Circular 16/2023/TT-BYT marketing authorization of drugs manufactured through contract manufacturing, technology transfer in Vietnam

CIRCULAR

SPECIFYING THE MARKETING AUTHORIZATION OF DRUGS MANUFACTURED THROUGH CONTRACT MANUFACTURING AND DRUGS MANUFACTURED THROUGH TECHNOLOGY TRANSFER IN VIETNAM

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

Pursuant to the Commercial Law No. 36/2005/QH11 dated June 14, 2005;

Pursuant to the Law on Foreign Trade Management No. 05/2017/QH14 dated June 12, 2017;

Pursuant to the Law on Technology Transfer No. 07/2017/QH14 dated June 19, 2017;

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

Pursuant to Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government on amendments to some articles related to business conditions under state management of the Ministry of Health;

Pursuant to 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;

Pursuant to Decree No. 95/2022/ND-CP dated November 15, 2022 of the Government 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 hereby promulgates Circular specifying the marketing authorization of drugs manufactured through contract manufacturing and drugs manufactured through technology transfer in Vietnam.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

1. This Circular specifies general provisions on marketing authorization of drugs manufactured through contract manufacturing and drugs manufactured through technology transfer in Vietnam; dossiers and procedures for granting, extending, modifying, supplementing and revoking marketing authorizations for drugs manufactured through contract manufacturing and drugs manufactured through technology transfer (pharmacochemical drugs, vaccines, biological products, herbal drugs) in Vietnam.

2. This Circular applies to domestic and foreign authorities, organizations and individuals engaged in contract drug manufacturing and technology transfer in Vietnam.

Article 2. Interpretation of terms

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

1. Contract drug manufacturing means the outsourced manufacturing of drugs pursuant to a lawful manufacturing agreement under which a contract manufacturing organization undertakes one stage or several/all stages of the drug manufacturing process at the request of the drug owner, and receives remuneration in return.

2. Drug manufacturing technology transfer means the transfer of ownership or assignment of usage rights of drug manufacturing technology from a facility allowed to conduct such transfer to a receiving facility, which enables the latter to conduct one or more phases of the drug manufacturing process under a contract between the two parties in accordance with the law.

3. Drug owner means the party that provides a portion or the entirety of ingredients, materials, manufacturing processes, and technical dossier demonstrating the quality, safety, and efficacy of the drugs to the contract manufacturing organization for it to manufacture drugs under a manufacturing contract between the two parties.

4. Contract manufacturing organization means a party that uses a portion or the entirety of ingredients, materials, manufacturing processes, and technical dossier provided to it by a drug owner to undertake one stage or several/all stages of the drug manufacturing process at the behest of the drug owner, and receive remuneration in return under the manufacturing contract between the two parties.

5. Sending facility means the party owing or having the right to use the drug manufacturing technology in accordance with the law, which transfers the ownership or assigns the right to use such drug manufacturing technology to a receiving facility for it to apply in one stage or several/all stages of the drug manufacturing process.

6. Receiving facility means the party receiving transfer of ownership or assignment of usage rights of drug manufacturing technology from a sending facility under a contract between two parties so as to apply in one stage or several/all stages of the drug manufacturing process.

7. Drug ordered for manufacturing means a drug that has either already or not yet authorized in Vietnam and is ordered for manufacturing by a drug owner in one stage or several/all stages of the manufacturing process of such drug by the contract manufacturing organization under the manufacturing contract between the two parties.

8. Drug manufactured through contract manufacturing means a drug of which one stage or several/all stages of the manufacturing process are undertaken by the contract manufacturing organization on behalf of the drug owner under the manufacturing contract between the two parties.

9. Drug before technology transfer means a drug that has either already or not yet authorized in Vietnam and of which the manufacturing technology ownership or usage right is transferred or assigned by the sending facility to the receiving facility for it to apply in one stage or several/all stages of the drug manufacturing process.

10. Drug manufactured through technology transfer means a drug of which one stage or several/all stages of the drug manufacturing process are undertaken by a receiving facility with the technology transferrer/assigned by a sending facility under the contract between the two parties.

Chapter II

GENERAL PROVISIONS ON APPLICATION FOR MARKETING AUTHORIZATION OF DRUGS MANUFACTURED THROUGH CONTRACT MANUFACTURING

Article 3. Rights and responsibilities of contract manufacturing organizations and applicants for marketing authorization of drugs manufactured through contract manufacturing

In addition to the rights and obligations specified in Article 181 of the Commercial Law and Clause 1, Article 42 of 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), the drug owner have the following specific rights, obligations and responsibilities:

1. Rights of the drug owner:

a) To authorize an eligible entity to apply for marketing authorization of drugs in its name in accordance with the law;

b) To apply for marketing authorization of drugs manufactured through contract manufacturing in one of the following cases:

- It is a Vietnamese drug owner holding a certificate of eligibility for pharmaceutical business which permits one of the following: manufacturing, wholesaling, export or import of drugs/drug materials.

- It is a foreign drug owner obtaining legal documents issued by foreign competent authorities which permit one of the following: manufacturing, wholesaling, export or import of drugs/drug materials, and a license to establish a representative office in Vietnam.

2. Responsibilities of the drug owner:

a) Complying with Article 3 of Circular No. 08/2022/TT-BYT dated September 5, 2022 of the Minister of Health on marketing authorization of drugs and drug materials (hereinafter referred to as Circular No. 08/2022/TT-BYT) if it applies for marketing authorization of drugs manufactured through contract manufacturing.

b) Providing the contract manufacturing organization:

- A proportion or the entirety of materials, ingredients, technical dossiers including the manufacturing process, quality standards and methods for testing starting materials, semi-finished products, finished products and auxiliary starting materials in the stage(s) that is outsourced;

- Other dossiers and documents related to the marketing authorization of drugs manufactured through contract manufacturing and the contract manufacturing of drugs.

c) Taking accountability for the legitimacy and truthfulness of intellectual property rights of drugs manufactured through contract manufacturing, ingredients, materials, manufacturing processes, and technical dossier transferred to the contract manufacturing organization;

d) Coordinating with the marketing authorization applicant in updating quality standards of drugs/drug materials in accordance with Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Ministry of Health on quality of drugs and drug materials and Circular No. 03/2020/TT-BYT dated January 22, 2020 of the Minister of Health amending and supplementing a number of articles of Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Ministry of Health on quality of drugs and drug materials;

d) Inspecting and supervising the contract manufacturing organization on the manufacturing of drugs under the manufacturing contract from proper ingredients, materials, dossiers and documents transferred to it, and the approved marketing authorization application dossiers in order to ensure the proper compliance with agreements in the manufacturing contract and Good Manufacturing Practices (GMP);

e) Taking accountability for the quality, safety and efficacy of drugs manufactured through contract manufacturing;

g) Reporting or coordinating with the applicant for marketing authorization of the drugs manufactured through contract manufacturing (if the contract manufacturing organization and the marketing authorization applicant are not the same) in reporting on the monitoring and assessment of the safety and efficacy of the drugs manufactured through contract manufacturing as specified in Clause 2, Article 5 of Circular No. 08/2022/TT-BYT.

h) Notifying the contract manufacturing organization and the marketing authorization applicant in the following cases:

- There are problems related to the safety and efficacy of the drug ordered for manufacturing;

- There are changes or additions to the technical dossier of the drug ordered for manufacturing on the market;

- There is a decision to revoke the marketing authorization of the drug ordered for manufacturing in any country in the world.

3. The applicant for marketing authorization of drugs manufactured through contract manufacturing shall be responsible for coordinating with the drug owner or the contract manufacturing organization in sending a written notice to the Drug Administration of Vietnam within 30 days from the date on which the decision to revoke the marketing authorization of the drug ordered for manufacturing is issued in any country in the world (within the validity period of the marketing authorizations of the drugs manufactured through contract manufacturing) and performing other responsibilities specified in Article 3 of Circular No. 08 2022/TT-BYT.

4. Other rights, obligations and responsibilities in accordance with relevant law regulations.

Article 4. Rights and responsibilities of contract manufacturing organizations

In addition to the rights and obligations specified in Article 181 of the Commercial Law and Clause 2, Article 42 of Decree No. 69/2018/ND-CP, the contract manufacturing organization has the following specific rights, obligations and responsibilities:

1. Rights of contract manufacturing organizations:

a) To manufacture drugs under manufacturing contracts within its business scope stated in the certificate of eligibility for pharmaceutical business, if the contract manufacturing organization is a Vietnam-based manufacturer that has been granted the certificate of eligibility for pharmaceutical business;

b) To manufacture drugs under manufacturing contracts within its operation scope stated in the GMP certificate, if the contract manufacturing organization is a non-commercial pharmaceutical entity specified at Point a, Clause 1, Article 35 of the Law on Pharmacy;

c) To apply for marketing authorization of drug manufactured through contract manufacturing when it is authorized by the drug owner.

2. Responsibilities of the contract manufacturing organization:

a) The responsibilities of a drug manufacturer specified in Article 4 of Circular No. 08/2022/TT-BYT;

b) Only manufacturing drugs under manufacturing contracts within its business scope stated in the certificate of eligibility for pharmaceutical business granted to it, or the operation scope stated in the GMP certificate if it is a non-commercial pharmaceutical entity specified at Point a, Clause 1, Article 35 of the Law on Pharmacy;

c) Manufacturing drugs under manufacturing contracts with proper ingredients, materials, manufacturing processes, technical dossiers transferred to it by the drug owner, ensuring the quality of the drugs in accordance with the application dossier for marketing authorization, complying with GMP requirements and the drug owner’s requirements in the manufacturing contract. Keeping dossiers, documents and drug samples related to the drug contract manufacturing process and provide such dossiers to competent State management agencies upon request;

d) Only making variations related to drug formulations; manufacturing processes; quality standards of ingredients; quality standards of finished products; brand name of drugs manufactured through contract manufacturing satisfying Point a, Clause 1, Article 6 of this Circular when the drug ordered for manufacturing has such respective variations which have been approved by competent authorities and only making variations and additions, which shall be approved by the Drug Administration of Vietnam, to the drugs manufactured through contract manufacturing at the request of the drug owner;

dd) Complying with regulations on manufacturing, transportation, import and export, marketing, use, destruction, delivery, reports, dossiers, books and detention of documents and documentary proof related to drugs and drug materials of drugs manufactured through contract manufacturing that are under special control in accordance with Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government on detailing a number of articles of and providing measures for implementing the Law on Pharmacy (hereinafter referred to as Decree No. 54/2017/ND-CP), Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government on amendments to some articles related to business conditions under state management of the Ministry of Health (hereinafter referred to as Decree No. 155/2018/ND-CP), Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health detailing a number of articles of the Law on Pharmacy and Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government on drugs and drug materials under special control (hereinafter referred to as Circular No. 20/2017/TT-BYT) and other relevant regulations on drugs under special control;

e) Carrying out the application procedures for a contract manufacturing license to manufacture drugs for the drug owner that is a foreign trader in accordance with Clause 4, Article 38 of Decree No. 69/2018/ND-CP.

3. Other rights, obligations and responsibilities in accordance with relevant law regulations.

Article 5. Manufacturing contract

In addition to the information specified in Article 39 of Decree No. 69/2018/ND-CP, a drug manufacturing contract must have the following contents:

1. Agreement on the supply of ingredients and materials. Provision of technical dossier of the drug owner to the contract manufacturing organization, including: manufacturing processes, quality standards, methods for testing starting materials, semi-finished products, finished products, auxiliary materials and other documents related to the contract manufacturing of the drugs.

2. Rights and responsibilities of the drug owner, the contract manufacturing organization, and the marketing authorization applicant (if any):

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

b) Retention of dossiers on manufacturing, quality control, distribution and marketing of drugs, storage of drug samples, and settlement of problems related to quality, complaints and recall of marketed products;

3. Responsibilities of the drug owner, the contract manufacturing organization, and the marketing authorization applicant (if any) for intellectual property issues related to the drugs manufactured through contract manufacturing.

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

5. A roadmap indicating outsourced stages of the contract drug manufacturing process to be conducted in Vietnam and responsibilities of related parties for the drugs manufactured through contract manufacturing as specified in Clause 2, Article 6 of this Circular.

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

Article 6. Marketing authorization of drugs manufactured through contract manufacturing

1. Drugs manufactured through contract manufacturing, upon marketing authorization, are classified as follows:

a) Drugs manufactured through contract manufacturing that have the same formulation; manufacturing process; quality standards of raw materials; quality standards of finished drugs; and brand name as the drug ordered for manufacturing;

In the case where the drug ordered for manufacturing is declared by the Ministry of Health as brand name drug or reference biological and at least one of the criteria as specified at this Point (other than the brand name) of the drug manufactured through contract manufacturing is changed in comparison to that of the drug ordered for manufacturing or otherwise in relation to the drug’s quality, such variation must be approved by the drug administration of the country of manufacture or the regulatory agency specified in Clause 9, Article 2 of Circular No. 08/2022/TT-BYT which has granted the marketing authorization for such drug or the applicant must provide data proving that the quality of the drug manufactured through contract manufacturing is equivalent to that of the drug ordered for manufacturing.

b) Drugs manufactured through contract manufacturing other than those specified at Point a of this Clause.

2. After the date on which the marketing authorization is granted, the applicant for marketing authorization of drugs manufactured through contract manufacturing as specified at Point a, Clause 1 of this Article or the contract manufacturing organization of such drugs shall, if the contract manufacturing roadmap indicates outsourced manufacturing stages to be conducted in Vietnam, send annual reports on the progress of the finished drug manufacturing process stages conducted in Vietnam to the Ministry of Health (via the Drug Administration of Vietnam), made using Form 04/TT provided in Appendix 1 to this Circular.

3. The validity of the marketing authorization of drugs manufactured through contract manufacturing shall comply with Clauses 1 and 2, Article 8 of Circular No. 08/2022/TT-BYT.

4. The deadline for submitting the application dossier for renewal of marketing authorization of drugs manufactured through contract manufacturing shall comply with Clause 4, Article 8 of Circular No. 08/2022/TT-BYT.

Chapter III

GENERAL PROVISIONS ON APPLICATION FOR MARKETING AUTHORIZATION OF DRUGS MANUFACTURED THROUGH TECHNOLOGY TRANSFER

Article 7. Rights and responsibilities of sending facilities and applicants for marketing authorization of drugs manufactured through technology transfer

In addition to the rights and obligations specified in Clauses 1 and 2, Article 25 of the Law on Technology Transfer, a sending facility has the following specific rights, obligations and responsibilities:

1. Rights of the sending facility:

To apply for marketing authorization of drugs manufactured through technology transfer in one of the following cases:

a) It is a Vietnamese sending facility holding a certificate of eligibility for pharmaceutical business which permits one of the following: manufacturing, wholesaling, export or import of drugs/drug materials.

b) It is a foreign sending facility obtaining legal documents issued by foreign competent authorities which permit one of the following: manufacturing, wholesaling, export or import of drugs/drug materials, and a license to establish a representative office in Vietnam.

2. Responsibilities of the sending facility:

a) Complying with Article 3 of Circular No. 08/2022/TT-BYT if it applies for marketing authorization of drugs manufactured through technology transfer;

b) Providing the receiving facility:

- Technical dossier including the manufacturing process, quality standards and methods for testing starting materials, semi-finished products, finished products and auxiliary starting materials in the stage for which the technology is transferred;

- Other dossiers and documents related to the marketing authorization of drugs manufactured through technology transfer and the transfer of drug manufacturing technology;

c) Taking accountability for the legitimacy and truthfulness of intellectual property rights of the dossiers and documents transferred to the receiving facility;

d) Notifying the receiving facility and the marketing authorization applicant in the following cases:

- There are problems related to the safety and efficacy of the drug before technology transfer;

- There are changes or additions to the technical dossier of the drug before technology transfer on the market;

- There is a decision to revoke the marketing authorization of the drug before technology transfer in any country in the world;

3. The applicant for marketing authorization of drugs manufactured through technology transfer shall be responsible for coordinating with the sending facility or the receiving facility in sending a written notice to the Drug Administration of Vietnam within 30 days from the date on which the decision to revoke the marketing authorization of the drug before technology transfer is issued in any country in the world (within the validity period of the marketing authorizations of the drugs manufactured through technology transfer) and performing other responsibilities specified in Article 3 of Circular No. 08 2022/TT-BYT.

4. Other rights, obligations and responsibilities in accordance with relevant law regulations.

Article 8. Rights and responsibilities of the receiving facility

In addition to the rights and obligations specified in Article 26 of the Law on Technology Transfer, a receiving facility has the following specific rights, obligations and responsibilities:

1. Rights of the receiving facility:

a) To receive the technology transfer to manufacture drugs within its business scope stated in the certificate of eligibility for pharmaceutical business, if the receiving facility is a Vietnam-based manufacturer that has been granted the certificate of eligibility for pharmaceutical business;

b) To receive the technology transfer to manufacture drugs within its operation scope stated in the GMP certificate, if the receiving facility is a non-commercial pharmaceutical entity specified at Point a, Clause 1, Article 35 of the Law on Pharmacy;

c) To apply for marketing authorization of the drugs manufactured through technology transfer or to authorize an eligible entity to apply for marketing authorization of drugs in its name in accordance with the law, unless otherwise agreed by the parties.

2. Responsibilities of the receiving facility:

a) The responsibilities of a drug manufacturer specified in Article 4 of Circular No. 08/2022/TT-BYT;

b) Only receiving technology transfer and manufacturing drugs within its business scope stated in the certificate of eligibility for pharmaceutical business granted to it, or the operation scope stated in the GMP certificate if it is a non-commercial pharmaceutical entity specified at Point a, Clause 1, Article 35 of the Law on Pharmacy;

c) Receiving technology transfer and manufacturing drugs with the proper manufacturing process and technical dossier, and ensuring the quality of the drugs in accordance with the application dossier for marketing authorization, complying with GMP requirements and the sending facility’s requirements in the technology transfer contract. Keeping dossiers, documents and drug samples related to the transferred drug manufacturing process and provide such dossiers to competent State management agencies upon request;

d) Only making variations related to drug formulations; manufacturing processes; quality standards of ingredients; quality standards of finished products; brand name of drugs manufactured through technology transfer satisfying Point a, Clause 1, Article 10 of this Circular when the drug before technology transfer has such respective variations which have been approved by competent authorities and only making variations and additions, which shall be approved by the Drug Administration of Vietnam, to the drugs manufactured through technology transfer under the notice of the sending facility;

dd) Complying with regulations on manufacturing, transportation, import and export, marketing, use, destruction, delivery, reports, dossiers, books and detention of documents and documentary proof related to drugs and drug materials of drugs manufactured through technology transfer that are under special control in accordance with Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP, Circular No. 20/2017/TT-BYT, and other relevant regulations on drugs under special control;

e) Carrying out procedures for technology transfer registration as specified 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.

3. Other rights, obligations and responsibilities in accordance with relevant law regulations.

Article 9. Technology transfer contract

In addition to the information specified in Article 23 of the Law on Technology Transfer, a technology transfer contract must have the following contents:

1. Agreement on the provision of technical dossier of the sending facility to the receiving facility, including: manufacturing processes, quality standards, methods for testing starting materials, semi-finished products, finished products, auxiliary materials and other documents related to the drug manufacturing technology transfer.

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

3. A roadmap indicating the technology transfer for manufacturing stages to be conducted in Vietnam and responsibilities of related parties for the drugs manufactured through technology transfer as specified in Clause 2, Article 10 of this Circular.

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

Article 10. Marketing authorization of drugs manufactured through technology transfer

1. Drugs manufactured through technology transfer, upon marketing authorization, are classified as follows:

a) Drugs manufactured through technology transfer that have the same formulation; manufacturing process; quality standards of raw materials; quality standards of finished drugs; and brand name as the drug before technology transfer;

In the case where the drug before technology transfer is declared by the Ministry of Health as brand name drug or reference biological and at least one of the criteria as specified at this Point (other than the brand name) of the drug manufactured through technology transfer is changed in comparison to that of the drug before technology transfer or otherwise in relation to the drug’s quality, such variation must be approved by the drug administration of the country of manufacture or the regulatory agency specified in Clause 9, Article 2 of Circular No. 08/2022/TT-BYT which has granted the marketing authorization for such drug or the applicant must provide data proving that the quality of the drug manufactured through technology transfer is equivalent to that of the drug before technology transfer.

b) Drugs manufactured through technology transfer other than those specified at Point a of this Clause.

2. After the date on which the marketing authorization is granted, the applicant for marketing authorization of drugs manufactured through technology transfer as specified at Point a, Clause 1 of this Article or the receiving shall, if the technology transfer roadmap indicates manufacturing stages to be conducted in Vietnam, send annual reports on the progress of the finished drug manufacturing process stages conducted in Vietnam to the Ministry of Health (via the Drug Administration of Vietnam), made using Form 04/TT provided in Appendix 1 to this Circular.

3. The validity of the marketing authorization of drugs manufactured through technology transfer shall comply with Clauses 1 and 2, Article 8 of Circular No. 08/2022/TT-BYT.

4. The deadline for submitting the application dossier for renewal of marketing authorization of drugs manufactured through technology transfer shall comply with Clause 4, Article 8 of Circular No. 08/2022/TT-BYT.

Chapter IV

DOSSIERS AND PROCEDURES FOR GRANT, RENEWAL, MODIFICATION, SUPPLEMENTATION, AND REVOCATION OF MARKETING AUTHORIZATIONS OF DRUGS MANUFACTURED THROUGH CONTRACT MANUFACTURING AND DRUGS MANUFACTURED THROUGH TECHNOLOGY TRANSFER IN VIETNAM

Article 11. Regulations on the application dossiers for marketing authorization of drugs manufactured contract manufacturing or drugs manufactured through technology transfer

1. Languages used in the application dossiers: Application dossiers for market authorization of drugs manufactured through contract manufacturing or drugs manufactured through technology transfer must be written in Vietnamese or English. The package insert and summary shall be written in Vietnamese language.

2. Application dossiers for market authorization of drugs manufactured through contract manufacturing or drugs manufactured through technology transfer shall be made using the forms attached to this Circular: Cover Page (Form 01/TT - Appendix 1) and arranged according to the table of contents (Form No. 05/TT - Appendix 1). The following documents shall be bound separately and enclosed with 01 application:

a) Bioequivalence study documents;

b) Pre-clinical and clinical documents.

3. The application dossier bears the seal of the applicant, the contract manufacturing organization or the receiving facility (drug manufacturer) on the first page of each part in the entire application dossier (or the seal of the representative office of the foreign applicant).

Documents provided by the drug owner or the sending facility must bear the seal of such entity. In the case where the drug owner or the sending facility does not use any seal in accordance with the law of its home country, the applicant for marketing authorization of drugs manufactured through contract manufacturing or drugs manufactured through technology transfer must affix its seal on such documents, undertake that the home country of the drug owner or the sending facility does not use such a seal, and take accountability for the truthfulness of the above-mentioned documents.

4. Different drugs may be included in the same marketing authorization application dossier if the following elements are the same: name of the drug; dosage form; route of administration; drug quality standards; name and address of the manufacturer (the contract manufacturing organization or the receiving facility); and formulation, in which:

a) Metered-dose solid drugs: the same content of active pharmaceutical ingredient per unit dose;

b) Non-metered solid drugs, liquid drugs or semi-solid drugs: the same content or concentration of active pharmaceutical ingredient; parenteral or intravenous drugs: the same concentration or content of active pharmaceutical ingredient and material of the primary package.

5. Regulations on documents to be included in an application dossier for grant, renewal, modification, or supplementation of the marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer shall comply with Article 22 of Circular No. 08/2022/TT-BYT.

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

a) 01 (one) dossier consisting of all documents specified in Article 12 of this Circular;

b) In addition to the documents specified at Point a, Clause 6 of this Article, 01 (one) set of copies of all documents with respect to vaccines or biological products; 02 (two) sets of copies of the application form, the quality standards, the testing methods with respect to others;

c) 02 (two) sets of samples of labels of the drugs to be marketed and the package inserts thereof bearing the seal of the applicant (or seal of a representative office of the foreign applicant) or the manufacturer (not applicable to the application dossier for renewal of the marketing authorization). The labels shall be attached to, presented on A4 papers. In case of online submission, the applicant shall submit only 01 set of samples of labels of the drugs and the package inserts thereof.

7. Quantity of mandatory documents to be included in an application dossier for modification or supplementation of the marketing authorization;

a) 01 (one) set of all documents specified in Article 15 of this Circular;

b) 02 (two) sets of samples of the labels of the drugs and the package inserts thereof bearing the seal of the applicant (or seal of a representative office of the foreign applicant) or the manufacturer in case of revision to the labels or package insert. The labels shall be attached to, presented on A4 papers. In case of online submission, the applicant shall submit only 01 set of samples of labels of the drugs and the package inserts thereof.

8. Regulations regarding online application:

The online submission of application dossiers shall comply with Clause 6, Article 6 of Circular No. 08/2022/TT-BYT

9. Marketing authorization fees: The applicant for marketing authorization of drugs manufactured through contract manufacturing or drugs manufactured through technology transfer must pay fees in accordance with the applicable law regulations on fees and charges.

10. The verification of the authenticity of legal documents included in the application dossier for market authorization of drugs manufactured through contract manufacturing or drugs manufactured through technology transfer shall comply with Article 12 of Circular No. 08/2022/TT-BYT.

Article 12. Application dossiers for grant of marketing authorizations of drugs manufactured through contract manufacturing or drugs manufactured through technology transfer

1. Application dossiers for grant of marketing authorizations of drugs manufactured through contract manufacturing or drugs manufactured through technology transfer in the case where the drugs ordered for manufacturing or drugs before technology transfer have already been authorized for marketing in Vietnam and such market authorization is still valid at time of application:

a) Administrative dossiers

- An application form made using Form No. 02A/TT provided in Appendix 1 to this Circular;

- Documents specified at Points b, c, d, g, i, k, Clause 1, Article 23 of Circular No. 08/2022/TT-BYT;

- Documents specified at Point e, Clause 1, Article 23 of Circular No. 08/2022/TT-BYT, if the applicant is a foreign entity;

- Documents specified at Point dd, Clause 1, Article 23 of Circular No. 08/2022/TT-BYT, if the applicant is a domestic entity;

- Documents specified at Point h, Clause 1, Article 23 of Circular No. 08/2022/TT-BYT, unless only the packaging stage is outsourced or for it the technology is transferred;

- A manufacturing contract or technology transfer contract;

In case the drug owner or the contract manufacturing organization is not the marketing authorization applicant, the manufacturing contract must be signed by the legal representatives of the drug owner, the marketing authorization applicant, and the contract manufacturing organization.

- A contract manufacturing license for the foreign trader as specified at Point e, Clause 2, Article 4 of this Circular, which shall be included in the application dossier for marketing authorization of drugs manufactured through contract manufacturing;

- A technology transfer registration certificate as specified in Clause 1, Article 31 of the Law on Technology Transfer, which shall be included in the application dossier for marketing authorization of drugs manufactured through technology transfer;

- The contract manufacturing roadmap (for drugs manufactured through contract manufacturing) as specified in Clause 2, Article 6, or the technology transfer roadmap (for drugs manufactured through technology transfer) as specified in Clause 2, Article 10 of this Circular, made using Form 03/TT provided in Appendix 1 to this Circular.

b) Quality dossier:

- Quality documents for pharmacochemical drugs, vaccines and biological products as specified in Article 13 of this Circular;

- Quality documents for herbal drugs as specified in Article 14 of this Circular.

c) Pre-clinical and clinical documents for vaccines and biological products as specified in Articles 25 and 26 of Circular No. 08/2022/TT-BYT.

Requirements on clinical data for assurance of safety and efficacy; criteria for exemption from clinical trial or certain stages thereof in Vietnam; drugs that have to undergo stage 4 clinical trial in Vietnam as specified in Chapter II of Circular No. 08/2022/TT-BYT.

d) Documents on the drug ordered for manufacturing or the drug before technology transfer

Reports on the safety and efficacy follow-up and the use of drugs made using Form No. 2/TT attached to Circular No. 08/2022/TT-BYT of the drugs ordered for manufacturing or the drugs before technology transfer for which safety and efficacy follow-up reports as prescribed in Clause 2, Article 5 of Circular No. 08/2022/TT-BYT are required;

2. Application dossiers for grant of marketing authorizations of drugs manufactured through contract manufacturing or drugs manufactured through technology transfer in the case where the drugs ordered for manufacturing or drugs before technology transfer have not yet been authorized for marketing in Vietnam or the market authorization thereof has expired at time of application.

a) Administrative dossiers:

- An application form made using Form No. 02A/TT provided in Appendix 1 to this Circular;

- Documents specified at Points b, c, d, g, h, i, k, Clause 1, Article 23 of Circular No. 08/2022/TT-BYT;

- Documents specified at Point e, Clause 1, Article 23 of Circular No. 08/2022/TT-BYT, if the applicant is a foreign entity;

- Documents specified at Point dd, Clause 1, Article 23 of Circular No. 08/2022/TT-BYT, if the applicant is a domestic entity;

- A manufacturing contract or technology transfer contract;

In case the drug owner or the contract manufacturing organization is not the marketing authorization applicant, the manufacturing contract must be signed by the legal representatives of the drug owner, the marketing authorization applicant, and the contract manufacturing organization.

- A contract manufacturing license for the foreign trader as specified at Point e, Clause 2, Article 4 of this Circular, which shall be included in the application dossier for marketing authorization of drugs manufactured through contract manufacturing;

- A technology transfer registration certificate as specified in Clause 1, Article 31 of the Law on Technology Transfer, which shall be included in the application dossier for marketing authorization of drugs manufactured through technology transfer;

- The contract manufacturing roadmap (for drugs manufactured through contract manufacturing) as specified in Clause 2, Article 6, or the technology transfer roadmap (for drugs manufactured through technology transfer) as specified in Clause 2, Article 10 of this Circular, made using Form 03/TT provided in Appendix 1 to this Circular.

b) Quality dossier:

- Quality documents for pharmacochemical drugs, vaccines and biological products as specified in Article 13 of this Circular;

- Quality documents for herbal drugs as specified in Article 14 of this Circular;

c) Pre-clinical and clinical documents for new pharmacochemical drugs, vaccines and biological products as specified in Articles 25 and 26 of Circular No. 08/2022/TT-BYT, unless the drug ordered for manufacturing or the drug before technology transfer is a pharmacochemical drug with pre-clinical and clinical dossiers submitted in accordance with Point dd, Clause 2 of this Article;

Requirements on clinical data for assurance of safety and efficacy; criteria for exemption from clinical trial or certain stages thereof in Vietnam; drugs that have to undergo stage 4 clinical trial in Vietnam as specified in Chapter II of Circular No. 08/2022/TT-BYT.

dd) Safety and efficacy documents of herbal drugs as specified in Article 29 of Circular No. 08/2022/TT-BYT;

dd) Documents on the drug ordered for manufacturing or drug before technology transfer

- Documents as specified for the application dossier for marketing authorization of any new pharmacochemical drug, vaccine, or biological at Points b, c, d, Clause 1, Article 27 of Circular No. 08/2022/TT-BYT or generic drugs at Point b, Clause 2, Article 27 of Circular No. 08/2022/TT-BYT or herbal drugs at Points b, c, Clause 1, Article 30 of Circular No. 08/2022/TT-BYT;

- Certificate of Pharmaceutical Product (CPP) of the drug ordered for manufacturing or the drug before technology transfer as specified at Point c, Clause 4, Article 22 of Circular No. 08/2022/TT-BYT if such drug ordered for manufacturing or drug before technology transfer is a foreign drug.

3. An application dossier for grant of the marketing authorization of the drug manufactured through contract manufacturing with technology transfer from the drug owner to the contract manufacturing organization:

a) Documents specified in Clause 1 or Clause 2 of this Article;

b) A technology transfer contract;

c) A technology transfer registration certificate as specified in Clause 1, Article 31 of the Law on Technology Transfer.

Article 13. Regulations on quality documents in application dossiers for marketing authorizations of pharmacochemical drugs, vaccines and biological products manufactured through contract manufacturing or technology transfer

Quality documents to be included in an application dossier for marketing authorization of any pharmacochemical drug, vaccine, or biological manufactured through contract manufacturing or technology transfer shall comply with the guidance in Part II – ACTD or 3-ICH-CTD, Clauses 1, 2, 3 and 5, Article 24 of Circular No. 08/2022/TT-BYT, and the following documents:

1. Quality documents of the drug ordered for manufacturing or the drug before technology transfer that has not yet authorized for marketing in Vietnam, which shall comply with Part II -ACTD specified in Appendix I to Circular No. 08/2022/TT-BYT or 3-TCH-CTD.

2. A table of variations (if any) between the drug ordered for manufacturing and the drugs manufactured through contract manufacturing or between the drug before technology transfer manufactured through technology transfer, and technical dossier as guided in Appendix II to Circular No. 08/2022/TT-BYT.

3. Dossiers on the pharmaceutical ingredients of the drug manufactured through contract manufacturing provided by the contract manufacturing organization, or of the drug manufactured through technology transfer provided by the receiving facility when the manufacturers of the pharmaceutical ingredients are different from that of the drug ordered for manufacturing or the drug before technology transfer.

4. Dossiers on finished products of the drug manufactured through contract manufacturing prepared by the contract manufacturing organization, or of the drugs manufactured through technology transfer prepared by the receiving facility, including:

a) The manufacturing process of the drugs manufactured through contract manufacturing or drugs manufactured through technology transfer;

b) A report on validation of the manufacturing process (regarding the stages conducted by the contract manufacturing organization or the receiving facility).

c) A report on conformity assessment of the analysis process (which can be replaced with documents about transfer of the analysis process jointly prepared by the drug owner and the contract manufacturing organization or by the sending facility and the receiving facility).

d) Batch analysis data, inspection report of finished product.

dd) Stability data: Submit stability study data in accordance with Item 4.7.9 ASEAN Guideline on Stability Study of Drug Product - Part II of Appendix I to Circular No. 08/2022/TT-BYT.

If there is on Zone IVb stability data of the drug ordered for manufacturing or the drug before technology transfer: Submit stability study data for drug to be authorized for marketing in Zone IVb in accordance with Guideline on Stability Study of Drug Product - Part II of Appendix I to Circular No. 08/2022/TT-BYT;

e) Bioequivalence studies of the drugs manufactured through contract manufacturing or the drugs manufactured through technology transfer to be classified as brand name drugs or drugs with demonstrated bioequivalence (including: drugs requiring bioequivalence studies as specified in Circular No. 07/2022/TT-BYT dated September 5, 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, or drugs requiring no bioequivalence studies as specified by the Minister of Health but the applicant submits a written request for classification of them as drugs with demonstrated bioequivalence). The applicant can replace such studies with the studies on equivalent solubility between the drugs manufactured through contract manufacturing and the drug ordered for manufacturing, or between the drug before technology transfer and the drug manufactured through technology transfer, if the following conditions are fully satisfied:

- The drug ordered for manufacturing or the drug before technology transfer has been authorized for marketing in Vietnam and declared as a brand name drug or a drug with proven bioequivalence, or the classification of such drug as a brand name drug or a drug with proven bioequivalence has been requested; or the drug ordered for manufacturing or the drug before technology transfer has not yet been authorized for marketing in Vietnam and the classification of such drug as a brand name drug or a drug with proven bioequivalence has been requested when applying for marketing authorization;

- The formulation; manufacturing process; quality standards of ingredients; quality standards of finished products of the drugs manufactured through contract manufacturing or drugs manufactured through technology transfer are the same as that of the drug ordered for manufacturing or the drug before technology transfer. If the submission of a bioequivalence study is not required for any variation of the above-mentioned criteria, the applicant must submit dossiers and documents corresponding to each variation as specified in the US-FDA's Guideline for Scale-Up and Post-Approval Changes (SUPACs).

5. If the secondary packaging stage is outsourced or, for it the technology is transferred, documents as specified at Points dd and e, Clause 4 of this Article are not required.

Article 14. Regulations on quality documents in application dossiers for marketing authorizations of herbal drugs manufactured through contract manufacturing or technology transfer

Quality documents to be included in an application dossier for marketing authorization of any herbal drug manufactured through contract manufacturing or technology transfer shall comply with Article 28 of Circular No. 08/2022/TT-BYT, and the following documents:

1. Quality documents of the drug ordered for manufacturing or the drug before technology transfer that has not yet authorized for marketing in Vietnam, which shall comply with Article 28 of Circular No. 08/2022/TT-BYT

2. A table of variations (if any) between the drug ordered for manufacturing and the drugs manufactured through contract manufacturing or between the drug before technology transfer manufactured through technology transfer, and technical documents as guided in Appendix II to Circular No. 08/2022/TT-BYT.

3. Dossiers prepared by the contract manufacturing organization or the receiving facility:

a) Regarding ingredients: Inspection report on herbal ingredients or inspection report on semi-finished herbal ingredients or herbal extracts;

b) Regarding finished products: inspection report on finished products; a stability study according to the guidelines for stability study specified in Part II of Appendix I to Circular No. 08/2022/TT-BYT.

Article 15. Application dossier for modification of the marketing authorization of the drug manufactured through contract manufacturing or technology transfer

1. An application form for modification or supplementation, made using Form 02C/TT provided in Appendix I to this Circular.

2. An application dossier for modification or supplementation of the marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer, which shall comply with Appendix II of Circular No. 08/2022/TT-BYT.

For any variation related to the technical dossier of the drug manufactured through contract manufacturing or drug manufactured through technology transfer, the applicant for marketing authorization thereof must provide evidence indicating that such variation compared to the drug ordered for manufacturing or the drug before technology transfer has been approved by a competent regulatory authority.

For vaccines of the same manufacturer or product license holder, the manufacturing location may be substituted with another within or outside the country in which the marketing authorization has been granted.

3. Changes related to the drug owner

a) The name and address of the drug owner is changed or information related to the drug owner is updated (the drug owner remains the same): The dossier shall comply with the regulations on change of the name and address of the applicant (MiV-N1) in Section 7, Appendix II to Circular No. 08/2022/TT-BYT;

b) The drug owner is changed:

The dossier and documents to be submitted:

- A document indicating the transfer of rights and responsibilities between the former drug owner and the new one in the performance of the manufacturing contract that have been submitted together with the application dossier for marketing authorization;

- A written statement of the new drug owner that the location of the contract manufacturer will not change and it undertakes to continue to exercise the rights and responsibilities of the drug owner in accordance with the application dossier for the marketing authorization of the drug that has been already authorized for marketing in Vietnam.

4. Changes related to the sending facility

a) The name and address of the sending facility is changed or information related to the sending facility is updated (the sending facility remains the same): The dossier shall comply with the regulations on change of the name and address of the applicant (MiV-N1) in Section 7, Appendix II to Circular No. 08/2022/TT-BYT;

b) The sending facility is changed

The dossier and documents to be submitted:

- A written announcement of the new sending facility on continuing the technology transfer contract that has been signed by the former sending facility;

- A modified technology transfer registration certificate (if any).

Article 16. Application dossier for renewal of the marketing authorization of the drug manufactured through contract manufacturing or technology transfer

1. An application form, made using Form 02B/TT provided in Appendix 1 to this Circular.

2. A manufacturing contract or technology transfer contract.

3. Regarding pharmacochemical drugs, vaccines, biological products: An application dossier for renewal of the marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer must comply with Clause 3, Article 27 of Circular No. 08/2022/TT-BYT.

4. Regarding herbal drugs: An application dossier for renewal of the marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer must comply with Clause 2, Article 30 of Circular No. 08/2022/TT-BYT

5. A report on the progress of the contract manufacturing roadmap (for drugs manufactured through contract manufacturing) as specified in Clause 2, Article 6, or the technology transfer roadmap (for drugs manufactured through technology transfer) as specified in Clause 2, Article 10, made using Form 04/TT provided in Appendix 1 to this Circular.

Article 17. Procedures for grant, renewal, modification, or supplementation of the marketing authorizations of drugs manufactured through contract manufacturing or drugs manufactured through technology transfer

1. Procedures for grant of a marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer in the case where the drug ordered for manufacturing or drug before technology transfer has already been authorized for marketing in Vietnam and such market authorization is still valid at time of application:

a) Within 03 months from the date of receiving the dossier in full, the Drug Administration of Vietnam shall grant the marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer. If the application is rejected or the marketing authorization is yet to be granted, the Drug Administration of Vietnam shall send a written reply explicitly stating the reasons therefor. Deadlines:

- Within 08 working days from the date of receiving the dossier, the Drug Administration of Vietnam shall review, classify, and transfer it to the appraisal experts or units. Within 01 month from the date of receiving the dossier from the Drug Administration of Vietnam, the appraisal experts or units shall complete and send appraisal reports to the Drug Administration of Vietnam for it to summarize them into a final appraisal report as specified in Clause 4, Article 35 of Circular No. 08/2022/ TT-BYT;

- Within 12 working days from the date of receiving the appraisal reports, the Drug Administration of Vietnam shall, if the application dossier is unsatisfactory, send a written reply explicitly stating the reasons therefor. If the Drug Administration of Vietnam proposes the marketing authorization to be whether granted or not, or the comments from the Marketing Authorization Advisory Council (hereinafter referred to as the Council) to be obtained, the Drug Administration of Vietnam shall forward the application dossier thereof to the Council’s Office which then will commence a meeting;

- Within 06 working days from the date of receiving the documents from the Drug Administration of Vietnam, the Council’s Office shall commence a meeting of the Council and send the minutes of such meeting to the Drug Administration of Vietnam;

- Within 18 working days from the date of receiving the meeting minutes of the Council, the Drug Administration of Vietnam shall issue the decision to grant the marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer if the application dossier is satisfactory. The Drug Administration of Vietnam shall send written reply explicitly stating reasons for the application dossier that is rejected or unsatisfactory according to comments of the Council.

b) Within 36 months from the day on which the Drug Administration of Vietnam sends a notice requiring pre-clinical and clinical documents, bioequivalence documents, stability study documents, or within 12 months if other documents are required, the applicant shall submit such required documents. Otherwise, the application will be rejected.

The applicant shall send written updates of the dossier that has been submitted and under validation to the Drug Administration of Vietnam in the case where information related to the safety and efficacy of the drug or legal documents of the applicant, the manufacturer of the drug and drug materials is updated in comparison to the dossier that has been submitted.

The period from the date the Drug Administration of Vietnam issues the request to the date the applicant submits the additional documents is not included in the time limits specified in Clause 5 Article 56 of the Law on Pharmacy.

c) Within 03 months from the date of receiving the additional documents, the Drug Administration of Vietnam shall issue the decision to grant the marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer if the application dossier is satisfactory. The Drug Administration of Vietnam shall send written reply explicitly stating reasons for the application dossier that is rejected or unsatisfactory according to comments of the Council.

Additional documents shall be examined following the process and within the time limits specified at Point a, Clause 1 of this Article.

2. Procedures for grant of a marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer in the case where the drug ordered for manufacturing or drug before technology transfer has not yet been authorized for marketing in Vietnam or the market authorization thereof has expired at time of application:

a) Within no more than 09 months from the date of receiving the dossier in full, the Drug Administration of Vietnam shall grant the marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer. If the application is rejected or the marketing authorization is yet to be granted, the Drug Administration of Vietnam shall send a written reply explicitly stating the reasons therefor. Deadlines:

- Within 02 months from the date of receiving the dossier, the Drug Administration of Vietnam shall review, classify, and transfer it to the appraisal experts or units. Within 04 month from the date of receiving the dossier from the Drug Administration of Vietnam, the appraisal experts or units shall complete and send appraisal reports to the Drug Administration of Vietnam for it to summarize them and make proposals onto a final appraisal report as specified in Clause 4, Article 35 of Circular No. 08/2022/TT-BYT;

- Within 01 month from the date of receiving the appraisal reports, the Drug Administration of Vietnam shall, if the application is unsatisfactory, send a written reply explicitly stating the reasons therefor. If the Drug Administration of Vietnam proposes the marketing authorization to be whether granted or not, or the comments from the Council to be obtained, the Drug Administration of Vietnam shall forward the application dossier thereof to the Council’s Office which then will commence a meeting;

- Within 01 month from the date of receiving the documents from the Drug Administration of Vietnam, the Council’s Office shall commence a meeting of the Council and send the minutes of such meeting to the Drug Administration of Vietnam;

- Within 01 month from the date of receiving the meeting minutes of the Council, the Drug Administration of Vietnam shall issue the decision to grant the marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer if the application dossier is satisfactory. The Drug Administration of Vietnam shall send written reply explicitly stating reasons for the application dossier that is rejected or unsatisfactory according to comments of the Council.

b) Within 36 months from the date on which the Drug Administration of Vietnam sends a notice requiring pre-clinical and clinical documents, bioequivalence documents, stability study documents, or within 12 months if other documents are required, the applicant shall submit such required documents. Otherwise, the application will be rejected.

The applicant shall send written updates of the application dossier that has been submitted and under appraisal to the Drug Administration of Vietnam in the case where information related to the safety and efficacy of the drug or legal documents of the applicant, the manufacturer of the drug and drug materials is updated in comparison to the dossier that has been submitted.

The period from the date the Drug Administration of Vietnam issues the request to the date the applicant submits the additional documents is not included in the time limit specified in Clause 5 Article 56 of the Law on Pharmacy.

c) Within 04 months from the date of receiving the additional documents, the Drug Administration of Vietnam shall issue the decision to grant the marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer if the application dossier is satisfactory, or send a written reply if the application dossier is rejected or a written reply explicitly stating reasons for the application dossier that is unsatisfactory according to comments of the Council. Deadlines:

- Within 12 working days from the date of receiving the dossier, the Drug Administration of Vietnam shall review, classify, and transfer it to the appraisal experts or units. Within 01 month from the date of receiving the dossier from the Drug Administration of Vietnam, the appraisal experts or units shall complete and send appraisal reports to the Drug Administration of Vietnam for it to summarize them and make proposals onto a final appraisal report as specified in Clause 4, Article 35 of Circular No. 08/2022/ TT-BYT;

- Within 01 month from the date of receiving the appraisal reports, the Drug Administration of Vietnam shall, if the application is unsatisfactory, send a written reply explicitly stating the reasons therefor. If the Drug Administration of Vietnam proposes the marketing authorization to be whether granted or not, or the comments from the Council to be obtained, the Drug Administration of Vietnam shall forward the application dossier thereof to the Council’s Office which then will commence a meeting;

- Within 1 month from the date of receiving the documents from the Drug Administration of Vietnam, the Council’s Office shall commence a meeting of the Council and send the minutes of such meeting to the Drug Administration of Vietnam;

- Within 10 working days from the date of receiving the meeting minutes of the Council, the Drug Administration of Vietnam shall issue the decision to grant the marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer if the application dossier is satisfactory. The Drug Administration of Vietnam shall send written reply explicitly stating reasons for the application dossier that is rejected or unsatisfactory according to comments of the Council.

3. Procedures for grant of the marketing authorization of the drug manufactured through contract manufacturing with technology transfer from the drug owner to the contract manufacturing organization shall comply with Clause 1 of this Article in the case where the drug ordered for manufacturing has already been authorized for marketing in Vietnam and such market authorization is still valid at time of application or with Clause 2 of this Article in the case where the drug ordered for manufacturing has not yet been authorized for marketing in Vietnam or the market authorization thereof has expired at time of application.

4. A join marketing authorization shall be granted to the drugs manufactured through contract manufacturing or drugs manufactured through technology transfer specified at Point a, Clause 4, Article 11 of this Circular, or separate marketing authorizations shall be granted to each of the drugs specified at Point b, Clause 4, Article 11 of this Circular.

5. Procedures for renewal, modification, and supplementation of the marketing authorizations of the drugs manufactured through contract manufacturing or drugs manufactured through technology transfer shall be the same as that of the drugs specified in Article 37 and Article 38 of Circular No. 08/2022/TT-BYT.

6. The authority to grant, renew, modify, or supplement the marketing authorizations of the drugs manufactured through contract manufacturing or drugs manufactured through technology transfer shall comply with Article 34 of Circular No. 08/2022/TT-BYT.

7. General regulations on the process for grant, renewal, modification, or supplementation of the marketing authorization of the drug manufactured through contract manufacturing or drug manufactured through technology transfer shall comply with Article 35 of Circular No. 08/2022/TT-BYT.

Article 18. Revocation of marketing authorizations, suspension of the receipt of application dossiers for grant or renewal of marketing authorizations of drugs manufactured through contract manufacturing or drugs manufactured through technology transfer

1. The authority to revoke and the responsibility to notify the revocation of the marketing authorizations shall comply with Clause 1, Article 40 of Circular No. 08/2022/TT-BYT.

2. Procedures for revocation of the marketing authorizations of the drugs manufactured through contract manufacturing or drugs manufactured through technology transfer shall comply with Article 40 of Circular No. 08/2022/TT-BYT.

3. Cases where the receipt of application dossiers for grant or renewal of marketing authorizations of drugs manufactured through contract manufacturing or drugs manufactured through technology transfer is suspended shall comply with Article 41 of Circular No. 08/2022/TT-BYT.

Chapter V

EFFECT

Article 19. Effect

1. This Circular takes effect on October 1, 2023.

2. Circular No. 23/2013/TT-BYT dated August 13, 2013 of the Minister of Health guiding drug processing ceases to be effective from the effective date of this Circular.

Article 20. Transitional provisions

1. The application dossiers submitted before the effective date of this Circular may continue to comply with the regulations applicable at the time of application, unless the applicants, in the written explanation or supplementation or in a written request, wish to voluntarily comply with regulations herein from the date Circular is signed and promulgated.

2. Drugs manufactured through contract manufacturing or drugs manufactured through technology transfer shall be authorized for marketing in accordance with the regulations applicable before the effective date of this Circular. If the entities need their drugs to be posted in accordance with Clause 1, Article 22 of this Circular, they must submit application dossiers for grant of new marketing authorizations in accordance with this Circular for consideration, appraisal and grant of marketing authorizations.

Article 21. Reference clauses

In the case where the documents referenced in this Circular are replaced, amended, or supplemented, the new ones shall prevail.

Article 22. Implementation

1. The Drug Administration of Vietnam is responsible for posting on its website, the Health and Life Newspaper following the guidelines provided in Appendix 2 to this Circular the lists below:

a) The list of drugs manufactured through contract manufacturing (without technology transfer) for which the marketing authorizations are granted/extended in accordance with Point a, Clause 1, Article 6 of this Circular;

b) The list of drugs manufactured through contract manufacturing (with technology transfer) for which the marketing authorizations are granted/extended in accordance with Point a, Clause 1, Article 6 of this Circular;

c) The list of drugs manufactured through technology transfer for which the marketing authorizations are granted/renewed in accordance with Point a, Clause 1, Article 10 of this Circular.

2. The Drug Administration of Vietnam shall consider suspending or removing any drug from the lists of drugs manufactured through contract manufacturing and drugs manufactured through technology transfer posted on its website and the Health and Life Newspaper in accordance with Clause 1 of this Article according to the Council's advice in one of the following cases:

a) There is no report on the progress of the contract manufacturing roadmap (if such drug is manufactured through contract manufacturing) as specified in Clause 2, Article 6, or the technology transfer roadmap (if such drug is manufactured through technology transfer) as specified in Clause 2, Article 10 of this Circular;

b) The drug contract manufacturing or technology transfer does not follow the roadmap with respect to the outsourced drug manufacturing stages conducted in Vietnam or the technology transfer roadmap with respect to the stages for which the technology is transferred in Vietnam, which has been already submitted together with the application dossier for grant of the marketing authorization;

c) The drug no longer satisfies the requirements specified at Point a, Clause 1, Article 6 of this Circular (if such drug is manufactured through contract manufacturing), or Point a, Clause 1, Article 10 of this Circular (if such drug is manufactured through technology transfer).

3. The labeling of drugs manufactured through contract manufacturing or drugs manufactured through technology transfer must comply with Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Ministry of Health on labeling and package inserts of drugs and drug materials.

4. For any drug manufactured under the manufacturing contract with a contract manufacturing organization that is a foreign trader for marketing in Vietnam, after such drug is authorized for marketing in accordance with regulations, the procedures for export and import of drugs manufactured through contract manufacturing as specified in Decree No. 69/2018/ND-CP may be carried out.

5. Foreign-invested enterprises engaged in drug contract manufacturing shall exercise the right to import and distribute drugs in accordance with Clauses 10 and 11, Article 91 of Decree No. 54/2017/ND-CP.

6. Each drug manufactured through contract manufacturing or drug manufactured through technology transfer that is authorized for marketing shall have an authorization number with the structure specified in Appendix VI to Circular No. 08/2022/TT-BYT. For any drug manufactured through contract manufacturing with technology transfer, the drug class code in Appendix VI is specified as follows:

7. The Drug Administration of Vietnam shall return labels and package inserts of the drugs manufactured through contract manufacturing or drugs manufactured through technology transfer to the applicants in accordance with Point m, Clause 1, Article 48 of Circular No. 08/2022/TT-BYT and announce the sources of medicinal materials of the drugs manufactured through contract manufacturing or drugs manufactured through technology transfer on its website in accordance with Point n, Clause 1, Article 48 of Circular No. 08/2022/TT-BYT.

8. For other issues related to the marketing authorization of drugs manufactured through contract manufacturing or drugs manufactured through technology transfer in Vietnam but not yet specified in this Circular, the relevant provisions in Circular No. 08/2022/TT-BYT shall prevail.

Article 23. Implementation responsibility

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 in inspecting and examining the implementation of this Circular by pharmaceutical manufacturers and sellers nationwide.

2. Departments of Health of provinces and centrally-run cities shall be responsible for inspecting and examining the implementation of this Circular by pharmaceutical manufacturers and sellers under their management.

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

Any difficulties arising during the implementation of this Circular should be reported to the Ministry of Health for consideration./.

Appendix 1

(Issued together with Circular No. 16/2023/TT-BYT dated April 15, 2023 of the Minister of Health)

1. Form 01/TT: Cover page of the application dossier for marketing authorization of drugs manufactured contract manufacturing or drugs manufactured through technology transfer.

2. Form 02/TT: Application form for marketing authorization of drugs manufactured through contract manufacturing or drug manufactured through technology transfer.

3. Form 03/TT: The contract manufacturing/technology transfer roadmaps for the stages of the finished drug manufacturing process in Vietnam.

4. Form 04/TT: Report on progress of the contract manufacturing/technology transfer roadmaps for the stages of the finished drug manufacturing process in Vietnam.

5. Form 05/TT: Table of Contents

Form 01/TT

COVER PAGE

OF THE APPLICATION DOSSIER FOR MARKETING AUTHORIZATION OF DRUGS MANUFACTURED THROUGH CONTRACT MANUFACTURING OR DRUGS MANUFACTURED THROUGH TECHNOLOGY TRANSFER

1. Name and address of the marketing authorization applicant:

2. Name and address of the drug owner/sending facility:

3. Name and address of the contract manufacturing organization/receiving facility (manufacturer):

4. Name of the drug; content or concentration; dosage form:

5. Type of drug to be authorized for marketing:

(Specifically, state: pharmacochemical drug/vaccine/biological/herbal drug).

6. Type of application:

(Specifically, state: First time application/Renewal/Major variation/Minor variation requiring approval/Minor variation only requiring notification).

7. Manner of contract manufacturing or technology transfer:

Specifically, state:

- Outsourcing or transfer of all manufacturing stages/Outsourcing or transfer of one or several manufacturing stage(s) at the time of application and a roadmap for outsourcing or transfer of all manufacturing stages/outsourcing or transfer of one or several manufacturing stage(s)/contract manufacturing with technology transfer.

- The drug ordered for manufacturing/drug before technology transfer has been authorized for marketing and such marketing authorization is still valid/has not yet been authorized for marketing or the marketing authorization has expired.

Form 02A/TT

APPLICATION FORM FOR MARKETING AUTHORIZATION OF DRUGS MANUFACTURED THROUGH CONTRACT MANUFACTURING/DRUGS MANUFACTURED THROUGH TECHNOLOGY TRANSFER

A. Details of the marketing authorization applicant; the drug owner or the sending facility; the contract manufacturing organization or the receiving facility (manufacturer); the manufacturer of the drug ordered for manufacturing or the manufacturer of the drug before technology transfer

1. Marketing authorization applicant

1.1. Name of the applicant:

1.2. Address:                                         Website (if any):

1.3. Tel.:                                               Fax:                       Email:

1.4. Name of its representative office in Vietnam (for foreign applicants):

Address:

Tel.:

2. The drug owner or the sending facility

2.1. Name of the drug owner/sending facility

2.2. Address:                              Website (if any):

2.3. Tel.:                                     Fax:                                  Email:

2.4. Name of the representative office in Vietnam

Address:

Tel.:

3. The contract manufacturing organization or the receiving facility (manufacturer)

3.1. Name of the manufacturer:

3.2. Address:                              Website (if any):

3.3. Tel.:                                     Fax:                       Email:

Other manufacturer (if any) (*):

(*) Such manufacturer(s) shall be engaged in the manufacturing process. Explicitly state the role of each manufacturer such as “manufacturing semi-finished products,” “primary packing,” “secondary packing,” “making granules,” etc.

4. The manufacturer of the drug ordered for manufacturing or the manufacturer of the drug before technology transfer

4.1. Name of the manufacturer of the drug ordered for manufacturing/drug before technology transfer

4.2. Address:                    Website (if any):

4.3. Tel.:                           Fax:                        Email:

B. Details of the product

1. Name of the drug:

2. Active ingredients, concentration/content thereof:

3. Dosage form:

4. Description of dosage form:

5. Route of administration

6. Quality standards (***):

7. Expiry date:

8. Storage conditions:

9. Packaging specifications:

10. Classification (check on the right box):

11. Generic name and formulation (including amount of active ingredients and excipients) for the smallest unit dose or for the smallest packing unit

Ingredients s:

(*) Specify the exact administration form (ester salts/other derivatives).

(**) If the dose is calculated on the basis of the pharmacological radical of the pharmaceutical ingredient (basic radical, etc.), additional information on the amount of the pharmaceutical ingredient converted to the pharmacological radical shall be added.

If the active pharmaceutical ingredient is used in a semi-finished product added with excipients, all excipients must be recorded in the formulation of the semi-finished product containing such active pharmaceutical ingredient.

(***) If it is a pharmacopoeial standard, please state the name of the pharmacopoeia and its version or the year of issue, or state the applicable pharmacopoeia.

C. Technical documents

1. Part I: Administrative

2. Part II: Quality

3. Part III: Pre-clinical

4. Part IV: Clinical

Note: The documents (Parts I, II, III, IV) shall be submitted depending on the product category/product class.

D. Variations between the drug manufactured through contract manufacturing and the drug ordered for manufacturing, or between the drug manufactured through technology transfer and the drug before technology transfer

DD. Special proposals regarding the drug to be authorized

1. Drugs with confidential data □

The drug applicant requests the Drug Administration of Vietnam to consider and keep the following data submitted together with the application dossier for marketing authorization:

□ Toxicology test data (Document No....)

□ Clinical trial data (Document No....)

The applicant hereby undertakes that the above-mentioned data fully satisfies the data confidentiality conditions as specified by the law and the applicant will perform the burden of proof upon request of the competent authority.

E. Classification criteria of the drug manufactured through contract manufacturing compared with that of the drug ordered for manufacturing, or of the drug manufactured through technology transfer compared with that of the drug before technology transfer (check on the right box)

1. Type of application

4. Criteria of the drug manufactured through contract manufacturing compared with that of the drug ordered for manufacturing, or of the drug manufactured through technology transfer compared with that of the drug before technology transfer

4.6. Supporting documents for the cases there is any change related to Items 4.1; 4.2; 4.3; 4.4 for drugs specified at Point a, Clause 1, Article 6 or Point a, Clause 1, Article 10: ……………………………………………………

G. Statement of the marketing authorization applicant

The marketing authorization applicant hereby undertakes:

1. To update and supplement the package inserts according to the brand name drug or reference biological in the cases specified in Clause 3, Article 38 of Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Ministry of Health on labeling and package inserts of drugs and drug materials (applicable to generic drugs or equivalent biological products).

2. That applicant has checked, signed the documents and affixed its seal thereto in accordance with the regulations, and confirmed that the documents are legitimate and the contents thereof are truthful. For any forgery or untruth, the applicant shall take full accountability and will undergo penalties in accordance with the law.

3. To ensure that the drug is manufactured in accordance with the marketing authorization application dossier the applicant has submitted.

4. To apply for modification or supplementation of the marketing authorization in accordance with regulations after the marketing authorization is granted.

5. To take full accountability for intellectual property rights of the drug of which the applicant applies for the marketing authorization.

Form 02B/TT

APPLICATION FORM FOR MARKETING AUTHORIZATION OF DRUGS MANUFACTURED THROUGH CONTRACT MANUFACTURING/DRUGS MANUFACTURED THROUGH TECHNOLOGY TRANSFER

(Renewal)

A. Details of the drug manufactured through contract manufacturing or the drug manufactured through technology transfer that have been granted marketing authorizations

1. Marketing authorization applicant

1.1. Name of the applicant:

1.2. Address:                    Website (if any):

1.3. Tel.:                           Fax:             Email:

1.4. Name of its representative office in Vietnam (for foreign applicants):

Address:

Tel.:

2. The drug owner or the sending facility

2.1. Name of the drug owner/sending facility

2.2. Address:                              Website (if any):

2.3. Tel.:                                     Fax:                       Email:

2.4. Name of the representative office in Vietnam

Address:

Tel.:

3. The contract manufacturing organization or the receiving facility (manufacturer)

3.1. Name of the manufacturer:

3.2. Address:                                         Website (if any):

3.3. Tel.:                                               Fax:                       Email:

Other manufacturer (if any) (*):

(*) Such manufacturer(s) shall be engaged in the manufacturing process. Explicitly state the role of each manufacturer such as “manufacturing semi-finished products,” “primary packing,” “secondary packing,” “making granules,” etc.

4. The manufacturer of the drug ordered for manufacturing or the manufacturer of the drug before technology transfer

4.1. Name of the manufacturer of the drug ordered for manufacturing/drug before technology transfer

4.2. Address:                    Website (if any):

4.3. Tel.:                           Fax:                        Email:

5. Name of drug/drug material:

6. Main active ingredients, concentration/content:

7. Packaging specifications:

8. Dosage form:

9. Quality standards:

10. Expiry date:

11. Registration number:        Issue date:                       Expiry date:

12. The stage that is outsourced or for which the technology is transferred for the drug authorized for marketing (if any)

B. Changes or additions to information upon application for marketing authorization:

1. Variations or additions upon application for marketing authorization

2. The drug has been declared as a brand name drug or reference biological (explicitly state if any).

3. The drug has been declared bioequivalent (explicitly state if any).

C. Required attachments

D. Statement of the marketing authorization applicant

The marketing authorization applicant hereby undertakes:

1. To update and supplement the package inserts according to the brand name drug or reference biological in the cases specified in Clause 3, Article 38 of Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Ministry of Health on labeling and package inserts of drugs and drug materials (applicable to generic drugs or equivalent biological products).

2. To update specifications of the drug and drug materials in accordance with Article 6 of Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Ministry of Health on quality of drugs and drug materials

3. That applicant has checked, signed the documents and affixed its seal thereto in accordance with the regulations, and confirmed that the documents are legitimate and the contents thereof are truthful. For any forgery or untruth, the applicant shall take full accountability and will undergo penalties in accordance with the law.

4. To ensure that the drug is manufactured in accordance with the marketing authorization application dossier the applicant has submitted.

5. To apply for modification or supplementation of the marketing authorization in accordance with regulations after the marketing authorization is renewed.

6. To take full accountability for intellectual property rights of the drug and drug materials of which the applicant applies for the marketing authorization.

7. All information stated in this renewal application is true. If wrong, the marketing authorization applicant is fully accountable to the law.

Form 02C/TT

APPLICATION FORM FOR VARIATION OR ADDITION(1)

(Major variation/Minor variation requiring approval/Minor variation only requiring notification)

A. Information of the product ⁽¹⁾

1. Name of the drug:

2. Active ingredients, concentration/content thereof

3. Dosage form:

4. Registration number:                        Issue date:                        Expiry date:

5. Name of the manufacturer:                                   Country of manufacture:

B. Classification of variation or addition

C. Details of the marketing authorization applicant; the drug owner or the sending facility; the contract manufacturing organization or the receiving facility (manufacturer); the manufacturer of the drug ordered for manufacturing or the manufacturer of the drug before technology transfer

1. Marketing authorization applicant

1.1. Name of the applicant:

1.2. Address:                    Website (if any):

1.3. Tel.:                           Fax:                        Email:

1.4. Name of its representative office in Vietnam (for foreign applicants):

Address:

Tel.:

2. The drug owner or the sending facility

2.1. Name of the drug owner/sending facility

2.2. Address:                    Website (if any):

2.3. Tel.:                           Fax:                        Email:

2.4. Name of the representative office in Vietnam (if any):

Address:

Tel.:

3. The contract manufacturing organization or the receiving facility (manufacturer)

3.1. Name of the manufacturer:

3.2. Address:                    Website (if any):

3.3. Tel.:                           Fax:             Email:

Other manufacturer (if any) (*):

(*) Such manufacturer(s) shall be engaged in the manufacturing process. Explicitly state the role of each manufacturer such as “manufacturing semi-finished products,” “primary packing,” “secondary packing,” “making granules,” etc.

4. The manufacturer of the drug ordered for manufacturing or the manufacturer of the drug before technology transfer

4.1. Name of the manufacturer of the drug ordered for manufacturing/drug before technology transfer

4.2. Address:                    Website (if any):

4.3. Tel.:                           Fax:                        Email:

D. DETAILS OF VARIATION (with the reasons therefor)

1. Specify the variation and the respective variation code (if any) based on the classification of the variations or additions:

2. Approved variation*:

3. Proposed variation:

* Can be presented in a comparison table attached to the application form and certified by the applicant.

4. The drug ordered for manufacturing/drug before technology transfer has the same variation

4.1. Already approved □

Attached supporting documents: ................................................................

4.2. Not approved yet □

DD. ATTACHED TECHNICAL DOCUMENTS

- Relevant documents demonstrating the approval.

E. STATEMENT OF THE MARKETING AUTHORIZATION APPLICANT

The applicant undertakes that it has checked, signed in relevant parts of all documents included in this application dossier and affixed its seal thereto, and confirms that the documents are legitimate and the contents thereof are truthful. For any forgery or untruth, the applicant shall take full accountability and will undergo penalties in accordance with the law.

(1) In the case where many drugs with the same variation or addition: Information of the product in the list corresponding to each drug (including information specified in Sections A 1, 2, 3, 4 of the Form).

(2) In case of change of the applicant, there must be certification of the former applicant and the new applicant in the application form for variation or addition. In the case where the manufacturer is entitled to change the marketing authorization applicant under the official notice of the Drug Administration of Vietnam, the certification of the manufacturer and the new applicant is required.

Form 03/TT

THE CONTRACT MANUFACTURING/TECHNOLOGY TRANSFER ROADMAP FOR THE STAGES OF THE FINISHED DRUG MANUFACTURING PROCESS TO BE CONDUCTED IN VIETNAM

A. Details of the marketing authorization applicant; the drug owner or the sending facility; the contract manufacturing organization or the receiving facility (manufacturer); the manufacturer of the drug ordered for manufacturing or the manufacturer of the drug before technology transfer

1. Marketing authorization applicant

1.1. Name of the applicant:

1.2. Address:

1.3. Tel.:

1.4. Name of its representative office in Vietnam (for foreign applicants):

Address:

Tel.:

2. The drug owner or the sending facility:

2.1. Name of the drug owner or the sending facility:

2.2. Address:

2.3. Tel.:

3. The contract manufacturing organization or the receiving facility (manufacturer)

3.1. Name of the drug manufacturer:

3.2. Address:

3.3. Tel.:

4. The manufacturer of the drug ordered for manufacturing or the manufacturer of the drug before technology transfer

4.1. Name of the manufacturer of the drug ordered for manufacturing/drug before technology transfer

4.2. Address:                    Website (if any):

4.3. Tel.:                           Fax:                        Email:

B. Details of the product:

1. Name of the drug:

2. Active ingredients, concentration/content:

3. Dosage form:

4. Route of administration

5. Quality standards:

6. Contract manufacturing/technology transfer registration:

7. Committed roadmap for the remaining outsourced stages or stages for which the technology is transferred:

The entities commit and take accountability for the accuracy of the contents herein./.

Form 04/TT

REPORT ON PROGRESS OF THE CONTRACT MANUFACTURING/TECHNOLOGY TRANSFER ROADMAPS FOR THE STAGES OF THE FINISHED DRUG MANUFACTURING PROCESS IN VIETNAM

Respectfully addressed to: The Ministry of Health (The Drug Administration of Vietnam)

A. Details of the marketing authorization applicant; the drug owner or the sending facility; the contract manufacturing organization or the receiving facility (manufacturer); the manufacturer of the drug ordered for manufacturing or the manufacturer of the drug before technology transfer

1. Marketing authorization applicant

1.1. Name of the applicant:

1.2. Address:

1.3. Tel.:

1.4. Name of its representative office in Vietnam (for foreign applicants):

Address:

Tel.:

2. The drug owner or the sending facility:

2.1. Name of the drug owner or the sending facility:

2.2. Address:

2.3. Tel.:

3. The contract manufacturing organization or the receiving facility (manufacturer)

3.1. Name of the drug manufacturer:

3.2. Address:

3.3. Tel.:

4. The manufacturer of the drug ordered for manufacturing or the manufacturer of the drug before technology transfer

4.1. Name of the manufacturer of the drug ordered for manufacturing/drug before technology transfer

4.2. Address:                    Website (if any):

4.3. Tel.:                           Fax:                        Email:

B. Details of the product:

1. Name of the drug:

2. Active ingredients, concentration/content:

3. Dosage form:

4. Route of administration

5. Quality standards:

6. Registration number:                        Issue date:                        Expiry date:

C. The entities shall report on the progress of implementing the contract manufacturing/technology transfer roadmaps for the stages of the finished drug manufacturing process in Vietnam for the drugs that have been granted marketing authorizations, specifically as follows:

(*) For the accomplished task, a respective supporting document shall be attached.

D. Recommendations and proposals (if any):

The entities commit and take accountability for the accuracy of the contents stated in the report and attachments hereto.

Form 05/TT

TABLE OF CONTENTS

I. Administrative documentation

II. Quality documentation

III. Pre-clinical documentation

IV. Clinical documentation

V. Other documents

Appendix 2

(Issued together with Circular No. 16/2023/TT-BYT dated April 15, 2023 of the Minister of Health)

Form 01:

The list of drugs manufactured through contract manufacturing (without technology transfer) for which the marketing authorizations are granted/extended in accordance with Point a, Clause 1, Article 6 of Circular No. 16/2023/TT-BYT dated August 15, 2023

Form 02:

The list of drugs manufactured through contract manufacturing (with technology transfer) for which the marketing authorizations are granted/extended in accordance with Point a, Clause 1, Article 6 of Circular No. 16/2023/TT-BYT dated August 15, 2023