorization for such drug, or the applicant must provide data proving that the drug manufactured by the new manufacturer is equivalent in quality to the proprietary drug or reference biological before the manufacturer is changed.

2. Cases in which drugs are classified as proprietary drugs and reference biologicals:

a) Drugs that have been declared by the Ministry of Health as proprietary drugs or reference biologicals manufactured entirely in the country of any regulatory authority specified in Clause 9, Article 2 of this Circular may continue to be classified as proprietary drugs or reference biologicals if they fall into any of the following cases:

- Drugs with valid, renewed or revised marketing authorizations, other than those specified at Point b, Clause 2, Article 55 of the Law on Pharmacy. The applicant shall not submit an application dossier for classification as proprietary drug or reference biological;

- Drugs for which marketing authorization approvals are reapplied in accordance with Circular No. 44/2014/TT-BYT dated November 25, 2014 of the Minister of Health on drug marketing authorization (hereinafter referred to as Circular No. 44/2014/TT-BYT) and so newly granted, which have the formulae, production processes, ingredient and finished drug product quality standards that are similar with the declared proprietary drugs or reference biologicals, or are changed of which the changes are approved by the Drug Administration of Vietnam or the reference country. The applicant shall submit a dossier to update the classification of the proprietary drugs or reference biologicals as specified in Appendix II hereof;

- Drugs of which the manufacturers are changed and for which new marketing authorization approvals are granted, satisfying the requirements specified at Point c, Clause 1 of this Article. The applicant shall submit a dossier to update the classification of the proprietary drugs or reference biologicals as specified in Appendix II hereof.

b) Foreign-manufactured drugs that have been declared by the Ministry of Health as proprietary drugs or reference biologicals which are not manufactured entirely in the country of any regulatory authority specified in Clause 9, Article 2 of this Circular but are authorized for marketing in such country may continue to be classified as proprietary drugs or reference biologicals if they fall into any of the following cases:

- Drugs with valid, renewed or revised marketing authorizations, other than those specified at Point b, Clause 2, Article 55 of the Law on Pharmacy;

- Drugs for which marketing authorization approvals are reapplied in accordance with Circular No. 44/2014/TT-BYT and so newly granted, which have the formulae, production processes, ingredient and finished drug product quality standards that are similar with the declared proprietary drugs or reference biologicals, or are changed of which the changes are approved by any regulatory authority of Vietnam or the reference country;

- Drugs of which the manufacturers are changed and for which new marketing authorization approvals are granted, satisfying the requirements specified at Point c, Clause 1 of this Article;

The applicant shall submit a dossier to update the classification of the proprietary drugs or reference biologicals in 03 above-mentioned cases as specified in Appendix II hereof.

c) Drugs that have been declared by the Ministry of Health as proprietary drugs or reference biologicals which are manufactured entirely in Vietnam or of which any or some of the manufacturing processes are conducted in Vietnam and the remainder are entirely conducted in the country of any regulatory authority specified in Clause 9, Article 2 of this Circular may continue to be classified as proprietary drugs or reference biologicals if they fall into any of the following cases:

- Drugs with valid, renewed or revised marketing authorizations, other than those specified at Point b, Clause 2, Article 55 of the Law on Pharmacy. The applicant shall not submit an application dossier for classification as proprietary drug or reference biological;

- Drugs for which marketing authorization approvals are reapplied in accordance with Circular No. 44/2014/TT-BYT and so newly granted, which have the formulae, production processes, ingredient and finished drug product quality standards that are similar with the declared proprietary drugs or reference biologicals, or are changed of which the changes are approved by any regulatory authority of Vietnam or the reference country. The applicant shall submit a dossier to update the classification of the proprietary drugs or reference biologicals as specified in Appendix II hereof;

- Drugs of which the manufacturers are changed and for which new marketing authorization approvals are granted, satisfying the requirements specified at Point c, Clause 1 of this Article. The applicant shall submit a dossier to update the classification of the proprietary drugs or reference biologicals as specified in Appendix II hereof.

d) Drugs that have been declared by the Ministry of Health as proprietary drugs or reference biologicals of which any or some of the manufacturing processes are conducted in Vietnam and the remainder are not entirely conducted in the country of the regulatory authorities specified in Clause 9, Article 2 of this Circular but are authorized for marketing in such country may continue to be classified as proprietary drugs or reference biologicals if they fall into any of the following cases:

- Drugs with valid, renewed or revised marketing authorizations, other than those specified at Point b, Clause 2, Article 55 of the Law on Pharmacy;

- Drugs for which marketing authorization approvals are reapplied in accordance with Circular No. 44/2014/TT-BYT and so newly granted, which have the formulae, production processes, ingredient and finished drug product quality standards that are similar with the declared proprietary drugs or reference biologicals, or are changed of which the changes are approved by any regulatory authority of Vietnam or the reference country;

- Drugs of which the manufacturers are changed and for which new marketing authorization approvals are granted, satisfying the requirements specified at Point c, Clause 1 of this Article;

The applicant shall submit a dossier to update the classification of the proprietary drugs or reference biologicals in 03 above-mentioned cases as specified in Appendix II hereof.

dd) For drugs that have been declared by the Ministry of Health as proprietary drugs or reference biologicals manufactured entirely in the country of any regulatory authority specified in Clause 9, Article 2 of this Circular, then are processed by outsource manufacturing or manufactured with transferred manufacturing processes in Vietnam, the drug products that are processed by outsource manufacturing in Vietnam or of which any or some or all of the manufacturing processes are transferred to Vietnam and then new marketing authorizations are granted therefor may continue to be classified as proprietary drugs or reference biological if they satisfy the requirements specified at Point b, Clause 1 of this Article. The applicant that is an outsource manufacturer or a transferee of manufacturing process(es) in Vietnam shall submit a dossier to update the classification of the proprietary drugs or reference biologicals as specified in Appendix II hereof;

e) For drugs that have been declared by the Ministry of Health as proprietary drugs or reference biologicals that are not manufactured entirely in the country of any regulatory authority specified in Clause 9, Article 2 of this Circular but are authorized for marketing such country, then are processed by outsource manufacturing or manufactured with transferred manufacturing processes in Vietnam, the drug products that are processed by outsource manufacturing in Vietnam or of which any or some or all of the manufacturing processes are transferred to Vietnam and then new marketing authorizations are granted therefor may continue to be classified as proprietary drugs or reference biological if they satisfy the requirements specified at Point b, Clause 1 of this Article. The applicant that is an outsource manufacturer or a transferee of manufacturing processes in Vietnam shall submit a dossier to update the classification of the proprietary drugs or reference biologicals as specified in Appendix II hereof;

g) Drugs that are yet declared by the Ministry of Health as proprietary drugs or reference biologicals but satisfy the requirements specified at Point a, Clause 1 of this Article shall be classified anyway as proprietary drugs or reference biologicals. The applicant shall submit a dossier to update the classification of the proprietary drugs or reference biologicals as specified in Appendix II hereof.

Article 10. Criteria for classifying drugs with proven bioequivalence

Any drug approved for marketing authorization in Vietnam shall be classified as a drug with proven bioequivalence when there is a bioequivalence report satisfying the requirements of the Ministry of Health on drugs subject to bioequivalence test and other requirements for dossiers and reports on bioequivalence study data with respect to drug marketing authorization in Vietnam.

Article 11. Confidentiality of information in the marketing authorization application dossier

The applicant that wishes to keep the information in the marketing authorization application dossier confidential shall follow instructions in Circular No. 05/2010/TT-BYT and specify the request in Form No. 5/TT enclosed herewith.

Article 12. Regulations on verification of legal documents

1. Before granting a marketing authorization, the Drug Administration of Vietnam shall verify the following legal documents included the application dossier:

a) CPP:

- CPP with information suspected of being erased or edited;

- CPP included in the marketing authorization application dossier of a manufacturer or applicant that has been sanctioned by Vietnamese competent authorities for the administrative violations of providing dossier-included information that are not based on study or actual manufacture of any manufacturer listed on the website of the Drug Administration of Vietnam. The time limit for verification of a CPP is 02 years from the end of the time limit for temporary suspension of the submission of the dossier for marketing authorization or renewal thereof to be received;

- CPP of the drug manufactured by the applicant that applies for marketing authorization in Vietnam for the first time, unless such drug is manufactured by many manufacturers of which at least one has been granted a marketing authorization in Viet Nam;

- Electronic CPP self-retrieved from any English website or database of a marketing authorizer or a competent authority of any other country, of the which the link provided by the applicant in the dossier cannot be accessed;

- CPP without a certification stamp of the competent authority of the country in which it is granted;

- The verification thereof required by the Committee.

b) Legal documents related to the applicant or the manufacturer: The verification is applicable to the legal documents of the applicant or manufacturer applying for marketing authorization in Vietnam for the first time.

2. With respect to drugs approved for marketing authorizations, the Drug Administration of Vietnam shall verify their legal documents if it is aware that such marketing authorization is suspiciously granted in the reference country or the foreign applicant or manufacturer is not eligible for operation thanks to information sent to it in writing or to its official email, or reported by the mass media.

3. The verification of the CPP and the legal documents included in the marketing authorization application dossier shall be done in writing or via official email in the following manner:

a) Verification of the consular authentication of legal documents: The Drug Administration of Vietnam shall coordinate with the Consular Department under the Ministry of Foreign Affairs or the overseas diplomatic missions of Vietnam which are competent to provide consular authentication to verify the competence and information related to the legal authentication of foreign legal documents to be used in Vietnam in the cases specified in Items 2 and 3, Point a; and Point b, Clause 1 of this Article;

b) Verification of the authenticity of legal documents: The Drug Administration of Vietnam shall coordinate with the authorities granting/promulgating the legal documents to verify the information stated in such documents in the cases specified in Items 1, 4, 5, 6, Point a, Clause 1 of this Article.

4. The verification of the legal documents specified in Clause 1 of this Article shall be simultaneous with validation of the marketing authorization application dossier and within the time limit specified in Clause 5, Article 56 of the Law on Pharmacy. Drugs may only be considered for marketing authorization if the verification results satisfy the requirements of the competent authorities mentioned in Clause 3 of this Article.

The written request for verification of legal documents shall be sent to the authorization applicant as well. Within 06 months from the day on which the Drug Administration of Vietnam conducts the verification, if the verification results are not delivered by the competent authorities, the Drug Administration of Vietnam shall report to the Committee and propose the refusal to marketing authorization.

Chapter II

REQUIREMENTS ON CLINICAL DATA FOR ASSURANCE OF SAFETY AND EFFICACY; CRITERIA FOR EXEMPTION FROM CLINICAL TRIAL OR CERTAIN STAGES THEREOF IN VIETNAM; DRUGS THAT HAVE TO UNDERGO STAGE 4 CLINICAL TRIAL

Article 13. Clinical data in an application dossier for marketing authorization of a pharmaceutical, vaccine or biological

1. Requirements on clinical data for assurance of safety and efficacy of a new pharmaceutical, vaccine or biological in its marketing authorization application dossier.

a) Clinical studies of the drug and data in clinical documents shall be conformable with guidelines of ICH, the Ministry of Health of Vietnam or other organizations recognized by Vietnam (including: international organizations to which Vietnam is a member and regulatory authorities specified in Clause 9, Article 2 of this Circular), unless otherwise specified in Clause 3 of this Article;

b) Clinical database (except biologicals similar to reference biologicals approved for marketing authorization in Vietnam) shall be sufficient for analysis and justification of the safety and efficacy of the drug in Asian populations for extrapolating clinical data from Asian populations according to instructions at Point a of this Clause, or bridging study data according to ICH-E5 for extrapolating clinical data from Asian populations;

c) If the vaccine has been approved for market authorization as specified at Point d, Clause 4, Article 22 of this Circular and has sufficient clinical data on safety and efficacy as specified at Point a and Point b of this Clause but its manufacturing processes are not entirely conducted in any member state specified in Clause 9, Article 2 of this Circular, it is required to have clinical data pertinent to safety and immunogenicity in the intended population in Vietnam before being approved for marketing authorization;

d) If the vaccine has sufficient clinical data for safety and efficacy as prescribed at Point a and Point b of this Clause but any requirement specified at Point d, Clause 4, Article 22 of this Circular is not satisfied, it is required to have clinical data pertinent to safety and immunogenicity in the intended population in Vietnam before market authorization.

2. Pharmaceuticals of which the content or concentration, route of administration, method of administration, dosage, indication, patient population or dosage form makes the biopharmacology of such drugs different from the proprietary drug approved for market authorization in Vietnam or different from the drugs approved for market authorization by any of the regulatory authorities specified in Clause 9, Article 2 of this Circular but their proprietary drug has yet been approved for marketing authorization in Vietnam must have clinical data as specified at Points a and b, Clause 1; and Clause 3 of this Article before marketing authorization.

3. If the study is carried out before the effective date of the regulations or instructions mentioned at Point a, Clause 1 of this Article, data of the study is acceptable.

Article 14. Requirements on clinical data for safety and efficacy in the application dossier for marketing authorization of a drug with new combination of similar biologicals or active ingredients

1. A drug with new combination of active ingredients shall have sufficient clinical data according to guidelines of US FDA, EMA or WHO for clinical development of fixed-dose combinations according to Appendix IV hereof.

2. Similar biologicals shall have sufficient clinical data according to the guideline of the Ministry of Health or WHO for development of similar biologicals. Guidelines of US FDA and EMA that are developed based on the aforementioned guidelines are acceptable. Guidelines of WHO, US FDA, EMA are provided in Appendix IV hereof.

Article 15. Requirements on clinical data for safety and efficacy in the application dossier for marketing authorization of a new pharmaceutical that is not a proprietary drug

1. If the drug that has been approved for market authorization in its home country is a prescription drug (except drugs manufactured in Vietnam) and at least a similar drug (with the same active ingredient, content, concentration thereof, dosage form and route of administration) has been approved for market authorization by any of the regulatory bodies specified in Clause 9, Article 2 of this Circular, the clinical data shall satisfy any of the following requirements:

a) The use of clinical data of the similar drug is permitted by its owner. The clinical data shall satisfy the requirements in Article 13 of this Circular;

b) There is clinical data from published studies and bioequivalence studies (unless the drug does not require bioequivalence test according to regulations of the country of origin).

2. If the drug that has been approved for market authorization in its country of origin is a prescription drug (except drugs manufactured in Vietnam and those specified in Clause 3 of this Article) and at least a similar drug (with the same active ingredient, content, concentration thereof, dosage form and route of administration) has been approved for market authorization by at least one country across the world, the clinical data shall satisfy any of the following requirements:

a) The use of clinical data of the similar drug is permitted by its owner. The clinical data shall satisfy the requirements in Article 13 of this Circular;

b) There is clinical data from published studies and bioequivalence studies (unless the drug does not require bioequivalence test according to regulations of the country of origin).

3. If the drug that is approved for marketing authorization is classified as non-proprietary by any of the regulatory authorities mentioned in Clause 9, Article 2 of this Circular, it is required to have justification and evidence that the use of the active ingredients (indications, dose, route, users) is specified in Vietnamese National Drug Formulary, Vietnam’s Pharmacopoeia, Formularies or other documents accepted by any of the reference authorities specified in Clause 9, Article 2 of this Circular.

Article 16. Requirements on clinical data for drugs approved for marketing authorization in Vietnam in case of changes in clinical data thereof

In case of changes to clinical data for a pharmaceutical, vaccine, biological or herbal drug that has been approved for marketing authorization in Vietnam, the applicant shall provide the additional clinical data in accordance with Appendix II of this Circular.

Article 17. Criteria for exemption of any or several stages of clinical trial of new pharmaceuticals, vaccines, biologicals before marketing authorization

In any of the following cases, the Minister of Health is entitled to exempt any or several stages of clinical trial (including clinical data) of a drug that fails to meet the requirements specified in Article 13 of this Circular on the basis of opinions given by the Committee:

1. The drug is meant to serve urgent needs for national defense and security, epidemic control, disaster relief and cannot be replaced by any other drug on the market.

2. The drug is approved for market authorization by at least any of the regulatory authorities specified in Clause 9, Article 2 of this Circular according to the reduced clinical documents they require.

3. The drug is meant to treat a rare or fatal disease.

4. Vaccines and biologicals manufactured in Vietnam through technology transfer of one, some or all of the manufacturing processes of the finished vaccine or biological whose clinical data satisfies the requirements in Clause 1, Article 13; and Article 14 of this Circular.

Article 18. Requirements on clinical data in an application dossier for marketing authorization of a new herbal drug

1. Requirements on clinical data for assurance of safety and efficacy in the application dossier for marketing authorization of a new herbal drug:

a) Clinical studies of the drug and data in clinical documents shall be conformable with guidelines on pre-clinical and clinical studies of herbal drugs issued by the Ministry of Health or other organizations recognized by Vietnam, including: WHO Research guidelines for evaluating the safety and efficacy of herbal drugs or guidelines of any regulatory authority specified in Clause 9, Article 2 of this Circular. If the study is carried out before the effective date of the aforementioned regulations or guidelines on drug development study, data of such study is acceptable for validation;

b) Data extracted from the following documents is acceptable as clinical data for consideration of safety and efficacy of the herbal drug:

- The treatises about safety and efficacy of the drug mentioned in pharmacopoeias and formularies of Vietnam and other countries;

- Evaluations of safety and efficacy of the drug published on SCI (Science Citation Index) journals and clinical data collected from other medical publications;

- Evaluations of safety and efficacy in a national, ministerial or provincial research which has been accepted.

2. Clinical data mentioned in Clause 1 of this Article is not required if the herbal drug satisfies any of the following requirements:

a) The herbal drug has the same composition, content of herbal ingredients, indications, route of administration, and dosage form as those of another herbal drug which has been approved for marketing authorization (even if it has expired) except traditional drugs the indications of which do not include any of the diseases on the list of diseases published by the Minister of Health in accordance with Point b, Clause 1, Article 89 of the Law on Pharmacy;

b) The herbal drug has the same composition, content of herbal ingredients, indications, route of administration, and dosage form as those of another herbal drug which has been approved for marketing authorization in Vietnam for at least 05 years, has sufficient clinical data as prescribed in Clause 1 of this Article and is not meant to treat the diseases on the list of diseases published by the Ministry of Health according to Point b, Clause 1, Article 89 of the Law on Pharmacy.

Article 19. Criteria for exemption of any or several stages of clinical trial of herbal drugs before marketing authorization

In any of the following cases, the Minister of Health is entitled to exempt any or several stages of clinical trial (including clinical data) of an herbal drug that fails to meet the requirements specified in Article 18 of this Circular on the basis of opinions given by the Committee:

1. The drug is meant to serve urgent needs for national defense and security, epidemic control, disaster relief and cannot be replaced by any other drug on the market.

2. The drug is approved for market authorization by at least any of the reference regulatory authorities specified in Clause 9, Article 2 of this Circular according to the reduced clinical documents they require.

3. The drug is meant to treat a disease on the list of diseases published by the Minister of Health according to Point b, Clause 1, Article 89 of the Law on Pharmacy but is not exempt from clinical trial as prescribed in Clause 3, Article 20 of this Circular.

4. The drug is new combination of herbal ingredients that have been used in Vietnam and the indications of which do not include any of the diseases on the list of diseases published by the Minister of Health according to Point b, Clause 1, Article 89 of the Law on Pharmacy.

Article 20. Criteria for exemption of clinical trial in Vietnam before marketing authorization

1. A generic drug has the same active ingredients, content and concentration thereof route of administration, uses, doses, indications, intended users and dosage form as those of another drug that has been approved for market authorization.

2. A new drug (except vaccines), has been approved for market authorization in at least another country and has sufficient clinical data according to Article 13 and Article 18 of this Circular.

3. An herbal drug is granted the marketing authorization before the effective date of the 2016 Law on Pharmacy and the indications of which do not include any of the diseases on the list of diseases published by the Minister of Health.

4. A vaccine satisfies the requirements specified at Point d, Clause 4, Article 22 of this Circular, all of the manufacturing processes of which are conducted in any member state specified in Clause 9, Article 2 of this Circular, and the clinical data is sufficient as specified in Article 13 of this Circular.

Article 21. When to carry out a State IV clinical trial in Vietnam

The drug has been approved for market authorization but its safety and efficacy need additional evaluation as proposed by the Committee.

Chapter III

APPLICATION DOSSIERS FOR MARKETING AUTHORIZATION OF DRUGS AND MEDICINAL INGREDIENTS

Section 1
GENERAL PROVISIONS ON APPLICATION DOSSIERS FOR MARKETING AUTHORIZATION OF DRUGS/MEDICINAL INGREDIENTS, OR RENEWAL OR REVISION THEREOF

Article 22. Documents in the application dossier for marketing authorization for drugs/medicinal ingredients, or renewal or revision thereof

1. Documents issued by foreign competent authorities shall be consular authenticated in accordance with law provisions on consular authentication, unless consular authentication is exempted under the law.

2. Licenses, certificates, confirmations, marketing authorizations (hereinafter referred to as “legal documents”) included in an application dossier must be valid on the date of receipt according to the receipt note, with respect to legal documents with the validity period. If the validity period is not written on the CPP, its validity period shall be 24 months from the day on which it is granted.

3. Legal documents:

a) The original legal documents must be fully signed and have names of signatories and certification stamps of competent authorities in the country in which they are issued or the certified true copies must be authenticated by competent Vietnamese authorities or organizations in accordance with the Vietnamese law provisions on authentication of original copies. The original copy may be required;

b) In case the legal documents are issued electronically (copies that do not bear all signatures, names or seals of the competent authorities of the issuing country are acceptable), the applicant must submit any of the following documents:

- Originals or certified true copies of such legal documents certified by the foreign competent authorities and consular authenticated in accordance with the provisions;

- Legal documents self-retrieved from any English website or database of the issuing authorities or the competent authorities of other countries with the applicant's certification stamp enclosed with a document stating the link thereof to the Drug Administration of Vietnam. The applicant must take full accountability before the law for the legality and accuracy of such documents and information and the results of its self-retrieval.

4. Regulations on CPP:

a) The CPP must be issued by a competent authority and contain sufficient contents in the format recommended by the WHO published on its website (https://www.who.int).

b) The CPP shall bear the signature, name of the signatory and seal of the issuing authority. In case of CPP without a certification stamp of the competent authority of the country in which it is granted, the applicant shall provide documents proving that the CPP does not require a seal under the law of the reference country.

c) For generic drugs, herbal drugs and probiotics; drugs whose marketing authorization is renewed or revised:

There must be 01 CPP issued by any competent authority of the producing country proving that the drug is actually approved for marketing authorization in such country.

In the case where the CPP confirms that the drug is not approved for marketing authorization in the country of origin or is approved but not actually marketed in such country, the applicant must provide 01 additional legal document issued by any regulatory authority specified in Clause 9, Article 2 of this Circular certifying that the drug is approved for marketing authorization and actually marketed in such country with the following minimum details: name of the drug, active ingredients, concentration or content of the active ingredients, dosage form, name and address of the manufacturer.

d) For imported new pharmaceuticals, vaccines and biologicals other than probiotics:

There must be 01 CPP issued by any competent authority of the producing country proving that the drug is actually approved for marketing authorization in such country.

In the case where the competent authority of the country of origin that grants the CPP is listed in Clause 9, Article 2 of this Circular, only 01 CPP must be submitted.

In the case where the regulatory authority in the country of origin granting the CPP is not listed in Clause 9, Article 2 of this Circular, the applicant must provide any legal document issued by the regulatory authority specified in Clause 9, Article 2 of this Circular certifying that the drug is approved for marketing authorization and actually marketed in such country with the following minimum details: name of the drug, active ingredients, concentration or content of the active ingredients, dosage form, name and address of the manufacturer or documents proving that the drug is on WHO Prequalified Lists.

dd) For drugs proposed to be classified as proprietary drugs or reference biologicals:

There must be 01 CPP issued by any competent authority of the producing country proving that the drug is actually approved for marketing authorization in such country.

In the case where the competent authority of the country of origin that grants the CPP is listed in Clause 9, Article 2 of this Circular, only 01 CPP must be submitted.

In the case where the regulatory authority in the country of origin granting the CPP is not listed in Clause 9, Article 2 of this Circular, the applicant must provide any legal document issued by the regulatory authority specified in Clause 9, Article 2 of this Circular certifying that the drug is approved for marketing authorization and actually marketed in such country with the following minimum details: name of the drug, active ingredients, concentration or content of the active ingredients, dosage form, name and address of the manufacturer.

e) In the case where an imported drug/vaccine/biological does not have a CPP that satisfies the requirements specified at Points c and d of this Clause, the Minister of Health, on the basis of opinions provided by the Committee, shall make the decision if the drug/vaccine/biological is approved for market authorization by at least one competent authority in any country and satisfies any of the following requirements:

- The drug/vaccine/biological is meant to serve national defense and security, epidemic control, disaster relief or a state-level health program;

- The vaccine is meant for the national expanded immunization program and another substitute vaccine with equivalent quantity, safety, efficacy or cost is not available on the domestic market;

- In other cases, under a mutual recognition agreement between competent authorities regarding conditions for manufacturing and marketing of drugs, vaccines and biologicals.

g) The information on the CPP shall be consistent with information in the application dossier for marketing authorization. In the case where the information shown on the CPP is not consistent with the administrative documents in the marketing authorization application dossier, the applicant shall provide a written explanation enclosed with supporting documents.

5. The application and other documents included in the relevant administrative dossiers must be signed and stamped, without the use of signature-seal. The applicant and the manufacturer may use digital signatures to sign its relevant documents. The registration and use of digital signatures shall comply with the Decree No. 130/2018/ND-CP dated September 27, 2018 of the Government on detailing the Law on E-Transactions regarding digital signatures and digital signature certification services. The above documents must be signed by any of the following persons:

a) Chairperson of the Members' Council or the Board of Directors; general manager; managing director; director of the applicant or manufacturer;

b) Any person assigned under the company's charter, a document on assignment of work, or other documents proving the signing competence of the signatory;

c) Any person authorized to sign on behalf of the persons specified at Point a or b of this Clause.

6. Regulations on letter of authorization:

a) A letter of authorization to act as the applicant must cover:

- Name and address of the marketing authorization holder or the authorized manufacturer;

- Name and address of the authorized applicant;

- Name of the drug; content or concentration of active ingredients; dosage form;

- Contents of authorization.

In case of authorization of more than one drug, the letter of authorization must include a list of drugs with all of the above details.

A letter of authorization of a foreign applicant shall bear an authenticated signature and be consular authenticated in accordance with the law provisions. The letter of authorization must be an original or certified true copy.

b) A letter of authorization to sign the application dossier must cover:

- Name and address of the authorized applicant;

- Name and title of the authorizer and authorized person;

- Name of the drug; content or concentration of active ingredients; dosage form;

- Contents of authorization;

- Validity of the letter of authorization.

In case of authorization of more than one drug, the letter of authorization must include a list of drugs with all of the above details.

In the case where the authorized person is not the representative office manager, the letter of authorization shall bear the seal and signature of the representative office manager in Vietnam.

The letter of authorization must be an original or certified true copy which bear the seal of the representative office (for foreign applicants) or the domestic applicant.

c) Quantity of letter of authorizations in the dossier:

- In the case where the applicant is different from the manufacturer, each dossier must be enclosed with a letter of authorization to act as the applicant;

- In the case where the title of the person signing on the application dossier is not listed at Points a and b, Clause 5 of this Article, each dossier must be enclosed with a letter of authorization to sign on the application dossier.

7. Certificate of eligibility for pharmacy business with respect to the following business forms: manufacture, wholesaling, export, import of drugs/medicinal ingredients (for Vietnamese applicants).

8. The license to establish a representative office in Vietnam.

If the name or address of the applicant on the license to establish a representative office in Vietnam is different from those on the legal documents issued by foreign competent authorities, proof must be provided.

9. Legal documents issued by foreign competent authorities permitting at least one of the following: manufacture, wholesaling, export, import of drugs/medicinal ingredients (for foreign applicants).

In the case where the applicant is also the manufacturer written on the CPP, the legal documents mentioned in this Clause are not required.

In the case where the license for manufacture, wholesaling, export or import of drugs/medicinal ingredients is not issued in any country, it is required to have the business license or business registration certificate that permits manufacture, wholesaling, export or import of drugs/medicinal ingredients and a certification issued by a competent authority that the applicant is eligible for operation and is operating in the pharmaceutical industry, or a certificate of Good Manufacturing Practice, Good Distribution Practice, Good Supply Practice or Good Storage Practice.

As for the applicant of marketing authorization of medicinal ingredients, if the reference countries do not grant pharmaceutical trading licenses to traders of medicinal ingredients, other licenses legally available in such countries may be accepted if they permit manufacture, wholesaling, export or import of medicinal ingredients.

10. If the applicant is already included in the list of applicants for drugs/medicinal ingredients posted on the website of Drug Administration of Vietnam, the documents mentioned in Clauses 7, 8, 9 of this Article are not required.

11. Supporting documents proving compliance with good manufacturing practices (GMP) submitted by a manufacturer of active ingredients, excipients, capsule shells, semi-finished herbal ingredients and herbal ingredients (for manufacture of herbal drugs) may be any of the following documents:

a) The GMP certificate;

b) The manufacture license that certifies GMP compliance;

c) The CPP if the active ingredient is conformable with GMP;

d) The Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP);

dd) For excipients in the application dossier for marketing authorization of finished drugs, and semi-finished medicinal ingredients:

In case of failure to provide the documents specified in any of Points a, b, d of this Clause, the manufacturer of finished or semi-finished drugs shall self-assess its compliance with Good Manufacturing Practices for pharmaceutical excipients as specified at Point dd, Clause 1, Article 3; Point b, Clause 3, Article 3; and Point dd, Clause 5, Article 20 of Circular No. 35/2018/TT-BYT dated November 22, 2018 of the Minister of Health on the Good Manufacturing Practice for drugs and medicinal ingredients (amended and supplemented at Points a, b and dd, Clause 6, Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020 of the Ministry of Health on amending, supplementing and repealing a number of legal documents promulgated and jointly promulgated by the Minister of Health) and self-announce in marketing authorization application dossier the Good Manufacturing Practice principles and standards that such manufacturer of excipients satisfies, and commit to take accountability before the law for such announcement which is made using Form No. 10/TT enclosed herewith;

e) For herbal ingredients in the marketing authorization application dossier:

In case of failure to provide the documents specified at Points a and b of this Clause, the applicant shall provide the certificate of compliance with Good Agricultural and Collection Practices (GACP) for medicinal plants;

g) Any other legal document issued by a competent authority, which contains at least the following: name and address of the manufacturer, GMP compliance certification of the manufacturer, and names of the active ingredients/excipients/capsules/semi-finished herbal ingredients/herbal ingredients.

12. Samples of the label of the drug/medicinal ingredient and the package insert of the drug that has been marketed in the country of origin or the country in which the CPP is issued which bears the seal of the representative office or applicant or manufacturer (color prints of the label marketed in the reference country is acceptable). If the package insert of the drug is marketed in the country of origin is not written in English, an English or Vietnamese translation bearing the seal of the representative office, applicant or manufacturer is required.

13. The label sample, the package insert of the to-be-marketed drug shall comply with the Minister of Health’s regulations on labeling of drugs/medicinal ingredients and the following requirements:

a) The label sample and package insert shall bear the seal of the representative office, applicant or manufacturer;

b) The secondary package shall have a bar code, QR (Quick response) code or DataMatrix Code (DMC) in accordance with Point l, Clause 1, Article 48 of this Circular.

14. If the manufacturer is already included in the list of GMP manufacturers posted on the website of the Drug Administration of Vietnam, the GMP documents are not required.

15. Quality standards, test method, test report and stability study documents (for both active ingredients and drug product) shall be original copies bearing the confirmation stamp of the manufacturer or the one responsible for drug quality control or release of the batch if multiple manufacturers involved in the manufacture of finished products; copies shall bear the seal of the applicant (or representative office of the foreign applicant).

In the case where the dossier with respect to active ingredients does not bear the seal of the manufacturer thereof, the manufacturer of the finished drug products must affix its seal and take accountability before the law for the accuracy, legality and truthfulness of such document.

The test report shall contain: administrative information (name and address of the manufacturer, test report number, name and signature of the responsible person, issuance date of the test report) and information about the drug/medicinal ingredient (name, batch number, expiry date, applicable quality standards, specifications, quality requirements, test results and conclusions on quality of the batch).

16. The test report, results of validation of quality standards and test method in Vietnam:

The test report, results of validation of quality standards and test method in Vietnam with respect to manufacturers that have not adopted GMP under the roadmap of the Ministry of Health or those required by Drug Administration of Vietnam according to Appendix III hereof shall be certified by a state-owned drug testing laboratory that satisfies GLP requirements or a profitable drug testing laboratory that has a certificate of eligibility which is an original copy or certified true copy.

17. The certificate that the medicinal ingredient is permitted to be manufactured or marketed in the country of origin, including the following mandatory information: name of the ingredient, name and address of the manufacturer, the country of origin, signature and full name of the signatory.

Article 23. General provisions on administrative documents included in an application dossier for marketing authorization for drug/medicinal ingredients, or for renewal or revision thereof

1. Administrative documents included in an application dossier for marketing authorization of a new pharmaceutical, vaccine or biological consists of:

a) The application made using Form No. 5/TT enclosed herewith;

b) The letter of authorization to act as the applicant (if any);

c) The letter of authorization to sign the application dossier (if any);

d) The label sample, the package insert of the to-be-marketed drug;

dd) The Certificate of Eligibility for Pharmacy Business, as for Vietnamese applicants;

e) Legal documents, license to establish a representative office in Vietnam, as for foreign applicants;

g) Summary of product properties for new pharmaceuticals, vaccines and biologicals, made using Form No. 6/TT enclosed herewith;

h) Legal documents of the manufacturer of active ingredients, excipients, capsule shells, semi-finished and finished herbal ingredients;

i) The certificate of the testing laboratory in the cases mentioned in Clause 16, Article 22 of this Circular;

k) The risk management plan (for vaccines), made using Form No. 7/TT enclosed herewith;

l) Samples of the drug label and package insert actually marketed in the country of origin or CPP-granting country, included in the application dossier for marketing authorization of a foreign drug;

m) CPP, as for foreign applicants;

n) Documents on assessment of GMP compliance in the cases mentioned in Article 95 of Decree No. 54/2017/ND-CP applicable to foreign drug/medicinal ingredient manufacturers applying for the marketing authorization in Vietnam, included in the application dossier for marketing authorization of a foreign drug (unless the applicant has self-announced its GMP compliance on the website of the Drug Administration of Vietnam or submitted an application dossier for GMP compliance assessment to the Drug Administration of Vietnam).

2. Administrative documents included in the application dossier for marketing authorization of generic drugs, herbal drugs, and medicinal ingredients as prescribed at Points a, b, c, d, dd, e, h, i, l, m, n, Clause 1 of this Article and the certificate that permit the medicinal ingredients to be manufactured or marketed in the country of origin included in the application dossier for marketing authorization of foreign-manufactured medicinal ingredients.

3. Administrative documents included in the application dossier for renewal of marketing authorization of pharmaceuticals, vaccines, biologicals, herbal drugs, and medicinal ingredients as prescribed at Points a, c, dd, e, m, n, Clauses 1 of this Article and the following documents:

a) The letter of authorization to act as the applicant in case of change of the applicant at the time the application dossier for renewal is submitted;

b) The marketing report made using Form No. 8/TT enclosed herewith;

c) A copy of the marketing authorization granted in Vietnam;

d) Reports on the safety and efficacy follow-up and the use of drugs made using Form No. 2/TT enclosed herewith to be included in application dossiers for renewal of pharmaceuticals, vaccines, biologicals, and herbal drugs, for which safety and efficacy follow-up reports as prescribed in Clause 2, Article 5 of this Circular are required;

dd) The certificate that permits the medicinal ingredients to be manufactured or marketed in the country of origin, included in the application dossier for marketing authorization of foreign-manufactured medicinal ingredients.

4. Administrative documents included in the application for revision of marketing authorization of pharmaceuticals, vaccines, biologicals, herbal drugs, and medicinal ingredients as prescribed at Points a and c, Clauses 1 of this Article.

5. Administrative documents included in the application dossiers for the marketing authorization following simplified procedures as prescribed at Points a, b, c, d, dd, e, h, i, l, m, Clause 1 of this Article.

Section 2
 APPLICATION DOSSIERS FOR MARKETING AUTHORIZATION OF PHARMACEUTICALS, VACCINES AND BIOLOGICALS, OR RENEWAL OR REVISION THERE OF

Article 24. Quality documents in the application dossier for marketing authorization of pharmaceuticals, vaccines and biologicals, or renewal or revision there of

Quality documents shall comply with Part II - ACTD or 3-ICH-CTD and the following regulations:

1. Regarding vaccines, antiserum, blood extracts and human plasma:

a) The batch release certificate issued by a competent authority of the country in which the CPP is issued as prescribed or any of the regulatory authorities specified in Clause 9, Article 2 of this Circular;

b) The test report, quality standards and test method certified by National Institute for Control of Vaccines and Biologicals.

2. Regarding orphan drugs, drugs meant to serve national defense and security; epidemic control and prevention or disaster relief, or special treatment drugs:

a) Orphan drugs to treat rare medical conditions: existing stability studies according to ASEAN or ICH guidelines;

b) Drugs meant to serve the needs for national defense and security, epidemic control and prevention or disaster relief:

Existing stability studies at the time the application dossiers for review of expiry dates of the drugs are submitted may be acceptable on the basis of opinions provided by the Committee if the duration of such stability studies do not satisfy the requirement for minimum study duration according to ASEAN guidelines.

After the marketing authorization is granted, the applicant must continue to submit the stability studies on the finished products until the actual stability study duration satisfies the ASEAN requirement to the Drug Administration following the procedures for revision as specified in Appendix II of this Circular for the expiry dates thereof to be reviewed and updated in according with the provisions.

In the case where, after the stability studies, the drugs fail to meet the stability as outlined in the application dossier, the applicant must immediately report it to the Drug Administration of Vietnam in order for it be submitted to the Committee for consideration of the expiry dates thereof.

On the basis of the Committee’s recommendations, the Drug Administration of Vietnam shall consider and decide on the expiry dates of the drugs including the manufactured batches based on the actual stability studies.

c) Special treatment drugs: existing stability studies according to ASEAN or ICH guidelines, or any decision of the Minister of Health, which is made on the basis of opinions provided by the Committee if the applicant proves that the drugs cannot be stored in climatic zone IVb according to ASEAN guidelines.

3. If the manufacturer uses medicinal ingredients that have been approved for marketing authorization in Vietnam:

a) Quality documents of the ingredients and the documents mentioned at Point h, Clause 1, Article 23 of this Circular are not required in the application dossier for marketing authorization of the drug;

b) The applicant shall submit the following documents:

- 01 test report of the medicinal ingredients provided by the manufacturer of the drug product the specifications in which are equivalent to or higher than those of the manufacturer of the medicinal ingredients. In the case the manufacturer of finished drug products is incapable of testing all quality criteria, the applicant must provide an analysis report on the missing criteria issued by any state-owned drug testing laboratory or any profitable drug testing laboratory that has a certificate of eligibility;

- 01 test report of the medicinal ingredients provided by the manufacturer of the ingredients.

4. For simplified validation procedures

a) Documents about active ingredients:

- Names of the active ingredients (international non-proprietary names);

- Name and address of the manufacturer of the active ingredients and semi-finished that contain the active ingredients;

- Quality standards and method for testing of the active ingredients and semi-finished that contain the active ingredients. If the Vietnam’s Pharmacopoeia or a reference pharmacopoeia accepted by the Ministry of Health is applied, only the name of the pharmacopoeia is required;

- 01 test report of active ingredients and semi-finished ingredients provided by the manufacturer thereof, and 01 test report of active ingredients and semi-finished ingredients provided by the manufacturer of the drug product;

- For semi-finished active ingredients, the manufacturer shall provide their formula and manufacturing process.

b) Documents about the drug product:

- The description and composition shall comply with Part P.1-ACTD;

- Quality standards and method for testing of the drug product. If the Vietnam’s Pharmacopoeia or a reference pharmacopoeia accepted by the Ministry of Health is applied, only the name of the pharmacopoeia is required;

- Manufacture of finished products, including: batch formulae, manufacturing processes and process controls; control of critical steps and intermediates.

- Test report of drug product;

- Primary package: Appearance description, materials and quality standards;

- Stability studies of the finished drug product.

c) Other quality documents shall comply with Part II - ACTD or 3-ICH-CTD and shall be retained by the authorization holder and the manufacturer.

5. The documents mentioned in this Article shall:

a) Comply with regulations of Appendix I hereof including:

- ACTD;

- Guideline for stability study;

- Guideline for manufacturing process validation;

- Guideline for analytical method validation;

- Guideline on bioavailability and bioequivalence study;

b) Documents that are prepared according to ICH-CTD and guidelines thereof are not required to be converted to the requirements at Point a of this Clause;

c) In case of materials with a Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP): The dossier with respect to active ingredients specified at Points a and b of this Clause may be substituted by the following set of documents:

- A Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) for active ingredients with all annexes issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM);

- Data on analysis of the batch;

- If the deadline for re-inspections of the quality of the active ingredients is not specified in CEP, data on stability study thereof shall be submitted instead.

Article 25. Pre-clinical documents included in the application dossier for marketing authorization of pharmaceuticals, vaccines or biologicals, or revision thereof

Pre-clinical documents shall comply with Part III - ACTD or 4-ICH-CTD.

Pre-clinical documents are not required for probiotics with origins, bacterial strain, concentration or content, indications, doses that are similar to biologicals licensed by any of the regulatory bodies specified in Clause 9, Article 2 of this Circular.

Article 26. Clinical documents in the application dossier for marketing authorization of pharmaceuticals, vaccines or biologicals, or revision thereof

Clinical documents shall comply with Part IV - ACTD or 5-ICH-CTD.

Clinical documents are not required for probiotics with origins, bacterial strain, concentration or content, indications, doses that are similar to biologicals licensed by any of the regulatory bodies specified in Clause 9, Article 2 of this Circular.

Article 27. Application dossier for marketing authorization of pharmaceuticals, vaccines or biologicals, or renewal or revision thereof

1. A dossier for marketing authorization of pharmaceuticals, vaccines or biologicals, or renewal or revision thereof consists of:

a) The administrative documents specified in Clause 1, Article 23 of this Circular;

b) The quality documents specified in Article 24 of this Circular;

c) The pre-clinical documents specified in Article 25 of this Circular;

d) The clinical documents specified in Article 26 of this Circular;

dd) The documents specified at Points a, b, c, d, Clause 1 of this Article and Item 2, Point a, Clause 1, Article 9 of this Circular, if the applicant requests for classification as proprietary drugs or reference biological products when applying for the marketing authorization.

2. An application dossier for marketing authorization of a generic drug consists of:

a) The administrative documents specified in Clause 2, Article 23 of this Circular;

b) The quality documents specified in Article 24 of this Circular.

3. An application dossier for renewal of marketing authorization:

a) The administrative documents specified in Clause 3, Article 23 of this Circular;

b) The documents specified in Appendix II hereof if there are changes to the administrative documents (excluding the change in samples of the label or package insert).

If the applicant has submitted the new administrative documents before submitting the application dossier for renewal but they are not approved, they are not required in the application dossier for renewal of marketing authorization.

4. An application dossier for revision of the marketing authorization consists of:

a) The administrative documents specified in Clause 4, Article 23 of this Circular;

b) Documents suitable for the major variations and minor variations specified in Appendix II hereof. For vaccines of the same manufacturer or product license holder, the manufacturing location may be substituted with another within or outside the country in which the marketing authorization has been granted.

5. An application dossier for the marketing authorization following simplified procedures shall consist of:

a) The administrative documents specified in Clause 5, Article 23 of this Circular;

b) The quality documents specified at Point a and Point b, Clause 4, Article 24 of this Circular.

Section 3. APPLICATION DOSSIERS FOR MARKETING AUTHORIZATION OF HERBAL MEDICINES, OR RENEWAL OR REVISION THEREOF

Article 28. Quality documents in application dossiers for marketing authorization of herbal medicines, or renewal or revision thereof

1. Ingredients

a) The manufacturing process (only applied to herbal ingredients): describe in details the preparation and processing of herbal ingredients. For semi-finished herbal ingredients and bone glue, it is required to describe in details the manufacturing process thereof, except for those that are already approved for marketing authorization;

b) Quality standards and test methods

- For herbal ingredients other than semi-finished herbal ingredients: comply with the provisions in Circular No. 38/2021/TT-BYT;

- Regulations on quality standards and test methods for herbal ingredients other than semi-finished herbal ingredients specified in Circular No. 38/2021/TT-BYT shall also be applied to semi-finished herbal ingredients.

c) Test report of ingredients

- 01 test report of herbal ingredients provided by the manufacturer of the drug product. In the case where the drug product manufacturer is unable to inspect all specifications, it shall provide test reports of remaining criteria provided by a state-owned drug testing laboratory or a profitable drug testing laboratory granted a certificate of eligibility for pharmacy business;

- 01 test report of semi-finished herbal ingredients and bone glue provided by the manufacturer thereof, and 01 test report of semi-finished herbal ingredients and bone glue provided by the manufacturer of the drug product.

2. Drug products

a) Manufacturing process

- Formula of a smallest packaging unit: name, content, concentration, weight, specs of each ingredient in a smallest packaging unit. If the drug product is made of semi-finished herbal ingredients or bone glue, it is required to specify the ratio of herbal ingredients to total weight of semi-finished herbal ingredients or bone glue, the ratio of bone glue or semi-finished herbal ingredients to the initial herbal ingredients and content (%) of the active ingredients or substances therein;

- Batch formula: names, weights, volumes of each ingredient in the formula;

- Manufacturing process diagram: present all stages in the manufacturing process, including the path of ingredients and its consistency with the manufacturing process description;

- Manufacturing process description: describe in details every step of the manufacturing process, including specifications thereof;

- Equipment list: names, specifications and uses of each piece of equipment;

- Control of manufacturing process: describe in details control criteria for each stage, including the criterion, specifications, control method, control frequency and sample size;

b) Quality standards and test methods

- Formula of a smallest packaging unit: name, content, concentration, weight, specs of each ingredient in a smallest packaging unit. If the drug product is made of semi-finished herbal ingredients or bone glue, it is required to specify the ratio of herbal ingredients to total weight of semi-finished herbal ingredients or bone glue, the ratio of bone glue or semi-finished herbal ingredients to the initial herbal ingredients and content (%) of the active ingredients or substances therein;

- Specifications of the drug product shall comply with Circular No. 11/2018/TT-BYT;

c) The test report of drug product;

d) Specifications of packages: Describe in details the material, specifications, quality and test methods;

dd) A stability study report according to the guidelines for stability study in Appendix I issued together with this Circular.

Article 29. Safety and efficacy documents in application dossiers for marketing authorization of herbal medicines, or renewal or revision thereof

1. Safety and efficacy documents of herbal medicines shall comply with the provisions in Appendix V issued together with this Circular, or ACTD or ICH-CTD.

2. The documents specified at Point b, Clause 1, Article 18 of this Circular (if any).

Article 30. Application dossiers for marketing authorization of herbal medicines, or renewal or revision thereof

1. An application dossier for marketing authorization of herbal medicines shall comprise:

a) The administrative documents specified in Clause 2, Article 23 of this Circular;

b) The quality documents specified in Article 28 of this Circular;

c) The safety and efficacy documents specified in Article 29 of this Circular;

2. An application dossier for renewal of marketing authorization of herbal medicines shall comprise:

a) The administrative documents specified in Clause 3, Article 23 of this Circular;

b) Relevant documents as specified in Section D, Appendix II issued together with this Circular in the case where there are changes in the administrative dossiers of the drug at the time of application for renewal of the marketing authorization (excluding changes in samples of the label and package insert).

If the marketing authorization applicant has submitted the changed documents included in the administrative dossier before submitting the application dossier for renewal, such documents are not required in the application dossier for renewal even if they are yet to be approved.

3. An application dossier for revision of the marketing authorization of herbal medicines shall comprise:

a) The administrative documents specified in Clause 4, Article 23 of this Circular;

b) Documents about major variations and minor variations according to Section D, Appendix II issued together with this Circular.

Section 4. MEDICINAL INGREDIENT MARKETING AUTHORIZATION APPLICATION DOSSIER

Article 31. Quality documents in application dossiers for marketing authorization of medicinal ingredients, or renewal or revision thereof

1. With regard to active ingredients: Comply with the documents of active ingredients specified in ACTD. Submit the Drug Master File if the manufacturer’s specifications are applied.

2. With regard to semi-finished active ingredients: Comply with the same documents specified in ACTD as those of drug products, in which the documents about the drug product will be replaced with the documents about the semi-finished products; the formula of a single dose or smallest packaging unit will be replaced with the batch formula.

3. With regard to semi-finished herbal ingredients, excipients and capsule shells:

a) Formula of the semi-finished herbal ingredients, pre-mixed excipients, capsule shells: composition, weight, volume, quality standards of each component of the formula. In cases of using ingredients derived from animals, information regarding adventitious agents shall be provided (viral safety data);

b) Manufacturing process

- Manufacturing process diagram: describe all stages in the manufacturing process, including the path of ingredients and its consistency with the manufacturing process description;

- Manufacturing process description: describe in details every step of the manufacturing process, including specifications thereof;

- Equipment list: names, specifications and uses of each equipment;

- Control of manufacturing process: Describe in details control criteria for each stage, including the criterion, specifications, control method, control frequency and sample size.

c) Quality standards and test method

- Regulations on quality standards and test methods for herbal ingredients other than semi-finished herbal ingredients specified in Circular No. 38/2021/TT-BYT shall also be applied to semi-finished herbal ingredients;

- Specifications of excipients and capsule shells shall comply with Circular No. 11/2018/TT-BYT.

d) The test report;

dd) Specifications of packages: Describe in details the material, specifications, quality and test method;

e) The stability study report, including the stability study proposal, data, result and discussion.

Article 32. Application dossiers for marketing authorization of medicinal ingredients, or renewal or revision thereof

1. An application dossier for marketing authorization of medicinal ingredients shall comprise:

a) The administrative documents specified in Clause 2, Article 23 of this Circular;

b) The quality documents specified in Article 31 of this Circular.

2. An application dossier for renewal of marketing authorization of medicinal materials shall comprise:

a) The administrative documents specified in Clause 3, Article 23 of this Circular;

b) Relevant documents as specified in Section B of Appendix II issued together with this Circular if there are changes to the administrative dossier of the medicinal ingredients at the time of application for renewal of the marketing authorization (excluding changes in samples of the label).

If the marketing authorization applicant has submitted the changed documents included in the administrative dossier before submitting the application dossier for renewal, such documents are not required in the application dossier for renewal even if they are yet to be approved.

3. An application dossier for revision of the marketing authorization of medicinal ingredients shall comprise:

a) The administrative documents specified in Clause 4, Article 23 of this Circular;

b) Documents about major variations and minor variations as specified in Section B, Appendix II issued together with this Circular.

Chapter IV

PROCEDURES FOR MARKETING AUTHORIZATION OF DRUGS/MEDICINAL INGREDIENTS, OR RENEWAL, OR REVISION THEREOF; PROCESS FOR VALIDATION OF APPLICATION DOSSIERS FOR IMPORT OF DRUGS THAT ARE YET TO BE APPROVED FOR MARKETING AUTHORIZATION

Article 33. Drugs eligible for quick and simplified validation

1. Drugs eligible for quick validation

A marketing authorization application dossier will be eligible for quick validation process if one of the following conditions is satisfied:

a) Drugs are included in the list of rare drugs announced by the Minister of Health;

b) Drugs serve urgent needs for national defense and security, epidemic control or disaster recovery;

c) Drugs are domestically manufactured by new production lines that satisfy GMP standard, or by upgraded production lines that satisfy GMP-EU or GMP-PIC/S standards and equivalent standards within 18 months from the issuance date of the GMP certificate;

d) Vaccines have been prequalified by WHO; vaccines are used for national expanded immunization programs;

dd) Specialty drugs, drugs with special dosage forms where not more than 02 similar drugs (with the same active ingredients, dosage form, content or concentration) have an unexpired marketing authorization in Vietnam when the application dossier is submitted, including:

- Antineoplastic drugs;

- Next-gen antiviral drugs;

- Next-gen antibiotics;

- Drugs for treatment of hemorrhagic fever, tuberculosis, malaria;

- Immunosuppressive drugs used in organ transplantation.

e) Drugs that can be domestically manufactured, including:

- Antineoplastic drugs, vaccines, biologicals, next-gen antiviral drugs, next-gen antibiotics, and immunosuppressive drugs used in organ transplantation that are manufactured in Vietnam under a processing agreement or technology transfers agreement;

- Herbal medicines under a national, ministerial or provincial research which has been accepted; drugs wholly obtained from domestic herbal ingredients that satisfy GACP standards;

- New domestically- manufactured drugs have undergone clinical trials in Vietnam;

g) New drugs (antineoplastic drugs, next-gen antiviral drugs, next-gen antibiotics), and reference biologicals;

h) Proprietary drugs are manufactured in Vietnam under a processing agreement or technology transfer agreement;

i) Drugs of which manufacturer is changed resulting in application for issuance of a new marketing authorization as prescribed at Point b Clause 2, Article 55 of the Law on Pharmacy.

2. Drugs eligible for simplified validation

A marketing authorization application dossier will be eligible for simplified validation process if all of the following conditions are satisfied:

a) Drugs are manufactured in a factory that periodically undergoes GMP inspection by the Drug Administration of Vietnam;

b) Drugs are included in the list of OTC drugs;

c) The dosage form of drugs is not modified-release;

d) Drugs are not directly applied to the eye.

Article 34. Power to grant marketing authorization, renewal, revision of marketing authorization for drugs and medicinal ingredients

1. The Drug Administration of Vietnam and units decided by the Minister of Health (hereinafter referred to as “validating units”) shall appraise application dossiers for marketing authorization of drugs and medicinal ingredients, renewal and revision thereof, except for regulations at Point b, Clause 2 of this Article.

2. The Drug Administration of Vietnam shall:

a) Grant the marketing authorization, renew and approve revision of the marketing authorization of drugs, declaration of proprietary drugs, reference biologicals, drugs with demonstrated bioequivalence on the basis of opinions given by the Committee in each specific case or general guidelines given by the Committee applied to each type of revision, except the cases specified at Point b of this Clause;

b) Publish on its website the minor variations to the marketing authorization of drugs/medicinal ingredients that only require notification.

Article 35. General provisions on procedures for marketing authorization of drugs/medicinal ingredients, or renewal, revision thereof

1. Application dossiers may be submitted online, in person or by post to the Drug Administration of Vietnam.

2. After receiving adequate dossiers, the Drug Administration of Vietnam shall issue the receipt note, made according to Form No. 9/TT issued together with this Circular to the applicant.

The Drug Administration of Vietnam shall receive the dossiers without requesting the applicant to submit CPP in the case prescribed at Point e, Clause 4, Article 22 of this Circular and the documents specified at Point b, Clause 1, Article 24 of this Circular at the submission time.

3. Receipt of application dossier for import of unapproved drugs shall comply with the provisions of Point b, Clause 1, Article 77 of Decree No. 54/2017/ND-CP.

4. Validation of application dossiers for the marketing authorization of drugs/medicinal ingredients, or renewal, revision thereof and application dossiers for import of drugs that are yet to be approved for marketing authorization (hereinafter referred to as unapproved drugs):

a) The Drug Administration of Vietnam shall send received dossiers to validators or units assigned by the Ministry of Health on the basis of the list of validators approved by the Drug Administration of Vietnam or validating units;

b) On the basis of opinions given by the validators or validating units and relevant information, the Drug Administration of Vietnam shall propose approval or rejection of the application dossiers for marketing authorization of drugs/medicinal ingredients, or renewal, revision thereof or application dossiers for import of unapproved drugs. The proposal of the Drug Administration of Vietnam shall be written on the validation record;

c) The Drug Administration of Vietnam shall consult with the Committee about its proposal as prescribed at Point b of this Clause in the following cases:

- Whether to issue, renew or approve the revision of the marketing authorization of drugs/medicinal materials, except for the cases specified in Clause 5 of this Article;

- Whether to declare the proprietary drugs or reference biologicals, unless the applicant is not required to submit the application dossier for classification of proprietary drugs or reference biologicals as prescribed in Article 9 of this Circular;

- Whether to issue the license to import an unapproved drug;

- Other cases proposed by the Drug Administration of Vietnam to serve urgent treatment.

5. An application dossier for marketing authorization of drugs/medicinal ingredients, renewal or revision thereof may be modified up to 03 times. If the dossier is still unsatisfactory after 03 times of modification, the Drug Administration of Vietnam shall give a notification to reject the dossier. The submitted application dossier will no longer be valid.

Article 36. Procedures for issuance of marketing authorization of drugs, and validation process for application dossiers for import of unapproved drugs

1. Within 12 months from the receipt of an adequate application dossier for marketing authorization (except for the case specified in Article 39 of this Circular), the Drug Administration of Vietnam shall issue marketing authorization. If the application dossier is not satisfactory, the Drug Administration of Vietnam shall respond in writing and provide explanations, specifically as follows:

a) Within 02 months from the receipt of an application dossier, the Drug Administration of Vietnam shall review, classify and transfer it to the validator or validating unit. Within 06 months from the receipt of the application dossier from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for making proposal in accordance with Clause 4 Article 35 of this Circular;

b) Within 02 months from the receipt of the validation record, the Drug Administration of Vietnam shall send a notice of rejection and provide explanation if the application dossier is not satisfactory. If the Drug Administration of Vietnam makes the proposal or needs to obtain opinions from the Committee about an application dossier, it shall transfer the application dossier to the Office of the Committee for holding a meeting;

c) Within 01 month from the receipt of documents from the Drug Administration of Vietnam, the Office of the Committee shall hold a meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 01 month from the receipt of the meeting minutes from the Committee, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application dossier is satisfactory; the Drug Administration of Vietnam shall send a notice of rejection and provide explanation if the application dossier is not satisfactory according to the conclusions given by the Committee.

2. Within 36 months from the date on which the Drug Administration of Vietnam requests submission of additional pre-clinical and clinical documents, bioequivalence documents, or stability study documents or 12 months for other additional documents, the marketing authorization applicant shall provide the additional documents as requested. In the case where the applicant fails to submit the additional documents after this time limit, the submitted application dossier shall be no longer valid.

During the validation of the submitted application dossier, the marketing authorization applicant shall be allowed to send a written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug or legal papers of the marketing authorization applicant, the drug or medicinal ingredient manufacturer compared with the submitted application dossier.

The time limit specified in Clause 5, Article 56 of the Law on Pharmacy shall exclude the period from the date on which the Drug Administration of Vietnam issues the request for additional documents to the date on which the additional documents are submitted.

3. Within 06 months from the receipt of adequate additional documents, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application dossier is satisfactory, or send a notice of rejection if the application dossier is not satisfactory according to the conclusions given by the Committee, or send a notice of rejection and provide explanation if the application dossier is not satisfactory. Processing deadlines are specified as follows:

a) Within 01 month from the receipt of an application dossier, the Drug Administration of Vietnam shall review, classify and transfer it to the validator or validating unit. Within 02 months from the receipt of the application dossier from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for summing up and making proposal in accordance with Clause 4, Article 35 of this Circular;

b) Within 01 month from the receipt of the validation record, the Drug Administration of Vietnam shall send a notice of rejection and provide explanation if the application dossier is not satisfactory. If the Drug Administration of Vietnam makes the proposal or needs to obtain opinions from the Committee about an application dossier, it shall transfer the application dossier to the Office of the Committee for holding a meeting;

c) Within 01 month from the receipt of documents from the Drug Administration of Vietnam, the Office of the Committee shall hold a Council meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 01 month from the receipt of the meeting minutes from the Committee, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application is satisfactory; the Drug Administration of Vietnam shall send a notice of rejection and provide explanation if the application dossier is not satisfactory according to the conclusions given by the Committee.

4. Validation of an application dossier for import of unapproved drugs:

a) Within 05 working days from the receipt of an adequate application dossier, the Drug Administration of Vietnam shall transfer it to the validator or validating unit.

The validation must be completed within a maximum duration of 30 days from the receipt of the dossier if clinical data or documents proving that the drug is similar to a reference biological are not mandatory, or 60 days from the receipt of the dossier if clinical data or documents proving that the drug is similar to a reference biological are mandatory;

b) Within 20 days from the receipt of the validation record:

- The Drug Administration of Vietnam shall consolidate opinions from the validators or validating units and consider relevant information to decide whether to propose the grant of the import license.

- If an application dossier needs to be submitted to the Committee as prescribed at Point c, Clause 4, Article 35 of this Circular, the Drug Administration of Vietnam shall submit it in the next meeting;

- If an application dossier is unsatisfactory, the Drug Administration of Vietnam shall send a notice of rejection and provide explanation.

c) Within 05 working days from the receipt of the meeting minutes from the Committee, the Drug Administration of Vietnam shall grant the import license if the dossier is satisfactory, or send a notice of rejection and provide explanation if the dossier is not satisfactory according to the conclusions given by the Committee;

d) After receiving the modified application dossier from the marketing authorization applicant, the Drug Administration of Vietnam shall comply with the provisions at Points a, b and c of this Clause.

If the Committee requests modification of the dossier without resubmission of the dossier, the Drug Administration of Vietnam shall inform the applicant and, if the modified dossier is satisfactory, grant the license without resubmitting to the Committee.

Article 37. Procedures for renewal of marketing authorization of drugs/medicinal ingredients

1. Within 03 months from the receipt of an adequate application dossier, the Drug Administration of Vietnam shall renew the marketing authorization of drug/medicinal ingredient. In case of refusing or delaying the renewal, the Drug Administration of Vietnam shall issue a written reply, clearly stating the reason. Processing deadlines are specified as follows:

a) Within 08 working days from the receipt of an application, the Drug Administration of Vietnam shall review, classify and transfer it to the validator or validating unit. Within 01 month from the receipt of the application from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for summarization and conclusion in accordance with Clause 4, Article 35 of this Circular;

b) Within 12 working days from the receipt of the validation record, the Drug Administration of Vietnam shall make a notice of rejection and provide explanation if the dossier is not satisfactory. If the Drug Administration of Vietnam makes the proposal or needs to obtain opinions from the Committee about an application dossier, it shall transfer the application dossier to the Office of the Committee for holding a meeting;

c) Within 06 working days from the receipt of documents from the Drug Administration of Vietnam, the Office of the Committee shall hold a Council meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 18 working days from the receipt of the meeting minutes from the Committee, the Drug Administration of Vietnam shall issue a decision to renew the marketing authorization if the application dossier is satisfactory; the Drug Administration of Vietnam shall give a notice of rejection and provide explanation if the application dossier is not satisfactory according to the conclusions given by the Committee.

2. The marketing authorization applicant shall provide additional documents within 12 months from the date on which it receives a request from the Drug Administration of Vietnam. In the case where the applicant fails to submit the additional documents after this time limit, the submitted application dossier shall be no longer valid.

During the validation of the submitted application dossier, the marketing authorization applicant shall be allowed to send a written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug or legal papers of the applicant, the drug or medicinal ingredient manufacturer compared with the submitted dossier.

The time limit prescribed in Clause 5, Article 56 of the Law on Pharmacy shall exclude the period from the date on which the Drug Administration of Vietnam issues the request for additional documents to the date on which the additional documents are submitted.

3. Within 03 months from the receipt of adequate additional documents, the Drug Administration of Vietnam shall issue a decision to renew the marketing authorization if the application dossier is satisfactory; the Drug Administration of Vietnam shall give a notice of rejection and provide explanation if the application dossier is not satisfactory according to the conclusions given by the Committee.

Order and time limits for examining additional documents shall comply with the provisions of Clause 1 of this Article.

Article 38. Procedures for revision of unexpired marketing authorization of drugs/medicinal ingredients

1. Revision of the marketing authorization of drugs/medicinal ingredients, except for the cases specified in Clause 2 of this Article

The Drug Administration of Vietnam shall process the revision application dossier within 03 months from the receipt of adequate documents. In case of refusing or delaying the approval, the Drug Administration of Vietnam shall issue a written reply, clearly stating the reason. Processing deadlines are specified as follows:

a) Within 08 working days from the receipt of an adequate application dossier, the Drug Administration of Vietnam shall review, classify and transfer it to the validator or validating unit. Within 01 month from the receipt of the application dossier from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for summing up and concluding in accordance with Clause 4, Article 35 of this Circular;

b) Within 12 working days from the receipt of the validation record, the Drug Administration of Vietnam shall make a notice of rejection and provide explanation if the application dossier is not satisfactory. If the dossier is satisfactory or requires opinions from the Committee, the Drug Administration of Vietnam shall transfer it to the Office of the Committee for holding a meeting;

c) Within 06 working days from the receipt of the application from the Drug Administration of Vietnam, the Office of the Committee shall hold a Council meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 18 working days from the receipt of the meeting minutes from the Committee, the Drug Administration of Vietnam shall declare the proprietary drug, reference biological or drug with demonstrated bioequivalence, approve revised contents or send a notice of rejection and provide explanation if the dossier is not satisfactory according to conclusions given by the Committee.

2. Minor variations that only require notification:

Within 15 working days from the receipt of an adequate application dossier, the Drug Administration of Vietnam shall classify and publish minor variations that only require notification on its website. If the revised contents cannot be classified as minor variations that only require notification, the Drug Administration of Vietnam shall give a written notification.

The applicant shall make and assume the full responsibility for the revised contents from the date of the application receipt note. The applicant/drug manufacturer shall assume legal responsibility for the accuracy and truthfulness of minor variations that only require notification, and retain relevant documents to serve competent agencies’ post-sale inspection.

3. Within 36 months from the date on which the Drug Administration of Vietnam requests submission of additional pre-clinical and clinical documents, bioequivalence documents or stability study documents or 12 months for other additional documents, the applicant shall provide the additional documents as requested. In the case where the applicant fails to submit the additional documents after this time limit, the submitted application dossier shall be no longer valid.

During the validation of the submitted application dossier, the applicant shall be allowed to send a written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug or legal papers of the applicant, the drug or medicinal ingredient manufacturer compared to the submitted dossier.

The time limit prescribed in Clause 5, Article 56 of the Law on Pharmacy shall exclude the period from the date on which the Drug Administration of Vietnam issues the request for additional documents to the date on which the additional documents are submitted.

4. Within 02 months from the receipt of adequate additional documents as prescribed in Clause 1 of this Article, the Drug Administration of Vietnam shall approve the revision if the application dossier is satisfactory, or send a notice of rejection and provide explanation if the application dossier is not satisfactory. Processing deadlines are specified as follows:

a) Within 05 working days from the receipt of an adequate application dossier, the Drug Administration of Vietnam shall review, classify and transfer it to the validator or validating unit. Within 08 working days from the receipt of the application dossier from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for consideration in accordance with Clause 4 Article 35 of this Circular;

b) Within 07 working days from the receipt of the validation record, the Drug Administration of Vietnam shall send a notice of rejection and provide explanation if the application dossier is not satisfactory. If the application dossier is satisfactory or requires opinions from the Committee, the Drug Administration of Vietnam shall transfer it to the Office of the Committee for holding a meeting;

c) Within 06 working days from the receipt of documents from the Drug Administration of Vietnam, the Office of the Committee shall hold a Council meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 18 working days from the receipt of the meeting minutes from the Committee, the Drug Administration of Vietnam shall declare the proprietary drug, reference biological or drug with demonstrated bioequivalence; approve the revision if the application dossier is satisfactory. The Drug Administration of Vietnam shall send a notice of rejection and provide explanation if the application dossier is not satisfactory according to conclusions given by the Committee.

5. The implementation of the revisions to the marketing authorization must be completed within 12 months from the date on which the Drug Administration of Vietnam gives approval for such revisions.

6. The marketing authorization applicant or drug manufacturer shall update the label and package insert of the drug without submitting a revision application dossier or sending notification to the Drug Administration of Vietnam in the following cases:

a) The label or package insert is carried out in accordance with Clause 2, Article 35 of Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health;

b) The label or package insert is revised according to the Official Dispatch given by the Drug Administration of Vietnam to instruct the implementation of guidelines of the Committee;

c) Unless the sample label or package insert has to be submitted in cases of revision specified in Appendix II issued together with this Circular, other revisions to the label or package insert shall be updated by the marketing authorization applicant or manufacturer after the revisions are approved by the Drug Administration of Vietnam.

d) Other contents:

- Change to information position or information about the importer on the label or package insert;

- Correction of spelling errors on the label or package insert;

- Change in the order of information on the package insert without change to information thereof which has been approved;

- Addition of information on quality standards to the label or package insert approved by the Drug Administration of Vietnam;

- Removal of information other than the compulsory one on the label or package insert.

Article 39. Issuance of marketing authorization of drugs following quick and simplified validation procedures and grant of marketing authorization of medicinal ingredients

1. Within 06 months from the receipt of an adequate application dossier, the Drug Administration of Vietnam shall grant the marketing authorization of drugs/medicinal ingredients. If the dossier is not satisfactory, the Drug Administration of Vietnam shall a notice of rejection and provide explanation. Processing deadlines are specified as follows:

a) Within 16 working days from the receipt of an adequate application dossier, the Drug Administration of Vietnam shall classify and transfer it to the validator or validating unit. Within 03 months from the receipt of the application dossier from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for summing up and concluding in accordance with Clause 4, Article 35 of this Circular;

b) Within 18 working days from the receipt of the validation record, the Drug Administration of Vietnam shall make a notice of rejection and provide explanation if the application dossier is not satisfactory. If the application dossier is satisfactory or unsatisfactory or requires opinions from the Committee, the Drug Administration of Vietnam shall transfer it to the Office of the Committee for holding a meeting;

c) Within 10 working days from the receipt of documents from the Drug Administration of Vietnam, the Office of the Committee shall hold a Council meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 01 month from the receipt of the meeting minutes from the Committee, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application dossier is satisfactory; the Drug Administration of Vietnam shall give a notice of rejection and provide explanation if the application dossier is not satisfactory according to the conclusions given by the Committee.

2. Within 36 months from the date on which the Drug Administration of Vietnam requests submission of additional pre-clinical and clinical documents, bioequivalence documents or stability study documents or 12 months for other additional documents, the marketing authorization applicant shall provide the additional documents as requested. In the case where the applicant fails to submit the additional documents after this time limit, the submitted application dossier shall be no longer valid.

During the validation of the submitted application dossier, the applicant shall be allowed to send a written notification to the Drug Administration of Vietnam of updated information about safety and efficacy of the drug or legal documents of the applicant, the drug or medicinal material manufacturer.

The time limit prescribed in Clause 5, Article 56 of the Law on Pharmacy shall exclude the period from the date on which the Drug Administration of Vietnam issues the request for the additional documents to the date on which the additional documents are submitted.

3. Within 03 months from the receipt of adequate additional documents, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application dossier is satisfactory; the Drug Administration of Vietnam shall send a notice of rejection and provide explanation if the application dossier is not satisfactory according to the conclusions given by the Committee. Processing deadlines are specified as follows:

a) Within 10 working days from the receipt of an application dossier, the Drug Administration of Vietnam shall review, classify and transfer it to the validator or validating unit. Within 16 working days from the receipt of the application dossier from the Drug Administration of Vietnam, the validator or validating unit shall send a validation record to the Drug Administration of Vietnam for summing up and making proposal in accordance with Clause 4, Article 35 of this Circular;

b) Within 08 working days from the receipt of the validation record, the Drug Administration of Vietnam shall send a notice of rejection and provide explanation if the dossier is not satisfactory. If the Drug Administration of Vietnam makes the proposal to approve or reject or needs to obtain opinions from the Committee about the application dossier, it shall transfer the dossier to the Office of the Committee for holding a meeting;

c) Within 10 working days from the receipt of documents from the Drug Administration of Vietnam, the Office of the Committee shall hold a Council meeting and send the meeting minutes to the Drug Administration of Vietnam;

d) Within 01 month from the receipt of the meeting minutes from the Committee, the Drug Administration of Vietnam shall issue a decision to grant the marketing authorization if the application dossier is satisfactory; the Drug Administration of Vietnam shall send a notice of rejection and provide explanation if the application dossier is not satisfactory according to the conclusions given by the Committee.

Chapter V

REVOCATION OF MARKETING AUTHORIZATION, TEMPORARY SUSPENSION OF SUBMISSION OF APPLICATION DOSSIERS FOR MARKETING AUTHORIZATION OR RENEWAL THEREOF

Article 40. Competence and procedures for revocation of marketing authorization of drugs and medicinal ingredients

1. Competence to revoke the marketing authorization and responsibility to inform the revocation:

a) The Drug Administration of Vietnam shall consider revoking the marketing authorization in the cases specified in Clause 1, Article 58 of the Law on Pharmacy;

b) Provincial or municipal Departments of Health and health authorities affiliated to supervisory ministries shall take charge of notifying the revocation decisions issued by the Drug Administration of Vietnam in their provinces.

2. Procedures for revocation of marketing authorization of the drugs and medicinal ingredients specified at Points a and b, Clause 1, Article 58 of the Law on Pharmacy:

Within 30 days from the issuance date of the decision to recall a drug, the Drug Administration of Vietnam shall issue a decision to revoke the marketing authorization of the drug/medicinal ingredient.

3. Procedures for revocation of marketing authorization of the drugs/medicinal ingredients specified at Points d and dd, Clause 1, Article 58 of the Law on Pharmacy

Within 30 days from the date on which a competent authority reaches the conclusion that documents in the marketing application dossier is forged, or the drug/medicinal ingredient is manufactured at a location other than the registered one, the Drug Administration of Vietnam shall issue a decision to revoke the marketing authorization of the drug/medicinal ingredient.

4. Procedures for revocation of marketing authorization of the drugs/medicinal ingredients specified at Points c and e, Clause 1, Article 58 of the Law on Pharmacy

Within 10 days from the date on which a notification that the drugs are not safe or effective on human is given by a Vietnamese competent authority or WHO or country of origin, or a foreign competent authority revokes the product certificate, the Drug Administration of Vietnam shall issue a decision to revoke the marketing authorization of the drugs/medicinal ingredients.

5. Procedures for revocation of marketing authorization of the drugs/medicinal ingredients specified at Point g, Clause 1, Article 58 of the Law on Pharmacy:

a) A written request for revocation of the marketing authorization, made according to Form No. 1/TT enclosed herewith, shall be submitted;

b) Within 20 days from receipt of the request, the Drug Administration of Vietnam shall issue a decision to revoke the marketing authorization of the drugs/medicinal ingredients.

Article 41. Temporarily suspending the submission application dossiers for marketing authorization of drugs and medicinal ingredients, or renewal thereof

1. The submission of application dossiers for marketing authorization or renewal thereof will be temporarily suspended in accordance with Clauses 2, 3 and 4, Article 100 of Decree No. 54/2017/ND-CP.

2. The Drug Administration of Vietnam shall be responsible for informing of the temporary suspension of application susbmissions.

Chapter VI

PRINCIPLES FOR ORGANIZATION AND OPERATION OF ADVISORY BOARD, VALIDATING UNITS AND VALIDATORS

Article 42. Organization and operation of the Committee

1. The Committee is established by the Minister of Health. The Committee is composed of experts whose qualifications and experience are appropriate for validating application dossiers, questioning opinions of validators and proposals of the Drug Administration of Vietnam, and providing the Minister of Health with advice about pharmacy laws, safety and efficacy documents of drugs/medicinal ingredients.

2. The Committee has the responsibility to provide the Minister of Health with advice on issuance, renewal, revision of marketing authorization; issuance of license to import unapproved drugs on the basis of validation conclusions given by validators and proposals of the Drug Administration of Vietnam, and relevant issues at the request of the Minister of Health. The Committee shall assume responsibility before the Minister of Health for its advice and opinions.

3. Operation of the Committee:

a) The Committee operates according to the principles of unanimity, democracy, objectivity and transparency. The Committee shall give opinions on a scientific and lawful basis while taking account of validation conclusions given by validators, clinical reality and proposals of the Drug Administration of Vietnam;

b) Every meeting of the Committee shall be attended by at least 2/3 of its qualified members (according to the regulations on organization and operation of the Committee announced by the Ministry of Health), including those who send their opinions in writing without attending the meeting;

The chairperson or a person authorized by the chairperson to chair the meeting shall draw the conclusion when it is approved by at least 2/3 of the participants. Dissenting opinions shall be reserved.

Opinions, including dissenting opinions, of the members and the conclusions drawn by the Committee shall be written in the meeting minutes.

c) In the case where a meeting is not held, the chairperson shall obtain written opinions from its members;

After the time limit for sending opinions, the chairperson or a person authorized by the chairperson shall reach conclusions when at least 2/3 of the members have sent their opinions to the Standing Unit of the Committee for summing up.    

The conclusions of the Committee shall be reached based on consenting opinions of at least 2/3 of its members, the consolidated report and proposal of the Drug Administration of Vietnam;

The conclusions of the Committee shall be written in the statement of conclusions of its chairperson or the person authorized by the chairperson.

d) Where necessary, members of the Committee are entitled to consider and validate the application dossier, and the chairperson may seek opinions from independent experts other than its members before reaching final conclusions. These experts may participate in the meeting of the Committee or send their written opinions, have the same responsibilities and rights as those of the members of the Committee;

dd) Conflict of interest rules must be observed.

4. The Drug Administration of Vietnam shall advise the Minister of Health to promulgate regulations on the organization and operation of the Committee, the mechanism for cooperation between the Committee and validators in the course of issuance, renewal and revision of marketing authorizations and licenses for import of unapproved drugs.

5. Operating budget of the Advisory Council shall comply with the law provisions.

6. The Standing Unit of the Committee shall be situated within the Drug Administration of Vietnam.

Article 43. Organization and operation of validating units, validators of application dossiers for issuance, renewal and revision of marketing authorization and application dossiers for license to import unapproved drugs

1. The Drug Administration of Vietnam and validating units shall establish validating teams in charge of validating legal documents, quality standards, pharmacology, clinical data, dosage form, stability, bioequivalence and list of experts of validating teams in charge of validating application dossiers for issuance, renewal and revision of marketing authorization and application dossiers for license to import unapproved drugs. The composition of each validating team shall be consistent with the registered product and the registration form or the product requested for import license and the form of application for import license.

2. Validators’ opinions shall be given on a lawful and scientific basis, and written in the validation records of application dossiers for issuance, renewal and revision of marketing authorization and application dossiers for license to import unapproved drugs. Validators shall assume the responsibility before the Director of the Drug Administration of Vietnam and validating units for their validation works and opinions about such application dossiers.

3. The Drug Administration of Vietnam shall, within the ambit of its assigned functions and tasks, formulate and issue regulations on organization and operation of teams of validators (including experts of validating units) in charge of validating application dossiers for issuance, renewal and revision of marketing authorization and application dossiers for license to import unapproved drugs; sign contracts with validators or validating units;

The Drug Administration of Vietnam and validating units shall provide training courses for validators; organize assessment of the validators’ knowledge and compliance with the law provisions, which is the basis for replacement or employment of validators.

4. Funding for validation shall be allocated in accordance with the law provisions.

Chapter VII

IMPLEMENTATION PROVISIONS

Article 44. Effect

1. This Circular takes effect on October 20, 2022.

2. The following provisions are annulled:

a) Circular No. 32/2018/TT-BYT dated November 12, 2018 of the Minister of Health, on marketing authorization of drugs and medicinal ingredients;

b) Clause 3, Article 1 of Circular No. 23/2021/TT-BYT dated December 09, 2021 of the Minister of Health, on amending and supplementing a number of legal documents promulgated by the Minister of Health;

c) Clause 5, Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020 of the Minister of Health, on amending, supplementing and annulling a number of legal documents promulgated and jointly promulgated by the Minister of Health;

d) Point h, Clause 3, Article 14 of Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health, on labeling and package inserts of drugs and medicinal ingredients.

Article 45. Transitional provisions

1. Application dossiers that have been submitted before the effective date of this Circular shall be processed in accordance with regulations in force at the submission time, unless the applicants wish to apply regulations of this Circular when it takes effect.

2. Application dossiers that have been submitted before the effective date of this Circular and are currently under consideration may be processed in accordance with relevant regulations of this Circular or regulations in force before the effective date of this Circular whichever is favorable for enterprises, organizations and individuals.

3. With regard to a drug for which the application dossier for marketing authorization has been submitted in accordance with regulations in force before the effective date of Circular No. 32/2018/TT-BYT and which has been granted the marketing authorization or has the marketing authorization renewed, drug products shall be only made of medicinal ingredients supplied by manufacturers that meet GMP requirements within an appropriate scope as specified in Article 141 of Decree No. 54/2017/ND-CP. Manufacturers and applicants shall retain documentary evidences as specified in Clause 11, Article 22 of this Circular and present them to competent agencies as requested.

4. Application dossiers for marketing authorization of Covid-19 vaccines to serve urgent demand shall comply with the provisions of Circular No. 11/2021/TT-BYT dated August 19, 2021 of the Minister of Health, guiding the marketing authorization of Covid-19 vaccines in urgent cases.

5. Within 12 months from the date on which the updated CPP format is published on WHO’s website, applicants shall provide CPP containing adequate information as the updated CPP format. CPP of former format may be accepted if it is still valid at the date of application submission.

6. Provisions on reference authorities specified in Clause 9, Article 2 of Circular No. 32/2018/TT-BYT referred to in other legal documents shall remain valid until these documents are amended, supplemented or annulled.

7. With regard to proprietary drugs declared by the Ministry of Health before the effective date of this Circular, the Drug Administration of Vietnam shall be assigned to modify or update information about such declared proprietary drugs at the request of applicants.

8. In the case where Appendixes I, III and IV enclosed herewith are updated according to ASEAN common technical requirements, within 06 months from the date on which updated technical documents are published on ASEAN website (https://asean.org/our-communities/economic-community/standard-and-comformance/key-documents-publications/), the Drug Administration of Vietnam shall organize translation and publish updated translations on both its website and the website of the Ministry of Health.

Within 06 months from the date on which updated translations are published on its website and the website of the Ministry of Health of, applicants and manufacturers are required to update them in their application dossiers.

9. Drugs manufactured in Vietnam under technology transfer agreements and drugs undergoing secondary packaging shall still be treated in accordance with the provisions of Circular No. 32/2018/TT-BYT until Circular prescribing marketing authorization of drugs manufactured in Vietnam under processing agreements or technology transfer agreements promulgated by the Ministry of Health is promulgated and takes effect.

Article 46. Implementation roadmap

1. Since this Circular takes effect, the manufacturer that has more than 02 drugs which have the same active ingredients or herbal ingredients, dosage form, administration route, content or concentration in a unit dose and which have been granted the marketing authorization shall, when applying for renewal of the marketing authorization, shall cooperate with the applicant to select and apply for renewal of the marketing authorization of 02 drugs as prescribed in Clause 6, Article 8 of this Circular; the marketing authorization of other drugs shall be renewed until December 31, 2025 inclusively.

2. When applying for import of medicinal ingredients which are excipients and capsule shells for manufacturing of domestically manufactured drugs/medicinal ingredients granted the marketing authorization before the effective date of this Circular: Before the first shipment to Vietnam, the applicant shall update information about the medicinal ingredients which are excipients and capsule shells in its approved application dossier on the online public service system of the Drug Administration of Vietnam. Within 05 working days from the date on which information is updated on the system, the Drug Administration of Vietnam shall complete the declaration. The applicant shall assume responsibility for the accuracy of its updated information in comparison with the information included in its approved application dossier, and shall not be required to update information for the following shipment.

3. Application of registration numbers using the structure specified in Appendix VI enclosed herewith when issuing or renewing marketing authorization shall start from January 01, 2023. When renewing the marketing authorization of drugs granted registration numbers before January 01, 2023, such registration numbers may continue to be used for a maximum duration of 12 months from the registration number issued using the structure specified in Appendix VI enclosed herewith.

Article 47. Reference provisions

If any legal documents or regulations referred to in this Circular are amended or supplemented, the newest one shall prevail.

Article 48. Responsibility for implementation

1. The Drug Administration of Vietnam shall, within the ambit of its assigned functions and tasks, and pursuant to the roadmap for ASEAN harmonization of drug registration, assume the responsibility to:

a) Implement and organize the implementation of this Circular;

b) Update on its website the list of drugs and medicinal ingredients whose marketing authorizations are granted or renewed within 05 days from the date on which the marketing authorizations are granted or renewed, and other information about registration of drugs and medicinal ingredients;

c) Publish and update on its website the list of drugs with demonstrated bioequivalence, proprietary drugs and reference biologicals within 05 days from the issuing date of the marketing authorization, and revisions to their information within 07 days from the date on which the revisions are approved;

d) Consider and review drugs with demonstrated bioequivalence, and declared proprietary drugs and reference biologicals when they may no longer satisfy the requirements as prescribed;

dd) Develop, issue and organize the implementation of SOPs in drug registration and QM;

e) Cooperate with the Traditional Medicine and Pharmacy Management Department in renewing and revising the marketing authorizations of traditional drugs and herbal ingredients that have been issued in accordance with Circular No. 44/2014/TT-BYT dated November 25, 2014 of the Minister of Health on drug registration;

g) In the case where an applicant forges or falsifies legal documents of Vietnamese or foreign authorities, uses a fraudulent seal or signature of an organization in the application dossiers, the Drug Administration of Vietnam shall issue a written warning and stop receiving the application dossiers from such applicant in accordance with Clauses 2, 3 and 4, Article 100 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017, detailing a number of articles and measures to implement the Law on Pharmacy.

Other than the above-mentioned methods, the Drug Administration of Vietnam shall make an announcement about the violation on its website, inform inspection agencies and competent agencies for taking appropriate actions in accordance with the law provisions;

h) In the case where a drug manufacturer forges or falsifies legal documents of Vietnamese or foreign authorities, or provides an applicant with documents which are issued without referring to studies or actual manufacturing activities, the Drug Administration of Vietnam shall issue a written warning and stop receiving the application dossiers from such manufacturer in accordance with Clauses 2, 3 and 4, Article 100 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017, detailing a number of articles and measures to implement the Law on Pharmacy.

Other than the above-mentioned methods, the Drug Administration of Vietnam shall make an announcement about the violation on its website, inform inspection agencies and competent agencies for taking appropriate actions in accordance with the law provisions;

i) Where necessary, the Drug Administration of Vietnam may hold a meeting with applicants, manufacturers or experts to clarify the issues that arise during validation of the application dossiers;

k) Publish on its website the list of applicants and manufacturers of drugs and medicinal ingredients in accordance with Clauses 10 and 14, Article 22 of this Circular;

l) Develop regulations on application of bar codes, QR codes and DataMatrix codes (DMCs) on secondary packages of drugs and medicinal materials of manufacturers in order to serve management, identification and tracing of origin of marketed drugs and medicinal materials, and a roadmap for implementation in accordance with the regulations of the Minister of Health;

m) Return the label and package insert to the applicant within 30 days from the date of issuance or renewal of the marketing authorization;

n) Publish on its website the origin of medicinal ingredients of domestically manufactured drugs within 15 days from the date of issuance or renewal of the marketing authorization, or within 07 days from the date on which the revisions to the marketing authorization are approved.

2. Provincial or municipal Departments of Health shall be responsible for carrying out inspection of the implementation of this Circular by pharmaceutical manufacturers and sellers in their localities.

3. Affiliated units of the Ministry of Health, Vietnam Pharmaceutical Corporation and drug sellers shall be responsible for the implementation of this Circular.

Any difficulties arising during the course of implementation shall be reported to the Ministry of Health (via the Drug Administration of Vietnam) for consideration./.

For the Minister

The Deputy Minister

DO XUAN TUYEN

* All Appendices are not translated herein.