Circular No. 32/2026/TT-BYT on prescribing marketing authorization of drugs and medicinal materials

 

CIRCULAR

PRESCRIBING MARKETING AUTHORIZATION OF DRUGS AND MEDICINAL MATERIALS

Pursuant to the Law on Pharmacy No. 105/2016/QH13, as amended by Law No. 44/2024/QH15;

Pursuant to the Government’s Decree No. 163/2025/ND-CP elaborating, and providing measures for the implementation of, the Law on Pharmacy;

Pursuant to the Government’s Decree No. 42/2025/ND-CP defining functions, tasks, powers and organizational structure of the Ministry of Health (MOH);

At the request of the Director of the Drug Administration of Vietnam (DAV);

The Minister of Health of Viet Nam promulgates a Circular prescribing the marketing authorization of drugs and medicinal materials.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

1. This Circular elaborates and provides guidelines for implementation of some Articles of the Law on Pharmacy No. 105/2016/QH13, as amended by Law No. 44/2024/QH15 (hereinafter referred to as “the Law on Pharmacy”), including:

a) Regulations on clinical data supporting the safety and efficacy of drugs in the application for marketing authorization; criteria for determining cases eligible for exemption from clinical trials or certain phases thereof in Viet Nam; and drugs subject to the requirement to undergo Phase IV clinical trials as prescribed in clause 4 Article 89 of the Pharmacy Law;

fb) Documentation requirements and procedures for granting, renewing, approving variations to, and revoking marketing authorizations for chemical drugs, vaccines, biologicals, herbal drugs, and medicinal materials for human use in Viet Nam in clause 9 Article 56 and clause 2 Article 58 of the Pharmacy Law;

c) Principles and criteria for classification of over-the-counter (OTC) drugs in clause 27 Article 2 of the Pharmacy Law;

d) Regulations on post-authorization safety and efficacy reporting for the purpose of conducting pharmacovigilance activities as prescribed in clause 2 Article 78 of the Pharmacy Law;

dd) Regulations on the organization and operation of the Advisory Council for the grant of marketing authorizations for drugs and medicinal materials (hereinafter referred to as “the Council”), validating units, and validators.

2. This Circular does not apply to traditional drugs and herbal materials.

Article 2. Definitions

For the purposes of this Circular, the terms used herein are construed as follows:

1. ASEAN common technical dossier (ACTD) means the standardized format of common technical dossier for the registration of drugs adopted by the Association of Southeast Asian Nations (ASEAN).

2. ICH-CTD means the Common Technical Document (CTD) developed by the International Conference for Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.

3. Major variations (MaV) means variations that have a significant and/or direct impact on the quality, safety, or efficacy of a drug, as specified in Appendix II to this Circular.

4. Minor variations (MiV) means variations that have no or minimal impact on the quality, safety, and efficacy of a drug, as specified in Appendix II to this Circular.

5. Applicant means the establishment whose name is stated in the application for the grant, renewal, or approval of variations to the marketing authorization of a drug or medicinal material.

6. Drug manufacturer means an establishment that carries out one or more manufacturing steps, or the entire manufacturing process, or batch release of a drug.

7. Medicinal material manufacturer means an establishment that manufactures medicinal materials for use in the manufacture of finished drugs or performs batch release of medicinal materials.

8. Certificate of Pharmaceutical Product (CPP) means a certificate issued under the World Health Organization (WHO) Certification Scheme on the quality of Pharmaceutical Products moving in International Commerce.

9. The European Medicines Agency (EMA) and Stringent Regulatory Authorities (SRAs) are the following authorities:

a) European Medicines Agency (EMA);

b) Stringent Regulatory Authorities (SRAs) classified by WHO as being on the list of SRAs, including:

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

– ICH Observers as of October 23, 2015, including: the drug regulatory authority of the European Free Trade Association (EFTA), represented by Swissmedic; and Health Canada;

– Members associated with ICH Members through association or mutual recognition agreements before October 23, 2015, including: Australia, Iceland, Liechtenstein and Norway.

10. Product license holder/marketing authorization holder means the establishment that holds the marketing authorization for the drug stated in the Certificate of Pharmaceutical Product (CPP) issued in the WHO-recommended format.

11. Drug processing means the manufacture of a drug under a processing contract in accordance with law, pursuant to which the processing establishment performs one or more, or all, stages of the drug manufacturing process in Viet Nam at the request of the ordering establishment and receives a processing fee.

12. Technology transfer in drug manufacturing means the transfer of ownership of, or the right to use, drug manufacturing technology as prescribed in Clause 1 Article 4 of the Law on Technology Transfer No. 07/2017/QH14, as amended by Law No. 115/2025/QH15 (hereinafter referred to as the “Law on Technology Transfer”), from an establishment having the right to transfer such technology to an establishment receiving the technology for application to one or more, or all, stages of the drug manufacturing process in Viet Nam under a contract between the parties in accordance with law.

13. Ordering establishment means the party that provides all or part of the ingredients, materials, manufacturing process, and technical documentation demonstrating the quality, safety, and efficacy of the drug to the processing establishment for the processing of the drug under a processing contract between the parties.

14. Processing establishment means the party that uses all or part of the ingredients, materials, manufacturing process, and technical documentation provided by the ordering establishment to perform one or more, or all, stages of the drug manufacturing process at the request of the ordering establishment and receives a processing fee under the processing contract between the parties.

15. Transferor establishment means the party that has the ownership of, or the right to use, drug manufacturing technology in accordance with law and transfers the ownership of, or the right to use, such technology to the transferee establishment for application to one or more, or all, stages of the drug manufacturing process.

16. Transferee establishment means the party that receives the ownership of, or the right to use, drug manufacturing technology from the transferor establishment under a contract between the parties for application to one or more, or all, stages of the drug manufacturing process.

17. Drug ordered for processing means a drug that has been granted a marketing authorization in Viet Nam or a product license in at least one country in the world and is subject to the processing of one or more, or all, stages of its manufacturing process by the processing establishment at the request of the ordering establishment under a processing contract between the parties.

18. Processed drug means a drug of which one or more, or all, stages of the manufacturing process are performed by the processing establishment for the ordering establishment under a processing contract between the parties.

19. Drug prior to technology transfer means a drug that has been granted a marketing authorization in Viet Nam or a product license in at least one country and for which the ownership of, or the right to use, the drug manufacturing technology is transferred by the transferor establishment to the transferee establishment for application to one or more, or all, stages of the drug manufacturing process.

20. Drug manufactured using transferred technology means a drug for which one or more, or all, stages of the manufacturing process are carried out by the transferee establishment using the technology transferred by the transferor establishment under a contract between the parties, as prescribed in Clause 1 Article 4 of the Law on Technology Transfer.

Article 3. Responsibilities of applicants

Each applicant shall:
1. Assume full responsibility before the law for the accuracy, legality, and truthfulness of all documents included in its marketing authorization application (MAA) for drugs and medicinal materials, except in the cases specified in Clause 1 Article 4 of this Circular; Coordinate with domestic and foreign authorities and manufacturers in responding to requests from the Drug Administration of Vietnam (DAV) for verification of the authenticity of legal documents included in its MAA.

2. Ensure the quality, safety, and efficacy of the drugs/medicinal materials as declared in its MAA.

3. Notify DAV in writing within 15 days from the date of a decision to revoke the marketing authorization or a decision to recall the drug/medicinal material in any country in the world, if the drug/medicinal material has been granted a marketing authorization in Viet Nam that remains valid, and specify the reason for such revocation or recall, except in cases of voluntary withdrawal of the marketing authorization that is unrelated to the quality, safety, or efficacy of the drug in countries other than the CPP-issuing country specified in the CPP submitted in the MAA in Viet Nam.

4. Closely coordinate with the drug manufacturer, at the request of the competent authorities, to conduct studies or provide additional information related to the registered drug when information or evidence concerning the safety and efficacy of the drug becomes available while the drug is marketed.

5. Coordinate with the drug manufacturer, importer, and distributor in monitoring, supervising, collecting, compiling, and evaluating information, and reporting cases of post-vaccination reactions and adverse drug reactions to the National Centre of Drug Information and Adverse Drug Reaction Monitoring (National DI & ADR Centre) in accordance with Clause 5 Article 77 of the Pharmacy Law, the National Pharmacovigilance Guidelines issued by the Ministry of Health (MOH), and relevant regulations.

6. Take responsibility for matters relating to the intellectual property rights of drugs/medicinal materials registered for marketing in Viet Nam, in accordance with the Law on intellectual property.

7. Implement the risk management plan approved as part of the MAA for a new chemical drug, vaccine, or biological (except probiotic biological products).

8. An applicant for a processed drug shall fulfill the responsibilities set forth in clauses 1, 2, 3, 4, 5, 6, 7 and 10 of this Article, and the following:

a) Notify DAV in writing within 30 days from the date on which a competent authority approves variations to the formulation, manufacturing process, quality specifications of materials, or quality specifications of the finished drug of the drug ordered for processing during its marketing, in case the processed drug meets the requirements specified in Clause 1 Article 9 of this Circular;

b) Notify DAV in writing within 15 days from the date on which a decision to revoke the marketing authorization of the drug ordered for processing is issued in any country in the world (during the validity period of the marketing authorization of the processed drug), except in cases of voluntary withdrawal of the marketing authorization that is unrelated to the quality, safety, or efficacy of the drug in countries other than the CPP-issuing country specified in the CPP submitted for the drug ordered for processing;

c) Notify DAV within 30 days from the date on which the manufacture of the drug ordered for processing is discontinued;

d) For a processed drug that meets the requirements specified in Clause 1 Article 9 of this Circular, when the drug ordered for processing is being manufactured or marketed in Viet Nam or in the country concerned and there are variations to its formulation, manufacturing process, quality specifications of materials, quality specifications of the finished drug, or trade name, the applicant shall, within 03 months from the date on which such variations are approved by DAV or the competent authority of the country concerned, submit an application for approval of variations corresponding to the variations to the drug ordered for processing.

9. An applicant for a drug manufactured using transferred technology shall fulfill the responsibilities specified in Clauses 1, 2, 3, 4, 5, 6, 7, and 10 of this Article, and the following:

a) Notify DAV in writing within 30 days from the date on which a competent authority approves variations to the formulation, manufacturing process, quality specifications of materials, or quality specifications of the finished drug of the drug prior to technology transfer during its marketing, in case the drug manufactured using transferred technology meets the requirements specified in Clause 1 Article 9 of this Circular;

b) Notify DAV in writing within 15 days from the date on which a decision to revoke the marketing authorization of the drug prior to technology transfer is issued in any country in the world (during the validity period of the marketing authorization of the drug manufactured using transferred technology), except in cases of voluntary withdrawal of the marketing authorization that is unrelated to the quality, safety, or efficacy of the drug in countries other than the CPP-issuing country specified in the CPP submitted for the drug prior to technology transfer;

c) Notify DAV in writing within 30 days from the date on which the manufacture of the drug prior to technology transfer is discontinued;

d) For a drug manufactured using transferred technology that meets the requirements specified in Clause 1 Article 9 of this Circular, when the drug prior to technology transfer is being manufactured or marketed in Viet Nam or in the country concerned and there are variations to its formulation, manufacturing process, quality specifications of materials, quality specifications of the finished drug, or trade name, the applicant shall, within 03 months from the date on which such variations are approved by DAV or the competent authority of the country concerned, submit an application for approval of variations corresponding to the variations to the drug prior to technology transfer.

10. Fulfill other responsibilities as prescribed in relevant laws.

Article 4. Responsibilities of drug/medicinal material manufacturers

1. Assume full responsibility before the law for the accuracy, legality, and truthfulness of all documents related to the drug/medicinal material provided by the manufacturer to the applicant for the purpose of obtaining marketing authorization in Viet Nam.

2. Closely coordinate with the applicant in fulfilling the responsibility specified in Clause 3 Article 3 of this Circular.

3. Coordinate with the applicant in fulfilling requests from competent authorities for inspection and evaluation of the manufacturer.

4. If the manufacturer has its manufacturing license revoked or fails to comply with GMP (Good Manufacturing Practices) requirements for drugs/medicinal materials as notified by a competent authority of the country concerned, the manufacturer shall notify DAV in writing within 15 days from the date of such notification.

5. Retain all documents on registration of the drug/medicinal material and provide them to competent authorities upon their request, including those documents specified in Point e Clause 7 Article 22 of this Circular.

6. Implement the risk management plan approved as part of the MAA for a new chemical drug, vaccine, or biological (except probiotic biological products).

7. A manufacturer that is a processing establishment shall fulfill the responsibilities specified in Clauses 1, 2, 3, 4, 5, 6, and 9 of this Article, and the following:

a) Fulfill the obligations prescribed in Article 182 of the Law on Commerce No. 36/2005/QH11 and Article 35 of the Government’s Decree No. 292/2026/ND-CP elaborating certain Articles and providing measures for implementation of the Law on Foreign Trade Management;

d) For a processed drug that meets the requirements specified in Clause 1 Article 9 of this Circular, when the drug ordered for processing is being manufactured or marketed in Viet Nam or in the country concerned and there are variations to its formulation, manufacturing process, quality specifications of materials, quality specifications of the finished drug, or trade name, the manufacturer shall, within 03 months from the date on which such variations are approved by DAV or the competent authority of the country concerned, coordinate with the applicant for the processed drug to submit an application for approval of variations corresponding to the variations to the drug ordered for processing.

8. A manufacturer that is a transferee establishment shall fulfill the responsibilities specified in Clauses 1, 2, 3, 4, 5, 6, and 9 of this Article, and the following:

a) Fulfill the obligations prescribed in Article 26 of the Law on Technology Transfer;

d) For a drug manufactured using transferred technology that meets the requirements specified in Clause 1 Article 9 of this Circular, when the drug prior to technology transfer is being manufactured or marketed in Viet Nam or in the country concerned and there are variations to its formulation, manufacturing process, quality specifications of materials, quality specifications of the finished drug, or trade name, the manufacturer shall, within 03 months from the date on which such variations are approved by DAV or the competent authority of the country concerned, coordinate with the applicant to submit an application for approval of variations corresponding to the variations to the drug prior to technology transfer;

c) Carry out the procedures for registration of the technology transfer as prescribed in Article 31 of the Law on Technology Transfer and Article 20 of the Government’s Decree No. 101/2026/ND-CP elaborating certain Articles and providing measures for implementation of the Law on Technology Transfer.

9. Fulfill other responsibilities as prescribed in relevant laws.

Article 5. Responsibilities of ordering establishments

1. Fulfill the obligations of the ordering establishment as prescribed in Article 181 of the Law on Commerce No. 36/2005/QH11 and Article 34 of the Government’s Decree No. 292/2026/ND-CP.

2. Provide the processing establishment with:

a) Part or all of the materials and technical documents, including the manufacturing process, quality specifications, and test methods for starting materials, semi-finished products, finished products, and auxiliary materials for the processing stage(s) to be performed;

b) Other documents related to the marketing authorization of the processed drug and drug processing.

3. Assume responsibility for the accuracy, legality, and truthfulness of the technical documents provided to the processing establishment, which shall be consistent with the registration dossier of the drug ordered for processing approved by the competent authority.

4. Coordinate with the applicant for the processed drug to fulfill the responsibilities specified in Clause 8 Article 3 of this Circular.

5. Fulfill other responsibilities as prescribed in relevant laws.

Article 6. Responsibilities of transferor establishments

1. Fulfill the obligations of the transferor establishment as prescribed in Clause 2 Article 25 of the Law on Technology Transfer.

2. Provide the transferee establishment with:

a) Technical documents, including the manufacturing process, quality specifications, and test methods for starting materials, semi-finished products, finished products, and auxiliary materials of the stage(s) covered by the technology transfer;

b) Other documents related to the marketing authorization of the drug manufactured using transferred technology and the technology transfer for drug manufacturing.

3. Assume responsibility for the accuracy, legality, and truthfulness of the technical documents provided to the transferee establishment, which shall be consistent with the registration dossier for the drug prior to technology transfer approved by the competent authority.

4. Coordinate with the applicant for the drug manufactured using transferred technology to fulfill the responsibilities specified in Clause 9 Article 3 of this Circular.

5. Fulfill other responsibilities as prescribed in relevant laws.

Article 7. Drug processing contract

In addition to the contents prescribed in Article 31 of the Decree No. 292/2026/ND-CP, a drug processing contract must also include the following:

1. Agreements on the supply of materials. The provision by the ordering establishment to the processing establishment of technical documents, including the manufacturing process, quality specifications, and test methods for starting materials, semi-finished products, finished drugs, and auxiliary materials, and other documents related to the processing of the drug.

2. Rights and responsibilities of the ordering establishment, processing establishment, and applicant (if any), with respect to:

a) Each stage of the manufacturing process of the processed drug, including the manufacturing process, quality control, storage and transportation of starting materials, semi-finished products, finished drugs, and auxiliary materials, packaging, printing or labeling procedures for the processed drug, and the responsibilities of the establishment signing the certificate of analysis (CoA) for each batch of finished drug and the batch release certificate for the processed drug;

b) Retention of records relating to the manufacture, quality control, distribution, and marketing of the drug; retention of drug samples; and handling of matters relating to quality, complaints, and recall of the drug from the market.

3. Responsibilities of the ordering establishment, processing establishment, and Applicant (if any) with respect to intellectual property matters related to the processed drug.

4. Procedures for inspection or supervision of the manufacturer.

5. Cases of termination of the agreement and responsibilities for breach of the agreement.

Article 8. Technology transfer contract

In addition to the contents prescribed in Article 23 of the Law on Technology Transfer, a technology transfer contract for drug manufacturing must include the following:

1. Agreements on the provision by the transferor establishment to the transferee establishment of technical documents, including the manufacturing process, quality specifications, and test methods for starting materials, semi-finished products, finished drugs, and auxiliary materials, and other documents related to the technology transfer for drug manufacturing.

2. Responsibilities of the transferor establishment, transferee establishment, and applicant with respect to intellectual property matters related to the drug manufactured using transferred technology.

3. Cases of termination of the agreement and responsibilities for breach of the agreement.

Article 9. Classification of processed drugs and drugs manufactured using transferred technology

A processed drug or drug manufactured using transferred technology shall be classified as:

1. A processed drug or drug manufactured using transferred technology having the same trade name, formulation, quality specifications of materials, and quality specifications of the finished drug as, and a manufacturing process similar to that of, the drug ordered for processing or the drug prior to technology transfer, respectively.

If a processed drug or a drug manufactured using transferred technology has a change in any of the above-mentioned criteria (except for a change in the trade name) or any other change related to the quality of the drug, the applicant shall provide a comparative tabulated summary (Form 01/TT in Appendix IX to this Circular) and the technical documents corresponding to each change in accordance with the guidelines in Appendix II to this Circular, to demonstrate quality equivalence to the drug ordered for processing or the drug prior to technology transfer, respectively.

2. Other processed drug or drug manufactured using transferred technology that does not fall under the case specified in Clause 1 of this Article.

Article 10. Reporting on safety and efficacy monitoring and evaluation

1. Each Applicant shall submit reports on the monitoring and evaluation of the safety and efficacy of the drug during marketing as follows:

a) Periodic reports for new drugs, vaccines, and biologicals (except probiotic biological products), using Form 2A/TT in Appendix IX to this Circular;

b) Individual case safety reports (ICSRs) of all adverse events (including adverse drug reactions, medication errors, suspected counterfeit or substandard drugs, and lack of or inadequate therapeutic efficacy) occurring in Viet Nam and related to the drug, using Form 2B/TT in Appendix IX to this Circular.

2. Reporting frequency and time limits:

a) For periodic reports as prescribed in Point a Clause 1 of this Article:

From the date on which the marketing authorization is granted, the applicant shall submit periodic reports every 6 months during the first 2 years; from the third year to the fifth year, the applicant shall submit periodic reports annually;

b) For ICSRs as prescribed in Point b Clause 1 of this Article:

The applicant shall submit ICSRs within the time limits specified in the National Pharmacovigilance Guidelines and other relevant regulations issued by MOH.

3. Methods of submission and recipients of reports:

The applicant shall comply with the National Pharmacovigilance Guidelines and other relevant regulations issued by MOH.

4. Processing and evaluation of reports, and provision of information to state regulatory authorities and Specialized Councils of MOH for the purpose of managing the marketing authorization of drugs:

Such activities shall be carried out in accordance with the National Pharmacovigilance Guidelines and other relevant regulations issued by MOH.

Article 11. Language and format of documents; number of required sets and submission methods; cases where multiple drugs/medicinal materials may be submitted in a single MAA; and validation methods

1. Language of the documents included in an MAA for drug/medicinal material:

The documents included in an MAA for drug/medicinal material must be prepared in Vietnamese or English. The package leaflet of the drug to be marketed in Viet Nam must be prepared in Vietnamese.

2. Format of documents:

The documents included in an MAA for drug/medicinal material must be prepared in accordance with the ACTD or ICH-CTD guidelines and the provisions of this Circular.

3. Number of required sets and submission methods for an MAA for drug/medicinal material:

a) One (01) complete set of documents shall be submitted for each administrative procedure prescribed in this Circular;

b) Where the MAA is submitted directly or through the public postal service, the applicant shall submit one (01) complete set of documents to DAV in accordance with Article 15 of the Government’s Decree No. 118/2025/ND-CP, as amended by Decree No. 367/2025/ND-CP;

c) Where the MAA is submitted via the MOH’s Online Public Service Portal, the applicant shall submit one (01) complete set of documents in accordance with the Government’s Decree No. 45/2020/ND-CP, as amended by Decree No. 68/2024/ND-CP, Decree No. 69/2024/ND-CP, and Decree No. 118/2025/ND-CP.

4. Multiple drugs may be submitted in a single MAA if they meet all of the following criteria:

a) They have the same drug name, drug substance(s) or herbal material(s), and dosage form;

b) They have the same manufacturer, or the same manufacturer with different packaging facilities or batch-release facilities;

c) They have the same strength, concentration, or mass of drug substance(s) or herbal material (s) in a single dose.

5. MAA validation methods:

a) An MAA for drug/medicinal material shall be reviewed by the respective subcommittees for legal affairs, quality standards, pharmaceutics, pharmacology, clinical matters, and bioequivalence, based on the parts of the application submitted for the grant, renewal, or approval of variations to the marketing authorization for drug/medicinal material;

b) The validation of the legal affairs, quality standards, pharmaceutics, pharmacology, clinical, and bioequivalence contents shall ensure that all contents are adequately covered in accordance with the ACTD or ICH-CTD guidelines and the provisions of this Circular, including the documents subject to validation and the corresponding requirements to be satisfied for each validation content as prescribed in this Circular;

c) Validation of an MAA in the case specified in Clause 10 Article 26 of this Circular is subject to the following provisions:

– Validation shall be conducted to verify the consistency between the technical documents in the MAA submitted in Viet Nam and the technical documents of the drug for which marketing authorization has been granted by the drug regulatory authority specified in Clause 9 Article 2 of this Circular, based on the documents specified in Clause 10 Article 26 of this Circular.

– The administrative part of the MAA and the parts of the technical documents for which differences have been reported between the MAA submitted in Viet Nam and the technical documents of the drug approved by the drug regulatory authority specified in Clause 9 Article 2 of this Circular shall be validated independently.

d) When considering the grant of a marketing authorization for a new drug indicated for the prevention and treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the Law on prevention and control of infectious diseases, DAV shall not validate the technical documents or assess compliance with GMP requirements on the basis of recognition of the licensing results of one of the drug regulatory authorities specified in Clause 9 Article 2 of this Circular.

Article 12. Validity, symbols of marketing authorizations for drugs/medicinal materials, and deadline for application submission

1. The validity of a marketing authorization for a drug/medicinal material is 05 years from the date on which it is granted or renewed, except for the cases specified in Clauses 2 and 3 of this Article.

2. The validity of a marketing authorization for a drug is 03 years from the date on which it is granted or renewed, for drugs subject to continued monitoring of safety and efficacy, including the following cases:

a) New drugs, vaccines, and biologicals (except probiotic biological products) granted a marketing authorization in Viet Nam for the first time;

b) Drugs having the same drug substance, concentration, strength, or dosage form as a new drug for which a 05-year marketing authorization has not been granted;

c) Drugs specified in Points a and b of this Clause that are not actually placed on the market during the validity period of their marketing authorization;

d) Drugs not falling under Points a, b, or c of this Clause but for which the Council requires continued monitoring of safety and efficacy.

3. Where the validity period of a marketing authorization for a drug/medicinal material has expired and DAV has received an application for renewal of such marketing authorization in accordance with applicable regulations, such marketing authorization may continue to be used until it is renewed or until DAV issues a written notification of non-renewal or suspension of the marketing authorization on the grounds that the drug/medicinal material is found to pose a potential safety risk to users or the legal documents are suspected of being forged.

4. Each MAA for a drug/medicinal material shall be granted a marketing authorization bearing a registration number in the format specified in Appendix V to this Circular.

The registration number is intended for the retrieval, compilation, and statistical analysis of data on the drug/medicinal material that has been granted marketing authorizations in Viet Nam, and shall be publicly disclosed on the MOH’s web portal and the DAV’s website. The classification and management of controlled drugs/medicinal materials shall comply with relevant legal documents.

5. An application for renewal of a marketing authorization for a drug/medicinal material must be submitted before its expiration date. DAV shall not accept an application for renewal of the marketing authorization which is submitted after it has expired, and the applicant shall be required to submit an application for the grant of a new marketing authorization.

6. An MAA for a drug subject to validation by reference to available validation results shall be submitted to DAV within 05 years from the date on which the drug was first approved by a drug regulatory authority specified in Clause 9 Article 2 of this Circular, as stated in the validation report.

Article 13. Criteria for classification of original brand-name drugs and reference biologicals

1. Criteria for classification of original brand-name drugs and reference biologicals:

a) A drug granted a marketing authorization that meets all of the following criteria shall be classified as an original brand-name drug:

– It is the first drug granted the marketing authorization on the basis of sufficient quality, safety, and efficacy data.

– Its clinical data meets the requirements laid down in Article 18 of this Circular;

b) A drug granted a marketing authorization that meets all of the following criteria shall be classified as a reference biological:

– It is a drug granted a marketing authorization in Viet Nam on the basis of sufficient quality, safety, and efficacy data.

– Its clinical data meets the requirements laid down in Article 18 of this Circular, based on the development of a biological product from the outset rather than development as a biosimilar.

2. Where a drug classified as an original brand-name drug or reference biological undergoes a change in its manufacturer or manufacturing site and is granted a new marketing authorization, it shall continue to be classified as an original brand-name drug or reference biological if its trade name, formulation, quality specifications for raw materials, and quality specifications for the finished drug product remain unchanged, and its manufacturing process before the change is similar to that after the change.

Where there are changes in any of the criteria mentioned in this Clause (except changes in the trade name) or other changes relating to the quality of the drug manufactured by the new manufacturer or at the new manufacturing site, such changes must be approved by the drug regulatory authority that granted the marketing authorization for the drug, or the applicant must provide the comparative tabulated summary of such changes (Form 01/TT in Appendix IX to this Circular) and relevant technical documents corresponding to each change according to the guidelines in Appendix II to this Circular, in order to demonstrate the quality equivalence between the drug manufactured by the new manufacturer or at the new manufacturing site and the original brand-name drug or reference biological.

Regarding changes in the manufacturer or manufacturing site of a reference biological, additional documents demonstrating quality equivalence must be provided according to the guidelines of the US FDA, ICH, WHO, EMA, international organizations of which Vietnam is a member, and the drug regulatory authorities prescribed in Clause 9 Article 2 of this Circular.

3. A drug ordered for processing or drug prior to technology transfer that has been classified as an original brand-name drug or reference biological, or that has not been so classified but has clinical data meeting the requirements specified in Point a or b, Clause 1 of this Article, and that is processed or manufactured using transferred technology in Viet Nam, shall be classified as an original brand-name drug or reference biological if it meets the criteria specified in Clause 2 of this Article and Point d Clause 2 Article 38 of this Circular.

4. Cases in which drugs are subject to classification as original brand-name drugs or reference biologicals:

a) A drug for which classification as an original brand-name drug or reference biological is requested upon submission of an MAA:

The applicant shall submit a request for classification of the drug as an original brand-name drug or reference biological when submitting the MAA for the drug. The MAA which is validated and approved for grant of a marketing authorization must meet the criteria set out in Clause 1, 2 or 3 of this Article;

b) A drug that has been granted a marketing authorization for which classification as an original brand-name drug or reference biological is requested:

The applicant shall submit an application for approval of variations to the marketing authorization to request classification of a drug that has been granted a marketing authorization as an original brand-name drug or reference biological, in accordance with Appendix II to this Circular. The application for approval of variations to the marketing authorization that is validated and approved must meet the criteria set out in Clauses 1, 2, or 3 of this Article.

5. A drug which has been classified as an original brand-name drug or reference biological shall continue to be classified as original brand-name drug or reference biological when its marketing authorization is considered for renewal or for approval of variations to the marketing authorization. The applicant shall not be required to submit an application for classification of the drug as an original brand-name drug or reference biological.

Article 14. Criteria for classification of drugs with demonstrated bioequivalence

A drug granted a marketing authorization in Viet Nam shall be classified as a drug with demonstrated bioequivalence if its bioequivalence study report meets the requirements specified in the Minister of Health’s Circular No. 07/2022/TT-BYT.

Article 15. Principles, criteria and methods for classification of OTC drugs

1. Principles for classification of OTC drugs:

a) Ensure the safety for drug users;

b) Ensure timely access to drugs for the public;

c) Be consistent with the actual use and supply of drugs in Viet Nam;

d) Be harmonized with the principles and regulations on the classification OTC drugs in countries in the region and around the world.

2. Criteria for determination of OTC drugs:

A drug shall be classified as an OTC drug if it meets all of the following criteria:

a) It must be demonstrated to be safe and effective in preventing, alleviating, or treating diseases; have a wide safety margin to ensure the safety of users; have low toxicity; not produce toxic degradation products during storage or after entering the human body; not cause reproductive toxicity, genotoxicity, or carcinogenicity; not cause adverse effects requiring supervision or monitoring by a physician or healthcare professional when the drug is self-administered in accordance with the package leaflet; and not interact with commonly used drugs or foods in a manner that may lead to serious adverse reactions;

b) It is indicated for short-term treatment of diseases that patients can self-treat without requiring a prescription or monitoring by a healthcare professional;

c) It has a low potential to cause dependence; poses a low risk of abuse or misuse that may affect the safety of users; and does not mask serious diseases, resulting in delays in diagnosis and treatment;

d) It must have a simple dosage form and route of administration that allow users to self-administer the drug without technical assistance or instructions from a physician or healthcare professional; and must not require special conditions for storage or handling before or after use;

dd) It does not contain any herbal material included in the List of Toxic herbal materials promulgated by the MOH.

3. Methods for classification of OTC drugs:

a) Generic drugs shall be classified as OTC drugs according to the classification of the original brand-name drug granted a marketing authorization in Viet Nam;

b) Where no original brand-name drug has been granted a marketing authorization in Viet Nam, a drug shall be classified as an OTC drug according to the classification of a drug having the same active ingredient(s), herbal material(s), strength, concentration, and dosage form as a drug granted a marketing authorization and marketed in a country whose drug regulatory authority is one of those specified in Clause 9 Article 2 of this Circular;

c) A drug shall be classified as an OTC drug according to the classification of a drug having the same active ingredient(s), herbal material(s), strength, concentration, and dosage form that has been granted a marketing authorization in Viet Nam, provided that it meets the principles and criteria specified in Clauses 1 and 2 of this Article;

d) Classification of OTC drugs in other cases shall be subject to opinions given by the Council on the basis of the principles and criteria set out in Clauses 1 and 2 of this Article.

Article 16. Protection of test data in MAAs

The protection of test data contained in MAAs shall be carried out in accordance with Clauses 1, 2, and 3 of Article 128 of the Law on Intellectual Property No. 50/2005/QH11, as amended by Law No. 36/2009/QH12, Law No. 42/2019/QH14, Law No. 07/2022/QH15, Law No. 93/2025/QH15, and Law No. 131/2025/QH15 (hereinafter referred to as the “Intellectual Property Law”).

Article 17. Verification of authenticity of legal documents in applications for grant, renewal, and approval of variations to marketing authorizations

1. The authenticity of a CPP included in an application for grant, renewal, or approval of variations to a marketing authorization shall be verified in the following cases:

a) The CPP contains erased or altered information;

b) The manufacturer or applicant has incurred administrative penalties imposed by a competent authority of Viet Nam for the violations in Point d and h Clause 2 Article 98 of the Decree No. 163/2025/ND-CP. Verification of the authenticity of the CPP shall apply for a period of 03 years from the date of the administrative penalty decision;

c) The manufacturer has, for the first time, a drug registered for marketing authorization in Viet Nam, including cases where the establishment participates in only one or several stages of the manufacturing process;

d) The CPP is an electronic document issued by a competent authority of another country but cannot be retrieved from the website or database provided by the applicant during validation of the application;

dd) Other cases in which the Council requires verification of authenticity. <0}

2. The authenticity of legal documents in MAAs shall be also verified in the following cases:

a) In the case of a foreign applicant whose drug/medicinal material is registered for marketing in Viet Nam for the first time, DAV shall verify the authenticity of the license to manufacture and trade in drugs issued in the applicant’s home country;

b) Legal documents of the applicant or manufacturer issued by a competent authority of a foreign country do not meet the requirements specified in Point b Clause 1 Article 22 of this Circular.

3. For drugs for which marketing authorization has been granted, DAV shall verify the authenticity of legal documents upon receiving information from the following sources concerning the licensing and/or marketing status of the drug in the country concerned that needs to be verified or clarified, or information indicating that the foreign manufacturer or applicant does not satisfy the conditions for operation:

a) A written document sent to DAV, containing the full name and address of the submitting agency, organization, or individual, together with relevant supporting documents;

b) Information obtained from the mass media.

4. The authenticity of CPPs and legal documents submitted in MAAs shall be verified by the following means:

a) Verification of the authenticity of legal documents relating to consular legalization: DAV shall cooperate with the Consular Department of the Ministry of Foreign Affairs of Viet Nam or Vietnamese diplomatic missions abroad competent to perform consular legalization to verify the authority and information relating to the consular legalization of foreign legal documents for use in Viet Nam in the cases specified in Point c Clause 1 and Point a Clause 2 of this Article, except where the legal documents are exempt from consular legalization in accordance with Point c Clause 1 Article 22 of this Circular;

b) Verification of the authenticity of the contents of legal documents:

DAV shall cooperate with the authorities that issue or grant the relevant legal documents to verify the information stated in such documents in the cases specified in Points a, b, d and dd Clause 1 and Point b Clause 2 of this Article;

c) Verification of the authenticity of legal documents shall be conducted concurrently with the validation of the MAA or upon receipt of information as prescribed in Clause 3 of this Article;

d) A written request for verification of the authenticity of legal documents shall be sent simultaneously to the applicant.

5. Regarding an MAA containing the legal documents subject to verification of authenticity as prescribed in Clauses 1 and 2 of this Article, the drug/medicinal material shall only be granted a marketing authorization when the verification results are deemed satisfactory by the competent authority specified in Clause 4 of this Article.

6. Regarding an application for renewal or approval of variations to the marketing authorization for a drug/medicinal material containing legal documents subject to verification of authenticity as prescribed in Clauses 1 and 2 of this Article, it is not mandatory to obtain the verification results before renewal or approval of variations to the marketing authorization.

Chapter II

REQUIREMENTS FOR CLINICAL DATA TO ENSURE SAFETY AND EFFICACY, CRITERIA FOR EXEMPTION FROM CLINICAL TRIALS OR CERTAIN PHASES THEREOF, AND DRUGS REQUIRED TO UNDERGO PHASE 4 CLINICAL TRIALS IN VIET NAM

Article 18. Clinical data requirements to ensure safety and efficacy

1. Any drug for which an MAA is submitted must have sufficient clinical data to demonstrate its safety and efficacy.

2. Sufficient clinical data means data from studies that have been conducted, reported, and assessed in accordance with guidelines issued by MOH or other organizations recognized by Viet Nam, including ICH, WHO, EMA, and other international organizations of which Viet Nam is a member, and guidelines issued by drug regulatory authorities as prescribed in Clause 9 Article 2 of this Circular.

Article 19. Criteria for exemption from clinical trials in Viet Nam

A drug is exempt from clinical trials in the following cases:

1. It is a generic drug that meets any of the following criteria:

a) It has bioequivalence data demonstrating compliance with the requirements specified in Circular No. 07/2022/TT-BYT;

b) It is not subject to the requirement to submit bioequivalence study data upon submission of an MAA in Viet Nam as prescribed in Circular No. 07/2022/TT-BYT.

2. It is a new drug (except for vaccines) that meets all of the following criteria:

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

b) It has sufficient clinical data as prescribed in Article 18 of this Circular;

c) Its clinical study data contain sufficient information to analyze and interpret the effects of ethnic factors of Asian populations on the safety and efficacy of the drug in accordance with the ICH-E5 guidelines.

3. It is an herbal drug that was granted marketing authorization before January 01, 2017.

Article 20. Criteria for exemption from certain phases of clinical trials in Viet Nam

1. The Minister of Health may, based on the advisory opinions of the Council, decide to grant an exemption from certain phases of clinical trials in Viet Nam for new drugs and vaccines in the following cases:

a) The drug or vaccine is intended to meet urgent needs for national defense and security, epidemic prevention and control, or response to the consequences of natural disasters or catastrophes, where no other alternative drug is available on the market; or is intended for the treatment of rare diseases or life-threatening diseases;

b) The drug or vaccine has been granted marketing authorization by at least one of the drug regulatory authorities prescribed in Clause 9 Article 2 of this Circular based on a reduced clinical data package in accordance with the requirements of that authority.

2. A new drug or vaccine granted an exemption from certain phases of clinical trials in Viet Nam must meet all of the following criteria:

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

b) It has clinical data that are either insufficient as prescribed in Article 18 of this Circular, or sufficient as prescribed in Article 18 of this Circular but without an adequate assessment of ethnic factors that may affect the safety and efficacy of the drug.

Article 21. Criteria for drugs required to undergo phase 4 clinical trials

A drug that has been granted marketing authorization but requires further evaluation of its safety and efficacy based on the advisory opinions of the Council shall undergo a Phase 4 clinical trial.

Chapter III

MARKETING AUTHORIZATION APPLICATIONS FOR DRUGS/MEDICINAL MATERIALS

Section 1. GENERAL PROVISIONS ON DOCUMENTS IN MARKETING AUTHORIZATION APPLICATIONS FOR DRUGS/MEDICINAL MATERIALS

Article 22. General provisions on administrative documents

1. The documents specified in Clauses 3, 4, 5, 6 and 7 of Article 26 of this Circular (hereinafter referred to as “legal documents”) included in an MAA must satisfy the following requirements:

a) A legal document submitted as part of an MAA for a drug/medicinal material must be an original or an electronic copy as prescribed in Decree No. 45/2020/ND-CP, as amended by Decree No. 68/2024/ND-CP, Decree No. 69/2024/ND-CP and Decree No. 118/2025/ND-CP, or a copy as prescribed in the Government’s Decree No. 23/2015/ND-CP;

b) A legal document must bear the signature, full name of the signatory, date of issuance, and seal of the competent authority of the issuing country, except where, under the regulations of the issuing country, a legal document is valid without containing all of such information;

c) A legal document issued by a competent foreign authority must undergo consular legalization in accordance with regulations of law on consular legalization, except in the following cases where consular legalization is not required:

– Documents exempt from consular legalization as prescribed in Clauses 1, 2 and 3 of Article 9 of the Government’s Decree No. 111/2011/ND-CP, as amended by Decree No. 196/2025/ND-CP.

– Cases where DAV is able to independently verify the authenticity of the document, including a legal document provided directly in writing or via the MOH’s email by the competent authority of the issuing country; or a legal document published by the competent authority of the issuing country or a competent regional authority on its website or in an English-language database.

The applicant or manufacturer shall submit the results of its own search, bearing its confirmation seal, together with a document providing information on the link to the search results;

d) A legal document that specifies a validity period must remain valid at the time of receipt of the MAA, as recorded in the MAA receipt note. Where a CPP does not specify a validity period, its validity period shall be deemed to be 24 months from the date of issuance.

2. For CPPs:

a) The CPP must contain all information required by the WHO template published on WHO’s website (https://www.who.int);

b) CPP must be issued by the competent authority of the manufacturing country, or by the authority competent to issue CPPs in a country whose drug regulatory authority is one of those prescribed in Clause 9 Article 2 of this Circular, certifying that the drug is licensed and actually marketed in that country;

c) In order to meet the needs for prevention or treatment of a Group A infectious disease for which an epidemic has been declared in accordance with regulations of law on disease prevention, the CPP may be replaced by another document issued by a competent authority, certifying that the drug is permitted to be marketed and used in the country concerned and containing all information on the name and address of the manufacturer and the licensing conditions;

d) Where the CPP does not satisfy the requirements specified in Points a and b of this Clause, the Minister of Health may, based on the advisory opinions of the Council, decide to accept an alternative where the drug has been granted marketing authorization by the competent authority of at least one country in the world and falls into one of the following cases:

– It is a drug, vaccine or biological intended to meet the needs of national defense and security, epidemic prevention and control, response to the consequences of natural disasters or catastrophes, or implementation of a State health program;

– It is a vaccine used in the national expanded immunization program where no other vaccine is available on the market that can serve as an alternative in terms of quantity, quality, safety, efficacy, or cost of use;

– Other special cases covered by a written mutual recognition agreement or arrangement between competent authorities regarding the requirements for the manufacture and marketing of drugs, vaccines and biologicals;

dd) The information stated on the CPP must be consistent with the relevant information in the MAA. Where the information stated on the CPP is inconsistent with the administrative documents included in the MAA, the applicant shall provide an explanatory report and relevant supporting documents.

3. For the application form and other administrative documents:

a) The application form and other relevant documents in the administrative section of the MAA must bear the signature and seal of the authorized signatory. Digital signatures are accepted but signature stamps are not permitted;

b) The above-mentioned documents must be signed by a person holding one of the following positions:

– Chairperson of the Board of Members or the Board of Directors; General Director; Chief Executive Officer; or Director of the applicant or manufacturer;

– A person assigned to sign documents in accordance with the company charter, a written assignment of duties, or another document evidencing the signatory’s authority;

– A person directly authorized to sign by any of the persons specified in the first or second sub-point of this Point.

4. For letters of authorization:

a) A letter of authorization appointing an applicant must be an original and contain all of the following information:

– Name and address of the product license holder/marketing authorization holder or the authorizing manufacturer.

– Name and address of the authorized applicant.

– Name of the drug, concentration/strength of the drug substance, and dosage form.

– Scope of authorization.

Where the authorization covers multiple drugs, the letter of authorization must be accompanied by a list of the drugs containing all information specified in the third sub-point of this Point;

b) A letter of authorization authorizing a person to sign documents included in an MAA must be an original and contain all of the following information:

– Name and address of the applicant.

– Name and title of the authorizing person and the authorized person.

– Name of the drug, concentration/strength of the drug substance, and dosage form.

– Scope of authorization.

– Validity period of the letter of authorization.

Where the authorization covers multiple drugs, the letter of authorization must be accompanied by a list of the drugs containing all information specified in the third sub-point of this Point;

c) Number of letters of authorization in an MAA:

– Where the applicant is not the manufacturer, the product license holder/marketing authorization holder, ordering establishment, or transferor establishment, each MAA must be accompanied by a letter of authorization appointing the applicant.

– Where the position of the person signing the documents included in the MAA is not one of the positions specified in Point b Clause 3 of this Article, each MAA must be accompanied by a letter of authorization authorizing that person to sign the documents included in the MAA.

5. An applicant must have one of the following legal documents:

a) A Vietnamese applicant must have a certificate of eligibility for pharmaceutical business covering one of the following business scopes: manufacture, wholesaling, importation, or exportation of drugs/medicinal materials;

b) A foreign applicant must have a license to manufacture or trade in drugs issued by a competent foreign regulatory authority, covering one of the following business scopes: manufacture, wholesaling, importation, or exportation of drugs/medicinal materials, and a license for establishment of a representative office in Viet Nam.

Where the name or address of the applicant stated in the license for establishment of a representative office in Viet Nam differs from that stated in the legal documents of the applicant issued by the competent foreign authority, documentary evidence of such difference must be provided.

Where the applicant is also the manufacturer stated on the CPP, the legal documents specified in this Clause are not required.

Where a country does not issue licenses for the manufacture, wholesaling, exportation, or importation of drugs/medicinal materials, the applicant must provide a license for establishment or a business registration certificate covering at least one of the following business scopes: manufacture, wholesaling, exportation, or importation of drugs/medicinal materials, together with a certificate issued by a competent authority certifying that the applicant meets the applicable conditions and is operating in the pharmaceutical sector, or one of the following certificates of Good Practices: Certificate of Good Manufacturing Practices (GMP) compliance, Certificate of Good Distribution Practices (GDP) compliance, Certificate of Good Supply Practices compliance, or Certificate of Good Storage Practices (GSP) compliance.

For an applicant for medicinal materials, where the country concerned does not issue pharmaceutical business licenses to establishments engaged in the business of medicinal materials, licenses issued in accordance with the laws of that country shall be accepted, provided that they specify one of the following business scopes: manufacture, wholesaling, exportation, or importation of medicinal materials.

6. The certificate confirming that the medicinal material is permitted to be manufactured or marketed in the manufacturing country must contain all of the following information: the name of the medicinal material; the name and address of the manufacturer; the manufacturing country; and the signature, seal, and full name of the signatory.

7. Documents demonstrating that a manufacturer of drug substances, excipients, capsule shells, or herbal materials (for the manufacture of herbal drugs) complies with GMP guideline for medicinal materials may be one of the following:

a) A Certificate of GMP compliance;

b) A manufacturing license containing a certification that the manufacturer complies with GMP guideline;

c) A CPP for the drug substance containing a statement confirming GMP compliance;

d) Other legal documents issued by a competent authority containing, at a minimum, the following information: the name and address of the manufacturer; confirmation that the manufacturer complies with GMP guideline; and the name of the drug substance, herbal material, excipient, or capsule shell;

dd) For excipients in an MAA: Where the documents specified in any of Points a, b or d of this Clause cannot be provided, the manufacturer of the finished drug product or semi-finished product shall conduct a self-assessment of the excipient manufacturer’s compliance with GMP guideline in accordance with the Circular No. 28/2025/TT-BYT of the Minister of Health, make a self-declaration in the MAA of the GMP principles and standards with which the excipient manufacturer complies (using Form No. 05/TT in Appendix IX to this Circular), and undertake legal responsibility for such declaration;

e) For herbal materials in an MAA:

Where the documents specified in any of Points a, b or d of this Clause cannot be provided, a certificate of compliance with Good Agricultural and Collection Practice (GACP) for herbal materials shall be provided.

8. Mock-ups of the labels of drugs/medicinal materials and the package leaflets intended for use in Viet Nam shall comply with the provisions of the Circular No. 01/2018/TT-BYT of the Minister of Health, as amended by the Circular No. 23/2023/TT-BYT, and the following specific provisions:

a) The mock-ups of the labels and package leaflets intended for use in Viet Nam shall bear the confirmation seal of the representative office in Viet Nam, the applicant, or the manufacturer;

b) The outer packaging of drugs/medicinal materials shall bear a barcode, QR code, DataMatrix code, or other form of coding as prescribed by relevant laws, printed on the outer packaging by the manufacturers, for the purposes of managing, identifying, and tracing the origin of drugs/medicinal materials placed on the market, in accordance with the roadmap prescribed in Point h Clause 1 Article 55 of this Circular;

c) The outer packaging label of a drug/semi-finished drug product shall state, in full, the name and strength, mass, or concentration of each drug substance and herbal material contained in the formulation of the drug/semi-finished drug product, per smallest dose unit or smallest pack size;

d) For dosage forms or packaging for which an in-use stability study after opening is required in accordance with the ACTD or ICH-CTD guidelines, the package leaflet shall include information on the shelf life and storage conditions after opening;

dd) The mock-ups of the labeling and package leaflet of a biosimilar shall clearly identify the reference biological to which it is similar.

Article 23. General provisions on quality documents

1. Specifications, test methods, certificates of analysis, and stability study data (applicable to both the drug substance and finished drug product sections of the MAA) shall be original documents bearing the seal of the manufacturer. Where more than one manufacturer is involved in the manufacture of the finished drug product, the seal of the establishment responsible for quality control of the drug or batch release shall be accepted.

Where the manufacturer does not use a seal but uses a digital signature instead, the applicant shall affix its seal to certify the document and shall be legally responsible for its accuracy, legality, and truthfulness.

Where the quality documents for the drug substance section of the MAA for a finished drug product are provided in the form of electronic documents without bearing the seal of the drug substance manufacturer, the seal of the finished drug product manufacturer or the applicant shall be accepted. The establishment whose seal is affixed to such documents shall be legally responsible for their accuracy, legality, and truthfulness.

2. The certificate of analysis (CoA) for a drug/medicinal material must meet the following requirements:

a) The CoA shall be in Vietnamese or English. Where the CoA is not in Vietnamese or English, a notarized translation into Vietnamese or English shall be provided;

b) Where two or more establishments are involved in the manufacture of a drug, the batch of the drug or medicinal material shall have a CoA issued by the manufacturer, the final packaging establishment, or the establishment responsible for batch release;

c) The CoA shall include the following information:

– The name and address of the manufacturer, the CoA number, the name and signature of the person responsible, and the date of issuance of the CoA. Where the CoA bears an electronic signature, such signature shall comply with the applicable laws on electronic transactions. Where the CoA does not bear the signature of the person responsible, a CoA bearing the seal of the manufacturer shall be accepted. The applicant shall bear full legal responsibility for the accuracy and validity of the CoA.

– Information on the drug/medicinal material sample, including: the product name; batch number; expiry date for the drug, or expiry date or retest date for the medicinal material; applicable specification; quality attributes; acceptance criteria; test results; and the conclusion on the quality of the product batch.

3. Requirements applicable to a CoA or results of experimental validation of a specification or test method conducted at a state laboratory for medicinal products and pharmaceutical ingredients at the request of a regulatory authority:

The CoA and the results of such experimental validation shall be certified by a state laboratory for drugs and medicinal materials that complies with GLP requirements.

Article 24. Provisions on clinical documents required for assurance of the drug safety and efficacy in MAAs

1. For a new chemical drug, vaccine or biological:

a) Full clinical data must be provided to demonstrate the safety and efficacy of the drug, vaccine, or biological, and must comply with the following requirements:

– The clinical studies on the drug and data included in the clinical documents must comply with ICH guidelines, MOH’s guidelines, or guidelines of other organizations recognized by Viet Nam, including guidelines issued by international organizations of which Viet Nam is a member and guidelines issued by drug regulatory authorities as prescribed in Clause 9 of Article 2 of this Circular.

– The clinical data, except for a biosimilar to a reference biological that has been granted a marketing authorization in Viet Nam, must contain sufficient information to permit analysis and justification in accordance with the ICH-E5 guidelines.

– A drug containing a new combination of drug substances must be supported by full clinical data in accordance with the WHO, US FDA, or EMA guidelines on the clinical development of fixed-dose combination medicinal products, as specified in Appendix I to this Circular;

b) A vaccine that has full clinical data demonstrating its safety and efficacy as prescribed in Point a of this Clause but has not been licensed or placed on the market by any drug regulatory authority prescribed in Clause 9 Article 2 of this Circular must have clinical data on the assessment of safety and immunogenicity in the target population in Viet Nam prior to being granted a marketing authorization;

c) A biosimilar must be supported by full clinical data in accordance with the MOH’s guidelines on the development of biosimilars or the guidelines of WHO, US FDA, or EMA, as specified in Appendix I to this Circular;

d) For a biological, where the manufacturer is changed, including a change in the manufacturing site, documentation must be provided to demonstrate the comparability in quality between the biological manufactured at the former manufacturing site and the biological manufactured at the new manufacturing site, in accordance with the guidelines of US FDA, ICH, WHO, or EMA, the guidelines of international organizations of which Viet Nam is a member, or the guidelines of any drug regulatory authority prescribed in Clause 9 Article 2 of this Circular.

2. For a new chemical drug that is not an original brand-name drug, clinical documents must be provided that meets one of the following requirements:

a) Clinical data that meet the requirements laid down in Point a Clause 1 of this Article;

b) Clinical data for a similar drug with the same drug substance, concentration, strength, dosage form, and route of administration that has been granted a marketing authorization by one of the drug regulatory authorities prescribed in Clause 9 Article 2 of this Circular, the use of which has been authorized by the owner of the clinical data. The clinical data for the similar drug must meet the requirements laid down in Point a Clause 1 of this Article;

c) Clinical data compiled from studies reported in the medical literature, meaning scientific publications in the field of medicine, including clinical study and clinical trial reports, scientific articles, medical journals, pharmaceutical journals, and specialized textbooks in the fields of medicine and pharmacy (hereinafter referred to as “medical literature”); and bioequivalence study data comparing the drug with a similar drug having the same drug substance, concentration, strength, dosage form, and route of administration, which has been granted a marketing authorization by one of the drug regulatory authorities prescribed in Clause 9 Article 2 of this Circular and meets the MOH’s requirements for reference drugs used in bioequivalence studies.

3. For a new herbal drug; an oral drug containing an herbal material in combination with a drug substance that is an essential oil or a pure substance extracted from an essential oil, including substances obtained by synthesis or semi-synthesis; or a drug containing a pure active ingredient extracted from an herbal material:

Clinical data or data cited from documents must be provided in accordance with one of the following requirements:

a) The clinical studies of the drug and the data in the clinical documents must meet the requirements of Article 18 of this Circular or comply with the MOH’s Guidance on Non-clinical and Clinical Studies of Herbal Drugs set out in Appendix III to this Circular, or with guidelines issued by other organizations recognized by Viet Nam, including the WHO Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines, or with guidelines issued by the drug regulatory authorities prescribed in Clause 9 Article 2 of this Circular;

b) Monographs on drugs/medicinal materials contained in the pharmacopoeias or drug formularies of Viet Nam or other countries in the world;

c) Articles evaluating the safety and efficacy of the drug published in international journals indexed in the Web of Science (WoS) and Scopus databases, and clinical data compiled from studies published in other medical literature;

d) Reports evaluating the safety and efficacy of national-, ministerial-, or provincial-level science and technology projects that have been formally accepted upon completion.

4. A chemical drug that has the same drug substance, strength, concentration, route of administration, and dosage form as a drug that has been granted a marketing authorization by one of the drug regulatory authorities prescribed in Clause 9 Article 2 of this Circular, but has a different indication, dosage regimen, bioavailability, or pharmacokinetic profile from a drug with the same drug substance that has already been granted a marketing authorization in Viet Nam, must have clinical data meeting one of the following requirements:

a) Clinical data that meet the requirements laid down in Point a Clause 1 of this Article;

b) Clinical data compiled from studies published in the medical literature, accompanied by the package leaflet or Summary of Product Characteristics (SmPC) of a drug with the same drug substance, strength, concentration, route of administration, and dosage form that has been granted a marketing authorization by one of the drug regulatory authorities prescribed in Clause 9 Article 2 of this Circular;

c) Clinical data developed in accordance with the guidelines on the clinical development of drugs with novel improvements over the original brand-name drug, as specified in Appendix I to this Circular.

5. Submission of safety and efficacy documents in MAAs for the following drugs is exempted:

a) Generic drugs;

b) A chemical drug with the same drug substance, strength, concentration, route of administration, and dosage form as a drug that has been granted a marketing authorization by one of the drug regulatory authorities prescribed in Clause 9 Article 2 of this Circular (including a case where the marketing of such drug has been discontinued for reasons unrelated to its quality, safety, or efficacy), and that does not fall under the case specified in Clause 4 of this Article;

c) A probiotic biological product with the same origin, bacterial strain, concentration, strength, indication, and dosage regimen as a biological that has been granted a marketing authorization by one of the drug regulatory authorities prescribed in Clause 9 Article 2 of this Circular;

d) A chemical drug for external use with a local action that has the same drug substance, strength, concentration, dosage form, and indication as a drug that has been granted a marketing authorization in Viet Nam for at least 30 years and for which a monograph is included in the Vietnamese Pharmacopoeia, a reference pharmacopoeia, or the Vietnamese National Formulary;

dd) An external-use drug containing an essential oil or a pure substance extracted from an essential oil as the drug substance (including substances obtained by synthesis or semi-synthesis), with the same drug substance, strength, concentration, and dosage form as a drug that has been granted a marketing authorization in Viet Nam for at least 10 years or that has been granted a marketing authorization and placed on the market in at least one other country in the world for at least 10 years;

e) An oral drug containing an herbal material in combination with an essential oil or a pure substance extracted from an essential oil as the drug substance (including substances obtained by synthesis or semi-synthesis), or a drug containing a pure active ingredient extracted from a herbal material, with the same drug substance, medicinal herb, strength, concentration, dosage form, and indication as a drug that has been granted a marketing authorization in Viet Nam;

g) A herbal drug with the same herbal materials, strength, concentration, mass of herbal materials, dosage form, indication, and route of administration as a drug that has been granted a marketing authorization by one of the drug regulatory authorities prescribed in Clause 9 Article 2 of this Circular, or as a drug that has been granted a marketing authorization in Viet Nam (including where such marketing authorization has expired);

h) A new drug, other than a vaccine, manufactured in Viet Nam for the prevention or treatment of a group A infectious disease for which an epidemic has been declared in accordance with the Law on disease prevention, and having the same drug substance, dosage form, route of administration, and indication as a drug that has been granted a marketing authorization, an emergency use authorization, or a conditional marketing authorization or conditional use authorization by one of the drug regulatory authorities prescribed in Clause 9 Article 2 of this Circular.

6. MAAs for any drugs other than those specified in clauses 1, 2, 3, 4 and 5 of this Article must be supported by clinical data to ensure the safety and efficacy of the drug in accordance with the guidelines of ICH, WHO, US FDA, EMA, the MOH’s guidelines, or guidelines of other organizations recognized by Viet Nam.

7. Where a clinical study has been conducted before the regulations or guidelines on drug development research referred to in Point a Clause 1 and Point a Clause 3 of this Article area adopted, the data from such study may be accepted.

Section 2. STRUCTURE AND COMPOSITION OF MARKETING AUTHORIZATION APPLICATIONS FOR DRUGS/MEDICINAL MATERIALS

Article 25. Structure of MAAs for drugs/medicinal materials

1. An MAA shall be prepared according to ACTD or ICH-CTD, and shall comply with the provisions of this Circular.

2. Structure of MAAs for chemical drugs, vaccines and biologicals:

a) An MAA for a chemical drug, vaccine, or biological prepared in accordance with the ACTD shall be structured as follows:

– Part I: Administrative Document.

– Part II: Technical Document (comprising quality document; non-clinical document; and clinical document);

b) An MAA for a chemical drug, vaccine, or biological prepared in accordance with the ICH-CTD shall be structured as follows:

– Module I: Administrative Document.

– Module II: Technical Document (comprising the quality, non-clinical, and clinical overviews and summaries; the quality document; non-clinical document; and clinical document).

3. Structure of MAAs for herbal drugs; oral drugs containing an herbal material in combination with an essential oil or a pure substance extracted from an essential oil as the drug substance (including substances obtained by synthesis or semi-synthesis), or drugs containing a pure active ingredient extracted from a herbal material:

a) For a new herbal drug; an oral drug containing a herbal material in combination with an essential oil or a pure substance extracted from an essential oil as the drug substance (including substances obtained by synthesis or semi-synthesis), or a drug containing a pure active ingredient extracted from a herbal material:

– Part I: Administrative Document.

– Part II: Technical Document (comprising the quality document prepared in accordance with the guidelines in Appendix III to this Circular, and clinical data or data cited from documents as prescribed in Clause 3 Article 24 of this Circular).

b) For an herbal drug that is not a new drug:

– Part I: Administrative Document.

– Part II: Technical Document (comprising the quality document prepared in accordance with the guidelines in Appendix III to this Circular).

4. Structure of MAAs for medicinal materials:

a) Part I: Administrative Document;

b) Part II: Technical Document (comprising the quality document prepared in accordance with the guidelines in Appendix IV to this Circular).

Article 26. Administrative Document

1. An application form, which is made using Form 4A/TT, Form 4B/TT, or Form 4C/TT in Appendix IX to this Circular.

2. Letters of authorization in an MAA:

a) A letter of authorization appointing the applicant, where the applicant is not the manufacturer, the product license holder/marketing authorization holder, ordering establishment, or transferor establishment;

b) A letter of authorization to sign documents in MAA (if any).

3. CPP (for an imported drug).

For the cases prescribed in the first and second sub-points of Point a Clause 2 Article 45 of this Circular, the applicant shall submit an explanatory report stating why the CPP could not be provided in the MAA at the time of initial MAA submission.

4. License to manufacture or trade drugs in the country concerned; license for establishment of a representative office in Viet Nam (for a foreign applicant).

5. Certificate of eligibility for pharmaceutical business (for a Vietnamese applicant).

6. Legal documents of the manufacturer of the drug substance, excipient, capsule shell, or herbal material, as prescribed in Clause 7 Article 22 of this Circular.

7. The certificate confirming that the medicinal material is permitted to be manufactured or marketed in the manufacturing country (for an MAA for a medicinal material manufactured overseas).

8. Mock-up of the label and package leaflet for drugs and medicinal materials:

a) For the drug or medicinal material intended to be placed on the market in Viet Nam;

b) For the drug as actually placed on the market in the manufacturing country or the CPP-issuing country, in the case of an MAA for an imported drug.

9. The SmPC or package leaflet approved in the CPP-issuing country, for a new drug, vaccine, or biological, or for a drug for which validation by reference to available validation results is requested.

10. For an MAA requesting the application of validation by reference to available validation results, or an MAA is for a drug manufactured in a country whose drug regulatory authority is not one of those specified in Clause 9 Article 2 of this Circular, where only a CPP issued by the competent authority responsible for issuing CPPs in a country whose drug regulatory authority is one of those specified in Clause 9 Article 2 of this Circular and certifying that the drug is licensed and actually placed on the market in that country is submitted, the following additional documents must be provided:

a) The validation report of the drug regulatory authority issuing the CPP, as specified in Clause 9 Article 2 of this Circular, which must meet the requirements of Article 30 of this Circular;

b) A comparative tabulated summary demonstrating the consistency between the MAA for the drug in Viet Nam and the information on the drug licensed in the country concerned, prepared using Form 09/TT in Appendix IX to this Circular.

Article 27. Quality Document

1. Quality documents are prepared according to the guidelines in Part II of ACTD or the guidelines in Module 2 and Module 3 of ICH-CTD, and relevant guidelines.

For a biosimilar, complete documents and data demonstrating its quality similarity to the reference biological shall be provided in accordance with the relevant guidelines of WHO, US-FDA, or EMA.

2. The drug substance documents may be replaced by the following documents:

a) A Certificate of Suitability to the European Pharmacopoeia (CEP), as prescribed in Clause 3 of this Article;

b) Batch analysis data for the drug substance;

c) Where the CEP does not specify a retest period for the drug substance, stability study data for the drug substance shall be submitted.

3. Requirements for CEPs in the Quality Document:

a) The CEP included in the submitted MAA must be valid at the time of receipt of the MAA, be issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM), and include all annexes/documents attached to the CEP.

For a CEP issued before September 01, 2023, the CEP must bear the seal of the finished drug manufacturer or the applicant. The establishment whose seal is affixed to the CEP shall be legally responsible for the accuracy, legality, and truthfulness of the CEP. The CEP must state in full the name of the applicant or the manufacturer authorized to use the CEP in the authorization section of the CEP.

For a CEP issued on or after September 01, 2023, the CEP included in the submitted MAA must be an electronic copy bearing a valid electronic signature, issued by the EDQM, and accompanied by a letter of authorization from the CEP holder authorizing the applicant or the manufacturer to use the CEP;

b) The applicant must submit a document providing the results of its own search for the CEP in the database published by the EDQM, including the search link and bearing the applicant’s confirmation. The document providing such results must include the following information:

– The name of the material, information on the CEP holder, number, issuance date, and validity status of the CEP, and the number of the applicable European Pharmacopoeia monograph.

– The date by which renewal is required or the expiry date, if applicable.

4. Where the manufacturer uses a medicinal material that has been granted a marketing authorization in Viet Nam and uses it in accordance with the approved information on the name of the medicinal material, the manufacturer, quality specifications, and source of the medicinal material:

a) The inclusion of quality documents relating to the medicinal material and the documents specified in Clause 6 Article 26 of this Circular in the MAA for the finished drug is not required;

b) The applicant must submit:

– One (01) CoA for the medicinal material, issued by the finished drug manufacturer, covering all quality specifications at levels equal to or more stringent than those specified in the standard announced by the medicinal material manufacturer. Where the finished drug manufacturer does not have the capacity to test the medicinal material for all quality specifications, it must provide an analysis report for the quality specifications not tested by the finished drug manufacturer, issued by a state testing authority or a drug and medicinal material testing service establishment that has been granted a certificate of eligibility for pharmaceutical business;

– One (01) CoA for the medicinal material, issued by the medicinal material manufacturer.

5. For vaccines, antisera, and human blood and plasma derivatives, documents shall be submitted according to Clause 1 of this Article and include the following:

a) A batch release certificate issued by the competent authority of the CPP-issuing country as prescribed or by one of the drug regulatory authorities prescribed in Clause 9 Article 2 of this Circular;

b) A CoA, quality specifications and test method confirmed by the National Institute for Control of Vaccines and Biologicals (NICVB) or a state drug testing establishment in charge of testing, evaluating and monitoring vaccines and medical biologicals as assigned by MOH.

6. For orphan drugs, drugs intended to meet needs for national defense and security, epidemic prevention and control, or response to the consequences of natural disasters or catastrophes, and drugs for special treatment needs:

a) Orphan drugs for the treatment of rare diseases: <0}

Available stability study data obtained according to the guidelines of ASEAN or ICH shall be accepted;

b) Drugs intended to meet needs for national defense and security, epidemic prevention and control, or response to the consequences of natural disasters or catastrophes:

Stability study data available at the date of MAA submission shall be accepted for consideration of the drug’s shelf life, based on the opinions given by the Council, where the period covered by the drug’s stability study data does not yet meet the minimum study duration required under ASEAN guidelines.

After the marketing authorization has been granted, the applicant shall continue to submit stability study data for the finished drug to the DAV until the period covered by the stability study actually meets the minimum study duration required under ASEAN guidelines. The applicant shall submit the data as a variation to the marketing authorization, as prescribed in Appendix II to this Circular, for consideration and updating of the drug’s shelf life in accordance with regulations.

Where the stability study results for the drug fail to comply with the study protocol included in the MAA, the applicant shall immediately report the matter to DAV for submission to the Council for consideration of the drug’s shelf life.

Based on opinions given by the Council, DAV shall consider and decide the shelf life of the drug, including the shelf life applicable to batches of the drug that have already been manufactured, based on the actual stability study data;

c) Drugs for special treatment needs:

Available stability study data generated in accordance with ASEAN or ICH guidelines shall be accepted, as decided by the Minister of Health based on the opinion of the Council, where the applicant demonstrates that the drug cannot be stored under Climatic Zone IVb conditions in accordance with ASEAN guidelines.

7. For the cases specified in Clause 2 Article 13 of this Circular:

The applicant must submit a comparative tabulated summary (using Form 01/TT in Appendix IX to this Circular) comparing the drug before and after the change, and the technical documents corresponding to each change, in accordance with the guidance in Appendix II to this Circular.

8. For an MAA for a drug ordered for processing or a drug manufactured using transferred technology that meets the requirements of Clause 1 Article 9 of this Circular:

a) Where the drug ordered for processing or the drug prior to technology transfer already has Climatic Zone IVb stability data, a minimum of 06 months of stability study data, including long-term and accelerated stability data, is required for the drug for which marketing authorization is sought, in accordance with ASEAN guidelines applicable to variations;

b) Where the drug ordered for processing or the drug prior to technology transfer does not yet have Climatic Zone IVb stability data, Climatic Zone IVb stability study data for the drug for which marketing authorization is sought are required, in accordance with ASEAN guidelines on drug stability studies;

c) For vaccines and biologicals, the stability data requirements shall follow the WHO, EMA, and US-FDA guidelines applicable to a change of manufacturer;

d) After the marketing authorization has been granted, the manufacturer shall continue to conduct stability studies of the finished drug in accordance with the study protocol included in the submitted MAA. Where the drug fails to meet the stability study requirements, the applicant shall report such failure to DAV and propose appropriate measures to address it.

9. For an MAA for a drug that has already been granted a marketing authorization upon a change of its manufacturer as prescribed in Point b Clause 2 Article 55 of the Pharmacy Law, where the MAA includes documents evidencing approval of the change of manufacturer by the competent authority of the country concerned and a comparative tabulated summary (using Form 01/TT in Appendix IX to this Circular):

a) A minimum of 06 months of stability study data, including long-term and accelerated stability data, is required for the drug for which marketing authorization is sought, in accordance with ASEAN guidelines applicable to variations;

b) For vaccines and biologicals, the stability data requirements shall follow the WHO, EMA, and US-FDA guidelines applicable to a change of manufacturer;

c) After the marketing authorization has been granted, the manufacturer shall continue to conduct stability studies of the finished drug in accordance with the study protocol included in the submitted MAA. Where the drug fails to meet the stability study requirements, the applicant shall report such failure to DAV and propose appropriate measures to address it.

Article 28. Non-clinical Document

Non-clinical documents are prepared in accordance with the guidelines in Part III of the ACTD or Module 2 and Module 4 of the ICH-CTD, and relevant guidelines or the guidelines in Appendix III to this Circular.

Article 29. Clinical Document

Clinical documents are prepared in accordance with the guidelines in Part IV of the ACTD or Module 2 and Module 5 of the ICH-CTD, and relevant guidelines or the guidelines in Appendix III enclosed herewith.

Article 30. Documents on validation results of drug regulatory authorities specified in Clause 9 Article 2 of the Circular in case where an MAA is validated by reference to available validation results

1. The document used as reference must be an official validation report issued by a drug regulatory authority specified in Clause 9 Article 2 of this Circular, setting out in detail the assessment and validation process regarding the quality, safety, and efficacy of the drug, as well as the scientific and legal basis for granting the marketing authorization for the drug in the country concerned.

2. The validation report used as reference must be the final report used by the drug regulatory authority to grant the marketing authorization for the product, together with all validation report(s) and document(s) approving variations to the product following the grant of marketing authorization.

3. A validation report used as reference for valuation of an MAA shall include, at a minimum, the following information:

a) Administrative information, including:

– Information on the drug.

– A list of all approved pack sizes and packaging specifications.

– The pharmacological group.

– Information on the manufacturer and the product license holder/marketing authorization holder;

b) Quality information, including:

– An assessment of the composition and manufacturing process.

– An assessment of quality control.

– An assessment of stability, including conclusions on the product quality;

c) Safety and efficacy information, including:

– A summary assessment of the key non-clinical data.

– A summary assessment of the key clinical data.

– A benefit-risk assessment.

– The basis for the approved indications.

4. Where the validation report of the drug regulatory authority prescribed in Clause 9 Article 2 of this Circular is not made in English, a notarized translation into English or Vietnamese must be submitted.

Section 3. SPECIFIC PROVISIONS ON MARKETING AUTHORIZATION APPLICATIONS FOR DRUGS/MEDICINAL MATERIALS

Article 31. MAAs for drugs specified in clauses 1, 2 and 6 Article 24 of this Circular

1. Administrative Document:

The documents specified in Article 26 of this Circular.

2. Quality Document:

The documents specified in Article 27 of this Circular.

3. Non-clinical Document:

The documents specified in Clauses 1, 2, 6 and 7 of Article 24 of this Circular and prepared in accordance with Article 28 of this Circular.

4. Clinical Document:

The documents specified in Clauses 1, 2, 6 and 7 of Article 24 of this Circular and prepared in accordance with Article 29 of this Circular.

5. A risk management plan, for a new chemical drug, vaccine or biological (except probiotic biological products) (using Form 03/TT in Appendix IX to this Circular).

Article 32. MAAs for generic drugs and drugs specified in Points b, c, d and h Clause 5 Article 24 of this Circular

1. Administrative Document:

The documents specified in Article 26 of this Circular.

2. Quality Document:

a) The documents specified in Article 27 of this Circular;

b) Documentary evidence of demonstrated bioequivalence for a drug containing a drug substance or having a dosage form for which bioequivalence study data are required to be reported upon submission of an MAA.

Article 33. MAAs for drugs specified in Clause 4 Article 24 of this Circular

1. Administrative Document:

The documents specified in Article 26 of this Circular.

2. Quality Document:

a) The documents specified in Article 27 of this Circular;

b) Documentary evidence of demonstrated bioequivalence for a drug containing a drug substance or having a dosage form for which bioequivalence study data are required to be reported upon submission of an MAA.

3. Clinical Document:

The documents specified in Clause 4 Article 24 of this Circular and prepared in accordance with Article 29 of this Circular.

4. The package leaflet or SmPC of the drug with the same drug substance, strength, concentration, route of administration, and dosage form that has been granted a marketing authorization by one of the drug regulatory authorities specified in Clause 9 Article 2 of this Circular, where clinical data compiled from studies published in the medical literature are submitted.

5. Additional safety and efficacy data shall be provided where necessary, based on the advisory opinion of the Council.

Article 34. MAAs for drugs specified in Points dd and e Clause 5 Article 24 of this Circular

1. Administrative Document:

The documents specified in Article 26 of this Circular.

2. Quality Document:

The documents specified in Appendix III to this Circular.

Article 35. MAAs for drugs specified in Clause 3 Article 24 of this Circular

1. Administrative Document:

The documents specified in Article 26 of this Circular.

2. Quality Document:

The documents prepared according to the guidelines in Appendix III to this Circular.

3. Clinical data or data cited from documents as prescribed in Clause 3 Article 24 of this Circular.

Article 36. MAAs for drugs specified in Point g Clause 5 Article 24 of this Circular

1. Administrative Document:

The documents specified in Article 26 of this Circular.

2. Quality Document:

The documents prepared according to the guidelines in Appendix III to this Circular.

Article 37. MAAs for medicinal materials

1. Administrative Document:

The documents specified in Article 26 of this Circular.

2. Quality Document:

The documents specified in Appendix IV to this Circular.

Section 4. SPECIFIC PROVISIONS ON MARKETING AUTHORIZATION APPLICATIONS FOR PROCESSED DRUGS AND DRUGS MANUFACTURED USING TRANSFERRED TECHNOLOGY IN VIET NAM

Article 38. MAA for a processed drug or a drug manufactured using transferred technology that is a chemical drug, vaccine, or biological

1. Administrative Document:

a) The administrative documents for the processed drug or the drug manufactured using transferred technology, as specified in Article 26 of this Circular. The legal documents of the manufacturer of the drug substance, excipient, capsule shell, or herbal material are not required where drug processing or technology transfer is limited to the packaging stage;

b) Other documents concerning the drug processing or technology transfer, including:

– The drug processing contract or technology transfer contract. Where the ordering establishment or the processing establishment is not the applicant, the processing contract must bear the signatures of the legal representatives of the ordering establishment, the applicant, and the processing establishment.

– The technology transfer registration certificate as prescribed in Article 31 of the Law on Technology Transfer, for an MAA for a drug manufactured using transferred technology;

c) The CPP for the drug ordered for processing or the drug prior to technology transfer, where the drug ordered for processing or the drug prior to technology transfer is an imported drug that has not been granted a marketing authorization in Viet Nam or whose marketing authorization in Viet Nam has expired at the time of MAA submission.

2. Quality Document:

a) The quality documents for the processed drug/the drug manufactured using transferred technology and the drug ordered for processing/the drug prior to technology transfer, as specified in Articles 31, 32, 33, 34, and 35 of this Circular;

b) The comparative tabulated summary (Form 01/TT in Appendix IX to this Circular), comparing the drug ordered for processing with the processed drug, or the drug prior to technology transfer with the drug manufactured using transferred technology, and the technical documents corresponding to each change, in accordance with the guidelines in Appendix II to this Circular.

c) Documents demonstrating quality comparability between the processed vaccine or biological and the vaccine or biological ordered for processing, or between the vaccine or biological manufactured using transferred technology and the vaccine or biological prior to technology transfer, in cases where the vaccine or biological is exempt from submission of the Non-clinical Document and Clinical Document as prescribed in Clause 3 of this Article, in accordance with US-FDA SUPAC guidelines, ICH, WHO, and EMA guidelines on variations, guidelines of international organizations of which Viet Nam is a member, or guidelines of the drug regulatory authorities specified in Clause 9 Article 2 of this Circular;

d) An MAA for a processed drug or a drug manufactured using transferred technology for which classification as an original brand-name drug or as a drug with demonstrated bioequivalence is requested must also include the following quality documents:

– The bioequivalence study report for the processed drug or the drug manufactured using transferred technology.

The may replace the bioequivalence study report for the processed drug or the drug manufactured using transferred technology with a dissolution equivalence study report comparing the processed drug with the drug ordered for processing, or the drug manufactured using transferred technology with the drug prior to technology transfer, provided that the processed drug and the drug ordered for processing, or the drug manufactured using transferred technology and the drug prior to technology transfer, have the same formulation, manufacturing process, material quality specifications, and finished-product quality specifications, in accordance with US-FDA SUPAC, ICH, WHO, and EMA guidelines, guidelines of international organizations of which Viet Nam is a member, or guidelines of the drug regulatory authorities specified in Clause 9 Article 2 of this Circular.

Where any of the above-mentioned items are changed at a level that does not require submission of a bioequivalence study report, the applicant must submit the supporting documents corresponding to each change in accordance with US-FDA SUPAC, ICH, WHO, and EMA guidelines, guidelines of international organizations of which Viet Nam is a member, or guidelines of the drug regulatory authorities specified in Clause 9 Article 2 of this Circular.

– The bioequivalence study report for the drug ordered for processing or the drug prior to technology transfer, where the drug ordered for processing or the drug prior to technology transfer has not been classified as a drug with demonstrated bioequivalence in Viet Nam and the processed drug or the drug manufactured using transferred technology is proposed for classification as a drug with demonstrated bioequivalence.

3. Non-clinical Document and Clinical Document:

a) For a processed drug or a drug manufactured using transferred technology:

The non-clinical documents specified in Clause 3 Article 31 of this Circular and the clinical documents specified in Clause 4 Article 31 of this Circular shall be submitted where the processed drug or the drug manufactured using transferred technology is a new chemical drug, vaccine, or biological.

Non-clinical and clinical documents are not required in the following cases:

– The drug ordered for processing or the drug prior to technology transfer is a chemical drug whose marketing authorization in Viet Nam remains valid at the time of MAA submission, or for which the non-clinical documents specified in Clause 3 Article 31 of this Circular and the clinical documents specified in Clause 4 Article 31 of this Circular have already been submitted.

– The drug ordered for processing or the drug prior to technology transfer is a biological whose marketing authorization in Viet Nam remains valid at the time of MAA submission, or for which the non-clinical documents specified in Clause 3 Article 31 of this Circular and the clinical documents specified in Clause 4 Article 31 of this Circular have already been submitted, and there are sufficient documents demonstrating quality comparability between the processed drug and the drug ordered for processing, or between the drug manufactured using transferred technology and the drug prior to technology transfer.

– The drug ordered for processing or the drug prior to technology transfer is a vaccine whose marketing authorization in Viet Nam remains valid at the time of MAA submission and for which documents demonstrating quality comparability between the processed drug and the drug ordered for processing, or between the drug manufactured using transferred technology and the drug prior to technology transfer, have been submitted;

b) For the drug ordered for processing or the drug prior to technology transfer:

The non-clinical documents specified in Clause 3 Article 31 of this Circular and the clinical documents specified in Clause 4 Article 31 of this Circular shall be submitted where the processed drug or the drug manufactured using transferred technology is a new chemical drug, vaccine, or biological, or where classification of the processed drug or the drug manufactured using transferred technology as an original brand-name drug or reference biological is requested, and the drug ordered for processing or the drug prior to technology transfer has not been classified as an original brand-name drug or reference biological, as applicable.

4. A risk management plan, for a new chemical drug, vaccine or biological (except probiotic biological products) (using Form 03/TT in Appendix IX to this Circular).

Article 39. MAA for a processed drug or a drug manufactured using transferred technology that is an herbal drug

1. Administrative Document:

a) The administrative documents for the processed drug or the drug manufactured using transferred technology, as prescribed in Article 26 of this Circular. The legal documents of the manufacturers of herbal materials, excipients, or capsule shells are not required where the processing or technology transfer is limited to the packaging stage;

b) Other documents concerning the drug processing or technology transfer, including:

– The drug processing contract or technology transfer contract. Where the ordering establishment or the processing establishment is not the applicant, the processing contract must bear the signatures of the legal representatives of the ordering establishment, the applicant, and the processing establishment.

– The technology transfer registration certificate as prescribed in Article 31 of the Law on Technology Transfer, for an MAA for a drug manufactured using transferred technology;

c) The CPP for the drug ordered for processing or the drug prior to technology transfer, where the drug ordered for processing or the drug prior to technology transfer is an imported drug that has not been granted a marketing authorization in Viet Nam or whose marketing authorization in Viet Nam has expired at the time of MAA submission.

2. Quality Document:

a) The quality documents for the processed drug/the drug manufactured using transferred technology and the drug ordered for processing/the drug prior to technology transfer, as prescribed in Articles 35 and 36 of this Circular;

b) The comparative tabulated summary (Form 01/TT in Appendix IX to this Circular), comparing the drug ordered for processing with the processed drug, or the drug prior to technology transfer with the drug manufactured using transferred technology, and the technical documents corresponding to each change, in accordance with the guidelines in Appendix II to this Circular.

3. Clinical Document:

a) For a processed drug or a drug manufactured using transferred technology:

The clinical documents specified in Clause 3 Article 35 of this Circular shall be submitted where the processed drug or the drug manufactured using transferred technology is a new drug.

Clinical documents are not required where the drug ordered for processing or the drug prior to technology transfer is an herbal drug whose marketing authorization in Viet Nam remains valid at the time of MAA submission, or for which the clinical documents specified in Clause 3 Article 35 of this Circular have already been submitted;

b) For the drug ordered for processing or the drug prior to technology transfer:

– The clinical documents specified in Clause 3 Article 35 of this Circular shall be submitted where the processed drug or the drug manufactured using transferred technology is a new drug.

– The clinical documents specified in Article 18 of this Circular shall be submitted where classification of the processed drug or the drug manufactured using transferred technology as an original brand-name drug or reference biological is requested, and the drug ordered for processing or the drug prior to technology transfer has not been classified as an original brand-name drug or reference biological, as applicable.

Article 40. MAA for a drug processed involving transfer of drug manufacturing technology from ordering establishment to processing establishment

1. The MAA includes the documents prescribed in Article 38 or 39 of this Circular.

2. The applicant shall concurrently submit:

a) The drug processing contract and the technology transfer contract;

b) The technology transfer registration certificate as prescribed in Article 31 of the Law on Technology Transfer.

Section 5. SPECIFIC PROVISIONS ON APPLICATIONS FOR RENEWAL OF, OR APPROVAL OF VARIATIONS TO, MARKETING AUTHORIZATION FOR DRUG/MEDICINAL MATERIAL

Article 41. Application for renewal of marketing authorization for drug/medicinal material

1. An application form for renewal of the marketing authorization for a drug/medicinal material which is made using Form 4B/TT in Appendix IX to this Circular.

2. An unexpired CPP, for an imported drug.

3. A report on the safety and efficacy of the drug during the period it has been placed on the market, using Form 2C/TT in Appendix IX to this Circular.

Article 42. Application for approval of variations to marketing authorization for drug/medicinal material

1. An application form for approval of variations to the marketing authorization for the drug/medicinal material (using Form 4C/TT in Appendix IX to this Circular), and a letter of authorization to sign documents in the MAA (if any).

2. The documents corresponding to the major variations (MaV) or minor variations (MiV) prescribed in Appendix II to this Circular.

3. For variations relating to the drug formulation, manufacturing process, quality specifications for starting materials, quality specifications for the finished drug, or the trade name of a processed drug or a drug manufactured using transferred technology that has been announced as meeting the criteria set out in Clause 1 Article 9 of this Circular, the applicant for the processed drug or the drug manufactured using transferred technology shall provide evidence that the corresponding variation to the drug ordered for processing or the drug prior to technology transfer, as manufactured and marketed in the country concerned, has been approved by a competent regulatory authority.

Chapter IV

AUTHORITY AND PROCEDURES FOR GRANTING, RENEWING, AND APPROVING VARIATIONS TO MARKETING AUTHORIZATIONS FOR DRUGS/MEDICINAL MATERIALS

Article 43. Authority to grant, renew, and approve variations to marketing authorizations for drugs/medicinal materials

1. The DAV shall grant, renew, or approve variations to marketing authorizations for drugs/medicinal materials based on the application validation and advisory opinions of the Council in the following cases:

a) Granting a marketing authorization for a drug/medicinal material;

b) Renewing a marketing authorization for a drug/medicinal material based on the application validation and the Council’s advisory opinion, in the following cases:

– A drug prescribed in Clause 2 of Article 12 of this Circular.

– A drug/medicinal material that has been subject to a mandatory recall decision or a voluntary recall for failure to meet quality specifications during the period it has been placed on the market since the most recent grant or renewal of the marketing authorization.

– A drug for which the report in Form 2C/TT in Appendix IX to this Circular indicates a new adverse event, a known adverse event occurring at a higher frequency than that stated in the approved package leaflet, or a known adverse event requiring further assessment;

c) Approving variations to a marketing authorization for a drug in accordance with Appendix II to this Circular, in the following cases:

Classification as a prescription or OTC drug; variations to the indication, dosage, route of administration, or intended patient population; and classification as an original brand-name drug, a reference biological, or a drug with demonstrated bioequivalence.

2. The DAV shall renew, or approve variations to, a marketing authorization for a drug/medicinal material based on the application validation without requiring the application validation and advisory opinions of the Council in the following cases:

a) Renewing a marketing authorization for a drug/medicinal material not falling under Point b Clause 1 of this Article;

b) Granting approval of variations to a marketing authorization for a drug/medicinal material not falling under Point c Clause 1 Clause 3 of this Article, and updates to the package leaflet to align with the original brand-name drug.

3. The DAV shall publish, on the MOH’s web portal and the DAV’s website, the variations to marketing authorizations for drugs/medicinal materials that do not require application validation, for minor variations (MiV) requiring notification only.

Article 44. Submission of supplementary documents, updated documents during validation, cases in which a variation application is not required, and periods for applying existing information before approval or announcement of variations

1. Within 06 months from the date of the DAV’s written notice, the applicant shall submit the requested supplementary documents. After this period, if the applicant fails to submit the supplementary documents as requested, the submitted application shall no longer be valid.

The period from the date of the DAV’s written notice to the date on which the applicant submits the supplementary documents shall not be counted toward the time limit prescribed in Clause 6 Article 56 of the Pharmacy Law.

2. Number of rounds of supplementary document submission for an application for grant, renewal, or approval of variations to a marketing authorization for a drug/medicinal material:

a) For an application for grant, renewal, or approval of variations to a marketing authorization for a drug/medicinal material, the applicant may submit supplementary documents no more than twice.

Where, following the second submission of supplementary documents, the application still does not meet the requirements based on the validators’ assessment, the DAV shall refer the case to the Council for consideration of refusing to grant or renew the marketing authorization, or refusing to approve the variations, for a drug falling under Clause 1 Article 43 of this Circular; or shall issue a written notice of refusal to renew the marketing authorization or approve the variations thereto, for a drug falling under Clause 2 Article 43 of this Circular.

Where, following the second submission of supplementary documents, the application does not meet the requirements based on the validators’ assessment due to new issues arising beyond the requirements previously communicated, the DAV shall refer the case to the Council for consideration of allowing the applicant one additional submission of supplementary documents to address the validators’ comments, for a drug falling under Clause 1 Article 43 of this Circular; or shall issue a written notice allowing one additional submission of supplementary documents, for a drug falling under Clause 2 Article 43 of this Circular;

b) Supplementary documents submitted at the Council’s request shall not count toward the number of permitted submissions of supplementary documents prescribed in Point a of this Clause.

3. During the validation of an application, the applicant shall not make any changes to or supplement the contents of the submitted application, unless requested by the DAV, except for the following documents:

a) Documents updating safety and efficacy information in the drug’s package leaflet, for an application for grant of, or approval of variations to, a marketing authorization for a drug;

b) Documents updating administrative information on the name and address of the applicant and the person signing documents in the MAA, provided that the applicant remains unchanged, for an application for grant of, or approval of variations to, a marketing authorization for a drug;

c) Documents updating administrative information on the manufacturer’s name and address format, provided that the manufacturer and manufacturing site remain unchanged, for an application for grant of, or approval of variations to, a marketing authorization for a drug;

d) Documents updating information on the actual marketing status of the drug in Viet Nam, for an application for renewal of a marketing authorization for a drug.

4. For an application for renewal of a marketing authorization for a drug/medicinal material as prescribed in Article 41 of this Circular, the applicant may change only the name of the drug in the renewal application and shall clearly state the change in the application form for renewal of the marketing authorization for the drug/medicinal material.

5. The applicant and the drug manufacturer shall be responsible for updating the label and package leaflet without being required to submit an application for approval of variations or notify the DAV, in the following cases:

a) A change to the position or information of the importer of the drug/medicinal material stated on the label or package leaflet;

b) Labeling the drug/medicinal material and preparing the package leaflet in accordance with Clause 2 Article 35 of Circular No. 01/2018/TT-BYT;

c) Making changes to the contents of the label or package leaflet pursuant to an official letter issued by the DAV based on the Council’s advisory opinion;

d) Except for cases requiring resubmission of the label mock-up or package leaflet following a variation as prescribed in Appendix II to this Circular, the Applicant and the manufacturer shall, on their own initiative, update other changes to the information on the label or package leaflet once such variations have been approved by the DAV;

dd) Other items:

– Correction of spelling errors on the label or package leaflet.

– Changes to the layout of sections in the package leaflet without changing the approved contents, in accordance with the requirements applicable to the package leaflet.

– Changes to or addition of information on quality specifications on the label or package leaflet in accordance with the application approved by the DAV.

– Removal of non-mandatory information from the label or package leaflet.

6. The applicant and the manufacturer shall apply a newly approved variation no later than 12 months from the date on which the DAV issues the approval letter. For a minor variation (MiV) requiring only notification, the variation shall take effect immediately upon receipt of the notification or no later than 12 months from the date on which the DAV publishes the variation.

During the 12-month period from the date on which the DAV issues the approval letter or publishes the variation, the variation shall apply as follows:

a) An imported drug/medicinal material may continue to be imported and marketed, up to its expiry date, with the information applicable before the variation was approved or published, provided that the drug/medicinal material was handed over at the port of departure in the exporting country before the date on which the new variation is required to apply;

b) A drug/medicinal material manufactured in Viet Nam may continue to be marketed, up to its expiry date, with the information applicable before the variation was approved or published, provided that the drug/medicinal material was manufactured before the date on which the new variation is required to apply.

7. No later than 12 months from the date on which the marketing authorization is renewed, where the name of a drug/medicinal material has been changed, the drug/medicinal material shall be marketed under the new name approved upon renewal of the marketing authorization.

During the 12-month period from the date on which the marketing authorization is renewed, the use of the drug’s name shall be governed as follows:

a) An imported drug/medicinal material may continue to be imported and marketed, up to its expiry date, under the name used before renewal of the marketing authorization, provided that the drug/medicinal material was handed over at the port of departure in the exporting country before the date on which the new name approved upon renewal of the marketing authorization is required to be used;

b) A drug/medicinal material manufactured in Viet Nam may continue to be marketed, up to its expiry date, under the name used before renewal of the marketing authorization, provided that the drug/medicinal material was manufactured before the date on which the new name approved upon renewal of the marketing authorization is required to be used.

Article 45. Procedures for granting marketing authorization for drug/medicinal material

1. Method of MAA submission:

The applicant shall submit the MAA in accordance with Article 15 of Decree No. 118/2025/ND-CP.

2. Receipt and time limits for processing of the MAA:

a) Receipt of the MAA:

Upon receipt of a complete MAA, the DAV shall issue the applicant an MAA receipt as prescribed.

The DAV shall accept the MAA without requiring the following documents to be submitted at the time of MAA submission:

– The CPP, for a new drug.

– The CPP, for the case prescribed in Point d Clause 2 Article 22 of this Circular.

– The documents prescribed in Point b Clause 5 Article 27 of this Circular.

No later than the second submission of supplementary documents prescribed in Point a Clause 2 Article 44 of this Circular, the applicant shall submit the documents referred to in this Point for consideration of the grant of the marketing authorization;

b) Time limits for processing an MAA from the date of its receipt:

– An MAA for a drug: not exceeding 12 months.

– An MAA for a drug validated by reference to available validation results: not exceeding 09 months.

– An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer has a valid marketing authorization in Viet Nam at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing has a valid marketing authorization in Viet Nam at the time of MAA submission: not exceeding 03 months.

– An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission: not exceeding 09 months.

– An MAA for a new drug indicated for the prevention or treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the Law on disease prevention: not exceeding 15 days.

– An MAA for a drug eligible for administrative-procedure priority as prescribed in Clause 5 Article 7 of the Pharmacy Law: not exceeding 06 months.

– An MAA for a medicinal material: not exceeding 06 months.

3. Organization of MAA validation:

a) From the date of receipt of the MAA, the DAV shall review, classify, and forward the MAA to the validators or validating units within the following time limits:

– An MAA for a drug: 10 days, for both the initial submission and any supplementary submission.

– An MAA for a drug validated by reference to available validation results: 10 days, for both the initial submission and any supplementary submission.

– An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer has a valid marketing authorization in Viet Nam at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing has a valid marketing authorization in Viet Nam at the time of MAA submission: 03 working days, for both the initial submission and any supplementary submission.

– An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission: 10 days, for both the initial submission and any supplementary submission.

– An MAA for a new drug indicated for the prevention or treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the Law on disease prevention: 01 working day, for both the initial submission and any supplementary submission.

– An MAA for a drug eligible for administrative-procedure priority as prescribed in Clause 5 Article 7 of the Pharmacy Law: 03 working days, for both the initial submission and any supplementary submission.

– An MAA for a medicinal material: 03 working days, for both the initial submission and any supplementary submission.

b) From the date of receipt of the MAA from the DAV, the validators and validating units shall conduct the validation, complete the validation record, and submit it to the DAV within the following time limits:

– An MAA for a drug: 07 months for the initial submission and 02 months for a supplementary submission.

– An MAA for a drug validated by reference to available validation results: 04 months for the initial submission and 02 months for a supplementary submission.

– An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer has a valid marketing authorization in Viet Nam at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing has a valid marketing authorization in Viet Nam at the time of MAA submission: 01 month for both the initial submission and any supplementary submission.

– An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission: 04 months for the initial submission and 01 month for a supplementary submission.

– An MAA for a new drug indicated for the prevention or treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the Law on disease prevention: 03 working day, for both the initial submission and any supplementary submission.

– An MAA for a drug eligible for administrative-procedure priority as prescribed in Clause 5 Article 7 of the Pharmacy Law: 04 months for the initial submission and 01 month for a supplementary submission.

– An MAA for a medicinal material: 04 months for the initial submission and 01 month for a supplementary submission.

4. Actions following MAA validation:

Upon receipt of the validation record, the DAV shall, based on the consolidated report on validation opinions of the validators and validating units and the regulations in force, issue a written request to the applicant for additional documents if the MAA has not yet met the requirements, or refer the MAA to the Council if the validation result indicates that the MAA meets the requirements, fails to meet the requirements, or requires the Council’s opinion, together with the DAV’s proposal to grant, refuse, or seek the Council’s opinion on marketing authorization, within the following time limits:

a) An MAA for a drug: 02 months for the initial submission and 01 month for a supplementary submission;

b) An MAA for a drug validated by reference to available validation results: 02 months for the initial submission and 01 month for a supplementary submission;

c) An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer has a valid marketing authorization in Viet Nam at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing has a valid marketing authorization in Viet Nam at the time of MAA submission: 15 days for both the initial submission and any supplementary submission;

d) An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission: 02 months for the initial submission and 01 month for a supplementary submission;

dd) An MAA for a new drug indicated for the prevention or treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the Law on disease prevention: 01 working day, for both the initial submission and any supplementary submission;

e) An MAA for a drug eligible for administrative-procedure priority as prescribed in Clause 5 Article 7 of the Pharmacy Law: 15 days, for both the initial submission and any supplementary submission;

g) An MAA for a medicinal material: 15 days, for both the initial submission and any supplementary submission.

5. Meeting of the Council:

From the date of receipt of the documents from the DAV, the Council’s Office shall convene a meeting of the Council within the following time limits:

a) An MAA for a drug: 01 month, for both the initial submission and any supplementary submission;

b) An MAA for a drug validated by reference to available validation results: 01 month, for both the initial submission and any supplementary submission;

c) An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer has a valid marketing authorization in Viet Nam at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing has a valid marketing authorization in Viet Nam at the time of MAA submission: 15 days for both the initial submission and any supplementary submission;

d) An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission: 01 month for the initial submission and 15 days for a supplementary submission;

dd) An MAA for a new drug indicated for the prevention or treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the Law on disease prevention: 03 working days, for both the initial submission and any supplementary submission;

e) An MAA for a drug eligible for administrative-procedure priority as prescribed in Clause 5 Article 7 of the Pharmacy Law: 15 days, for both the initial submission and any supplementary submission;

g) An MAA for a medicinal material: 15 days, for both the initial submission and any supplementary submission.

6. Actions following the Council meeting:

a) Finalization of the minutes of the Council meeting:

From the date of the Council meeting, the Council’s Office shall finalize the minutes of the Council meeting and forward them to the DAV within the following time limits:

– An MAA for a drug: 15 days, for both the initial submission and any supplementary submission.

– An MAA for a drug validated by reference to available validation results: 15 days, for both the initial submission and any supplementary submission.

– An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer has a valid marketing authorization in Viet Nam at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing has a valid marketing authorization in Viet Nam at the time of MAA submission: 10 days, for the initial submission or a supplementary submission.

– An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission: 15 days, for the initial submission or a supplementary submission.

– An MAA for a new drug indicated for the prevention or treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the Law on disease prevention: 01 working day, for the initial submission or a supplementary submission.

– An MAA for a drug eligible for administrative-procedure priority as prescribed in Clause 5 Article 7 of the Pharmacy Law: 10 days, for the initial submission or a supplementary submission.

– An MAA for a medicinal material: 10 days, for the initial submission or a supplementary submission;

b) From the date of receipt of the minutes of the Council meeting, the DAV shall grant marketing authorization using Form 6A/TT in Appendix IX to this Circular where the MAA meets the requirements; or issue a written notice to the applicant on the basis of the Council’s conclusion where the MAA has not yet met, or fails to meet, the requirements, within the following time limits:

– An MAA for a drug: 35 days, for the initial submission or a supplementary submission.

– An MAA for a drug validated by reference to available validation results: 35 days, for the initial submission or a supplementary submission.

– An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer has a valid marketing authorization in Viet Nam at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing has a valid marketing authorization in Viet Nam at the time of MAA submission: 15 days, for the initial submission or a supplementary submission.

– An MAA for a processed drug or a drug manufactured using transferred technology, where the drug ordered for processing or the drug prior to technology transfer does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission, or an MAA for a processed drug involving the transfer of drug manufacturing technology from the ordering establishment to the processing establishment, where the drug ordered for processing does not have a marketing authorization in Viet Nam or has an expired marketing authorization at the time of MAA submission: 35 days for the initial submission and 20 days for a supplementary submission.

– An MAA for a new drug indicated for the prevention or treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the Law on disease prevention: 02 working days, for the initial submission or a supplementary submission.

– An MAA for a drug eligible for administrative-procedure priority as prescribed in Clause 5 Article 7 of the Pharmacy Law: 15 days, for the initial submission or a supplementary submission.

– An MAA for a medicinal material: 15 days, for the initial submission or a supplementary submission.

Article 46. Procedures for renewal of marketing authorizations for drugs/medicinal materials

1. Method of submission of an application for renewal of marketing authorization (“renewal application”):

The applicant shall submit the renewal application in accordance with Article 15 of Decree No. 118/2025/ND-CP.

2. Receipt and time limits for processing of the renewal application:

a) Receipt of the renewal application:

Upon receipt of a complete renewal application, the DAV shall give an application receipt to the applicant as prescribed;

b) Time limits for processing a renewal application from the date of its receipt: not exceeding 03 months.

3. Organization of validation of the renewal application:

a) Within 03 working days from the date of receipt of the renewal application as prescribed in Clause 2 of this Article, the DAV shall review and classify the application and refer it to the validators or validating units;

b) Within 01 month from the date of receipt of the renewal application from the DAV, the validators and validating units shall conduct the validation, complete the validation record, and submit it to the DAV.

4. Actions following validation of the renewal application:

a) For a renewal application prescribed in Point b Clause 1 Article 43 of this Circular:

Within 15 days from its receipt of the validation record, the DAV shall, based on the consolidated report on validation opinions of the validators or validating units and the regulations in force, issue a written request to the applicant for additional documents if the application has not yet met the requirements, or refer the application to the Council if the validation result indicates that the application meets the requirements, fails to meet the requirements, or requires the Council’s opinion, together with the DAV’s proposal to renew, refuse to renew, or seek the Council’s opinion on the renewal of, the marketing authorization;

b) For a renewal application prescribed in Point a Clause 2 Article 43 of this Circular, based on the consolidated report on validation opinions of the validators or validating units and the regulations in force, the DAV shall:

– within 10 days, issue a written request to the applicant for additional documents where the application has not yet met the requirements, or issue a written notice of refusal to renew the marketing authorization where the application fails to meet the requirements; or

– within 15 days, renew the marketing authorization (using Form 6B/TT in Appendix IX to this Circular) where the application meets the requirements.

5. Meeting of the Council:

Within 15 days from its receipt of the documents from DAV, the Council’s Office shall convene a meeting of the Council.

6. Actions following the Council meeting:

a) Within 10 days from the date of the Council meeting, the Council’s Office shall finalize the minutes of the Council meeting and send them to the DAV;

b) Within 15 days from the date of receipt of the minutes of the Council meeting, the DAV shall renew the marketing authorization (using Form 6B/TT in Appendix IX to this Circular) where the application meets the requirements; or issue a written notice to the applicant on the basis of the Council’s conclusion where the application has not yet met, or fails to meet, the requirements.

Article 47. Procedures for approval of variations to marketing authorizations for drugs/medicinal materials

1. Method of submission of an application for approval of variations to a marketing authorization (“variation application”):

The applicant shall submit the variation application in accordance with Article 15 of Decree No. 118/2025/ND-CP.

2. Receipt and time limits for processing of the variation application:

a) Receipt of the variation application:

Upon receipt of a complete variation application, the DAV shall give an application receipt to the applicant as prescribed;

b) Time limits for processing a variation application from the date of its receipt:

– For a variation application prescribed in Clause 3 Article 43 of this Circular: not exceeding 20 days.

– For a variation application prescribed in Point c Clause 1 or Point b Clause 2 Article 43 of this Circular: not exceeding 03 months.

3. Organization of validation of the variation application:

a) Upon its receipt of the variation application as prescribed in Clause 2 of this Article, the DAV shall publish the application prescribed in Clause 3 Article 43 of this Circular within 20 days; or review, classify and refer the application prescribed in Point c Clause 1 or Point b Clause 2 Article 43 of this Circular to the validators or validating units within the following time limits:

– For a variation application prescribed in Point c Clause 1 Article 43 of this Circular: 03 working days for the initial submission and 02 working days for a supplementary submission.

– For a variation application prescribed in Point b Clause 2 Article 43 of this Circular: 03 working days for both the initial submission and any supplementary submission;

b) From the date of receipt of the variation application from the DAV, the validators and validating units shall conduct the validation, complete the validation record, and submit it to the DAV within the following time limits:

– For a variation application prescribed in Point c Clause 1 Article 43 of this Circular: 01 month for the initial submission and 15 days for a supplementary submission.

– For a variation application prescribed in Point b Clause 2 Article 43 of this Circular: 01 month for both the initial submission and any supplementary submission.

4. Actions following validation of the variation application:

a) For a variation application prescribed in Point c Clause 1 Article 43 of this Circular:

From the date of its receipt of the validation record, the DAV shall, based on the consolidated report on validation opinions of the validators or validating units and the regulations in force, issue a written request to the applicant for additional documents if the application has not yet met the requirements, or refer the application to the Council if the validation result indicates that the application meets the requirements, fails to meet the requirements, or requires the Council’s opinion, together with the DAV’s proposal to approve, refuse to approve, or seek the Council’s opinion on the approval of, variations to the marketing authorization, within 15 days for the initial submission and 10 days for a supplementary submission;

b) For a variation application prescribed in Point b Clause 2 Article 43 of this Circular:

From the date of its receipt of the validation record, the DAV shall, based on the consolidated report on validation opinions of the validators or validating units and the regulations in force, issue a written request to the applicant for additional documents if the application has not yet met the requirements, or issue a written approval of the variations to the marketing authorization where the application meets the requirements, or issue a written notice of refusal to approve the variations where the application fails to meet the requirements, within 25 days for both the initial submission and any supplementary submission.

5. Meeting of the Council:

Within 15 days from its receipt of the documents from DAV, the Council’s Office shall convene a meeting of the Council.

6. Actions following the Council meeting:

a) Within 10 days from the date of the Council meeting, the Council’s Office shall finalize the minutes of the Council meeting and send them to the DAV;

b) Within 15 days for the initial submission, and 08 days for a supplementary submission, from the date of its receipt of the minutes of the Council meeting, the DAV shall issue a written approval of the variations to the marketing authorization where the application meets the requirements; or issue a written notice to the applicant on the basis of the Council’s conclusion where the application has not yet met, or fails to meet, the requirements.

Chapter V

DOCUMENTATION REQUIREMENTS AND PROCEDURES FOR WITHDRAWAL AND REVOCATION OF MARKETING AUTHORIZATIONS FOR DRUGS AND MEDICINAL MATERIALS

Article 48. Documentation requirements for withdrawal and revocation of marketing authorizations for drugs/medicinal materials

1. Where the marketing authorization for a drug is revoked as prescribed in Points a, b Clause 1 Article 58 of the Pharmacy Law, the following documents are required:

A written drug recall notice issued by a competent regulatory authority.

2. Where the marketing authorization for a drug/medicinal material is revoked as prescribed in Points d, dd Clause 1 Article 58 of the Pharmacy Law, the following documents shall be required:

A written conclusion drawn by a competent regulatory authority stating that the MAA on the basis of which the marketing authorization was granted is forged, or that the drug/medicinal material was manufactured at a location other than that specified in the MAA.

3. Where the marketing authorization for a drug/medicinal material is revoked as prescribed in Point c Clause 1 Article 58 of the Pharmacy Law, the following documents shall be required:

A notice, issued by the competent CPP-issuing authority, of the revocation of the CPP on which the DAV’s grant of the marketing authorization for the drug/medicinal material in Viet Nam was based.

4. Where the marketing authorization for a drug/medicinal material is revoked as prescribed in Point e Clause 1 Article 58 of the Pharmacy Law, the following documents shall be required:

A notice, issued by WHO or a competent regulatory authority of Viet Nam or of the country of origin of the drug/medicinal material, of warning that the drug/medicinal material is ineffective or unsafe for human use.

5. Where the marketing authorization for a drug/medicinal material is withdrawn as prescribed in Point g Clause 1 Article 58 of the Pharmacy Law, the following documents shall be required:

A written request for withdrawal of the marketing authorization for drug/medicinal material in Viet Nam which is made by the manufacturer or applicant using Form 07/TT in Appendix IX to this Circular.

Article 49. Procedures for revocation and withdrawal of marketing authorizations for drugs/medicinal materials

1. Within a maximum duration of 30 days from its receipt of the documents specified in Clause 1 Article 48 of this Circular, the DAV shall issue a decision to revoke the marketing authorization for the drug.

2. Within a maximum duration of 30 days from its receipt of the documents specified in Clause 2 Article 48 of this Circular, the DAV shall issue a decision to revoke the marketing authorization for the drug/medicinal material.

3. Within a maximum duration of 10 days from its receipt of the documents specified in Clauses 3 and 4 Article 48 of this Circular, the DAV shall issue a decision to revoke the marketing authorization for the drug/medicinal material.

4. Within a maximum duration of 20 days from its receipt of the documents specified in Clause 5 Article 48 of this Circular, the DAV shall issue a decision to withdraw the marketing authorization for the drug/medicinal material.

Chapter VI

REGULATIONS ON ORGANIZATION AND OPERATION OF ADVISORY COUNCIL FOR GRANT OF MARKETING AUTHORIZATIONS FOR DRUGS AND MEDICINAL MATERIALS, VALIDATING UNITS, AND VALIDATORS

Article 50. Organization and operation of the Council

1. The Council for the grant of marketing authorizations for drugs and medicinal materials shall be established by the Minister of Health. The Council is composed of experts whose qualifications and experience are appropriate to ensure their capacity to assess applications, provide critical review of the opinions of validators and the proposals of the DAV, and advise the Minister of Health on matters relating to pharmacy legislation and the quality, safety and efficacy of drugs and medicinal materials.

2. The Council shall advise the Minister of Health and shall be accountable to the Minister of Health and before the law for its validation opinions and advice on:

a) the grant and renewal of marketing authorizations for drugs/medicinal materials, and approval of variations to such marketing authorizations, based on the validation results of validators, the proposals of the DAV, and relevant matters at the request of the Minister of Health;

b) the grant of import licenses for drugs that are not yet granted a marketing authorization in Viet Nam, in respect of applications for import licenses received and processed by the MOH, based on the validation results of validators, the proposals of the DAV, and relevant matters at the request of the Minister of Health;

c) assessing the conformity of the GMP principles and standards of an exporting country that are different from the manufacturing principles and standards issued or recognized by the Minister of Health as prescribed in Point c Clause 1 Article 97 of the Government’s Decree No. 163/2025/ND-CP;

d) proposing guidelines and policies relating to the grant of marketing authorizations for drugs/medicinal materials and matters relating to ensuring the quality, safety and efficacy of drugs.

3. The organization and operation of the Council and the mechanism for coordination between the Council and validators during the processing of MAAs for drugs, and applications for import licenses for drugs that are not yet granted a marketing authorization in Viet Nam are prescribed in Appendix VI to this Circular.

4. The management of conflicts of interest of members of the Council is prescribed in Appendix VII to this Circular.

5. Funding for covering operating expenses of the Council shall comply with regulations of law.

6. The standing committee of the Council shall be located on the same premises as DAV.

Article 51. Organization and operation of validating units and validators

1. The DAV and validating units shall establish sub-committees of validators to validate relevant documents in MAAs for drugs/medicinal materials relating to legal compliance, quality specifications, pharmaceutical formulation, pharmacology, clinical data and bioequivalence, and shall compile lists of validators who are members of such sub-committees for the validation of applications for the grant and renewal of, and approval of variations to, marketing authorizations for drugs/medicinal materials. The composition of each sub-committee of validators shall be appropriate to the classification of the product for which the application is submitted and the type of application.

2. The responsibilities, organization and operation of validating units and validators are prescribed in Appendix VIII to this Circular.

3. The management of conflicts of interest of validators is prescribed in Appendix VII to this Circular.

4. Funding for covering expenses associated with the validation of applications shall comply with regulations of law.

Chapter VII

IMPLEMENTATION PROVISIONS

Article 52. Effect

1. This Circular comes into force from October 01, 2026.

2. The following regulations and Circulars shall cease to have effect from the effective date of this Circular:

a) The Circular No. 12/2025/TT-BYT of the Minister of Health;

b) The first sub-point of Point a Clause 1 Article 16 and the second sub-point of Point c Clause 3 Article 29 of the Circular No. 01/2018/TT-BYT;

c) Clause 8 Article 1 and Clause 10 Article 1 of the Circular No. 23/2023/TT-BYT of the Minister of Health.

3. For medicinal materials that are excipients or capsule shells for which no marketing authorization has been granted, intended for use in the manufacture of a drug under an MAA for which the marketing authorization was granted before October 20, 2022 and which have not yet been published on the DAV’s website, where an establishment wishes to import such excipients or capsule shells into Viet Nam for the manufacture of that drug:

The applicant shall update all information concerning medicinal materials that are excipients and capsule shells contained in its approved application on the DAV’s online public service system. Within 05 working days from the date on which the information is updated on the system, the DAV shall publish information on the sources of medicinal materials that are excipients and capsule shells on its website. The applicant shall be responsible for the accuracy of the updated information as compared with the information in the approved application and shall not be required to update the information again for each subsequent importation.

4. For a drug/medicinal material for which a marketing authorization was granted before January 01, 2023, the label of the drug/medicinal material must bear the registration number in the format specified in Appendix V to this Circular no later than 12 months after the date on which the marketing authorization is renewed. Within 12 months from the date on which the marketing authorization for a drug/medicinal material is renewed, the registration number shall be indicated in accordance with the following provisions:

a) A domestically manufactured drug/medicinal material may continue to be manufactured and placed on the market until the end of its shelf life with its label bearing the registration number granted before the renewal of the marketing authorization;

b) An imported drug/medicinal material may continue to be imported and placed on the market with its label bearing the registration number granted before the renewal of the marketing authorization, provided that the shipment is delivered at the port of departure in the exporting country before the date from which the registration number is required to be indicated on the label under this Clause.

5. Drugs that were classified as prescription drugs or OTC drugs before the effective date of this Circular shall not be required to undergo reclassification during the validity period of their marketing authorizations. A drug shall be reviewed for classification as a prescription drug or OTC drug in accordance with this Circular upon renewal of its marketing authorization. Where the applicant proposes a change in the classification of a drug as a prescription drug or OTC drug, the applicant shall comply with Appendix II to this Circular.

6. For an MAA submitted to the DAV before the effective date of this Circular, where the marketing authorization for the drug covered by the MAA has not yet been granted or renewed, the classification of the drug as an OTC drug shall be reviewed in accordance with this Circular.

Article 53. Transition

1. MAAs for drugs/medicinal materials submitted before the effective date of this Circular shall continue to be processed in accordance with the regulations in force at the time of the MAA submission, or may, from the effective date of this Circular, be processed in accordance with this Circular where this facilitates and simplifies administrative procedures for enterprises, organizations and individuals.

2. A drug that has been classified as an original brand-name drug, a reference biological, a drug with demonstrated bioequivalence, or a drug for which all manufacturing stages are carried out in Viet Nam on a manufacturing line complying with EU-GMP principles and standards or equivalent standards and has been granted a marketing authorization by the drug regulatory authority of a country on the SRA list or by the EMA before the effective date of this Circular shall retain its classification for the validity period of its marketing authorization, unless the DAV, at the request of the applicant, reviews and updates or makes variations to the information published on the DAV’s website.

Article 54. Terms of reference

Where any legislative documents or regulations referred to in this Circular are amended or replaced, the new ones shall apply.

Article 55. Implementation organization

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

a) Provide guidelines for and organize the implementation of this Circular;

b) Publish the following on the DAV’s website:

– The list of drugs and medicinal materials for which marketing authorizations have been granted or renewed (including information on the drug prior to technology transfer, for drugs manufactured using transferred technology in Viet Nam, and on the drug ordered for processing, for processed drugs manufactured in Viet Nam), within 05 working days from the date of grant or renewal of the marketing authorization, together with information on whether the drug is classified as a prescription drug or OTC drug and other information relating to the marketing authorization of drugs and medicinal materials.

– The list of drugs with demonstrated bioequivalence and drugs classified as original brand-name drugs or reference biologicals within 05 working days from the date on which the marketing authorization for the drug is granted, and information on variations to such drugs within 07 working days from the date on which an approval of the variations to the marketing authorization for the drug is granted.

– The lists of processed drugs and drugs manufactured using transferred technology which are made using Form 8A/TT, Form 8B/TT and Form 8C/TT in Appendix IX to this Circular, within 07 working days from the date on which the marketing authorization for the drug is granted.

– Drugs for which all manufacturing stages are carried out in Viet Nam at a manufacturing line that complies with EU-GMP principles and standards or equivalent standards, and which have been granted a marketing authorization by the drug regulatory authority of a country on the SRA list or by the EMA, within 07 working days from the date of approval of the variation to the marketing authorization;

c) Remove from the lists any drug classified as an original brand-name drug, a reference biological, or a drug with demonstrated bioequivalence that no longer meets the classification criteria prescribed in this Circular, based on the advisory opinion of the Council; remove any published drug for which all manufacturing stages are carried out in Viet Nam at a manufacturing line that complies with EU-GMP principles and standards or equivalent standards and which has been granted a marketing authorization by the drug regulatory authority of a country on the SRA list or by the EMA, where such drug no longer meets the requirements set out in this Circular;

d) Remove drugs from the lists of processed drugs and drugs manufactured using transferred technology published as prescribed in the third sub-point of Point b of this Clause, based on the advisory opinion of the Council, when such drugs no longer meet the requirements prescribed in Clause 1 Article 9 of this Circular;

dd) Formulate, promulgate, and organize the implementation of standard operating procedures (SOPs) in the registration of drugs; guidelines on the application for marketing authorization of drugs and medicinal materials; and guidelines on the validation of MAAs for drugs and medicinal materials;

e) Coordinate with the Traditional Medicine Administration of Viet Nam in the renewal of and approval of variations to the marketing authorizations for traditional drugs and herbal materials for which marketing authorizations were granted in accordance with Circular No. 44/2014/TT-BYT dated November 25, 2014 of the Minister of Health;

g) Where necessary, the DAV shall hold meetings with applicants, manufacturers, and validators to clarify the issues that arise during the validation of MAAs for drugs and medicinal materials;

h) Formulate regulations on use of barcodes, QR codes, DataMatrix codes, or other forms of printed codes, as prescribed by relevant laws, to the outer packaging of drugs and medicinal materials manufactured by manufacturers, for the management, identification, and traceability of drugs and medicinal materials placed on the market, and formulate a roadmap for implementation in accordance with regulations of the Minister of Health;

i) Within 15 days from the date of grant or renewal of a marketing authorization, or 07 working days from the date of approval of variations to a marketing authorization, the DAV shall share quality specifications for drugs with the testing system; share information on risk management plans with the National DI & ADR Centre in respect of MAAs for new chemical drugs, vaccines, and biologicals (except probiotic biological products); publish information on medicinal materials for domestically manufactured drugs; and publish the list of drugs classified as original brand-name drugs, reference biologicals, or drugs with demonstrated bioequivalence;

k) Within 03 working days from the date of receipt of an application for renewal of the marketing authorization of a drug or medicinal material, the DAV shall publish on the MOH’s web portal and the DAV’s website information on the drug or medicinal material for which an application for renewal has been received in accordance with regulations and whose marketing authorization may continue to be used in accordance with Point c Clause 8 Article 56 of the Pharmacy Law;

l) For drugs and medicinal materials already published on the DAV’s website as prescribed in Point k of this Clause, within 03 working days from the date on which the DAV issues a written notice of refusal to renew, or a written notice of suspension of the use of, the marketing authorization on the grounds that the drug or medicinal material poses a potential safety risk to users or is suspected of involving forged legal documents, or a written notice of the validation result of the renewal application indicating that the time limit for submission of supplementary documents prescribed in Clause 1 Article 44 of this Circular has expired, the DAV shall publish on the MOH’s web portal and the DAV’s website the drugs and medicinal materials that no longer meet the requirements for continued use of the marketing authorization;

m) Publish on the DAV’s website the technical documents prescribed in Appendix I to this Circular;

n) Remove medicinal materials already published on the MOH’s web portal and the DAV’s website upon receipt of written notice from a competent authority that such medicinal materials are no longer permitted for use;

o) Publish on the MOH’s web portal and the DAV’s website information on a subsequent MAA that relies on the fact that a drug has already been granted a marketing authorization, or on data demonstrating the safety and efficacy of a drug that has already been granted a marketing authorization, to obtain a marketing authorization for another drug, in accordance with Clause 3 Article 128 of the Law on Intellectual Property;

p) Within 01 month from the date on which the DAV issues a written notice to the applicant of its refusal to grant or renew, or approve variations to, the marketing authorization of a drug/medicinal material, where a written request from the applicant for reconsideration of the application processing result is received, the DAV shall review the case and report it to the Council or refer the applicant’s request to validators for consideration. Procedures for handling the case:

– Where the Council or the validators accept the applicant’s explanation and agree to grant or renew the marketing authorization, or approve the variations to the marketing authorization, the DAV shall issue a decision to grant or renew the marketing authorization, or a written approval of the variations to the marketing authorization, as applicable; the applicant shall not be required to resubmit the application in its entirety.

– Where the Council or the validators do not accept the applicant’s explanation, the DAV shall issue a written notice of refusal to grant or renew the marketing authorization, or approve the variations to the marketing authorization;

q) Issue a written request for a Phase IV clinical trial of a drug in accordance with Clause 2 Article 87 of the Pharmacy Law, on the basis of the advisory opinion of the Council.

2. Manufacturers of drugs/medicinal materials shall comply with the labeling requirements set out in Circular No. 01/2018/TT-BYT and the following requirements when stating the expiry date of their drugs/medicinal materials on the labels:

The expiry date of a drug/medicinal material stated on the label must not be later than the end of its shelf life as approved in the MAA, and must not be more than 31 days earlier than that shelf life.

Article 56. Responsibility for implementation

The Chief of the Ministry’s Office, the Director of the Drug Administration of Vietnam, heads of departments and affiliates of the Ministry of Health, Directors of Provincial-level Departments of Health, and relevant authorities, organizations and individuals are responsible for the implementation of this Circular.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Health (via the Drug Administration of Vietnam) for consideration./.