Circular 12/2025/TT-BYT marketing authorization of medicinal products and medicinal materials

CIRCULAR

On marketing authorization of medicinal products and medicinal materials

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Pursuant to the Law on Pharmacy dated April 06, 2016;

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

Pursuant to the Law on Technology Transfer dated June 19, 2017;

Pursuant to the Government’s Decree No. 69/2018/ND-CP dated May 15, 2018 detailing a number of articles of the Law on Foreign Trade Management;

Pursuant to the Government’s Decree No. 76/2018/ND-CP dated May 15, 2018 detailing and guiding the implementation of a number of articles of the Law on Technology Transfer;

Pursuant to the Government’s Decree No. 42/2025/ND-CP dated February 27, 2025 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director-General of the Drug Administration of Vietnam;

The Minister of Health promulgates a Circular on marketing authorization of medicinal products and medicinal materials.

Chapter I
GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Circular details, and guides the implementation thereof, a number of articles of the Law on Pharmacy dated April 6, 2016 and the Law Amending and Supplementing a Number of Articles of the Law on Pharmacy dated November 21, 2024 (hereinafter referred to as the Law on Pharmacy), including:

a) Regulations on clinical data for assurance of safety and efficacy in any dossier for registration of medicinal products and criteria for exemption from clinical trial or certain phases thereof in Vietnam and medicinal products that have to undergo Phase 4 clinical trial as prescribed in Clause 4, Article 89 of the Law on Pharmacy;

b) Regulations on dossiers and procedures for grant, renewal, change, addition, and revocation of marketing authorization for chemical medicinal products, vaccines, biological products, herbal medicinal products and medicinal materials for human use in Vietnam as prescribed in Clause 9, Article 56 and Clause 2, Article 58 of the Law on Pharmacy;

c) Regulations on principles and criteria for classifying over-the-counter medicinal products as prescribed in Clause 27, Article 2 of the Law on Pharmacy;

d) Regulations on reporting on safety and efficacy of medicinal products after they are granted marketing authorizations, in order to implement pharmacovigilance as prescribed in Clause 2, Article 78 of the Law on Pharmacy;

dd) Principles of organization and operation of the Council, evaluation body, and expert evaluators.

2. This Circular does not prescribe dossiers for registration of traditional medicinal products; the dossiers for registration of medicinal materials that are herbal medicinal materials or traditional herbal medicinal materials.

Article 2. Interpretation of terms

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

1. ASEAN Common Technical Dossier (ACTD) means the common technical dossier for registration of pharmaceuticals for human use of the Association of Southeast Asian Nations (ASEAN).

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

3. Major variation means a variation in a medicinal product that may affect significantly and directly the quality, safety, and efficacy thereof prescribed in Appendix II to this Circular.

4. Minor variation means a variation in a medicinal product that do not affect or barely affect the quality, safety, and efficacy thereof prescribed in Appendix II to this Circular.

5. Marketing authorization applicant means any entity that applies for grant, renewal, change, or addition of marketing authorization for a medicinal product or medicinal material.

6. Drug manufacturer means any entity that undertakes one stage or several or all stages of the medicinal product manufacturing process or is responsible for batch release.

7. Medicinal material manufacturer means the manufacturer of materials for production of finished medicinal products or the manufacturer responsible for batch release of medicinal materials.

8. Certificate of pharmaceutical product (CPP) means a certificate issued in the format recommended by WHO according to WHO’s Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.

9. European Medicines Agency (EMA) and Stringent Regulatory Authorities (SRA) mean authorities that include:

a) European Medicines Agency (EMA);

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

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

- An observer of ICH before October 23, 2015, including: the regulatory authority of the European Free Trade Association (EFTA) as represented by the Swiss Agency for Therapeutic Products (Swissmedic) and Health Canada;

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

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

11. Contract manufacturing means the outsourced manufacturing of medicinal products pursuant to a legally-binding contract manufacturing agreement under which a contract acceptor undertakes one stage or several or all stages of the medicinal product manufacturing process at the request of the contract giver, and receives remuneration in return.

12. Medicinal product manufacturing technology transfer means the assignment of ownership or the licensing of medicinal product manufacturing technology as prescribed in Clause 1, Article 4 of the Law on Technology Transfer by a sending unit allowed to conduct such transfer to a receiving unit, which enables the latter to undertake one stage or several or all stages of the medicinal product manufacturing process under a legally-binding agreement between the two parties.

13. Contract giver means the party that provides a portion or the entirety of ingredients, materials, manufacturing processes, and technical documentation demonstrating the quality, safety, and efficacy of the medicinal products to the contract acceptor for it to manufacture medicinal products under a contract manufacturing agreement between the two parties.

14. Contract acceptor means a party that uses a portion or the entirety of ingredients, materials, manufacturing processes, and technical documentation provided to it by a contract giver to undertake one stage or several or all stages of the medicinal product manufacturing process as required by the contract giver for a fee under the contract manufacturing agreement between the two parties.

15. Sending unit means the party owing or having the right to use the medicinal product manufacturing technology in accordance with the law, which assigns the ownership or licenses such medicinal product manufacturing technology to a receiving unit for the latter to apply such technology in one stage or several or all stages of the medicinal product manufacturing process.

16. Receiving unit means the party assigned the ownership of medicinal product manufacturing technology or licensed by a sending unit under an agreement between two parties to apply such technology in one stage or several or all stages of the medicinal product manufacturing process.

17. Contract giver’s medicinal product means a medicinal product that has been granted marketing authorization in Vietnam or in at least one country worldwide, of which one stage or several or all stages of the manufacturing process are outsourced by a contract giver to a contract acceptor under the contract manufacturing agreement between the two parties.

18. Contract-manufactured medicinal product means a medicinal product of which one stage or several or all stages of the manufacturing process are undertaken by a contract acceptor on behalf of the contract giver under the contract manufacturing agreement between the two parties.

19. Medicinal product before technology transfer means a medicinal product that has been granted marketing authorization in Vietnam or in at least one country worldwide and of which the manufacturing technology ownership or usage right is transferred or assigned by the sending unit to the receiving unit for the latter to apply such technology in one stage or several or all stages of the medicinal product manufacturing process.

20. Medicinal product manufactured through technology transfer means a medicinal product of which one stage or several or all stages of the manufacturing process are undertaken by a receiving unit with the technology transferred in accordance with Clause 1, Article 4 of the Law on Technology Transfer by a sending unit under the agreement between the two parties.

Article 3. The marketing authorization applicant shall:

1. Take full accountability to the law for the accuracy, legitimacy, truthfulness of all documents in the dossier for registration of the medicinal product or medicinal material, unless otherwise prescribed in Clause 1, Article 4 of this Circular. Coordinate with the manufacturer and any domestic or foreign competent authority in responding to written inquiries of the Drug Administration of Vietnam regarding the validation of the authenticity of legal documents in the dossier for registration of the medicinal product or medicinal material.

2. Ensure the quality, safety and efficacy of the medicinal product/medicinal material as declared in the registration dossier.

3. Notify in writing the Drug Administration of Vietnam within a time limit of 15 days from the date of the decision to revoke the marketing authorization or the decision to recall the medicinal product or medicinal material in any country worldwide for the medicinal product or medicinal material that has been granted a marketing authorization, which is still valid, in Vietnam and clearly state therein the reason for such revocation, unless the marketing authorization is voluntarily revoked for commercial reasons in countries other than the country granting the CPP submitted in the marketing authorization dossier in Vietnam.

4. At the request of any competent authority, cooperate with the manufacturer in studying or providing additional information about the medicinal product applied for marketing authorization when there is information or evidence about the safety and efficacy of the medicinal product while it is on the market.

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

6. Take accountability for issues relevant to intellectual property rights of the medicinal product/medicinal materials of which the applicant applies for the authorization of marketing in Vietnam in accordance with the law on intellectual property.

7. Implement the approved risk management plan in the dossier for registration of a new chemical medicine, vaccine or biological product (except for probiotics).

8. The marketing authorization applicant for contract-manufactured medicinal product shall fulfill the responsibilities prescribed in Clauses 1, 2, 3, 4, 5, 6, 7 and 10 of this Article and:

a) Notify in writing the Drug Administration of Vietnam within a time limit of 30 days from the date the competent authority approves any change or addition of the technical documentation of the contract giver’s medicinal product while it is on the market in cases where the contract-manufactured medicinal product meets the requirements prescribed in Clause 1, Article 9 of this Circular;

b) Notify in writing the Drug Administration of Vietnam within a time limit of 15 days from the date of the decision to revoke the marketing authorization of the contract-manufactured medicinal product in any country worldwide (during the validity period of the marketing authorization of the contract-manufactured medicinal product);

c) Notify the Drug Administration of Vietnam in writing within a time limit of 30 days from the date the manufacturing of the contract giver’s medicinal product is terminated;

d) For a contract-manufactured medicinal product that meets the requirements prescribed in Clause 1, Article 9 of this Circular, when the contract giver’s medicinal product, which is manufactured and marketed in its country of origin, undergoes any change or addition of the formulation, manufacturing process, quality standard of the materials, quality standard of the finished product, or the trade name, the applicant must carry out the procedure for a change or addition of the contract-manufactured medicinal product corresponding to such change or addition, within a time limit of 03 months from the date such change or addition is approved by the competent regulatory authority of the country of origin.

9. The marketing authorization applicant for the medicinal product manufactured through technology transfer shall fulfill the responsibilities prescribed in Clauses 1, 2, 3, 4, 5, 6, 7 and 10 of this Article and:

a) Notify in writing the Drug Administration of Vietnam within a time limit of 30 days from the date the competent authority approves any change or addition of the technical documentation of the medicinal product before technology transfer while it is on the market, in cases where the medicinal product manufactured through technology transfer meets the requirements prescribed in Clause 1, Article 9 of this Circular;

b) Notify in writing the Drug Administration of Vietnam within a time limit of 15 days from the date of the decision to revoke the marketing authorization of the medicinal product before technology transfer in any country worldwide (during the validity period of the marketing authorization of the medicinal product manufactured through technology transfer);

c) Notify the Drug Administration of Vietnam in writing within a time limit of 30 days from the date the manufacturing of the medicinal product before technology transfer is terminated;

d) For a medicinal product manufactured through technology transfer that meets the requirements prescribed in Clause 1, Article 9 of this Circular, when the medicinal product before technology transfer, which is manufactured and marketed in its country of origin, undergoes any change or addition of the formulation, manufacturing process, quality standard of the materials, quality standard of the finished product, or the trade name, the applicant must carry out the procedure for a change or addition of the medicinal product manufactured through technology transfer corresponding to such change or addition, within a time limit of 03 months from the date such change or addition is approved by the competent regulatory authority of the country of origin.

10. Fulfill other responsibilities as prescribed by relevant laws.

Article 4. The manufacturer of a medicinal product or medicinal material shall:

1. Take full accountability before the law for the accuracy, legitimacy, and truthfulness of all documents related to the medicinal product or medicinal material supplied by such manufacturer to the applicant for marketing authorization in Vietnam.

2. Closely cooperate with the applicant in implementation of Clause 3, Article 3 of this Circular.

3. Cooperate with the applicant/authorization holder in fulfilling competent authorities’ request for inspection or evaluation of the manufacturing facility.

4. In cases where the manufacturer has its manufacturing license revoked or fails to comply with Good Manufacturing Practices for medicinal products and medicinal materials, according to a notice from the competent regulatory authority of the country of origin, the applicant must notify in writing the Drug Administration of Vietnam within a time limit of 15 days from the date of such notice.

5. Keep complete records of medicinal product and medicinal product ingredient registration and provide records to competent management agencies upon request, including documents prescribed in Point e, Clause 7, Article 22 of this Circular.

6. Implement the approved risk management plan in the dossier for registration of a new chemical medicine, vaccine or biological product (except for probiotics).

7. The manufacturer that is a contract acceptor shall fulfill the responsibilities prescribed in Clauses 1, 2, 3, 4, 5, 6 and 9 of this Article and:

a) Perform the obligations prescribed in Article 182 of the Commercial Law and Clause 2, Article 42 of the Decree No. 69/2018/ND-CP dated May 15, 2018 of the Government detailing a number of articles of the Law on Foreign Trade Management (hereinafter referred to as Decree No. 69/2018/ND-CP);

b) For a contract-manufactured medicinal product that meets the requirements prescribed in Clause 1, Article 9 of this Circular, when the contract giver’s medicinal product, which is manufactured and marketed in its country of origin, undergoes any change or addition of the formulation, manufacturing process, quality standard of the materials, quality standard of the finished product, or the trade name, the manufacturer shall coordinate with the marketing authorization applicant to carry out the procedure for a change or addition of the contract-manufactured medicinal product corresponding to such change or addition, within a time limit of 03 months from the date such change or addition is approved by the competent regulatory authority of the country of origin;

c) Carry out the procedures for grant of a contract manufacturing license to manufacture medicinal products for the contract giver that is a foreign trader in accordance with Clause 4, Article 38 of Decree No. 69/2018/ND-CP, if it is the dossier for registration of a contract-manufactured medicinal product exported or imported under the license;

8. If the manufacturer is the receiving unit, it shall fulfill the responsibilities prescribed in Clauses 1, 2, 3, 4, 5, 6, and 9 of this Article and:

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

b) For a medicinal product manufactured through technology transfer that meets the requirements prescribed in Clause 1, Article 9 of this Circular, when the medicinal product before technology transfer, which is manufactured and marketed in its country of origin, undergoes any change or addition of the formulation, manufacturing process, quality standard of the materials, quality standard of the finished product, or the trade name, the manufacturer must coordinate with the applicant to carry out the procedure for a change or addition corresponding to such change or addition within a time limit of 03 months from the date such change or addition is approved by the competent regulatory authority of the country of origin;

c) Carry out procedures for technology transfer registration as prescribed in Article 31 of the Law on Technology Transfer, Article 5 of Decree No. 76/2018/ND-CP dated May 15, 2018 of the Government detailing and guiding the implementation of a number of articles of the Law on Technology Transfer.

9. Fulfill other responsibilities as prescribed by relevant laws.

Article 5. The contract giver shall:

1. Duly perform the obligations of the contract giver as prescribed in Article 181 of the Law on Commerce and Clause 1, Article 42 of Decree No. 69/2018/ND-CP.

2. Provide the contract acceptor:

a) A proportion or the entirety of  raw materials, other materials, technical documentation including the manufacturing process, quality standards and methods for testing starting materials, intermediates, finished products and excipients in the stage(s) that is outsourced;

b) Other dossiers and documents related to marketing authorization for the contract-manufactured medicinal product and the contract manufacturing process itself.

3. Take accountability for the accuracy, legitimacy and truthfulness of technical documentation provided to the contract acceptor, consistent with the contract giver’s medicinal product dossier approved by the competent authority.

4. Coordinate with the marketing authorization applicant for the contract-manufactured medicinal product to fulfill the responsibilities prescribed in Clause 8, Article 3 of this Circular.

5. Fulfill other responsibilities as prescribed by relevant laws.

Article 6. The sending unit shall:

1. Fulfill the responsibilities of the sending unit as prescribed in Clause 2, Article 25 of the Law on Technology Transfer.

2. Provide the receiving unit:

a) Technical documentation including the manufacturing process, quality standards and methods for testing starting materials, intermediates, finished products and excipients in the stage(s) for which the technology is transferred;

b) Other dossiers and documents related to the marketing authorization of the medicinal product manufactured through technology transfer and the technology transfer itself.

3. Take accountability for the accuracy, legitimacy and truthfulness of technical documentation provided to the receiving unit, consistent with the dossier of the medicinal product before technology transfer approved by the competent authority.

4. Coordinate with the marketing authorization applicant for the medicinal product manufactured through technology transfer to fulfill the responsibilities prescribed in Clause 9, Article 3 of this Circular.

5. Fulfill other responsibilities as prescribed by relevant laws.

Article 7. Contract manufacturing agreement

In addition to the information prescribed in Article 39 of Decree No. 69/2018/ND-CP, a contract manufacturing agreement for a medicinal product must contain the following details:

1. Agreement on the supply of ingredients and materials. Provision of the technical documentation of the contract giver to the contract acceptor, including: manufacturing processes, quality standards, methods for testing starting materials, intermediates, finished products, excipients and other documents related to the contract manufacturing.

2. Rights and responsibilities of the contract giver, the contract acceptor, and the marketing authorization applicant (if any):

a) In each stage of the medicinal product manufacturing for the manufacturing processes, quality control, preservation and transportation of starting materials, intermediates, finished products, excipients, the process of packaging, printing or labeling of contract-manufactured medicinal products and provisions on the responsibilities of the signatory of the inspection report of each batch of finished products and the release notes of the contract-manufactured medicinal products;

c) Retention of dossiers on manufacturing, quality control, distribution and marketing of medicinal products, storage of medicinal product samples, and settlement of problems related to quality, complaints and recall of marketed products;

3. Responsibilities of the contract giver, the contract acceptor, and the marketing authorization applicant (if any) for intellectual property issues related to the medicinal products manufactured by the contract acceptor.

4. Process and procedures for inspection and supervision of the manufacturing organization.

5. Cases where agreements and liabilities are discharged due to breach of contract.

Article 8. Technology transfer agreement

In addition to the information prescribed in Article 23 of the Law on Technology Transfer, a technology transfer agreement must contain the following details:

1. Agreement on the provision of technical documentation of the sending unit to the receiving unit, including: manufacturing processes, quality standards, methods for testing starting materials, intermediates, finished products, excipients and other documents related to the technology transfer.

2. Responsibilities of the sending unit, the receiving unit, and the marketing authorization applicant for intellectual property issues related to the medicinal product manufactured through technology transfer.

3. Cases where agreements and liabilities are discharged due to breach of contract.

Article 9. Classification of contract-manufactured medicinal products and medicinal products manufactured through technology transfer

Contract-manufactured medicinal products and medicinal products manufactured through technology transfer are classified as follows:

1. Contract-manufactured medicinal products and medicinal products manufactured through technology transfer that have the same trade name, same formulation, same quality standard of materials, same quality standard of the finished product, and a similar manufacturing process as the contract giver's medicinal product or the medicinal product before technology transfer.

In cases where a contract-manufactured medicinal product or a medicinal product manufactured through technology transfer undergoes a change to one of the criteria mentioned above (except for a change in the trade name) or any other change related to the quality of the medicinal product, the applicant must provide a comparison table made using Form 01/TT and technical documentation in accordance with the guidance in Appendix II to this Circular to demonstrate quality equivalence with the contract giver's medicinal product or the medicinal product before technology transfer.

2. Other contract-manufactured medicinal products and medicinal products manufactured through technology transfer that are not prescribed in Clause 1 of this Article.

Article 10. Regulations on reports on safety and efficacy follow-up and evaluation

1. The marketing authorization applicant shall be responsible for submitting reports on the follow-up of the safety and efficacy of the medicinal product while it is on the market, including:

a) Periodic reports if it is a new medicinal product, vaccine, or biological product (except for probiotics) made using Form 2A/TT attached to this Circular;

b) Individual reports for all adverse events (including adverse drug reactions, medication errors, suspected falsified or substandard medicinal products, and lack of therapeutic efficacy) related to the medicinal product that occur in Vietnam, made using Form 2B/TT attached to this Circular.

2. Timeline for report submission:

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

From the date the marketing authorization is granted, the marketing authorization applicant shall make semi-annually reports for the first 2 years; and annually reports from the 3rd to the 5th year;

b) For individual reports as prescribed at Point b, Clause 1 of this Article:

The marketing authorization applicant shall submit reports within the timeline prescribed in the National Guidelines on Pharmacovigilance issued by the Ministry of Health.

3. Method of submission and recipient of reports:

The marketing authorization applicant shall comply with the regulations prescribed in the National Guidelines on Pharmacovigilance issued by the Ministry of Health.

4. The processing and evaluation of reports and the provision of information to State regulatory authorities and the expert councils of the Ministry of Health for administrative purposes related to marketing authorization:

Shall be carried out in accordance with the regulations prescribed in the National Guidelines on Pharmacovigilance issued by the Ministry of Health.

Article 11. Language, dossier format, modalities of dossier submission, joint submission of a single dossier for registration of different medicinal products and medicinal materials, and modalities of dossier evaluation

1. Language used in the dossiers for registration of medicinal products and medicinal materials:

Every document included in a dossier for the registration shall be written in Vietnamese or English. However, the package insert for a medicinal product to be marketed in Vietnam must be written in Vietnamese.

2. Dossier format:

a) The dossier for registration of a medicinal product or medicinal material must be prepared in accordance with the ACTD or ICH-CTD guidelines and the regulations prescribed in this Circular;

b) For a dossier for registration of a medicinal product or medicinal material with a data exclusivity requirement, the marketing authorization applicant shall comply with the regulations prescribed in Circular No. 05/2010/TT-BYT dated March 01, 2010, of the Minister of Health guiding the keeping of confidentiality of trial data in medicine registration (hereinafter referred to as Circular No. 05/2010/TT-BYT).

3. Forms of submission of dossiers for the registration:

a) The marketing authorization applicant for a medicinal product shall submit the dossier to the Drug Administration of Vietnam as prescribed in Article 16 of the Government’s Decree No. 61/2018/ND-CP dated April 23, 2018 on the implementation of the single-window and inter-agency single-window mechanism in the performance of administrative procedures, which was amended and supplemented by Decree No. 107/2021/ND-CP dated December 06, 2021 (hereinafter referred to as Decree No. 61/2018/ND-CP);

b) In cases of dossier submission via the Online Public Service Portal of the Ministry of Health, the marketing authorization applicant for a medicinal product shall submit the dossier as prescribed in the Government’s Decree No. 45/2020/ND-CP dated April 08, 2020 on performance of administrative procedures in the electronic environment, which was amended and supplemented by the Government’s Decree No. 59/2022/ND-CP dated September 05, 2022 on electronic identification and authentication, the Government’s Decree No. 68/2024/ND-CP dated June 25, 2024, on specialized digital signatures for official use, and the Government’s Decree No. 69/2024/ND-CP dated June 25, 2024, on electronic identification and authentication.

4. A single dossier for the registration may be submitted for different medicinal products and medicinal materials which:

a) are manufactured by the same manufacturer;

b) have the same name; active substances or herbal medicinal materials; strength, concentration, mass of active ingredients or herbal medicinal materials per dose unit; dosage form; route of administration; formulation; medicinal product quality standards.

5. Modalities of dossier evaluation:

a) A dossier for registration of a medicinal product or a medicinal material shall be evaluated by subcommittees for legal affairs, quality standards, formulation, pharmacology, clinical aspects, and bioequivalence, based on the submitted sections of the dossier corresponding to the registration types, namely granting, renewal, change, and addition of marketing authorization;

b) The evaluations with respect to legal affairs, quality standards, formulation, pharmacology, clinical aspects, and bioequivalence must fully comply with the ACTD or ICH-CTD guidelines and the regulations prescribed in this Circular, including the names of the documents to be evaluated and the corresponding requirements to be met for each evaluation aspect, as prescribed in this Circular;

c) Dossier evaluation in the cases prescribed in Clause 10, Article 26 of this Circular:

- An evaluation to verify the consistency between the technical documentation section of the dossier submitted in Vietnam and the technical documentation of the medicinal product granted marketing authorization by a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular, based on the documentation prescribed in Clause 10, Article 26 of this Circular.

- An independent evaluation of the Administrative Information and Prescribing Information part and the sections of the technical documentation that are reported to be different from the technical documentation of the medicinal product already approved by a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular.

Article 12. Validity and numbering of marketing authorizations for medicinal products and medicinal materials, and deadlines for dossier submission

1. The validity of a marketing authorization for a medicinal product or a medicinal material shall be 05 years from the date it is granted or renewed, unless otherwise prescribed in Clause 2 of this Article.

2. The validity of a marketing authorization for a medicinal product shall be 03 years from the date it is granted or renewed, if continued follow-up of safety and efficacy is required for such medicinal product, including:

a) A new medicinal product, vaccine, or biological product (except for probiotics) that is granted a marketing authorization in Vietnam for the first time;

b) A medicinal product with the same active substance, concentration, strength, and dosage form as that of a new medicinal product, where such new medicinal product has not yet been granted a marketing authorization with a 05-year validity period;

c) A medicinal product prescribed at Point a or Point b of this Clause that is not de facto marketed during the validity period of its marketing authorization;

d) A medicinal product not prescribed at Point a, b, or c of this Clause, but for which the Advisory Council for grant of Marketing Authorizations for Medicinal Products and Medicinal Materials (hereinafter referred to as the Council) requires continued follow-up of its safety and efficacy.

3. A marketing authorization for a medicinal product or medicinal material that has expired, but for which an dossier for the renewal has been received by the Drug Administration of Vietnam as prescribed, may continue to be used until it is renewed or until the Drug Administration of Vietnam issues a written notice of non-renewal or a notice to suspend its use, due to the discovery that the medicinal product or medicinal material poses a safety risk to users or due to suspected forgery of legal documentation.

4. Each dossier for registration of a medicinal product or medicinal material shall be granted a single marketing authorization with a registration number in the format prescribed in Appendix V to this Circular.

5. The dossier for the renewal of marketing authorization for a medicinal product or medicinal material must be submitted before the expiration date of such marketing authorization. After the marketing authorization has expired, the Drug Administration of Vietnam shall not accept dossier for the renewal of marketing authorization of the medicinal product or medicinal material, and the applicant must submit a dossier for grant of a new marketing authorization.

6. A dossier for registration of a medicinal product to be evaluated by referencing the evaluation results of another authority must be submitted to the Drug Administration of Vietnam within a time limit of a period of no more than 05 years from the date the medicinal product was first approved by the drug regulatory authority prescribed in Clause 9, Article 2 of this Circular, as stated in the evaluation report.

Article 13. Criteria for classification of originator brand-name products and reference biological products

1. Criteria for classification of originator brand-name products and reference biological products:

a) A medicinal product that has been granted a marketing authorization is eligible for classification as an originator brand-name product when it simultaneously meets the following criteria:

- It is the first medicinal product to be granted marketing authorization on the basis of a complete dossier of quality, safety, and efficacy data;

- Its clinical data meets the requirements prescribed in Article 18 of this Circular.

b) Medicinal products granted marketing authorizations shall be classified as reference biological products when they satisfy all following criteria:

- It is a medicinal product granted marketing authorization in Vietnam on the basis of a complete dossier of quality, safety, and efficacy data;

- Its clinical data meets the requirements prescribed in Article 18 of this Circular, based on a stand-alone development pathway for a biological product and not a biosimilar development pathway.

2. A medicinal product that has been classified as an originator brand-name product or a reference biological product shall, upon a change of the manufacturer or the manufacturing site and grant of a new marketing authorization, continue to be classified as such, provided that it has the same trade name, same formulation, same quality standard of materials, same quality standard of the finished product, and a similar manufacturing process.

In cases where the medicinal product manufactured by a new manufacturer or at the new manufacturing site undergoes a change to one of the criteria in this Clause (except for a change in the trade name) or other changes related to its quality, either such change must be approved by the drug regulatory authority that granted the marketing authorization for such medicinal product, or the marketing authorization applicant must provide a comparison table made using Form 01/TT and technical documentation in accordance with the guidance in Appendix II to this Circular to demonstrate quality equivalence with the originator brand-name product or the reference biological product.

For a reference biological product that undergoes a change of the manufacturer or the manufacturing site, additional documentation demonstrating quality equivalence must be provided, in accordance with the guidance of the US FDA, ICH, WHO, EMA, other international organizations of which Vietnam is a member, or the guidance of a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular.

3. In cases where a contract giver's medicinal product or a medicinal product before technology transfer, which either has been classified as an originator brand-name product or a reference biological product, or has not been so classified but possesses clinical data that meets the requirements prescribed at Point a or Point b, Clause 1 of this Article, is contract-manufactured or has its technology transferred in Vietnam, the resulting contract-manufactured medicinal product or medicinal product manufactured through technology transfer shall be classified as an originator brand-name product or a reference biological product, provided that it meets the criteria prescribed in Clause 2 of this Article and at Point d, Clause 2, Article 38 of this Circular.

4. Cases where medicinal products are classified as originator brand-name products or reference biological products:

a) For a medicinal product for which classification as an originator brand-name product or a reference biological product is proposed at the time of submitting the dossier for grant of marketing authorization:

The marketing authorization applicant shall propose the classification as an originator brand-name product or a reference biological product when submitting the dossier for grant of marketing authorization for the medicinal product. The dossier for grant of marketing authorization that is evaluated and for which a marketing authorization is granted must meet the criteria prescribed in one of Clauses 1, 2, or 3 of this Article;

b) For a medicinal product that has already been granted a marketing authorization and for which classification as an originator brand-name product or a reference biological product is proposed:

The marketing authorization applicant shall submit a dossier proposing classification as an originator brand-name product or a reference biological product for a medicinal product that has already been granted a marketing authorization, following the procedure for a change or addition as prescribed in Appendix II to this Circular. The dossier for the change or addition of marketing authorization that is evaluated and approved must meet the criteria prescribed in one of Clauses 1, 2, or 3 of this Article.

5. A medicinal product that has already been classified as an originator brand-name product or a reference biological product shall continue to be classified as such when its marketing authorization is being considered for renewal or when a change or addition of its marketing authorization is being considered. The marketing authorization applicant is not required to submit a dossier proposing such classification.

Article 14. Criteria for classification of medicinal products with demonstrated bioequivalence

A medicinal product granted a marketing authorization in Vietnam is classified as a medicinal product with demonstrated bioequivalence when it has a bioequivalence study report that meets the requirements prescribed in Circular No. 07/2022/TT-BYT dated September 05, 2022 of the Ministry of Health providing for regulations on drugs subject to in vivo bioequivalence study and requirements for dossiers on bioequivalence study data reporting upon marketing authorization of the drugs in Vietnam (hereinafter referred to as Circular No. 07/2022/TT-BYT).

Article 15. Principles, criteria, and methods for the classification of over-the-counter medicinal products

1. Principles for the classification of over-the-counter medicinal products:

a) Ensuring safety for the users;

b) Ensuring timely access to medicinal products for the public;

c) Being consistent with the real-life situation of medicinal product use and supply in Vietnam;

d) Harmonization with the principles and regulations for the classification of over-the-counter medicinal products of countries in the region and around the world.

2. Criteria for the determination of an over-the-counter medicinal product:

A medicinal product is classified as an over-the-counter medicinal product if it meets all of the following criteria:

a) The medicinal product must be demonstrated to be safe and effective in preventing, alleviating, or treating diseases; it must have a wide safety margin to be safe for the user's health; it must have low toxicity and, during storage or upon entering the human body, must not create toxic degradation products, cause reproductive toxicity, genotoxicity, or carcinogenicity; it must not have adverse effects that require monitoring or follow-up by a doctor or healthcare professional when the medicinal product is self-administered according to the package insert; and it must not have interactions with commonly used medicinal products or foods that could lead to serious adverse reactions;

b) The medicinal product is indicated for short-term treatment for diseases that patients can self-treat, which do not necessarily require a prescription from and follow-up by a healthcare professional;

c) The medicinal product has a low potential to cause dependence; has a low risk of abuse or misuse that could affect the user's safety; and does not mask serious diseases, which could lead to a delay in diagnosis and treatment;

d) The medicinal product must have a simple dosage form and route of administration that allows for self-administration by the user without technical assistance or guidance from a doctor or healthcare professional; and it must not have special requirements for storage conditions or for the handling of the medicinal product before and after use;

dd) Its composition must not contain any medicinal materials that are on the List of toxic medicinal materials issued by the Ministry of Health.

3. Methods for classifying over-the-counter medicinal products

a) A generic medicinal product is classified as an over-the-counter medicinal product, consistent with the classification of the originator brand-name product that has been granted marketing authorization in Vietnam;

b) In cases where no such originator brand-name product has been granted a marketing authorization in Vietnam, a medicinal product is classified as an over-the-counter medicinal product consistent with the classification of a medicinal product having the same active ingredient, herbal medicinal materials, strength, concentration, and dosage form that has been granted a marketing authorization and is on the market in countries with a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular;

c) A medicinal product is classified as an over-the-counter medicinal product, consistent with the classification of a medicinal product having the same active ingredient, herbal medicinal materials, strength, concentration, and dosage form that has already been granted a marketing authorization in Vietnam, provided that it meets the principles and criteria prescribed in Clause 1 and Clause 2 of this Article;

d) Other cases shall be decided based on the opinion of the Council, on the basis of the principles and criteria prescribed in Clause 1 and Clause 2 of this Article.

Article 16. Data exclusivity requirements for dossiers for registration of medicinal products and medicinal materials

A marketing authorization applicant for a medicinal product that has a data exclusivity requirement for the dossier for the registration shall comply with the regulations prescribed in Circular No. 05/2010/TT-BYT and must clearly state such requirement in the application form made using Form 4A/TT attached to this Circular.

Article 17. Regulations on the verification of authenticity of legal documents within the dossier for grant, renewal, change, or addition of marketing authorization

1. Verification of the authenticity of the CPP in the dossier for grant, renewal, change, or addition of marketing authorization shall be carried out in the following cases:

a) The CPP shows signs of erasure or has its information altered;

b) The manufacturer or the marketing authorization applicant has been imposed penalties by a competent authority of Vietnam for any administrative violation prescribed at Point q, Clause 2, Article 42 of the Law on Pharmacy. The period for applying CPP authenticity verification shall be 03 years from the date of the decision to impose penalties on the administrative violation or from the end of the period of temporary suspension of receiving dossiers for grant or renewal of marketing authorization, if such a measure was applied;

c) A manufacturer has a medicinal product applied for marketing authorization in Vietnam for the first time, including cases where it only undertakes one stage or several stages of the manufacturing process;

d) The CPP is an electronic version issued by a competent foreign authority, but during dossier evaluation, it cannot be looked up on the website or database provided by the marketing authorization applicant;

dd) Other cases where the Council requires authenticity verification.

2. Verification of the authenticity of legal documents in the dossier for registration of medicinal products and medicinal materials in some other cases:

a) For a foreign applicant that has a medicinal product or medicinal material applied for marketing authorization in Vietnam for the first time, the Drug Administration of Vietnam shall verify the authenticity of the license for manufacturing and trading of such medicinal product in the country of origin;

b) A legal document issued by a competent foreign authority does not yet meet the requirements prescribed at Point b, Clause 1, Article 22 of this Circular.

3. For medicinal products that have been granted a marketing authorization, the Drug Administration of Vietnam shall verify the authenticity of legal documents upon receiving information related to the marketing authorization of the medicinal product in its country of origin that requires clarification, or information about the failure of the manufacturer or the foreign applicant to meet operating conditions, from the following sources:

a) Written documents sent to the Drug Administration of Vietnam that include the full name and address of the sending agency, organization, or individual, accompanied by documents related to the information;

b) Information from the mass media.

4. Modalities for verifying the authenticity of the CPP and other legal documents submitted in the dossier for registration of a medicinal product or medicinal material:

a) Verification of the consular authentication of legal documents:

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

b) Verification of the authenticity of legal documents:

The Drug Administration of Vietnam shall coordinate with the authorities granting or promulgating the legal documents to verify the information stated in such documents in the cases prescribed at Points a, b, d, and dd, Clause 1 and Point b, Clause 2 of this Article;

c) The verification of authenticity of legal documents shall be carried out concurrently with the dossier evaluation procedure or upon receipt of information as prescribed in Clause 3 of this Article;

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

5. For a dossier for grant of marketing authorization for a medicinal product or medicinal material containing legal documents that require authenticity verification as prescribed in Clause 1 and Clause 2 of this Article, the marketing authorization shall only be granted when the verification results from the competent authority prescribed in Clause 4 of this Article are satisfactory.

6. For a dossier for renewal, change, or addition of marketing authorization for a medicinal product or medicinal material containing legal documents that require authenticity verification as prescribed in Clause 1 and Clause 2 of this Article, it is not mandatory to have the verification results before the time of renewal, change, or addition.

Chapter II

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

Article 18. Requirements on clinical data to ensure safety and efficacy

1. A medicinal product applied for marketing authorization must have sufficient clinical data to demonstrate that it ensures safety and efficacy.

2. Sufficient clinical data means research data that is conducted, reported, and evaluated in accordance with the guidelines of the Ministry of Health or other organizations recognized by Vietnam (ICH, WHO, EMA, international organizations of which Vietnam is a member, or the guidance of a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular).

Article 19. Criteria for determination of medicinal products to be exempt from clinical trials in Vietnam

A medicinal product shall be exempt from clinical trials in the following cases:

1. A generic medicinal product that meets one of the following criteria:

a) There is data demonstrating its bioequivalence in accordance with the guidance in Circular No. 07/2022/TT-BYT; or

b) The submission of bioequivalence study data is not required for it upon registration for marketing authorization in Vietnam, as prescribed in Circular No. 07/2022/TT-BYT.

2. A new medicinal product (excluding vaccines) that simultaneously meets the following criteria:

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

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

c) Its clinical research data contains sufficient information to allow for the analysis and interpretation of the influence of Asian ethnic factors on the safety and efficacy of the medicinal product, in accordance with the ICH-E5 guideline.

3. An herbal medicinal product that was granted a marketing authorization before January 01, 2017.

Article 20. Criteria for determination of medicinal products to be exempt from certain phases of clinical trials in Vietnam

1. A new medicinal product or a vaccine may be considered by the Minister of Health for a decision of exemption from certain phases of clinical trials in Vietnam, based on the advisory opinion of the Council, in the following cases:

a) It is meant to serve urgent needs for national defense, security, disease prevention and control, or for overcoming the consequences of natural disasters and calamities, for which no other alternative medicinal products are available on the market; or for the treatment of rare or life-threatening diseases;

b) It has been granted a marketing authorization by at least one of the drug regulatory authorities prescribed in Clause 9, Article 2 of this Circular, based on an abridged clinical dossier in accordance with the regulations of such authorities.

2. A new medicinal product or a vaccine that is granted an exemption from certain phases of clinical trials in Vietnam must simultaneously meet the following criteria:

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

b) It has clinical data that is not yet complete as prescribed in Article 18 of this Circular, or it has sufficient clinical data as prescribed in Article 18 of this Circular but lacks a full evaluation of the ethnic factors that may affect the safety and efficacy of the medicinal product.

Article 21. Criteria for medicinal products which must undergo Phase 4 clinical trial

A medicinal product that has been granted a marketing authorization but requires further evaluation of its safety and efficacy, based on the advisory opinion of the Council.

Chapter III

DOSSIERS FOR REGISTRATION OF MEDICINAL PRODUCTS AND MEDICINAL MATERIALS

Section 1

GENERAL PROVISIONS FOR DOCUMENTS IN DOSSIERS FOR MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS AND MEDICINAL MATERIALS

Article 22. General provisions for administrative documentation

1. The documents prescribed in Clauses 3, 4, 5, 6, and 7 of Article 26 of this Circular (hereinafter collectively referred to as legal documents) in the dossier must meet the following requirements:

a) Any legal document submitted in the dossier for registration of a medicinal product or medicinal material must be either the original or a copy as prescribed in the Government’s Decree No. 23/2015/ND-CP dated February 16, 2015 on grant of duplicates from master registers, certification of copies from originals, certification of signatures and certification of contracts and transactions. Legal documents issued by foreign competent authorities shall be consular authenticated in accordance with law provisions on consular authentication, unless consular authentication is exempted under the law;

b) Legal documents must bear the signature, name of the signatory, date of issuance, and seal of the competent authority of the issuing country, unless the document is considered valid without all of such information according to the regulations of the issuing country;

c) In cases where the issued legal document is an electronic version (a version without a signature, name of the signatory, or seal of the issuing authority is acceptable), the marketing authorization applicant must submit one of the following:

- The legal document printed from the website or database of the competent issuing authority, or from a website operated by the competent authority of the country of origin or a regional authority;

- The result of a self-lookup of the legal document from the English-language website or database of the competent issuing authority, or from a website operated by the competent authority of the country of origin or a regional authority. The self-lookup result must bear the seal of the marketing authorization applicant, accompanied by a document providing the lookup link;

d) For legal documents that have a specified validity period, they must be valid at the time of receipt as stated on the dossier receipt slip. If the validity period is not written on the CPP, its validity period shall be 24 months from the day on which it is granted.

2. Regulations on CPP:

a) The CPP must contain sufficient details in the format recommended by the WHO published on its website (https://www.who.int);

b) The CPP must be issued by the competent authority of the manufacturing country, or by the competent CPP-issuing authority of a country with a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular, confirming that the medicinal product is granted a marketing authorization and de facto marketed in such country;

c) In cases where it is to meet the needs for the prevention and treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the law on the prevention and control of infectious diseases, the CPP may be replaced by another document issued by a competent authority, which confirms that the medicinal product is granted a marketing authorization and used in the country of origin and fully states the information on the name and address of the manufacturer and the marketing authorization conditions;

d) In cases where the CPP does not yet meet the requirements prescribed at Points a and b of this Clause, the Minister of Health shall consider and decide based on the advisory opinion of the Council when the medicinal product has been granted a marketing authorization by the competent authority of at least one country worldwide and falls under one of the following cases:

- A medicinal product, vaccine, or biological product to serve the needs for national defense and security; disease and epidemic prevention and control; overcoming the consequences of natural disasters and calamities; or a medicinal product for a State-level health program;

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

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

dd) The information on the CPP shall be consistent with information in the dossier for registration of the medicinal product or medicinal material. In cases where the information shown on the CPP is not consistent with the administrative documents in the dossier for registration of the medicinal product or medicinal material, the applicant shall provide a written explanation enclosed with supporting documents.

3. Regulations for the application form and other administrative documentation and documents:

a) The application form and other relevant documents in the Administrative Information and Prescribing Information part must be signed and sealed (digital signatures are also accepted); signature stamps shall not be used;

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

- The Chairperson of the Board of Members or the Board of Directors; the General Director; the Chief Executive Officer (CEO); or the Director of the marketing authorization applicant or the manufacturer;

- A person who is assigned signing authority as prescribed in the company's charter, a work assignment document, or another document proving the signatory's authority to sign;

- A person directly authorized to sign by one of the persons prescribed in Item 1 or Item 2 of this Point.

4. Regulations on the power of attorney:

a) The power of attorney to act as the marketing authorization applicant must be the original and contain the following details:

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

- Name and address of the authorized applicant;

- Name of the medicinal product; concentration and strength of active substance; dosage form;

- Contents of authorization.

In case of authorization of more than one medicinal product, the power of attorney must be enclosed with a list of medicinal products with all the details prescribed at Item 3 of this Point;

b) The power of attorney to sign the dossier for registration of a medicinal product or medicinal material must be the original and contain the following details:

- Name and address of the authorized applicant;

- Name and title of the authorizer and authorized person;

- Name of the medicinal product; concentration and strength of active substance; dosage form;

- Contents of authorization;

- Validity of the power of attorney.

In case of authorization of more than one medicinal product, the power of attorney must be enclosed with a list of medicinal products with all the details prescribed at Item 3 of this Point;

c) Number of powers of attorney in the dossier for registration of a medicinal product or medicinal material:

- In cases where the marketing authorization applicant is different from the manufacturer or the marketing authorization holder, each dossier must be accompanied by one power of attorney to act as the marketing authorization applicant;

- In cases where the title of the person signing the dossier is not one of those prescribed at Point b, Clause 3 of this Article, each dossier must be accompanied by one power of attorney to sign the dossier for registration of the medicinal product or medicinal material.

5. The marketing authorization applicant shall provide any of the following legal documents:

a) For a Vietnamese marketing authorization applicant, a certificate of eligibility for pharmaceutical business must be provided, with a scope of business covering one of the following: manufacturing, wholesale, export, or import of medicinal products and medicinal materials;

b) For a foreign medicinal product marketing authorization applicant, a license for manufacturing or trading of medicinal products issued by a competent foreign State regulatory authority must be provided, with a scope of business covering one of the following: manufacturing, wholesale, export, or import of medicinal products and medicinal materials, along with a license to establish a representative office in Vietnam.

In cases where the name and address of the marketing authorization applicant on the license to establish a representative office in Vietnam are different from the name and address on the legal document issued by the competent foreign authority, supporting documents must be provided.

In cases where the medicinal product marketing authorization applicant is also the manufacturer stated on the CPP, submission of the legal documents prescribed at this Point is not required.

In cases where the country does not issue licenses for manufacturing, wholesale, export, or import of medicinal products and medicinal materials, a license for establishment or a business registration certificate must be provided, with a scope of business covering at least one of the following: manufacturing, wholesale, export, or import of medicinal products and medicinal materials, accompanied by a certificate from a competent authority certifying that the applicant meets the conditions for and is currently operating in the pharmaceutical sector, or one of the Certificates of Good Manufacturing, Distribution, Supplying, or Storage Practices.

For a marketing authorization applicant for a medicinal material, in cases where the country of origin does not issue a pharmaceutical business license for establishments trading in medicinal materials, licenses as prescribed by the country of origin shall be accepted, provided they specify that the applicant's scope of business covers one of the following: manufacturing, wholesale, export, or import of medicinal materials.

6. The certificate that the medicinal material is permitted to be manufactured or marketed in the country of origin, on which the following information is mandatory: name of the material; name and address of the manufacturer; the country of origin; signature and full name of the signatory.

7. Supporting documents proving compliance with good manufacturing practices (GMP) submitted by a manufacturer of active ingredients, excipients, capsule shells, and herbal medicinal materials (for manufacture of herbal medicinal products) may be any of the following documents:

a) The GMP certificate;

b) The manufacture license that certifies GMP compliance;

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

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

dd) Other legal documents issued by a competent authority, which must include the following minimum details: the name and address of the manufacturer, confirmation that the manufacturer meets GMP, and the name of the active substance, medicinal material, excipient, or capsule shell;

e) For excipients in the dossier for registration of a medicinal product or medicinal material:

In cases where a document prescribed at one of Points a, b, d, or dd of this Clause cannot be provided, the manufacturer of the finished or intermediate medicinal product shall conduct a self-assessment of the excipient manufacturer's compliance with Good Manufacturing Practices, as prescribed at Point dd, Clause 1, Article 3; Point b, Clause 3, Article 3; and Point dd, Clause 5, Article 20 of Circular No. 35/2018/TT-BYT dated November 22, 2018, of the Minister of Health on Good Manufacturing Practices for medicinal products and medicinal materials (as amended and supplemented at Points a, b, and dd, Clause 6, Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020), and shall make a self-declaration in the dossier for the registration regarding the principles and standards of Good Manufacturing Practices that the excipient manufacturer meets, and commit to taking accountability to the law for such declaration, made using Form 05/TT attached to this Circular;

g) For medicinal materials in the dossier for registration of a medicinal product or medicinal material:

In cases where a document prescribed at Point a, b, or dd of this Clause cannot be provided, the applicant shall provide a Certificate of compliance with Good Agricultural and Collection Practices (GACP).

8. The label template for the medicinal product and medicinal material and the package insert for the medicinal product to be marketed in Vietnam shall comply with the regulations prescribed in Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health on labeling and package inserts of medicinal products and medicinal materials, which was amended and supplemented by Circular No. 23/2023/TT-BYT dated November 30, 2023 of the Ministry of Health amending and supplementing a number of articles in Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health on labeling and package inserts of medicinal products and medicinal materials (hereinafter referred to as Circular No. 01/2018/TT-BYT), and the following specific regulations:

a) The label template and the package insert must bear the confirmation seal of the representative office in Vietnam, the marketing authorization applicant, or the manufacturer;

b) The outer packaging label of the medicinal product or medicinal material must be printed with a Barcode, QR code, DataMatrix code, or other forms of code printing in accordance with relevant laws, for the management, identification, and traceability of medicinal products and medicinal materials on the market, according to the roadmap prescribed at Point h, Clause 1, Article 55 of this Circular;

c) The outer packaging label of the medicinal product or medicinal intermediate, which fully states the name and the strength, mass, or concentration of each active substance and medicinal material in the formulation, per smallest dosage unit or per smallest packaging unit;

d) For dosage forms or packaging that require an in-use stability study in accordance with ACTD or ICH-CTD guidelines, the package insert must include information on the shelf-life and storage conditions after opening;

dd) For a biosimilar, the label template and the package insert must clearly state which reference biological product it is similar to.

Article 23. General provisions for quality documentation

1. The quality standard, testing methods, certificate of analysis, and the stability study dossier (applicable to both the active substance and finished medicinal product sections of the dossier) must be originals bearing the seal of the manufacturer; in cases where multiple manufacturers participate in the manufacturing process, the seal of the manufacturer responsible for quality control testing or batch release is acceptable.

In cases where the manufacturer does not use a physical seal but uses a digital signature, the marketing authorization applicant must affix its own confirmation seal and take accountability to the law for the accuracy, legitimacy, and truthfulness of such document.

2. The Certificate of Analysis for a medicinal product or medicinal material must meet the following requirements:

a) The Certificate of Analysis must be presented in Vietnamese or English. In cases where the Certificate of Analysis is not presented in Vietnamese or English, a notarized translation into Vietnamese or English must be provided;

b) In cases where 02 or more manufacturers participate in the manufacturing of the medicinal product, the batch of the medicinal product or medicinal material must have a Certificate of Analysis from the manufacturer, the final packaging manufacturer, or the manufacturer responsible for batch release;

c) The Certificate of Analysis must include the following information:

- Name and address of the manufacturer, the certificate number, the name and signature of the responsible person, and the date of issuance of the certificate. In cases where an electronic signature is used, it must comply with the law regulations on electronic transactions. In cases where the Certificate of Analysis does not show the signature of the responsible person, a certificate bearing the confirmation seal of the manufacturer is acceptable. The marketing authorization applicant shall take full accountability to the law for the accuracy and validity of the Certificate of Analysis;

- Information on the medicinal product or medicinal material sample, including: product name; batch number; expiry date for a medicinal product/expiry date or re-test date for a medicinal material; the applied quality standard; quality parameters; specifications; test results; and the conclusion on the quality of the product batch.

3. Regulations for the Certificate of Analysis, the results of the quality standard evaluation, and experimental testing methods conducted at a state-owned testing laboratory for medicinal products and medicinal materials, as requested by a regulatory authority:

The Certificate of Analysis, the results of the quality standard evaluation, and the experimental testing methods must bear the confirmation of the state-owned testing laboratory for medicinal products and medicinal materials that complies with GLP.

Article 24. Regulations on clinical documentation to ensure the safety and efficacy of the medicinal product in the dossier for the registration thereof

1. For new chemical medicines, vaccines, biological products:

a) There must be sufficient clinical data to demonstrate safety and efficacy, meeting the following requirements:

- Clinical studies of the medicinal product and the data in the clinical dossier must comply with the guidelines of the ICH, the Ministry of Health, or other organizations recognized by Vietnam (including: guidelines of international organizations of which Vietnam is a member, and guidelines of a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular);

- The clinical data (except for that of a biosimilar to a reference biological product that has already been granted a marketing authorization in Vietnam) must contain sufficient information to be analyzed and interpreted in accordance with the ICH-E5 guideline;

- A medicinal product with a new combination of active substances must have sufficient clinical data in accordance with the WHO, US FDA, or EMA guidelines for clinical development of fixed-dose combinations, as prescribed in Appendix I to this Circular;

b) A vaccine that has sufficient clinical data evaluating its safety and efficacy as prescribed at Point a of this Clause but has not yet been granted marketing authorization by a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular, must have clinical data related to the assessment of its safety and immunogenicity in the target population in Vietnam before being granted marketing authorization;

c) A biosimilar must have sufficient clinical data in accordance with the guideline on the development of biosimilars issued by the Ministry of Health, or the WHO, US FDA, or EMA guidelines as prescribed in Appendix I to this Circular;

d) For a biological product that undergoes a change of the manufacturer (including a change of manufacturing site), there must be documentation demonstrating the quality equivalence of the biological product manufactured at the former manufacturer with the biological product manufactured at the new manufacturer, in accordance with the guidelines of US FDA, ICH, WHO, EMA, other international organizations of which Vietnam is a member, or the guidance of a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular.

2. For new chemical medicinal products which are not originator brand-name products:

Clinical documentation must be provided, including the following:

a) Clinical data that meets the requirements prescribed at Point a, Clause 1 of this Article;

b) Clinical data of a similar medicinal product with the same active 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, where the owner of the clinical data consents its use. The clinical data for the similar medicinal product must meet the requirements prescribed in Point a, Clause 1 of this Article;

c) Clinical data compiled from published research in medical literature (which includes scientific documents in the medical field such as research reports, clinical trials, scientific articles, medical journals, pharmaceutical journals, and specialized books in medicine and pharmacy, hereinafter referred to as medical literature), and bioequivalence study data comparing it with a similar medicinal product that has the same active substance, concentration, strength, dosage form, and route of administration, 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 Ministry of Health's regulations for a comparator medicinal product in a bioequivalence study.

3. For a new herbal medicinal product; an oral medicinal product containing herbal ingredients in combination with an active substance that is an essential oil or a pure substance extracted from an essential oil (including via synthetic or semi-synthetic methods); or a medicinal product containing a pure active substance extracted from a medicinal material:

There must be clinical data or bibliographical data from documents that meet one of the following cases:

a) Clinical studies of the medicinal product and the data in the clinical dossier must meet the requirements prescribed in Article 18 of this Circular or comply with the Guideline on Nonclinical and Clinical Research for Herbal Medicinal Products of the Ministry of Health as prescribed in Appendix III to this Circular, or those of other organizations recognized by Vietnam, including: the WHO “Research guidelines for evaluating the safety and efficacy of herbal medicines”, or a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular;

b) Monographs for the medicinal product or medicinal materials in the pharmacopoeias or formularies of Vietnam or other countries worldwide;

c) Review articles on the safety and efficacy of the medicinal product published in international journals within the WOS (Web of Science) and Scopus systems, and other clinical data compiled from published research in medical literature;

d) A report evaluating the safety and efficacy from a national-level, ministry-level, or provincial-level science and technology project that has been accepted upon completion.

4. For a chemical medicinal product that has the same active substance, strength, concentration, route of administration, and dosage form as a medicinal product granted marketing authorization by one of the drug regulatory authorities prescribed in Clause 9, Article 2 of this Circular, but for which no originator brand-name product has been granted marketing authorization in Vietnam, or which differs in one of the following aspects: strength, concentration, route of administration, or dosage form from an originator brand-name product that has been granted a marketing authorization in Vietnam, it must have clinical data that meets one of the following conditions:

a) Clinical data that meets the requirements prescribed at Point a, Clause 1 of this Article;

b) Clinical data compiled from published research in medical literature, accompanied by the package insert or the summary of product characteristics of a medicinal product with the same active 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.

5. Medicinal products for which submission of safety and efficacy documentation in the dossier for the registration is exempt:

a) A generic medicinal product;

b) A medicinal product with the same active substance, strength, concentration, route of administration, and dosage form as a medicinal product that has been granted a marketing authorization as prescribed in Clause 4 of this Article. In this case, the package insert for the medicinal product must be consistent with that of the medicinal product granted a marketing authorization as prescribed in Clause 4 of this Article;

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

d) A topical chemical medicinal product with local action that has the same active substance composition, strength, concentration, dosage form, and indication as a medicinal product that has been granted marketing authorization in Vietnam for at least 30 years and has a monograph in the Vietnamese Pharmacopoeia, a reference pharmacopoeia, or the Vietnam National Formulary;

dd) A topical medicinal product containing an active substance that is an essential oil or a pure substance extracted from an essential oil (including via synthetic or semi-synthetic methods) that has the same active substance composition, strength, concentration, and dosage form as a medicinal product that has been granted marketing authorization in Vietnam for at least 10 years or has been granted a marketing authorization and marketed in at least one other country worldwide for at least 10 years;

e) An oral medicinal product containing herbal ingredients in combination with an active substance that is an essential oil or a pure substance extracted from an essential oil (including via synthetic or semi-synthetic methods), or a medicinal product containing a pure active substance extracted from a herbal medicinal material, which has the same active substance composition, herbal medicinal materials, strength, concentration, dosage form, and indication as a medicinal product that has been granted a marketing authorization in Vietnam;

g) An herbal medicinal product with the same herbal ingredients, strength, concentration, mass of medicinal materials, dosage form, indication, and route of administration as a medicinal product granted a marketing authorization by one of the drug regulatory authorities prescribed in Clause 9, Article 2 of this Circular, or a medicinal product that has been granted a marketing authorization in Vietnam (including cases where the marketing authorization has expired).

6. Medicinal products not prescribed in Clauses 1, 2, 3, 4, and 5 of this Article must, upon marketing authorization, have sufficient clinical data to ensure the safety and efficacy thereof, in compliance with the guidelines of the ICH, WHO, US FDA, EMA, the Ministry of Health, or the guidelines of other organizations recognized by Vietnam.

7. In cases where a clinical study was conducted before the regulations or guidelines on medicinal product development prescribed at Point a, Clause 1 and Point a, Clause 3 of this Article came into effect, the data from such study may be considered acceptable for evaluation.

Section 2

REGULATIONS ON ORGANIZATION AND PARTS OF DOSSIERS FOR REGISTRATION OF MEDICINAL PRODUCTS AND MEDICINAL INGREDIENTS

Article 25. Organization of the dossier for registration of a medicinal product or medicinal material

1. The dossier for registration of a medicinal product shall comply with the ASEAN Common Technical Dossier (ACTD) or the ICH Common Technical Document (ICH-CTD) and adhere to the regulations prescribed in this Circular.

2. Organization of the dossier for registration of chemical medicinal products, vaccines, and biological products:

a) The overall organization of the ASEAN Common Technical Dossier (ACTD) is presented on the following in Parts:

- Part I: Administrative Information and Prescribing Information.

- Part II: Quality Document.

- Part III: Nonclinical Document.

- Part IV: Clinical Document.

b) ICH Common Technical Dossier (ICH-CTD):

- Module I: Administrative Information and Prescribing Information.

- Module II: Quality Overall Summary, Nonclinical Overview, Clinical Overview

- Module III: Quality.

- Module IV: Nonclinical Study Reports.

- Module V:  Clinical Study Reports.

3. Structure of the dossier of the registration of herbal medicinal products; oral medicinal products containing herbal ingredients in combination with an active substance that is an essential oil or a pure substance extracted from an essential oil (including via synthetic or semi-synthetic methods); and medicinal products containing a pure active substance extracted from a medicinal material:

a) For a new herbal medicinal product; an oral medicinal product containing herbal ingredients in combination with an active substance that is an essential oil or a pure substance extracted from an essential oil (including via synthetic or semi-synthetic methods); or a medicinal product containing a pure active substance extracted from a medicinal material:

- Part I: Administrative Information and Prescribing Information.

- Part II: Quality Document:

Follow the guidance in Appendix III to this Circular.

- Part III: Clinical data or bibliographical data as prescribed in Clause 3, Article 24 of this Circular;

b) For an herbal medicinal product that is not a new medicinal product:

- Part I: Administrative Information and Prescribing Information.

- Part II: Quality Document:

Follow the guidance in Appendix III to this Circular.

4. Structure of the dossier of the registration of medicinal materials:

a) Part I: Administrative Information and Prescribing Information.

b) Part II: Quality Document:

Follow the guidance in Appendix IV to this Circular.

Article 26. Regulations on administrative information and prescribing information

1. The application form, made using Form 4A/TT, Form 4B/TT, or Form 4C/TT attached to this Circular.

2. Powers of attorney in the dossier for registration of a medicinal product or medicinal material:

a) The power of attorney to act as the marketing authorization applicant, in cases where the applicant is not the manufacturer;

b) The power of attorney to sign the dossier for registration of the medicinal product or medicinal material (if any).

3. The CPP (for the dossier for registration of an imported medicinal product).

4. A license for manufacturing or trading of medicinal products in the country of origin; a license to establish a representative office in Vietnam (for a foreign marketing authorization applicant).

5. The Certificate of Eligibility for Pharmacy Business (for Vietnamese applicants).

6. The legal documents of the manufacturer of the active substance, excipients, capsule shells, and herbal medicinal materials as prescribed in Clause 7, Article 22 of this Circular.

7. The certificate that permits the medicinal material to be manufactured or marketed in the country of origin (for a dossier for registration of a foreign-manufactured medicinal material).

8. Label template for the medicinal product or medicinal material, and the package insert:

a) For the medicinal product or medicinal material to be marketed in Vietnam;

b) For the medicinal product being de facto marketed in the manufacturing country or the CPP-issuing country, for the dossier for registration of an imported medicinal product.

9. The summary of product characteristics or the package insert that has been approved in the country of origin, for a new medicinal product, vaccine, biological product, or a medicinal product for which the application of the modality of referencing evaluation results is proposed.

10. For a registration dossier for which the modality of referencing evaluation results is proposed, or in cases where the dossier for grant of marketing authorization is for a medicinal product manufactured in a country not on the list of countries with a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular, but for which there is only one CPP issued by the competent CPP-issuing authority of a country with a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular confirming that the medicinal product is granted a marketing authorization and de facto marketed in such country, the following additional documents are required:

a) The evaluation report from the drug regulatory authority prescribed in Clause 9, Article 2 of this Circular, which must meet the requirements in Article 30 of this Circular;

b) A table comparing the similarities between the dossier for the registration in Vietnam and the information on the medicinal product that has been granted a marketing authorization in the country of origin, made using Form 09/TT attached to this Circular.

Article 27. Regulations on quality document

1. The quality documentation shall be prepared in accordance with the guidance in Part II of the ACTD or the guidance in Modules 2 and 3 of the ICH-CTD and relevant guidelines.

For a biosimilar, there must be a complete dossier and data demonstrating quality similarity with the reference biological product, in accordance with the WHO, US FDA, or EMA guidelines.

2. In cases where the material has a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP), the documentation for the active substance may be replaced by the submission of the following documents:

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

- Data on analysis of the active substance batch;

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

3. For vaccines, serums containing antibodies, and human blood and plasma derivatives, the submission shall comply with the regulations prescribed in Clause 1 of this Article and the following documents shall be included:

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

b) A Certificate of Analysis, quality standard, and testing methods confirmed by the National Institute for Control of Vaccine and Biologicals (NICVB) or a state-owned testing laboratory assigned by the Ministry of Health with the task of controlling, evaluating, and monitoring vaccines and medical biologicals.

4. For orphan medicinal products, medicinal products to serve the needs for national defense and security; disease and epidemic prevention and control; overcoming the consequences of natural disasters and calamities; and medicinal products for special treatment needs:

a) Orphan medicinal products to treat rare diseases:

The available stability study data shall be accepted in accordance with ASEAN or ICH guidelines;

b) Medicinal products to serve the needs for national defense and security; disease and epidemic prevention and control; overcoming the consequences of natural disasters and calamities:

The available stability study data at the time of dossier submission shall be accepted for the consideration of the medicinal product's shelf-life, based on the opinion of the Council, in cases where the duration of the stability study data does not yet sufficiently meet the requirement for the minimum study duration according to ASEAN guidelines.

After the marketing authorization is granted, the applicant must continue to submit the stability study dossier for the finished product to the Drug Administration of Vietnam following the procedure for a change or addition as prescribed in Appendix II to this Circular, until the actual minimum duration of the stability study meets ASEAN guidelines, in order to have the shelf-life considered and updated as prescribed.

In cases where the medicinal product fails to meet the stability study results according to the protocol in the registration dossier, the applicant must immediately report to the Drug Administration of Vietnam for submission to the Council for consideration regarding the medicinal product's shelf-life.

Based on the advisory opinion of the Council, the Drug Administration of Vietnam shall consider and decide on the shelf-life of the medicinal product, including for batches that have already been manufactured, based on the actual stability study data;

c) Medicinal products for special treatment needs:

The available stability study data shall be accepted in accordance with ASEAN or ICH guidelines, as decided by the Minister of Health based on the opinion of the Council, in cases where the marketing authorization applicant demonstrates that the medicinal product cannot be stored in climatic zone IVb according to ASEAN guidelines.

5. In the cases prescribed in Clause 2, Article 13 of this Circular:

The marketing authorization applicant must submit a comparison table made using Form 01/TT attached to this Circular, showing a comparison between the pre-variation medicinal product and the post-variation medicinal product, and the technical documentation in accordance with the guidance in Appendix II to this Circular.

Article 28. Regulations on nonclinical documentation

The nonclinical documentation shall be prepared in accordance with the guidance in Part III of the ACTD or the guidance in Modules 2 and 4 of the ICH-CTD and relevant guidelines, or the guidance in Appendix III to this Circular.

Article 29. Regulations on clinical documentation

The clinical documentation shall be prepared in accordance with the guidance in Part IV of the ACTD or the guidance in Modules 2 and 5 of the ICH-CTD and relevant guidelines, or the guidance in Appendix III to this Circular.

Article 30. Regulations on the documentation on the evaluation results from a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular in cases where the modality of referencing evaluation results is applied

1. It must be an official evaluation report issued by a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular, which details the process of assessment and evaluation of the quality, safety, and efficacy of the medicinal product, as well as the scientific and legal basis for grant of the marketing authorization in the country of origin.

2. The evaluation report must be the final report used by the drug regulatory authority to grant a marketing authorization for the product, and must include the evaluation reports and written approvals for any change or addition in the product after grant of the marketing authorization.

3. The evaluation report must include the following minimum details to be used in the modality of referencing evaluation results:

a) Regarding administrative information, it must include the following:

- Information on the medicinal product;

- A complete list of the approved presentations and pack sizes;

- The pharmacological group;

- Information on the manufacturer and the marketing authorization holder;

b) Regarding quality, it must include the following:

- An assessment of the composition and manufacturing process;

- An assessment of the quality control;

- An assessment of the stability, with a conclusion on the product quality;

c) Regarding safety and efficacy, it must include the following:

- A summary assessment of the main nonclinical data;

- A summary assessment of the main clinical data;

- An assessment of the benefits and risks;

- The basis for the approved indications.

4. In cases where the evaluation report from the drug regulatory authority prescribed in Clause 9, Article 2 of this Circular is not in English, a notarized translation into English or Vietnamese is required.

Section 3

SPECIFIC REGULATIONS ON THE DOSSIER FOR GRANT OF MARKETING AUTHORIZATION FOR MEDICINAL PRODUCTS AND MEDICINAL MATERIALS

Article 31. Dossier for grant of marketing authorization for a medicinal product as prescribed in Clauses 1, 2, and 6 of Article 24 of this Circular

1. Administrative Information and Prescribing Information:

The documents prescribed in Article 26 of this Circular.

2. Quality document:

The documents prescribed in Article 27 of this Circular.

3. Nonclinical document:

Documents as prescribed in Clauses 1, 2, 6 and 7, Article 24 of this Circular that meet the requirements prescribed in Article 28 of this Circular.

4. Clinical document:

Documents as prescribed in Clauses 1, 2, 6 and 7, Article 24 of this Circular that meet the requirements prescribed in Article 29 of this Circular.

5. A Risk Management Plan for a new chemical medicinal product, vaccine, or biological product (except for probiotics), made using Form 03/TT attached to this Circular.

Article 32. Dossier for grant of marketing authorization for a generic medicinal product and for medicinal products as prescribed at Points b, c, and d, Clause 5, Article 24 of this Circular

1. Administrative Information and Prescribing Information:

The documents prescribed in Article 26 of this Circular.

2. Quality document:

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

b) Documentation demonstrating that the medicinal product has demonstrated bioequivalence, for a medicinal product containing an active substance or having a dosage form that requires the submission of bioequivalence study data upon registration for marketing authorization.

Article 33. Dossier for grant of marketing authorization for a medicinal product as prescribed in Clause 4, Article 24 of this Circular

1. Administrative Information and Prescribing Information:

The documents prescribed in Article 26 of this Circular.

2. Quality document:

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

b) Documentation demonstrating that the medicinal product has demonstrated bioequivalence, for a medicinal product containing an active substance or having a dosage form that requires the submission of bioequivalence study data upon registration for marketing authorization.

3. Clinical document:

The documents as prescribed in Clause 4, Article 24 of this Circular that meet the requirements prescribed in Article 29 of this Circular.

4. The package insert or the summary of product characteristics of a medicinal product with the same active 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, in cases where clinical data compiled from published medical literature is submitted.

5. In necessary cases, additional safety and efficacy data must be provided, based on the advisory opinion of the Council.

Article 34. Dossier for grant of marketing authorization for a medicinal product as prescribed at Points dd and e, Clause 5, Article 24 of this Circular

1. Administrative Information and Prescribing Information:

The documents prescribed in Article 26 of this Circular.

2. Quality document:

The documents as prescribed in Appendix III to this Circular

Article 35. Dossier for grant of marketing authorization for a medicinal product as prescribed in Clause 3, Article 24 of this Circular

1. Administrative Information and Prescribing Information:

The documents prescribed in Article 26 of this Circular.

2. Quality document:

The documents as guided in Appendix III to this Circular.

3. Clinical data or bibliographical data as prescribed in Clause 3, Article 24 of this Circular.

Article 36. Dossier for grant of marketing authorization for a medicinal product as prescribed at Point g, Clause 5, Article 24 of this Circular

1. Administrative Information and Prescribing Information:

The documents prescribed in Article 26 of this Circular.

2. Quality document:

The documents as guided in Appendix III to this Circular.

Article 37. Dossier for grant of marketing authorization for a medicinal material

1. Administrative Information and Prescribing Information:

The documents prescribed in Article 26 of this Circular.

2. Quality document:

The documents as prescribed in Appendix IV to this Circular

Section 4

SPECIFIC REGULATIONS ON THE DOSSIER FOR GRANT OF MARKETING AUTHORIZATION FOR CONTRACT-MANUFACTURED MEDICINAL PRODUCTS OR MEDICINAL PRODUCTS MANUFACTURED THROUGH TECHNOLOGY TRANSFER IN VIETNAM

Article 38. Dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured through technology transfer that is a chemical medicinal product, vaccine, or biological product

1. Administrative Information and Prescribing Information:

a) The administrative documents for the contract-manufactured medicinal product or the medicinal product manufactured through technology transfer as prescribed in Article 26 of this Circular. Submission of the legal documents of the manufacturer of the active substance, excipients, capsule shells, or herbal medicinal materials is not required in cases where only the packaging stage is subject to contract manufacturing or technology transfer;

b) Other documents related to contract manufacturing or technology transfer, including:

- The contract manufacturing agreement or the technology transfer agreement. In cases where the contract giver or the contract acceptor is not the marketing authorization applicant, the contract manufacturing agreement must be signed by the legal representatives of the contract giver, the marketing authorization applicant, and the contract acceptor.

- The license for contract manufacturing for a foreign trader, as prescribed in Clause 4, Article 38 of Decree No. 69/2018/ND-CP, if it is the dossier for registration of a contract-manufactured medicinal product exported or imported under the license;

-The Certificate of Technology Transfer Registration as prescribed in Article 31 of the Law on Technology Transfer, if it is the dossier for registration of a medicinal product manufactured through technology transfer;

c) CPP of the contract giver’s medicinal product or the medicinal product manufactured through technology transfer in the case where the contract giver’s medicinal product or medicinal product manufactured through technology transfer has not yet been granted a marketing authorization in Vietnam or the market authorization in Vietnam has expired at time of application.

2. Quality document:

a) The quality documentation of the contract-manufactured medicinal product, the medicinal product manufactured through technology transfer, the contract giver's medicinal product, or the medicinal product before technology transfer, as prescribed in Articles 31, 32, 33, 34, and Article 35 of this Circular;

b) A comparison table made using Form 01/TT attached to this Circular, showing a comparison between the contract giver's medicinal product and the contract-manufactured medicinal product, or between the medicinal product before technology transfer and the medicinal product manufactured through technology transfer; and the technical documentation in accordance with the guidance in Appendix II to this Circular;

c) Documentation demonstrating quality equivalence between the contract-manufactured vaccine or biological product and the contract giver's vaccine or biological product, or between the vaccine or biological product manufactured through technology transfer and the vaccine or biological product before technology transfer, in cases where the vaccine or biological product for which the submission of the nonclinical and clinical documentation is exempt as prescribed in Clause 3 of this Article, in accordance with the US FDA SUPAC guidance, the ICH, WHO, or EMA variation guidelines, international organizations of which Vietnam is a member, or the guidelines of a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular;

d) A contract-manufactured medicinal product or a medicinal product manufactured through technology transfer that is proposed for classification as an originator brand-name product or for classification as a medicinal product with demonstrated bioequivalence must have the following additional quality documentation submitted:

- The bioequivalence study report for the contract-manufactured medicinal product or the medicinal product manufactured through technology transfer;

The applicant may replace the bioequivalence study report for the contract-manufactured medicinal product or the medicinal product manufactured through technology transfer with a comparative dissolution profile report between the contract-manufactured medicinal product and the contract giver's medicinal product, or between the medicinal product manufactured through technology transfer and the medicinal product before technology transfer, provided that the contract-manufactured medicinal product and the contract giver's medicinal product, or the medicinal product manufactured through technology transfer and the medicinal product before technology transfer, have the same formulation, manufacturing process, quality standards of the materials, and quality standards of the finished product, in accordance with the guidance of the US FDA SUPAC, ICH, WHO, EMA, other international organizations of which Vietnam is a member, or the guidance of a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular.

In cases where there is a change related to the above detail, and such change falls under a level that does not require the submission of a bioequivalence study report for the medicinal product, the marketing authorization applicant must submit the appropriate dossier and documents for each change, in accordance with the guidelines of the US FDA SUPAC, ICH, WHO, EMA, other international organizations of which Vietnam is a member, or the guidance of a drug regulatory authority prescribed in Clause 9, Article 2 of this Circular.

- The bioequivalence study report of the contract giver's medicinal product or the medicinal product before technology transfer, in cases where the original medicinal product has not been announced as having demonstrated bioequivalence in Vietnam and where the applicant proposes the contract-manufactured medicinal product or the medicinal product manufactured through technology transfer for bioequivalence announcement.

3. Nonclinical and clinical documents:

a) If it is a contract-manufactured medicinal product or a medicinal product manufactured through technology transfer:

Nonclinical documentation as prescribed in Clause 3, Article 31 of this Circular and clinical documentation as prescribed in Clause 4, Article 31 of this Circular, in cases where the contract-manufactured medicinal product or the medicinal product manufactured through technology transfer is a new chemical medicinal product, a vaccine, or a biological product.

Submission of nonclinical and clinical documentation is not required in the following cases:

- The contract giver's medicinal product or the medicinal product before technology transfer is a chemical medicinal product that either has been granted a marketing authorization in Vietnam still valid at the time of dossier submission, or for which nonclinical documentation meeting the requirements prescribed in Clause 3, Article 31 of this Circular and clinical documentation as prescribed in Clause 4, Article 31 of this Circular have been submitted;

- The contract giver's medicinal product or the medicinal product before technology transfer is a biological product that either has been granted a marketing authorization in Vietnam still valid at the time of dossier submission, or for which nonclinical documentation meeting the requirements prescribed in Clause 3, Article 31 of this Circular and clinical documentation as prescribed in Clause 4, Article 31 of this Circular have been submitted, and for which there is documentation demonstrating quality equivalence between the contract-manufactured medicinal product and the contract giver's medicinal product, or between the medicinal product manufactured through technology transfer and the medicinal product before technology transfer;

- The contract giver's medicinal product or the medicinal product before technology transfer is a vaccine that has been granted a marketing authorization in Vietnam still valid at the time of dossier submission, and for which there is documentation demonstrating quality equivalence between the contract-manufactured medicinal product and the contract giver's medicinal product, or between the medicinal product manufactured through technology transfer and the medicinal product before technology transfer;

b) If it is the contract giver’s medicinal product or medicinal product before technology transfer:

Nonclinical documentation as prescribed in Clause 3, Article 31 of this Circular and clinical documentation as prescribed in Clause 4, Article 31 of this Circular, in cases where the contract-manufactured medicinal product or the medicinal product manufactured through technology transfer is a new chemical medicinal product, a vaccine, or a biological product; or is proposed for classification as an originator brand-name product or a reference biological product in cases where the contract giver's medicinal product or the medicinal product before technology transfer has not yet been so classified.

4. A Risk Management Plan for a new chemical medicinal product, vaccine, or biological product (except for probiotics), made using Form 03/TT attached to this Circular.

Article 39. Dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured through technology transfer that is an herbal medicinal product

1. Administrative Information and Prescribing Information:

a) The administrative documents for the contract-manufactured medicinal product or the medicinal product manufactured through technology transfer as prescribed in Article 26 of this Circular. Submission of the legal documents of the manufacturer of the medicinal material, excipients, or capsule shells is not required in cases where only the packaging stage is subject to contract manufacturing or technology transfer;

b) Other documents related to contract manufacturing or technology transfer, including:

- The contract manufacturing agreement or the technology transfer agreement. In cases where the contract giver or the contract acceptor is not the marketing authorization applicant, the contract manufacturing agreement must be signed by the legal representatives of the contract giver, the marketing authorization applicant, and the contract acceptor.

- The license for contract manufacturing for a foreign trader, as prescribed in Clause 4, Article 38 of Decree No. 69/2018/ND-CP, if it is the dossier for registration of a contract-manufactured medicinal product exported or imported under the license;

-The Certificate of Technology Transfer Registration as prescribed in Article 31 of the Law on Technology Transfer, if it is the dossier for registration of a medicinal product manufactured through technology transfer;

c) CPP of the contract giver’s medicinal product or the medicinal product manufactured through technology transfer in the case where the contract giver’s medicinal product or medicinal product manufactured through technology transfer has not yet been granted a marketing authorization in Vietnam or the market authorization in Vietnam has expired at time of application.

2. Quality document:

a) The quality documentation of the contract-manufactured medicinal product, the medicinal product manufactured through technology transfer, the contract giver's medicinal product, or the medicinal product before technology transfer, as prescribed in Article 35 and Article 36 of this Circular;

b) A comparison table made using Form 01/TT attached to this Circular, showing a comparison between the contract giver's medicinal product and the contract-manufactured medicinal product, or between the medicinal product before technology transfer and the medicinal product manufactured through technology transfer; and the technical documentation in accordance with the guidance in Appendix II to this Circular.

3. Clinical document:

a) If it is a contract-manufactured medicinal product or a medicinal product manufactured through technology transfer:

Clinical documentation as prescribed in Clause 3, Article 35 of this Circular, in cases where the contract-manufactured medicinal product or the medicinal product manufactured through technology transfer is a new medicinal product.

Submission of clinical documentation is not required in cases where the contract giver's medicinal product or the medicinal product before technology transfer is an herbal medicinal product that either has been granted a marketing authorization in Vietnam still valid at the time of dossier submission, or for which clinical documentation meeting the requirements prescribed in Clause 3, Article 35 of this Circular has already been submitted;

b) If it is the contract giver’s medicinal product or medicinal product before technology transfer:

- Clinical documentation as prescribed in Clause 3, Article 35 of this Circular, in cases where the contract-manufactured medicinal product or the medicinal product manufactured through technology transfer is a new medicinal product;

- Clinical documentation as prescribed in Article 18 of this Circular, for a contract-manufactured medicinal product or a medicinal product manufactured through technology transfer that is proposed for classification as an originator brand-name product, in cases where the corresponding contract giver's medicinal product or medicinal product before technology transfer has not yet been so classified.

Article 40. Dossier for grant of marketing authorization for the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor

1. The documents as prescribed in Article 38 or Article 39 of this Circular.

2. The marketing authorization applicant must submit the following simultaneously:

a) The contract manufacturing agreement and the technology transfer agreement;

b) The license for contract manufacturing for a foreign trader, as prescribed in Clause 4, Article 38 of Decree No. 69/2018/ND-CP, if the contract-manufactured medicinal products are exported or imported under the license, and the Certificate of Technology Transfer Registration as prescribed in Article 31 of the Law on Technology Transfer.

Section 5

SPECIFIC REGULATIONS ON THE DOSSIER FOR THE RENEWAL, CHANGE OR ADDITION OF MARKETING AUTHORIZATIONS FOR MEDICINAL PRODUCTS AND MEDICINAL MATERIALS

Article 41. Dossier for the renewal of marketing authorization for a medicinal product or medicinal material

1. The application form for the renewal of marketing authorization for a medicinal product or medicinal material, using Form 4B/TT attached to this Circular.

2. A valid CPP if the medicinal product is imported.

3. A report on the safety and efficacy of the medicinal product while it is on the market, using Form 2C/TT attached to this Circular.

Article 42. Dossier for the change or addition of marketing authorization for a medicinal product or medicinal material

1. The application form for the change or addition of marketing authorization for a medicinal product or medicinal material, using Form 4C/TT attached to this Circular, and the power of attorney to sign the registration dossier (if any).

2. The documents corresponding to the major and minor variations as prescribed in Appendix II to this Circular.

3. For changes related to the technical documentation of a contract-manufactured medicinal product or a medicinal product manufactured through technology transfer, which has been announced as meeting the criteria prescribed in Clause 1, Article 9 of this Circular, the applicant must provide evidence that the changes to the corresponding contract giver's medicinal product or the medicinal product before technology transfer, which is being manufactured and marketed in its country of origin, have been approved by the competent regulatory authority of such country.

Chapter IV

COMPETENCE AND PROCEDURES FOR GRANT, RENEWAL, CHANGE, ADDITION OF MARKETING AUTHORIZATION FOR MEDICINAL PRODUCTS AND MEDICINAL MATERIALS

Article 43. Competence for grant, renewal, change, addition of marketing authorization for medicinal products and medicinal materials

1. The Drug Administration of Vietnam shall grant; renew; and approve changes or additions of marketing authorization for medicinal products and medicinal materials based on dossier evaluation and the advisory opinion of the Council in the following cases:

a) Grant of marketing authorization for a medicinal product or medicinal material;

b) Renewal of marketing authorization for a medicinal product or medicinal material based on dossier evaluation and the advisory opinion of the Council in the following cases:

- The medicinal product is prescribed in Clause 2, Article 12 of this Circular;

- The medicinal product or medicinal material has been subject to a compulsory or voluntary recall due to failure to meet quality standards when it is marketed since the last granting or renewal of the marketing authorization;

- For a medicinal product for which information reported in Form 2C/TT attached to this Circular indicates the appearance of a new adverse event; a known adverse event with a frequency higher than that stated in the approved package insert; or a known adverse event that requires further evaluation;

c) Approval of changes or additions of marketing authorization for a medicinal product as prescribed in Appendix II to this Circular for the following cases:

Classification as a prescription or over-the-counter medicinal product; changes or additions to the indication, dosage, route of administration, or target population; classification as an originator brand-name product, a reference biological product, or a medicinal product with demonstrated bioequivalence.

2. The Drug Administration of Vietnam shall renew and approve changes or additions of marketing authorization for medicinal products and medicinal materials based on dossier evaluation without requiring an evaluation or advisory opinion from the Council in the following cases:

a) Renewal of marketing authorization for a medicinal product or medicinal material not prescribed at Point b, Clause 1 of this Article;

b) Approval of changes or additions of marketing authorization for a medicinal product or medicinal material not prescribed at Point c, Clause 1 and Clause 3 of this Article, and updating the package insert to be consistent with the originator brand-name product.

3. The Drug Administration of Vietnam shall make public on the web portal of the Ministry of Health and the website of the Drug Administration of Vietnam the changes or additions of the marketing authorizations for medicinal products and medicinal materials that do not require dossier evaluation for minor changes or additions requiring only notification.

Article 44. Regulations on supplementary dossiers, documents updated during the evaluation process, cases where the submission of a dossier for the change or addition is required, and the period of implementation for the former detail before the change, addition is approved or announced

1. Within a time limit of 06 months from the date of the written notice from the Drug Administration of Vietnam, the marketing authorization applicant must submit the supplementary documentation as requested. After this time limit, if the marketing authorization applicant fails to submit the supplementary documentation, the submitted dossier shall no longer be valid.

The time period from the issuance of the written notice from the Drug Administration of Vietnam until the marketing authorization applicant submits the supplementary documentation shall not be counted towards the timeline prescribed in Clause 6, Article 56 of the Law on Pharmacy.

2. Number of supplementary submissions for the dossier for grant, renewal, change, or addition of marketing authorization for a medicinal product or medicinal material:

a) For dossiers for grant, renewal, change, or addition of marketing authorization for a medicinal product or medicinal material, the marketing authorization applicant is permitted to submit a supplementary dossier no more than 02 times.

In cases where the second supplementary dossier is still not satisfactory according to the expert evaluation, the Drug Administration of Vietnam shall accelerate the case to the Council for consideration to disapprove grant or renewal of the marketing authorization, or to disapprove the dossier for the change or addition for a medicinal product prescribed in Clause 1, Article 43 of this Circular; or shall issue a written notice of disapproval for the renewal of the marketing authorization or disapproval of the dossier for the change or addition for the medicinal product prescribed in Clause 2, Article 43 of this Circular.

In cases where the second supplementary dossier is still not satisfactory because new issues have arisen compared to previous requests, the Drug Administration of Vietnam shall accelerate the case to the Council to consider allowing the marketing authorization applicant 01 more supplementary submission to provide clarification on the expert's opinion for a medicinal product prescribed in Clause 1, Article 43 of this Circular; or shall issue a written notice allowing 01 more supplementary submission for a medicinal product prescribed in Clause 2, Article 43 of this Circular;

b) A supplementary dossier submitted at the request of the Council shall not be counted towards the number of permitted supplementary submissions as prescribed at Point a of this Clause.

3. For a dossier that is under evaluation, the marketing authorization applicant is not permitted to make any change or addition to the submitted dossier unless so requested by the Drug Administration of Vietnam, except for the following documents:

a) Documentation on updated safety and efficacy in the package insert for the dossier for grant, change, or addition of marketing authorization for the medicinal product;

b) Documentation updating administrative information on the name or address of the marketing authorization applicant that does not change the identity of the marketing authorization applicant, for the dossier for grant, change, or addition of marketing authorization for the medicinal product;

c) Documentation updating administrative information on the name or the way the address of the manufacturer is written that does not change the identity of the manufacturer or the manufacturing location, for the dossier for grant, change, or addition of marketing authorization for the medicinal product;

d) Documentation updating information on the medicinal product being de facto marketed in Vietnam, for the dossier for the renewal of marketing authorization for the medicinal product.

4. For a dossier for the renewal of marketing authorization for a medicinal product or medicinal material as prescribed in Article 41 of this Circular, the marketing authorization applicant is only permitted to change the name of the medicinal product in the dossier for the renewal and must clearly state this in the application form for renewal of the marketing authorization.

5. When considering grant of a marketing authorization for a new medicinal product with an indication for use in the prevention and treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the law on the prevention and control of infectious diseases, the Drug Administration of Vietnam is not required to evaluate the technical documentation of the medicinal product and is not required to assess compliance with Good Manufacturing Practices, on the basis of recognizing the marketing authorization results from one of the drug regulatory authorities prescribed in Clause 9, Article 2 of this Circular.

6. The medicinal product marketing authorization applicant and the medicinal product manufacturer are responsible for self-updating the label and the package insert and are not required to submit a dossier for the change or addition thereof, or to notify the Drug Administration of Vietnam, in the following cases:

a) Change in the site or information of the medicinal product or medicinal material importer as stated on the label or in the package insert;

b) Labeling of the medicinal product, medicinal material, and the package insert as prescribed in Clause 2, Article 35 of Circular No. 01/2018/TT-BYT;

c) Change or addition to the label and the package insert in accordance with a written communication from the Drug Administration of Vietnam, based on the advisory opinion of the Council;

d) Unless resubmission of the label template and package insert is required upon a change or addition as prescribed in Appendix II to this Circular, for other changes related to the information on the label or in the package insert, the marketing authorization applicant and the manufacturer must self-update them after they have been approved by the Drug Administration of Vietnam;

dd) Other details:

- Change in the site or information about the medicinal product or medicinal material importer on the label or package insert;

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

- Change in the outline of sections in the package insert that does not alter its approved information, in accordance with the regulations on package inserts;

- Change or addition to information on the quality standard on the label or in the package insert, in accordance with the dossier already approved by the Drug Administration of Vietnam;

- Deletion of non-mandatory information on the label and in the package insert.

7. No later than 12 months from the date the Drug Administration of Vietnam issues a written approval or announces a change or addition, the new information that has been approved must be applied to the medicinal product or medicinal material. Within the 12-month period from the date the Drug Administration of Vietnam issues a written approval or announces a change or addition, the application of the new information shall be as follows:

a) The imported medicinal product or medicinal material may continue being imported and marketed with the former information until its expiry date, provided it is shipped at the port of departure of the exporting country before the date on which the new information must be applied as prescribed;

b) A medicinal product or medicinal material manufactured in Vietnam may continue to be manufactured and marketed with the former information until its expiry date before the new information is approved or announced.

8. No later than 12 months from the date the marketing authorization is renewed, in cases where the name of the medicinal product or medicinal material has been changed, the new name approved upon renewal must be used. Within the 12-month period from the date the marketing authorization is renewed, the name shall be applied as follows:

a) The imported medicinal product or medicinal material may continue being imported and marketed with the former name until its expiry date, provided it is shipped at the port of departure of the exporting country before the date on which the new name approved upon renewal must be used;

b) A medicinal product or medicinal material manufactured in Vietnam may continue to be manufactured and marketed with the former name until its expiry date before the new name is approved upon renewal.

Article 45. Procedure for granting the marketing authorization for a medicinal product or medicinal material

1. Modalities of dossier submission:

The applicant shall submit the registration dossier in accordance with Article 16 of Decree No. 61/2018/ND-CP.

2. Dossier receipt and processing time:

a) Receipt of the dossier:

Upon receipt of a complete dossier, the Drug Administration of Vietnam shall issue a dossier receipt slip to the marketing authorization applicant in accordance with the regulations.

The Drug Administration of Vietnam shall accept the dossier without requiring the submission of a CPP, if it is prescribed at Point d, Clause 2, Article 22 of this Circular, and the documentation prescribed at Point b, Clause 3, Article 27 of this Circular at the time of dossier submission;

b) Processing time for the dossier from the date of receipt:

- For a dossier for grant of marketing authorization for a medicinal product: no more than 12 months;

- For a dossier for grant of marketing authorization for a medicinal product for which the modality of referencing evaluation results is applied: no more than 09 months;

- For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has been granted a marketing authorization in Vietnam still valid at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has been granted a marketing authorization in Vietnam still valid at the time of dossier submission: no more than 03 months;

- For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission: no more than 09 months.

- For a dossier for grant of marketing authorization for a new medicinal product with an indication for use in the prevention and treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the law on the prevention and control of infectious diseases: no more than 15 days;

- For a dossier for grant of marketing authorization for a medicinal product, which is eligible for prioritized administrative procedures as prescribed in Clause 5, Article 7 of the Law on Pharmacy: no more than 06 months;

- For a dossier for grant of marketing authorization for a medicinal material: no more than 06 months.

3. Evaluation:

a) From the date of dossier receipt, the Drug Administration of Vietnam shall review, classify, and forward the dossier to the expert evaluators or evaluation body within the following time limits:

- For a dossier for grant of marketing authorization for medicinal product: 10 days for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a medicinal product to be evaluated by referencing the evaluation results of another authority: 10 days for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has been granted a marketing authorization in Vietnam still valid at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has been granted a marketing authorization in Vietnam still valid at the time of dossier submission: 03 working days for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission: 10 working days for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a new medicinal product with an indication for use in the prevention and treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the law on the prevention and control of infectious diseases: 01 working day for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a medicinal product, which is eligible for prioritized administrative procedures as prescribed in Clause 5, Article 7 of the Law on Pharmacy: 03 working days for both the initial dossier submission and any supplementary dossier submission thereof;

- For a dossier for grant of marketing authorization for a medicinal material: 03 working days for both the initial dossier submission and any supplementary dossier submission thereof;

b) From the date of receiving the dossier from the Drug Administration of Vietnam, the experts and evaluation body shall organize the evaluation, finalize the evaluation report, and send it to the Drug Administration of Vietnam within the following time limits:

- For a dossier for grant of marketing authorization for a medicinal product: 07 months for an initial dossier submission, 02 months for a supplementary dossier submission thereof;

- For a dossier for grant of marketing authorization for a medicinal product for which the modality of referencing evaluation results is applied: 04 months for an initial dossier submission thereof, 02 months for a supplementary dossier submission thereof;

- For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has been granted a marketing authorization in Vietnam still valid at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has been granted a marketing authorization in Vietnam still valid at the time of dossier submission: 01 month for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission: 04 months for the initial submission thereof or 01 month for any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a new medicinal product with an indication for use in the prevention and treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the law on the prevention and control of infectious diseases: 03 working day for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a medicinal product, which is eligible for prioritized administrative procedures as prescribed in Clause 5, Article 7 of the Law on Pharmacy: 04 months for an initial dossier submission, 01 month for a supplementary dossier submission thereof;

- For a dossier for grant of marketing authorization for a medicinal material: 04 months for an initial dossier submission thereof, 01 month for a supplementary dossier submission thereof.

4. Consequences of the evaluation:

From the date of receiving the evaluation report, based on a summary of the evaluation opinions from experts and the evaluation body and on current regulations, the Drug Administration of Vietnam shall issue a written notice to the medicinal product marketing authorization applicant to request supplementary documentation for dossiers with an unsatisfactory evaluation, or shall forward to the Council those dossiers with a satisfactory or unsatisfactory evaluation result, or those requiring an opinion, and for which the Drug Administration of Vietnam proposes granting, not granting, or requests an opinion from the Council, within the following time limits:

a) For a dossier for grant of marketing authorization for a medicinal product: 02 months for an initial dossier submission, 01 month for a supplementary dossier submission thereof;

b) For a dossier for grant of marketing authorization for a medicinal product for which the modality of referencing evaluation results is applied: 02 months for an initial dossier submission, 01 month for a supplementary dossier submission thereof;

c) For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has been granted a marketing authorization in Vietnam still valid at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has been granted a marketing authorization in Vietnam still valid at the time of dossier submission: 15 days for both the initial submission and any supplementary submission thereof;

d) For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission: 02 months for the initial submission thereof or 01 month for any supplementary submission thereof;

dd) For a dossier for grant of marketing authorization for a new medicinal product with an indication for use in the prevention and treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the law on the prevention and control of infectious diseases: 01 working day for both the initial submission and any supplementary submission thereof;

e) For a dossier for grant of marketing authorization for a medicinal product, which is eligible for prioritized administrative procedures as prescribed in Clause 5, Article 7 of the Law on Pharmacy: 15 days for both the initial submission and any supplementary submission thereof;

g) For a dossier for grant of marketing authorization for a medicinal material: 15 days for both the initial submission and any supplementary submission thereof.

5. Meeting of the Council:

From the date of receiving the documentation from the Drug Administration of Vietnam, the Office of the Council shall hold a meeting of the Council within the following time limits:

a) For a dossier for grant of marketing authorization for a medicinal product: 01 month for both the initial dossier submission and any supplementary dossier submission thereof;

b) For a dossier for grant of marketing authorization for a medicinal product for which the modality of referencing evaluation results is applied: 01 month for both the initial dossier submission and any supplementary dossier submission thereof;

c) For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has been granted a marketing authorization in Vietnam still valid at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has been granted a marketing authorization in Vietnam still valid at the time of dossier submission: 15 days for both the initial submission and any supplementary submission thereof;

d) For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission: 01 month for the initial submission thereof or 15 days for any supplementary submission thereof;

dd) For a dossier for grant of marketing authorization for a new medicinal product with an indication for use in the prevention and treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the law on the prevention and control of infectious diseases: 03 working day for both the initial submission and any supplementary submission thereof;

e) For a dossier for grant of marketing authorization for a medicinal product, which is eligible for prioritized administrative procedures as prescribed in Clause 5, Article 7 of the Law on Pharmacy: 15 days for both the initial submission and any supplementary submission thereof;

g) For a dossier for grant of marketing authorization for a medicinal material: 15 days for both the initial submission and any supplementary submission thereof.

6. Consequences of the Council’s meeting:

a) Finalization of the minutes of the Council's meeting:

From the date of the Council's meeting, the Office of the Council shall finalize and send the minutes of the Council's meeting to the Drug Administration of Vietnam within the following time limits:

- For a dossier for grant of marketing authorization for a medicinal product: 01 month for both the initial dossier submission and any supplementary dossier submission thereof;

- For a dossier for grant of marketing authorization for a medicinal product for which the modality of referencing evaluation results is applied: 01 month for both the initial dossier submission and any supplementary dossier submission thereof;

- For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has been granted a marketing authorization in Vietnam still valid at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has been granted a marketing authorization in Vietnam still valid at the time of dossier submission: 10 days for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission: 01 month for the initial submission thereof or 15 days for any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a new medicinal product with an indication for use in the prevention and treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the law on the prevention and control of infectious diseases: 01 working day for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a medicinal product, which is eligible for prioritized administrative procedures as prescribed in Clause 5, Article 7 of the Law on Pharmacy: 10 days for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a medicinal material: 10 days for both the initial dossier submission and any supplementary dossier submission thereof;

b) From the date of receiving the minutes of the Council's meeting, the Drug Administration of Vietnam shall grant a marketing authorization using Form 6A/TT attached to this Circular if the dossier is satisfactory; or shall issue a written notice to the marketing authorization applicant in accordance with the Council's conclusion if the dossier is unsatisfactory or non-compliant, within the following time limits:

- For a dossier for grant of marketing authorization for medicinal product: 20 days for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a medicinal product to be evaluated by referencing the evaluation results of another authority: 20 days for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has been granted a marketing authorization in Vietnam still valid at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has been granted a marketing authorization in Vietnam still valid at the time of dossier submission: 15 days for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a contract-manufactured medicinal product or a medicinal product manufactured with technology transfer in cases where the contract giver’s medicinal product or the medicinal product before technology transfer has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission or the contract-manufactured medicinal product with technology transferred from the contract giver to the contract acceptor in cases where the contract giver’s medicinal product has not yet been granted a marketing authorization in Vietnam, or has been granted one which has expired, at the time of dossier submission: 20 working days for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a new medicinal product with an indication for use in the prevention and treatment of a Group A infectious disease for which an epidemic has been declared in accordance with the law on the prevention and control of infectious diseases: 02 working day for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a medicinal product, which is eligible for prioritized administrative procedures as prescribed in Clause 5, Article 7 of the Law on Pharmacy: 15 days for both the initial submission and any supplementary submission thereof;

- For a dossier for grant of marketing authorization for a medicinal material: 15 days for both the initial dossier submission and any supplementary dossier submission thereof.

Article 46. Procedures for the renewal of marketing authorization

1. Modalities of dossier submission:

The applicant shall submit the registration dossier in accordance with Article 16 of Decree No. 61/2018/ND-CP.

2. Dossier receipt and processing time:

a) Receipt of the dossier:

Upon receipt of a complete dossier, the Drug Administration of Vietnam shall issue a dossier receipt slip to the marketing authorization applicant in accordance with the regulations;

b) Processing time for the dossier from the date of receipt: no more than 03 months.

3. Evaluation:

a) Within a time limit of 03 working days from the date of receiving the dossier as prescribed in Clause 2 of this Article, the Drug Administration of Vietnam shall review, classify, and forward the dossier to the expert evaluators or evaluation body;

b) Within a time limit of 01 month from the date of receiving the dossier from the Drug Administration of Vietnam, the experts and the evaluation body shall organize the evaluation, finalize the evaluation report, and send it to the Drug Administration of Vietnam.

4. Consequences of the evaluation:

a) For a renewal dossier as prescribed at Point b, Clause 1, Article 43 of this Article:

Within a time limit of 15 days from the date of receiving the evaluation report, based on a summary of the evaluation opinions from experts and evaluation units and on current regulations, the Drug Administration of Vietnam shall issue a written notice to the medicinal product marketing authorization applicant to request supplementary documentation for dossiers with an unsatisfactory evaluation, or shall forward to the Council those dossiers with a satisfactory or unsatisfactory evaluation result, or those requiring an opinion, and for which the Drug Administration of Vietnam proposes renewal, non-renewal, or requests an opinion from the Council;

b) For a renewal dossier as prescribed at Point a, Clause 2, Article 43 of this Circular, based on a summary of the evaluation opinions from experts and the evaluation body and on current regulations, the Drug Administration of Vietnam shall perform the following:

- Issue a written notice to the marketing authorization applicant to request supplementary documentation for dossiers with an unsatisfactory evaluation, or issue a written notice of non-renewal if the dossier is unsatisfactory, within a time limit of 10 days;

- Renew the marketing authorization using Form 6B/TT attached to this Circular if the dossier is satisfactory within a time limit of 15 days.

5. Meeting of the Council:

- Within a time limit of 15 days from the date of receiving the documentation from the Drug Administration of Vietnam, the Office of the Council shall hold a meeting of the Council.

6. Consequences of the Council’s meeting:

a) Within a time limit of 10 days from the date of the Council’s meeting, the Office of the Council shall finalize and send the minutes of the Council’s meeting to the Drug Administration of Vietnam;

b) Within a time limit of 15 days from the date of receiving the minutes of the Council’s meeting, the Drug Administration of Vietnam shall renew the marketing authorization using Form 6B/TT attached to this Circular if the dossier is satisfactory; and shall issue a written notice to the medicinal product marketing authorization applicant in accordance with the Council's conclusion if the dossier is unsatisfactory or non-compliant.

Article 47. Procedures for the change or addition of marketing authorization for a medicinal product or medicinal material

1. Modalities of dossier submission:

The applicant shall submit the registration dossier in accordance with Article 16 of Decree No. 61/2018/ND-CP.

2. Dossier receipt and processing time:

a) Receipt of the dossier:

Upon receipt of a complete dossier, the Drug Administration of Vietnam shall issue a dossier receipt slip to the marketing authorization applicant in accordance with the regulations;

b) Processing time for the dossier from the date of receipt:

- For a dossier as prescribed in Clause 3, Article 43 of this Circular: no more than 20 days;

- For a dossier as prescribed at Point c, Clause 1 and Point b, Clause 2, Article 43 of this Circular: no more than 03 months.

3. Evaluation:

a) From the date of receiving the dossier as prescribed in Clause 2 of this Article, the Drug Administration of Vietnam shall, within a time limit of 20 days, make public the information for a dossier prescribed in Clause 3, Article 43 of this Circular; and shall review, classify, and forward the dossier to the expert evaluators or evaluation body for a dossier prescribed at Point c, Clause 1 or Point b, Clause 2, Article 43 of this Circular within the following time limits:

- For a dossier as prescribed at Point c, Clause 1, Article 43 of this Circular: 03 working days for an initial dossier submission, 02 working days for a supplementary dossier submission thereof;

- For a dossier as prescribed at Point b, Clause 2, Article 43 of this Circular: 03 working days for both the initial dossier submission and any supplementary dossier submission thereof;

b) From the date of receiving the dossier from the Drug Administration of Vietnam, the experts and evaluation body shall organize the evaluation, finalize the evaluation report, and send it to the Drug Administration of Vietnam within the following time limits:

- For a dossier as prescribed at Point c, Clause 1, Article 43 of this Circular: 01 month for an initial dossier submission thereof, 15 days for a supplementary dossier submission thereof;

- For a dossier as prescribed at Point b, Clause 2, Article 43 of this Circular: 01 month for both the initial dossier submission and any supplementary dossier submission.

4. Consequences of the evaluation:

a) For a dossier for the change or addition as prescribed at Point c, Clause 1, Article 43 of this Article:

From the date of receiving the evaluation report, based on a summary of the evaluation opinions from experts and the evaluation body and on current regulations, the Drug Administration of Vietnam shall either issue a written notice to the medicinal product marketing authorization applicant to request supplementary documentation for dossiers with an unsatisfactory evaluation; or forward to the Council these dossiers with a satisfactory or unsatisfactory evaluation result, or those requiring an opinion, and for which the Drug Administration of Vietnam proposes approval, non-approval, or requests an opinion from the Council: 15 days for an initial dossier submission thereof and 10 days for a supplementary dossier submission thereof;

b) For a dossier for the change or addition as prescribed at Point b, Clause 2, Article 43 of this Article:

From the date of receiving the evaluation report, based on a summary of the evaluation opinions from experts and the evaluation body and on current regulations, the Drug Administration of Vietnam shall issue a written notice to the marketing authorization applicant requesting supplementary documentation if the dossier is unsatisfactory; or issue a written approval of the change or addition of marketing authorization if the dossier is satisfactory; or issue a written notice of non-approval if the dossier is unsatisfactory: 25 days for both initial and supplementary dossier submissions.

5. Meeting of the Council:

- Within a time limit of 15 days from the date of receiving the documentation from the Drug Administration of Vietnam, the Office of the Council shall hold a meeting of the Council.

6. Consequences of the Council’s meeting:

a) Within a time limit of 10 days from the date of the Council’s meeting, the Office of the Council shall finalize and send the minutes of the Council’s meeting to the Drug Administration of Vietnam;

b) Within a time limit of 15 days for an initial dossier submission and 08 days for a supplementary dossier submission from the date of receiving the minutes of the Council’s meeting, the Drug Administration of Vietnam shall issue a written approval of the change or addition of marketing authorization if the dossier is satisfactory; and shall issue a written notice to the medicinal product marketing authorization applicant in accordance with the Council's conclusion if the dossier is unsatisfactory or non-compliant.

Chapter V

DOSSIER AND PROCEDURES FOR REVOCATION OF THE MARKETING AUTHORIZATIONS FOR MEDICINAL PRODUCTS OR MEDICINAL MATERIALS

Article 48. Dossier for revocation of marketing authorization for a medicinal product or medicinal material

1. For the revocation of a marketing authorization for a medicinal product as prescribed at Points a and b, Clause 1, Article 58 of the Law on Pharmacy, the dossier shall consist of:

a) The decision to impose penalties on administrative violations issued by the competent regulatory authority;

b) A written recall of the medicinal product from a competent regulatory authority.

2. For the revocation of a marketing authorization for a medicinal product or medicinal material as prescribed at Points d and dd, Clause 1, Article 58 of the Law on Pharmacy, the dossier shall consist of:

A written conclusion from a competent regulatory authority stating that the dossier for the medicinal product for which the marketing authorization was granted is fraudulent, or that the medicinal product or medicinal material was not manufactured at the address stated in the application dossier.

3. For the revocation of a marketing authorization for a medicinal product or medicinal material as prescribed at Point c, Clause 1, Article 58 of the Law on Pharmacy, the dossier shall consist of:

A notice from the competent authority that issued the CPP regarding the revocation of such CPP, where such certificate was the basis for the Drug Administration of Vietnam to grant the marketing authorization for the medicinal product or medicinal material in Vietnam.

4. For the revocation of a marketing authorization for a medicinal product or medicinal material as prescribed at Point e, Clause 1, Article 58 of the Law on Pharmacy, the dossier shall consist of:

A notice from the WHO, a competent authority of Vietnam, or of the country of origin of the medicinal product or medicinal material, recommending against its safety or efficacy for users.

5. For the revocation of a marketing authorization for a medicinal product or medicinal material as prescribed at Point g, Clause 1, Article 58 of the Law on Pharmacy, the dossier shall consist of:

An application form for the revocation of marketing authorization for the medicinal product or medicinal material in Vietnam from the manufacturer or the medicinal product marketing authorization applicant, made using Form 07/TT attached to this Circular.

Article 49. Procedures for revocation of marketing authorization for a medicinal product or medicinal material

1. Within a time limit of 30 days from the date of receiving the dossier as prescribed in Clause 1, Article 48 of this Circular, the Drug Administration of Vietnam shall issue a decision to revoke the marketing authorization for the medicinal product.

2. Within a time limit of 30 days from the date of receiving the dossier as prescribed in Clause 2, Article 48 of this Circular, the Drug Administration of Vietnam shall issue a decision to revoke the marketing authorization for the medicinal product or medicinal material.

3. Within a time limit of 10 days from the date of receiving the dossier as prescribed in Clause 3 and Clause 4, Article 48 of this Circular, the Drug Administration of Vietnam shall issue a decision to revoke the marketing authorization for the medicinal product or medicinal material.

4. Within a time limit of 20 days from the date of receiving the dossier as prescribed in Clause 5, Article 48 of this Circular, the Drug Administration of Vietnam shall issue a decision to revoke the marketing authorization for the medicinal product or medicinal material.

Chapter VI

PRINCIPLES OF ORGANIZATION AND OPERATION OF THE COUNCIL, EXPERT ADVISORY BODY, AND EXPERT EVALUATORS

Article 50. Organization and operations of the Council

1. Marketing Authorization Advisory Board is established by the Minister of Health. Members of the Council are experts with suitable professional qualifications and experience to ensure the ability to evaluate dossiers, provide counter-arguments to the opinions of expert evaluators and the recommendations of the Drug Administration of Vietnam, and advise the Minister of Health on issues related to pharmaceutical legal affairs and the quality, safety, and efficacy dossiers of medicinal products and medicinal materials.

2. The Council is responsible for advising the Minister of Health on grant, renewal, change, or addition of marketing authorization for medicinal products and medicinal materials, based on the evaluation results of the experts, the recommendations of the Drug Administration of Vietnam, and other related matters as requested by the Minister of Health. The Council shall take accountability to the Minister of Health for its advisory opinions.

3. Operation of the Advisory Board:

a) The Advisory Board operates according to unanimity, democracy, objectivity and transparency principles. The Council's opinions must be legally and scientifically sound, taking into account the findings of expert evaluators, real-world clinical practices, and recommendations from the Drug Administration of Vietnam;

b) The Council shall meet when at least 2/3 of the eligible Council members (according to the Regulations on the Organization and Operation of the Council issued by the Ministry of Health) are in attendance; in cases where a Council member does not attend the meeting but submits a written opinion, they shall be considered as having attended;

The chairperson or a person authorized by the chairperson to preside over the meeting shall announce the verdict when it is approved of by at least 2/3 of the participants. Dissenting opinions shall be reserved.

The opinions of the Council members and the conclusion of the Council must be recorded in the minutes of the Council's meeting, including any opinions that are not in agreement with the Council's conclusion;

c) If a meeting is not held, the chairperson shall obtain written comments from the members;

After the deadline for sending comments, the chairperson or a person authorized by the chairperson shall announce a verdict when at least 2/3 of the members have sent their comments.

The concluding opinion of the Council, based on the consensus of at least 2/3 of the members who have submitted their opinions to the Standing Committee of the Council, and on the basis of the summary report and recommendations of the Drug Administration of Vietnam;

The concluding opinion of the Council shall be presented in a Submission Form stating the concluding opinion of the Chairperson of the Council or of the person authorized by the Chairperson of the Council;

d) In necessary cases, the Council’s members have the right to review and evaluate the dossier, and the Chairperson of the Council has the right to further consult with independent experts from outside the Council before making a final conclusion. These experts may participate in the Advisory Board meeting or send their comments, have the same responsibilities and interests as those of the members;

dd) Conflict of interest rules are not violated.

4. The Drug Administration of Vietnam shall develop and submit regulations to the Minister of Health for approval. Such regulations will govern the Council's organization and operations, and detail the coordination process between the Council and expert evaluators for grant, renewal, change, or addition of marketing authorization for medicinal products and medicinal materials.

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

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

Article 51. Organization and operation of the Council, evaluation body, and expert evaluators

1. The Drug Administration of Vietnam and the evaluation body shall establish subcommittees of expert evaluators for the relevant documentation in the dossier for the registration concerning legal affairs, quality standards, formulation, pharmacology, clinical aspects, and bioequivalence, and shall establish the list of experts in the subcommittees for evaluating dossiers for grant, renewal, change, or addition of medicinal products and medicinal materials. The structure of the subcommittees of expert evaluators must be appropriate for the classification of the registered product and the type of marketing authorization.

2. Principles of operation for expert reviewers and the evaluation body:

a) The evaluation opinions must ensure a legal and scientific basis and must be recorded in the evaluation report for the dossier for grant, renewal, change, or addition of marketing authorization of the medicinal product or medicinal material;

b) Expert evaluators are responsible to the Director General of the Drug Administration of Vietnam and to the evaluation body for their evaluations and recommendations related to the evaluation of application dossiers for grant, renewal, change, or addition of medicinal products and medicinal materials.

3. The Drug Administration of Vietnam, based on its assigned functions and duties, shall develop and issue regulations on the organization and operations of the groups of expert evaluators (including experts from the evaluation body) for the evaluation of application dossiers for grant, renewal, change, or addition of medicinal products and medicinal materials; and shall sign agreements with expert evaluators or evaluation body for dossier evaluation;

The Drug Administration of Vietnam and the evaluation body shall organize training courses for expert evaluators; and shall evaluate the professional capacity of the expert evaluators appointed by the evaluation body and their compliance with regulations in order to make appropriate adjustments and additions to the list of expert evaluators.

4. Provision of funding for validation shall comply with regulations of law.

Chapter VII

IMPLEMENTATION PROVISIONS

Article 52. Effect

1. This Circular takes effect on July 01, 2025.

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

a) The regulations on chemical medicinal products, biological products, and herbal medicinal products as prescribed in Circular No. 07/2017/TT-BYT dated May 03, 2017, of the Minister of Health, promulgating the list of over-the-counter medicinal products;

b) Item 1, Point a, Clause 1, Article 16 and Item 2, Point c, Clause 3, Article 29 of Circular No. 01/2018/TT-BYT dated January 18, 2018, of the Minister of Health on the labeling of medicinal products, medicinal materials, and their package inserts;

c) Circular No. 08/2022/TT-BYT dated September 05, 2022, of the Minister of Health on the marketing authorization of medicinal products and medicinal materials;

d) Circular No. 16/2023/TT-BYT dated August 15, 2023, of the Minister of Health on the marketing authorization for contract-manufactured medicinal products and medicinal products manufactured through technology transfer in Vietnam;

dd) Circular No. 55/2024/TT-BYT dated December 31, 2024, of the Minister of Health, amending and supplementing a number of articles on the renewal of marketing authorizations for medicinal products and medicinal materials in Circular No. 08/2022/TT-BYT dated September 05, 2022, of the Minister of Health, on the marketing authorization of medicinal products and medicinal materials.

3. For a domestically manufactured medicinal product or medicinal material that was granted a marketing authorization before October 20, 2022, and for which the applicant wishes to import excipients or capsule shells as medicinal materials into Vietnam:

Before the first importation into Vietnam, the marketing authorization applicant shall update all information on the excipients and capsule shells as medicinal materials in the approved dossier onto the online public service system of the Drug Administration of Vietnam. Within 05 working days from the date the establishment updates the information on the system, the Drug Administration of Vietnam must complete the publication of the source of the excipients and capsule shells as medicinal materials on its official website. The marketing authorization applicant shall take accountability for the accuracy of the updated information compared to the information in the approved marketing authorization application dossier and is not required to re-update the information for subsequent importations.

4. For a medicinal product or medicinal material that was granted a marketing authorization before January 01, 2023, the registration number must be stated on the label in the format prescribed in Appendix V to this Circular, no later than 12 months from the date the marketing authorization is renewed. Within the 12-month period from the date the marketing authorization is renewed, the stating of the registration number shall be applied as follows:

a) A domestically manufactured medicinal product or medicinal material may continue to be manufactured and marketed until its expiry date with the former registration number that was issued before the renewal;

b) The imported medicinal product or medicinal material may continue being imported and marketed with the former registration number that was issued before the renewal, provided it is shipped at the port of departure of the exporting country before the date on which the new registration number must be stated as prescribed at Point a of this Clause.

5. Medicinal products that were classified as prescription or over-the-counter before the effective date of this Circular are not required to be re-classified during the remaining validity period of their marketing authorizations. The classification of a medicinal product as prescription or over-the-counter shall be reviewed in accordance with this Circular upon renewal of its marketing authorization. In cases where a change in the classification as a prescription or over-the-counter medicinal product is proposed, the marketing authorization applicant shall proceed as prescribed in Appendix II to this Circular.

6. For dossiers for registration of drugs submitted to the Drug Administration of Vietnam before the effective date of this Circular for which the marketing authorizations have not yet been granted or renewed, the classification as over-the-counter drugs shall be considered in accordance with this Circular.

Article 53. Transitional provisions

1. Registration dossiers submitted before the effective date of this Circular shall continue to be processed in accordance with the regulations in effect at the time of submission, or shall be subject to the regulations of this Circular from its effective date, in a manner that is convenient and simplifies administrative procedures for businesses, organizations, and individuals.

2. In cases where a medicinal product has been classified and announced by the Ministry of Health as an originator brand-name product, a reference biological product, or a medicinal product with demonstrated bioequivalence, the Drug Administration of Vietnam shall make adjustments and updates to the published information upon the request of the medicinal product marketing authorization applicant.

Article 54. Reference clauses

In cases where a legislative document or regulation incorporated by reference in this Circular is amended or replaced, the amendment or replacement shall apply.

Article 55. Organization of implementation

1. Drug Administration of Vietnam, following the roadmap for ASEAN harmonization of medicinal product registration, shall:

a) Organize the implementation of this Circular;

b) Announce on the website of the Drug Administration of Vietnam:

- Lists of medicinal products and medicinal materials for which marketing authorizations have been granted or renewed (including information on the medicinal products before technology transfer for medicinal products manufactured through technology transfer in Vietnam, and on the contract giver's medicinal products for contract-manufactured medicinal products in Vietnam), to be published on the official website of the Drug Administration of Vietnam within a time limit of 05 working days from the date they are granted or renewed, together with their classifications as prescription or over-the-counter medicinal products and other relevant marketing authorization information;

- Lists of medicinal products with demonstrated bioequivalence and medicinal products announced as originator brand-name products or reference biological products, to be published within a time limit of 05 working days from the date the marketing authorizations are granted; and information on changes or additions for such products to be published within a time limit of 07 working days from the date such change or additions or additions is approved;

- Lists of contract-manufactured medicinal products and medicinal products manufactured through technology transfer, made using Form 8A/TT, Form 8B/TT, and Form 8C/TT attached to this Circular;

c) Remove medicinal products from the published lists of medicinal products with demonstrated bioequivalence, originator brand-name products, and reference biological products that no longer meet the classification criteria as prescribed in this Circular, based on the advisory opinion of the Council;

d) Remove medicinal products from the lists of contract-manufactured medicinal products and medicinal products manufactured through technology transfer that have been published as prescribed at Item 3, Point b of this Clause, based on the advisory opinion of the Council, when the medicinal products no longer meet the requirements prescribed in Clause 1, Article 9 of this Circular;

dd) Develop, issue, and organize the implementation of standard operating procedures for medicinal product registration; guidance documents for the registration of marketing authorization for medicinal products and medicinal materials; and guidance documents for the evaluation of such registration dossiers;

e) Cooperate with Traditional Medicine Administration of Vietnam in renewing and revising the marketing authorizations of traditional medicinal products and herbal medicinal products that were issued under Circular No. 44/2014/TT-BYT dated November 25, 2024 of the Minister of Health on medicinal product registration;

g) In necessary cases, organize meetings with marketing authorization applicants, manufacturers, and expert evaluators to clarify issues related to the evaluation of dossiers for registration of medicinal products and medicinal materials;

h) Develop regulations for the application of barcodes, QR codes, DataMatrix codes, or other forms of code printing in accordance with relevant laws on the outer packaging of medicinal products and medicinal materials by manufacturers to manage, identify, and trace the origin of products on the market, and formulate an implementation roadmap as prescribed by the Minister of Health;

i) Within a time limit of 15 days from the date of granting or renewal, and within a time limit of 07 working days from the date of approving a change or addition of marketing authorization, the Drug Administration of Vietnam shall share the quality standard of the medicinal product with the testing laboratory system; share information from the Risk Management Plan with the National DI & ADR Center for registration dossiers for new chemical medicinal products, vaccines, and biological products (except for probiotics); publish information on medicinal materials for domestically manufactured medicinal products; and publish the lists of medicinal products classified as originator brand-name products, reference biological products, and medicinal products with demonstrated bioequivalence;

k) Within a time limit of 03 working days from the date of receiving an dossier for the renewal of marketing authorization, the Drug Administration of Vietnam shall make public the information of dossier receipt on the web portal of the Ministry of Health and the website of the Drug Administration of Vietnam;

l) Within a time limit of 03 working days from the date the Drug Administration of Vietnam issues a written notice of non-renewal or a notice to suspend the use of a marketing authorization due to the discovery that a medicinal product or medicinal material poses a safety risk to users or due to suspected forgery of legal documents, the Drug Administration of Vietnam shall make this information public on the web portal of the Ministry of Health and the website of the Drug Administration of Vietnam;

m) Make public the technical documentation prescribed in Appendix I to this Circular on the website of the Drug Administration of Vietnam.

2. The manufacturer of a medicinal product or medicinal material, when stating the expiry date on the label, must comply with the labeling regulations in Circular No. 01/2018/TT-BYT and the following regulation:

The expiry date on the label of the medicinal product or medicinal material must not be longer than the shelf-life approved in the marketing authorization dossier, but must not be shorter than the approved shelf-life by more than 31 days.

Article 56. Responsibilities for implementation

1. The Drug Administration of Vietnam shall be responsible for guiding the implementation of this Circular; assume the prime responsibility for, or coordinate with the Inspectorate of the Ministry of Health, functional departments and agencies, and Departments of Health of municipalities and provinces in inspecting and examining the implementation of this Circular by pharmaceutical manufacturers and sellers nationwide.

2. Affiliated units of the Ministry of Health, Vinapharm, pharmaceutical manufacturers and sellers shall be responsible for implementing this Circular.

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