CIRCULAR

MARKETING AUTHORIZATION REGISTRATION OF CONTRACT MANUFACTURED MEDICINE, MEDICINE OF TECHNOLOGY TRANSFER IN VIETNAM

Pursuant to the Law on Pharmaceutical No. 105/2016/QH13 dated April 6, 2016;

Pursuant to the Law on Commerce 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 8, 2017 of the Government elaborating the Law on Pharmaceutical;

Pursuant to Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government on amendment to regulations relating to investment and business conditions under state management of the Ministry of Health;

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Pursuant to Decree No. 95/2022/ND-CP dated November 15, 2022 of the Government on functions, tasks, powers, and organizational structures of Ministry of Health;

At request of Director of the Drug Administration of Vietnam;

The Minister of Health promulgates Circular on marketing authorization registration of contract manufactured medicine and medicine of technology transfer in Vietnam.

Chapter I

GENERAL PROVISIONS

Article 1. Scope and regulated entities

1. This Circular prescribes marketing authorization registration of contract manufactured medicine, medicine of technology transfer in Vietnam; application and procedures for issuance, extension, revision, addition, and revocation of marketing authorization of contract manufactured medicine, medicine of technology transfer (pharmaceutics, vaccine, biologicals, herbal medicine) in Vietnam.

2. This Circular applies to domestic and foreign agencies, organizations, individuals relating to contract manufacturing of medicine and transfer of medicine technology in Vietnam.

Article 2. Definitions

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1. Medicine contract manufacturing means to legally produce medicine under contract manufacturing contract where manufacturing facility performs one, several, or all stages in medicine production process at request of ordering facility for a payment.

2. Medicine manufacturing technology transfer means to transfer ownership or use right of medicine manufacturing technology from a sending facility to a receiving facility to perform one, several or all stages of medicine production under contract between the parties in a law-compliant manner.

3. Ordering facility (hereinafter referred to as “owner”) means the party that provides a part or all ingredients, materials, production process, technical instruments proving quality, safety, and efficacy to manufacturing facility in order to order medicine production under contract manufacturing contract between the parties.

4. Manufacturing facility (hereinafter referred to as “contract facility”) means the party that uses a part or all ingredients, materials, production process, and technical instruments of the owner to perform one, several, or all medicine manufacturing stages at request of the owner in exchange for a payment according to contract between the parties.

5. Facility sending medicine manufacturing technology (hereinafter referred to as “sending facility”) means the party that possesses technology ownership or use right of medicine manufacturing technology as per the law and transfers technology ownership or use right of medicine manufacturing technology to contract facility for application in one, several, or all medicine production process.

6. Facility receiving medicine production transfer (hereinafter referred to as “receiving facility”) means the party that receives technology ownership or use right of medicine manufacturing technology from the sending facility according to contract between the parties in order to apply in one, several, or all medicine production stages.

7. Medicine to be contract manufactured means a medicine whose marketing authorization in Vietnam has been/has not been granted and whose one, several, or all production stages executed by a contract facility have been requested by an owner in accordance with manufacturing contract between the parties.

8. Contract manufactured medicine means a medicine whose one, several, or all production stages are executed by a contract facility at request of an owner according to manufacturing contract between the parties.

9. Medicine for technology transfer means a medicine whose marketing authorization in Vietnam has been/has not been granted and whose technology ownership or use right is transferred by sending facility to receiving facility for application in one, several, or all drug production stages.

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Chapter II

GENERAL PROVISIONS ON MARKETING AUTHORIZATION REGISTRATION OF CONTRACT MANUFACTURED MEDICINE

Article 3. Rights and responsibilities of owners and facilities registering for marketing authorization (hereinafter referred to as “applicants”) of contract manufactured medicine

In addition to rights and obligations under Article 181 of the Law on Commerce and Clause 1 Article 42 of Decree No. 69/2018/ND-CP dated May 15, 2018 of the Government elaborating the Law on Foreign Trade Management (hereinafter referred to as “Decree No. 69/2018/ND-CP”), owners have rights, obligations, and responsibilities below:

1. Owners have the right to:

a) authorize eligible facilities to register for marketing authorization of medicine as per the law;

b) register for marketing authorization of medicine when:

- They possess certificate of eligibility for pharmaceutical business which permits them to: manufacture, trade, export, or import medicine, medicinal ingredients in regard to Vietnamese owners;

- They possess legitimate documents issued by foreign competent authority and granting them permission to: manufacture, trade, export, or import medicine, medicinal ingredients and license to establish representative office in Vietnam in regard to foreign owners.

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a) comply with Article 3 of Circular No. 08/2022/TT-BYT dated September 5, 2022 of the Minister of Health on marketing authorization registration of medicine and medicinal ingredients (hereinafter referred to as “Circular No. 08/2022/TT-BYT”);

b) provide contract facilities with:

- Partial or total ingredients, materials, and technical specifications including production procedures, quality standards, testing methods for starting ingredients, semi-finished products, finished products, and excipients for the purpose of contract manufacturing;

- Other documents relating to market authorization registration of contract manufactured medicine and contract manufacturing of medicine.

c) be responsible for legitimacy and authenticity of intellectual property of contract manufactured medicine, ingredients, materials, production procedures, and technical specifications transferred to contract facility;

d) cooperate with applicants in staying up-to-date with quality standards of medicine and medicinal ingredients in accordance with Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Minister of Health on quality of medicine and medicinal ingredients, Circular No. 03/2020/TT-BYT dated t h1 22, 2020 of the Minister of Health on amendment to Circular No. 11/2018/TT-BYT dated May 4, 2018;

d) examine and supervise contract facility regarding production of contract manufactured medicine with the right transferred ingredients, materials, specifications, documents, and approved medicine marketing authorization in order to properly adhere to manufacturing contract and comply with GMP;

e) assume responsibility for quality, safety, and efficacy of contract manufactured medicine;

g) file report or cooperate with applicants of contract manufactured medicine (if the owner does not register for marketing authorization) in filing report on monitoring and assessment of safety and efficacy of contract manufactured medicine in accordance with Clause 2 Article 5 of Circular No. 08/2022/TT-BYT.

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- Issues relating to medicine to be contract manufactured in terms of safety or efficacy;

- Change or addition to technical specifications of medicine to be contract manufactured during circulation;

- Decision on revocation of market authorization of medicine to be contract manufactured issued in any country.

3. Applicants are responsible for cooperating with owners and contract facilities in informing Drug Administration of Vietnam in writing within 30 days from the date on which decision on revocation of marketing authorization of medicine to be contract manufactured is issued in any country (if current marketing authorization is still effective) and exercising other responsibilities under Article 3 of Circular No. 08/2022/TT-BYT.

4. Exercise other rights, obligations, and responsibilities as per relevant law provisions.

Article 4. Rights and responsibilities of contract facilities

In addition to rights and obligations under Article 181 of the Law on Commerce and Clause 2 Article 42 of Decree No. 69/2018/ND-CP, contract facilities have rights, obligations, and responsibilities below:

1. Contract facilities have the right to:

a) manufacture medicine under contract in a manner that is appropriate to the scope of certificate of eligibility for pharmacy business with respect to contract facilities that are manufacturing facilities in Vietnam issued with certificate of eligibility for pharmacy business;

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c) register contract manufactured medicine under their name if they are authorized by owners.

2. Contract facilities have the responsibility to:

a) exercise responsibilities of medicine manufacturing facilities under Article 4 of Circular No. 08/2022/TT-BYT;

b) manufacture medicine under contract in a manner that is appropriate to the scope under certificate of eligibility for pharmacy business or GMP certificate with respect to facilities that conduct pharmacy business for non-commercial purposes under Point a Clause 1 Article 35 of the Law on Pharmacy;

c) manufacture medicine under contract with the right ingredients, materials, production procedures, and technical specifications transferred by owners, ensure medicine quality according to marketing authorization, and comply with GMP requirements and request of the owners under manufacturing contracts. Store documents, files, medicine samples relating to medicine contract manufacturing process and provide the documents for competent authority upon requested;

d) make changes relating to formula; production procedure; ingredient quality standards; finished product quality standards; trade name in case of contract manufactured medicine satisfying Point a Clause 1 Article 6 hereof if corresponding changes of contract manufactured medicine have been approved by competent authority are made. Changes to contract manufactured medicine shall only be implemented if owners require and if the Drug Administration of Vietnam approves these changes;

dd) exercise regulations pertaining to production, transportation, import, export, circulation, use, disposal, delivery, reporting, documentation, and storage of documents relating to contract manufactured medicine and ingredients thereof that are controlled drugs according to Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government elaborating 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 amendment to business and investment 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 elaborating the Law on Pharmacy and Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government on controlled medicine and medicinal ingredients (hereinafter referred to as “Circular No. 54/2017/ND-CP”) and other relevant law provisions on controlled drugs;

e) apply for contract manufacturing permit in order to manufacture medicine under contract with owners that are foreign traders in accordance with Clause 4 Article 38 of Decree No. 69/2018/ND-CP.

3. Exercise other rights, obligations, and responsibilities as per relevant law provisions.

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In addition to satisfying provisions under Article 39 of Decree No. 69/2018/ND-CP, drug manufacturing contracts must contain:

1. Agreement on supply of ingredients and materials. Technical specifications provided for contract facilities by owners include: production procedures, quality standard, test methods for starting ingredients, semi-finished products, finished products, excipients, and other documents relating to contract manufacturing of medicine.

2. Owners, contract facilities, and applicants (if any) have rights and responsibilities pertaining to:

a) production procedures, quality inspection, preservation and transportation of starting ingredients, semi-finished products, finished products, excipients, packaging procedures, printing or application of label of contract manufactured medicine and detailing of responsibilities of facilities signing batch certificate of analysis and factory release certificate of contract manufactured medicine;

b) storage of recordings pertaining to production, quality inspection, distribution, circulation, storage of drug samples, settlement of issues relating to quality, complaints, product recall.

3. Responsibilities of owners, contract facilities, and applicants (if any) regarding intellectual property issues relating to contract manufactured medicine.

4. Procedures for inspecting, supervising contract facilities.

5. Contract manufacturing roadmap for production stages of contract manufactured medicine in Vietnam and responsibilities of relevant parties in regard to contract manufactured medicine under Clause 2 Article 6 hereof.

6. Situations that lead to termination of the agreement and responsibilities of infringing party.

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1. For the purpose of registration for marketing authorization, contract manufactured medicine shall be classified as follows:

a) Contract manufactured medicine share the followings with medicine to be contract manufactured: formula; production procedures; ingredient quality standards; finished product quality standards; trade name;

If changes to at least one criterion under this Point (not including trade name) or to quality have been made to contract manufactured medicine relative to medicine to be contract manufactured which has had original proprietary drug and reference product declared by the Ministry of Health, either these changes must be approved by pharmacy authority of manufacturing country or authority under Clause 9 Article 2 of Circular No. 08/2022/TT-BYT which previously granted marketing authorization for the medicine or applicants must provide proof that the contract manufactured medicine has quality equivalent to that of medicine to be contract manufactured.

b) Other contract manufactured medicine that does not fall under cases of Point a of this Clause.

2. In regard to contract manufactured medicine whose contract production stages in Vietnam follow a roadmap, applicants or contract facilities implement contract manufacturing of medicine under Point a Clause 1 of this Article must file report on contract manufacturing progress of production stages of finished products in Vietnam to the Ministry of Health (via the Drug Administration of Vietnam) using Form No. 04/TT under Appendix 1 attached hereto on an annual basis from the date on which marketing authorization is issued.

3. Effective period of marketing authorization of contract manufactured medicine shall conform to Clause 1 and Clause 2 Article 8 of Circular No. 08/2022/TT-BYT.

4. Deadline for applying for marketing authorization of contract manufactured medicine shall conform to Clause 4 Article 8 of Circular No. 08/2022/TT-BYT.

Chapter III

GENERAL PROVISIONS ON MARKETING AUTHORIZATION REGISTRATION OF MEDICINE OF TECHNOLOGY TRANSFER

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In addition to rights and obligations under Clause 1 and Clause 2 Article 25 of the Law on Technology Transfer, sending facilities have rights, obligations, and responsibilities below:

1. Sending facilities have the right to:

Register medicine of technology transfer for market authorization under their name when:

a) they have certificate of eligibility for pharmacy business which grants them permission to: produce, trade, export, and import medicine and medicinal ingredients for Vietnamese sending facilities; or

b) They possess legitimate documents issued by foreign competent authority and granting them permission to: manufacture, trade, export, or import medicine, medicinal ingredients and license to establish representative office in Vietnam in regard to foreign sending facilities.

2. Sending facilities have the responsibility to:

a) comply with Article 3 of Circular No. 08/2022/TT-BYT if they register medicine of technology transfer for marketing authorization under their name;

b) provide receiving facilities with:

- Technical specifications including production procedures, quality standards and test methods of starting ingredients, semi-finished products, finished products, and excipients of technology transfer;

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c) assume responsibility for legitimacy and authenticity of intellectual property of documents transferred to receiving facilities;

d) inform receiving facilities and applicants of medicine of technology transfer about:

- Issues relating to medicine for technology transfer in terms of safety or efficacy;

- Changes to technical specifications of medicine for technology transfer during circulation;

- Decision on revocation of marketing authorization of medicine for technology transfer in any country;

3. Applicants of medicine of technology transfer are responsible for cooperating with sending facilities and receiving facilities in notifying Drug Administration of Vietnam in writing within 30 days from the date on which decision on revocation of marketing authorization of medicine for technology transfer is issued in any country during effective period of marketing authorization of medicine of technology transfer and fulfill other responsibilities under Article 3 of Circular No. 08/2022/TT-BYT.

4. Exercise other rights, obligations, and responsibilities as per relevant law provisions.

Article 8. Rights and responsibilities of receiving facilities

In addition to rights and obligations under Article 26 of the Law on Technology Transfer, receiving facilities have rights, obligations, and responsibilities below:

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a) receive technology to manufacture medicine in a manner that is appropriate to the scope of certificate of eligibility for pharmacy business with respect to receiving facilities that are manufacturing facilities in Vietnam issued with certificate of eligibility for pharmacy business;

b) manufacture medicine under contract in a manner that is appropriate to the scope of GMP certificate with respect to contract facilities that conduct pharmacy business for non-commercial purposes under Point a Clause 1 Article 35 of the Law on Pharmacy;

c) register medicine of technology transfer for marketing authorization under their name or authorize eligible facilities to register medicine of technology transfer for marketing authorization under their name as per the law, unless otherwise agreed upon by the parties.

2. Receiving facilities have the responsibility to:

a) exercise responsibilities of medicine manufacturing facilities under Article 4 of Circular No. 08/2022/TT-BYT;

b) manufacture medicine of technology transfer in a manner that is appropriate to the scope under certificate of eligibility for pharmacy business or GMP certificate with respect to facilities that conduct pharmacy business for non-commercial purposes under Point a Clause 1 Article 35 of the Law on Pharmacy;

c) produce medicine of technology transfer in accordance with production procedures, technical specifications, ensure medicine quality as per medicine marketing authorization, comply with GMP requirements and request of sending facilities under technology transfer agreement. Store documents, files, medicine samples relating to manufacturing process of medicine of technology transfer and provide the documents for competent authority upon requested;

d) make changes relating to formula; production procedure; ingredient quality standards; finished product quality standards; trade name in case of medicine of technology transfer satisfying Point a Clause 1 Article 10 hereof if corresponding changes of medicine of technology transfer have been approved by competent authority are made. Changes to medicine of technology transfer shall only be implemented if sending facilities notify and if the Drug Administration of Vietnam approves these changes;

dd) comply with regulations on manufacturing, transportation, import, export, circulation, use, disposal, delivery, reporting, documents, filing, and storage of documents relating to medicine of technology transfer and ingredients thereof that are controlled drugs in accordance with Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP, Circular No. 20/2017/TT-BYT and other relevant law provisions regarding controlled drugs;

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3. Exercise other rights, obligations, and responsibilities as per relevant law provisions.

Article 9. Technology transfer agreement

In addition to fulfilling Article 23 of the Law on Technology Transfer, technology transfer agreement for medicine manufacturing technology must also include:

1. Agreement on provision of technical specifications of sending facilities for receiving facilities includes:

2. Responsibilities of sending facilities, receiving facilities, and applicants regarding intellectual property relating to medicine of technology transfer.

3. Technology transfer roadmap for medicine production stages in Vietnam and responsibilities of relevant parties in regard to medicine of technology transfer under Clause 2 Article 10 hereof.

4. Situations that lead to termination of the agreement and responsibilities of infringing party.

Article 10. Market authorization registration of medicine of technology transfer

1. For the purpose of registering for market authorization, medicine of technology transfer shall be classified as follows:

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If changes to at least one criterion under this Point (not including trade name) or to quality have been made to medicine of technology transfer relative to medicine for technology transfer which has had original proprietary drug and reference product declared by the Ministry of Health, either these changes must be approved by pharmacy authority of manufacturing country or authority under Clause 9 Article 2 of Circular No. 08/2022/TT-BYT which previously granted marketing authorization for the medicine or applicants must provide proof that the medicine of technology transfer has quality equivalent to that of medicine for technology transfer.

b) Other medicine of technology transfer that does not fall under cases of Point a of this Clause.

2. In regard to medicine of technology transfer whose production stages in Vietnam follow a roadmap, applicants or receiving facilities implement technology transfer of medicine under Point a Clause 1 of this Article must file report on technology transfer progress of production stages of finished products in Vietnam to the Ministry of Health (via the Drug Administration of Vietnam) using Form No. 04/TT under Appendix 1 attached hereto on an annual basis from the date on which marketing authorization is issued.

3. Effective period of marketing authorization of medicine of technology transfer shall conform to Clause 1 and Clause 2 Article 8 of Circular No. 08/2022/TT-BYT.

4. Deadline for applying for marketing authorization of medicine of technology transfer shall conform to Clause 4 Article 8 of Circular No. 08/2022/TT-BYT.

Chapter IV

APPLICATION AND PROCEDURES FOR ISSUANCE, EXTENSION, REVISION, REVOCATION OF MARKETING AUTHORIZATION OF CONTRACT MANUFACTURED MEDICINE AND MEDICINE OF TECHNOLOGY TRANSFER IN VIETNAM

Article 11. Regulation on application for marketing authorization of contract manufactured medicine and medicine of technology transfer

1. Language of the application: Application for marketing authorization of contract manufactured medicine, medicine of technology transfer must be filed in Vietnamese or English. Package insert and summary of product characteristics must be written in Vietnamese.

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a) Bioequivalence study documents;

b) Nonclinical and clinical documents.

3. Application must bear verification seal of applicants or receiving facilities, manufacturing facilities on the first page of each component of the application set (seal of representative office is acceptable with respect to application of foreign applicants).

Documents provided by owners or sending facilities must bear verification seal of appropriate establishments. If owners or sending facilities do not use seals in accordance with regulation of their home country, applicants for marketing authorization of contract manufactured medicine or medicine of technology transfer must append verification seals to these documents declare that home country of owners or sending facilities does not use verification seals, and assume responsibilities for authenticity of the documents.

4. It is possible to apply for multiple medicines in the same application if they share: name; dosage form; administration; standard quality; name and address of manufacturer (manufacturing facilities or receiving facilities); formula, in which:

a) Solid dosage medicine: Having the same active pharmaceutical ingredients (API) per unit dose;

b) Medicines of non-dosage solid, liquid, or semi-solid form of the same concentration or API; injection and intravenous injection medicines of the same concentration or API and primary packaging materials.

5. Regulations regarding contents of application for issuance, extension, revision of marketing authorization of contract manufactured medicine, medicine of technology transfer shall conform to Article 22 of Circular No. 08/2022/TT-BYT.

6. Number of documents required in application for issuance, extension of marketing authorization:

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b) In addition to documents under Point a Clause 6 of this Article, one copy of the application with respect to vaccine, biologicals and two copies of written applications, quality standards, and test methods with respect to other cases;

c) 2 sets of prescription label and package insert of medicine to be sold bearing verification seals of applicants (seal of representative office is acceptable in case of foreign applicants) or manufacturing facilities (this does not apply to application for extension of marketing authorization). Prescription labels shall be displayed, designed on A4 format. In case of online application, one set of prescription label and package insert is sufficient.

7. Number of documents required in application for revision to marketing authorization;

a) 1 set containing adequate documents under Article 15 hereof;

b) 2 sets of prescription label and package insert to which revision is requested in case of changing labels, instructions bearing verification seals of applicants (seal of representative office is acceptable in case of foreign applicants) or manufacturing. Prescription labels shall be displayed, designed on A4 format. In case of online application, one set of prescription label and package insert is sufficient.

8. Regulations on online application:

Online application shall conform to Clause 6 Article 6 of Circular No. 08/2022/TT-BYT

9. Registration fee: Applicants are required to pay fee in accordance with applicable fees and charges laws.

10. Verification of authenticity of legal documents in application for marketing authorization of contract manufactured medicine, medicine of technology transfer shall conform to Article 12 of Circular No. 08/2022/TT-BYT.

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1. Application for marketing authorization of contract manufactured medicine, medicine of technology transfer when marketing authorization has been granted to medicine to be contract manufactured or medicine for technology transfer and is still effective at the time of application:

a) Administrative documents

- Application using Form No. 02A/TT - Appendix 1 attached hereto;

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

- Documents mentioned under Point e Clause 1 Article 23 of Circular No. 08/2022/TT-BYT in case of foreign applicants:

- Documents mentioned under Point dd Clause 1 Article 23 of Circular No. 08/2022/TT-BYT in case of domestic applicants;

- Documents mentioned under Point h Clause 1 Article 23 of Circular No. 08/2022/TT-BYT, unless contract manufacturing or technology transfer only covers the packaging stage;

- Manufacturing contract or technology transfer contract;

If owners or manufacturing facilities are not the applicants, medicine manufacturing contract must bear signatures of legal representatives of owners, applicants, and manufacturing facilities.

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- Registration certificate of technology transfer according to Clause 1 Article 31 of the Law on Technology Transfer in regard to application for marketing authorization of medicine of technology transfer;

- Contract manufacturing roadmap for contract manufactured medicine under Clause 2 Article 6 or technology transfer roadmap for medicine of technology transfer under Clause 2 Article 10 hereof using Form No. 03/TT - Appendix 1 attached hereto.

b) Quality records:

- Quality records for pharmaceutics, vaccine, biologicals shall conform to Article 13 hereof;

- Quality records for herbal medicines shall conform to Article 14 hereof.

c) Non-clinical and clinical documents for vaccine, biologicals under Article 25 and Article 26 of Circular No. 08/2022/TT-BYT.

Requirements regarding clinical data for safety, efficacy assurance, and criteria for identifying cases of non-clinical trial exemption, non-clinical trial stage exemption, medicines required to undergo phase 4 clinical trial in Vietnam shall conform to Chapter II of Circular No. 08/2022/TT-BYT.

d) Documents of medicine to be contract manufactured, medicine for technology transfer

Report on monitoring, evaluation of safety and efficacy and drug use using Form No. 2/TT attached to Circular No. 08/2022/TT-BYT in case of medicine to be contract manufactured, medicine for technology transfer that requires report on monitoring and evaluation of safety, efficacy in accordance with Clause 2 Article 5 of Circular No. 08/2022/TT-BYT.

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a) Administrative documents:

- Application using Form No. 02A/TT - Appendix 1 attached hereto;

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

- Documents mentioned under Point e Clause 1 Article 23 of Circular No. 08/2022/TT-BYT in case of foreign applicants:

- Documents mentioned under Point dd Clause 1 Article 23 of Circular No. 08/2022/TT-BYT in case of domestic applicants;

- Manufacturing contract or technology transfer contract;

If owners or manufacturing facilities are not the applicants, medicine manufacturing contract must bear signatures of legal representatives of owners, applicants, and manufacturing facilities.

- Contract manufacturing permit under Point e Clause 2 Article 4 hereof in case of application for marketing authorization of contract manufactured medicine;

- Registration certificate of technology transfer according to Clause 1 Article 31 of the Law on Technology Transfer in regard to application for marketing authorization of medicine of technology transfer;

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b) Quality records:

- Quality records for pharmaceutics, vaccine, biologicals shall conform to Article 13 hereof;

- Quality records for herbal medicines shall conform to Article 14 hereof.

c) Non-clinical and clinical documents for new pharmaceutics, vaccine, biologicals shall conform to Article 25 and Article 26 of Circular No. 08/2022/TT-BYT, except for cases where medicine to be contract manufactured or medicine for technology transfer that are pharmaceutics whose non-clinical and clinical documents have been submitted in accordance with Point dd Clause 2 of this Article;

Requirements regarding clinical data for safety, efficacy assurance, and criteria for identifying cases of non-clinical trial exemption, non-clinical trial stage exemption, medicines required to undergo phase 4 clinical trial in Vietnam shall conform to Chapter II of Circular No. 08/2022/TT-BYT.

dd) Documents on safety and efficacy for herbal medicine according to Article 29 of Circular No. 08/2022/TT-BYT;

dd) Documents of medicine to be contract manufactured, medicine for technology transfer:

- Documents with respect to application for marketing authorization of new pharmaceutics, vaccine, biologicals under Points b, c, and d Clause 1 Article 27 of Circular No. 08/2022/TT-BYT or generic drugs under Point b Clause 2 Article 27 of Circular No. 08/2022/TT-BYT or herbal medicine under Point b and Point c Clause 1 Article 30 of Circular No. 08/2022/TT-BYT;

- Certificate of pharmaceutical products of medicine to be contract manufactured or medicine for technology transfer according to Point c Clause 4 Article 22 of Circular No. 08/2022/TT-BYT in case medicine to be contract manufactured or medicine for technology transfer is foreign medicine.

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a) Documents under Clause 1 or Clause 2 of this Article;

b) Technology transfer agreement;

c) Registration certificate of technology transfer acceding to Clause 1 Article 31 of the Law on Technology Transfer.

Article 13. Regulations on quality records of application for marketing authorization of contract manufactured medicine, medicine of technology transfer that are pharmaceutics, vaccine, biologicals

Quality records in application for marketing authorization of contract manufactured medicine, medicine of technology transfer that are pharmaceutics, vaccine, biologicals shall conform to guidance under section II-ACTD or joint section 3-ICH-CTD, Clauses 1, 2, 3, and 5 Article 24 of Circular No. 08/2022/TT-BYT and:

1. Quality records of medicine to be contract manufactured or medicine for technology transfer which have not been granted marketing authorization in Vietnam: conform to guidance under Section II-ACTD of Appendix I attached to Circular No. 08/2022/TT-BYT or Joint Section 3-TCH-CTD.

2. Summary of changes (if any) between medicine to be contract manufactured and contract manufactured medicine, medicine for technology transfer and medicine of technology transfer and technical specifications according to guidance under Appendix II attached to Circular No. 08/20227TT-BYT.

3. API master file of contract manufactured medicine provided by manufacturing facilities or that of medicine of technology transfer provided by receiving facilities in case of changes to API manufacturers in relative to medicine to be contract manufactured or medicine for technology transfer.

4. Finished product documents of contract manufactured medicine produced by manufacturing facilities or those of medicine of technology transfer produced by receiving facilities include:

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b) Assessment report of manufacturing procedures (for stages implemented at manufacturing facilities or receiving facilities);

c) Conformity assessment report of analysis process (which can be replaced by documents on transfer of analysis process produced by owners and manufacturing facilities or sending facilities and receiving facilities);

d) Batch analysis data, and certificate of analysis of finished products;

dd) Data on stability: submit stability research data of registered medicine under 4.7,9 of ASEAN guideline on stability study of drug product - Part II Appendix I attached to Circular No. 08/2022/TT-BYT.

If medicine to be contract manufactured or medicine for technology transfer lacks stability data of zone IVb: submit stability study data of registered medicine in zone IVb in accordance with ASEAN guideline on stability study of drug product Part II Appendix I attached to Circular No. 08/2022/TT-BYT;

e) Documents on bioequivalence study of contract manufactured medicine, medicine of technology transfer that requires original proprietary drug classification, and medicine with bioequivalence proof (including: medicine that requires bioequivalence study report according to Circular No. 07/2022/TT-BYT dated September 5, 2022 of the Minister of Health, medicine that does not require bioequivalence study report according to regulations of Minister of Health but is requested by applicants to be classified as medicine that requires bioequivalence study report). Applicants are allowed to replace with equivalence dissolution study between contract manufactured medicine and medicine to be contract manufactured or between medicine of technology transfer and medicine for technology transfer if all conditions below are met:

- Medicine to be contract manufactured, medicine for technology transfer has been granted marketing authorization in Vietnam and declared as original proprietary drug, medicine requiring bioequivalence study or medicine requested to be classified as original proprietary drug, as medicine requiring bioequivalence study; medicine to be contract manufactured, medicine for technology transfer has not been granted marketing authorization in Vietnam but has been requested to be classified as original proprietary drug, medicine requiring bioequivalence at the time of application;

- Contract manufactured medicine, medicine of technology transfer have the same formula; manufacturing procedures, ingredient quality standards; quality standards of finished products relative to medicine to be contract manufactured, medicine for technology transfer. In case of changes relating to details above that do not require submission of bioequivalence study, applicants must submit documents appropriate to each change according to regulations under guidelines on increasing batch size and implement the changes after obtaining marketing authorization for solid oral dosage forms under the US - FDA (SUPACs).

5. In regard to contract manufactured medicine, medicine of technology transfer during secondary packaging stage, documents under Points dd and e Clause 4 of this Article are not required.

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Quality records in application for marketing authorization of contract manufactured medicine, medicine of technology transfer that are herbal medicine shall conform to Article 28 of Circular No. 08/2022/TT-BYT and:

1. Quality records of medicine to be contract manufactured or medicine for technology transfer in case said medicine to be contract manufactured or medicine for technology transfer have not been granted marketing authorization in Vietnam: conform to Article 28 of Circular No. 08/2022/TT-BYT.

2. Summary of changes (if any) between medicine to be contract manufactured and contract manufactured medicine, medicine for technology transfer and medicine of technology transfer and technical specifications according to guidance under Appendix II attached to Circular No. 08/2022/TT-BYT.

3. Documents produced by manufacturing facilities or receiving facilities:

a) Ingredient: certificate of analysis of medicinal herbs or certificate of analysis of semi-finished products of medicinal herbs, bone glue;

b) Finished product: certificate of analysis of finished products; stability study report according to guidance on stability study under Part II of Appendix I attached to Circular No. 08/2022/TT-BYT.

Article 15. Application for revision to marketing authorization of contract manufactured medicine, medicine of technology transfer

1. Application for revision shall use Form No. 02C/TT - Appendix I attached hereto.

2. Application for revision to marketing authorization of contract manufactured medicine, medicine of technology transfer shall conform to Appendix II of Circular No. 08/2022/TT-BYT.

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In regard to vaccine of the same manufacturers or holders of medicine marketing authorization, changes to location of manufacturers in the same country or outside of the country where the vaccine has been granted marketing authorization are allowed.

3. Changes to details relating to owners

a) Changes to name, address of owners, update to information relating to owners (while the owners do not change): Application shall conform to regulations on changing name, address of applying company (MiV-N1) Section 7 of Appendix II attached to Circular No. 08/2022/TT-BYT;

b) Changes to owners:

Documents required;

- Documents indicating carry-over of rights and responsibilities between previous owners and new owners regarding execution of manufacturing contract in application for marketing authorization;

- Documents of new owners declaring unchanged location of manufacturing facilities and declaring further execution of rights and responsibilities of owners according to application for marketing authorization of contract manufactured medicine.

4. Changes of details relating to sending facilities

a) Changes to name, address of sending facilities, update to information relating to sending facilities (while the sending facilities are not changed): Application shall conform to regulations on changing name, address of applying company (MiV-N1) under section 7 Appendix II attached to Circular No. 08/2022/TT-BYT;

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Documents required:

- Documents of new sending facilities declaring further execution of medicine manufacturing technology transfer agreement signed by previous sending facilities;

- Registration certificate of technology transfer (if any).

Article 16. Application for extension of marketing authorization of contract manufactured medicine, medicine of technology transfer

1. Application shall use Form No. 02B/TT - Appendix 1 attached hereto.

2. Manufacturing contract or technology transfer contract.

3. Pharmaceutics, vaccine, biologicals: Application for extension of marketing authorization of contract manufactured medicine, medicine of technology transfer shall conform to Clause 3 Article 27 of Circular No. 08/2022/TT-BYT.

4. Herbal medicine: Application for extension of marketing authorization of contract manufactured medicine, medicine of technology transfer shall conform to Clause 2 Article 30 of Circular No. 08/2022/TT-BYT.

5. Report on progress of contract manufacturing roadmap for contract manufactured medicine under Clause 2 Article 6 or technology transfer roadmap for medicine of technology transfer under Clause 2 Article 10 hereof using Form No. 04/TT - Appendix 1 attached hereto.

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1. Procedures for issuing marketing authorization for contract manufactured medicine, medicine of technology transfer when marketing authorization has been granted to medicine to be contract manufactured or medicine for technology transfer and is still effective at the time of application:

a) Within 3 months from the date on which application is received, the Drug Administration of Vietnam shall issue marketing authorization for contract manufactured medicine, medicine of technology transfer. If marketing authorization is not issued or not issued immediately, the Drug Administration of Vietnam shall respond in writing and provide reason. Time limit for resolving each step is as follows:

- Within 8 working days from the date on which application is received, the Drug Administration of Vietnam shall review, classify, and send the application to assessing experts or assessing bodies. Within 1 month from the date on which application sent by the Drug Administration of Vietnam is received, assessing experts or assessing bodies must finalize assessment records and file to the Drug Administration of Vietnam for conclusion in accordance with Clause 4 Article 35 of Circular No. 08/2022/TT-BYT;

- Within 12 working days from the date on which assessment records are received, the Drug Administration of Vietnam shall issue written response for inadequate application and state reason. In regard to applications approved, rejected, or deemed requiring assessment of Advisory Council for marketing authorization of medicine and medicinal ingredients (hereinafter referred to as “Council”) by the Drug Administration of Vietnam, the Drug Administration of Vietnam shall send the applications to office of the Council;

- Within 6 working days from the date on which applications sent by the Drug Administration of Vietnam are received, office of the Council shall hold council meetings and send meeting records to the Drug Administration of Vietnam;

- Within 18 working days from the date on which meeting records sent by the Council are received, the Drug Administration of Vietnam shall promulgate decision issuing marketing authority for contract manufactured medicine, medicine of technology transfer if the application is adequate; the Drug Administration of Vietnam shall issue written response according to conclusion of the Council if the application is inadequate and state reason.

b) The Drug Administration of Vietnam shall request applicants to submit additional documents and the applicants must fulfill said request within 36 months in case additional documents are non-clinical and clinical documents, bioequivalence documents, stability study or within 12 months in case additional documents are other documents. If applicants fail to submit additional documents within the time limit above, the filed applications are no longer valid.

While filed application is being assessed, the applicants are allowed to notify Drug Administration of Vietnam in writing of update to information relating to safety, efficacy of medicine or legal documents of the applicants, manufacturers of medicine and medical ingredients relative to filed applications.

The period between the date on which the Drug Administration of Vietnam sends request to the date on which the applicants submit additional documents shall be added to time limit under Clause 5 Article 56 of the Law on Pharmacy.

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Procedures and time limit for reviewing additional documents shall conform to Point a Clause 1 of this Article.

2. Procedures for issuing marketing authorization for contract manufactured medicine, medicine of technology transfer when marketing authorization has not been granted to medicine to be contract manufactured or medicine for technology transfer or has expired by the time of application:

a) Within 9 months from the date on which application is received, the Drug Administration of Vietnam shall issue marketing authorization for contract manufactured medicine, medicine of technology transfer. If marketing authorization is not issued or not issued immediately, the Drug Administration of Vietnam shall respond in writing and provide reason. Time limit for resolving each step is as follows:

- Within 2 months from the date on which application is received, the Drug Administration of Vietnam shall review, classify, and send the application to assessing experts or assessing bodies. Within 4 months from the date on which application sent by the Drug Administration of Vietnam is received, assessing experts or assessing bodies must finalize assessment records and file to the Drug Administration of Vietnam for conclusion in accordance with Clause 4 Article 35 of Circular No. 08/2022/TT-BYT;

- Within 01 month from the date on which assessment records are received, the Drug Administration of Vietnam shall issue written response for inadequate application and state reason. In regard to applications approved, rejected, or deemed requiring assessment of the Council by the Drug Administration of Vietnam, the Drug Administration of Vietnam shall transfer the applications to office of the Council;

- Within 1 month from the date on which applications sent by the Drug Administration of Vietnam are received, office of the Council shall hold council meetings and send meeting records to the Drug Administration of Vietnam;

- Within 01 month from the date on which meeting records sent by the Council are received, the Drug Administration of Vietnam shall promulgate decision issuing marketing authority for contract manufactured medicine, medicine of technology transfer if the application is adequate; the Drug Administration of Vietnam shall issue written response according to conclusion of the Council if the application is inadequate and state reason.

b) The Drug Administration of Vietnam shall request applicants to submit additional documents and the applicants must fulfill said request within 36 months in case additional documents are non-clinical and clinical documents, bioequivalence documents, stability study or within 12 months in case additional documents are other documents. If applicants fail to submit additional documents within the time limit above, the filed applications are no longer valid.

While filed application is being assessed, the applicants are allowed to notify Drug Administration of Vietnam in writing of update to information relating to safety, efficacy of medicine or legal documents of the applicants, manufacturers of medicine and medical ingredients relative to filed applications.

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c) Within 4 months from the date on which adequate additional documents are received, the Drug Administration of Vietnam shall promulgate decision on marketing authorization for contract manufactured medicine, medicine of technology transfer if the application is adequate; the Drug Administration of Vietnam shall issue written respond based on conclusion of the Council if the application is inadequate and state reason. Time limit for resolving each step is as follows:

- Within 12 working days from the date on which application is received, the Drug Administration of Vietnam shall review, classify, and send the application to assessing experts or assessing bodies. Within 1 month from the date on which application sent by the Drug Administration of Vietnam is received, assessing experts or assessing bodies must finalize assessment records and file to the Drug Administration of Vietnam for conclusion in accordance with Clause 4 Article 35 of Circular No. 08/2022/TT-BYT;

- Within 01 month from the date on which assessment records are received, the Drug Administration of Vietnam shall issue written response for inadequate application and state reason. In regard to applications approved, rejected, or deemed requiring assessment of the Council by the Drug Administration of Vietnam, the Drug Administration of Vietnam shall transfer the applications to office of the Council;

- Within 1 month from the date on which they receive applications from the Drug Administration of Vietnam. Council office shall hold meetings and send meeting records to the Drug Administration of Vietnam;

- Within 10 working days from the date on which meeting records sent by the Council are received, the Drug Administration of Vietnam shall promulgate decision issuing marketing authority for contract manufactured medicine, medicine of technology transfer if the application is adequate; the Drug Administration of Vietnam shall issue written response according to conclusion of the Council if the application is inadequate and state reason.

3. Procedures for issuing marketing authorization for contract manufactured medicine which involves technology transfer from owners to manufacturing facilities shall conform to Clause 1 of this Article if marketing authorization in Vietnam of medicine to be contract manufactured is still valid at the time of application or Clause 2 of this Article if marketing authorization has not been granted to medicine to be contract manufactured or has expired at the time of application.

4. Marketing authorization of contract manufactured medicine, medicine of technology transfer shall be issued as a single document in case of medicine under Point a Clause 4 Article 11 of this Circular or as several documents in case of medicine under Point b Clause 4 Article 11 of this Circular.

5. Procedures for extending, revising marketing authorization of contract manufactured medicine, medicine of technology transfer shall conform to procedures for extending, revising medicine marketing authorization under Article 37 and Article 38 of Circular No. 08/2022/TT-BYT.

6. Entitlement to issue, extend, revise marketing authorization of contract manufactured medicine, medicine of technology transfer shall conform to Article 34 of Circular No. 08/2022/TT-BYT.

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Article 18. Revocation of marketing authorization, temporary rejection of application for issuance, extension of marketing authorization of contract manufactured medicine, medicine of technology transfer

1. Entitlement to revoke and responsibility for notifying revocation of marketing authorization shall conform to Clause 1 Article 40 of Circular No. 08/2022/TT-BYT.

2. Procedures for revoking marketing authorization of contract manufactured medicine, medicine of technology transfer shall conform to Article 40 of Circular No. 08/2022/TT-BYT.

3. Cases of temporary rejection of application for issuance, extension of application for marketing authorization of contract manufactured medicine, medicine of technology transfer shall conform to Article 41 of Circular No. 08/2022/TT-BYT.

Chapter V

ENTRY INTO FORCE

Article 19. Entry into force

1. This Circular comes into force from October 1, 2023.

2. Circular No. 23/2013/TT-BYT dated August 13, 2013 of the Minister of Health guiding contract manufacturing of medicine expires from the effective date hereof.

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1. Applications submitted before the effective date hereof shall conform to regulations applicable at the date of submission, unless the applicants state their wish to conform to regulations applicable from the signing date of this Circular under written presentation, additional documents, or written request.

2. If facilities wish to have contract manufactured medicine, medicine of technology transfer that has been granted marketing authorization before the effective date hereof declared in accordance with Clause 1 Article 22 hereof, they must submit application for new marketing authorization in accordance with this Circular.

Article 21. Terms of reference

If documents referred to in this Circular are replaced or amended, the replacing or amending version shall prevail.

Article 22. Organizing implementation

1. The Drug Administration of Vietnam is responsible for publicizing the following medication lists on their website, “Sức khỏe và Đời sống” Newspaper in accordance with guidelines under Appendix 2 hereof:

a) List of contract manufactured medicine (without manufacturing technology transfer) with new/extended marketing authorization satisfying Point a Clause 1 Article 6 hereof;

b) List of contract manufactured medicine (with manufacturing technology transfer) with new/extended marketing authorization satisfying Point a Clause 1 Article 6 hereof;

c) List of medicine of technology transfer with new/extended marketing authorization satisfying Point a Clause 1 Article 10 hereof.

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a) Report on progress of contract manufacturing roadmap for contract manufactured medicine under Clause 2 Article 6 or progress of technology transfer roadmap for medicine of technology transfer under Clause 2 Article 10 hereof is not produced;

b) Production stages in Vietnam under contract manufacturing roadmap or technology transfer roadmap according to application for marketing authorization are not adequately adhered to;

c) Contract manufactured medicine no longer satisfies Point a Clause 1 Article 6 hereof; medicine of technology transfer no longer satisfies Point a Clause 1 Article 10 hereof.

3. Labeling of contract manufactured medicine, medicine of technology transfer shall conform to Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health.

4. In regard to medicine manufactured under contract with owners that are foreign traders for trading in Vietnam, once contract manufactured medicine is granted as per the law, import and export procedures for contract manufactured medicine shall be conducted in accordance with Decree No. 69/2018/ND-CP.

5. Foreign-invested enterprises engaging in contract manufacturing of medicine shall exercise the right to import, distribute medicine in accordance with Clause 10, Clause 11 Article 91 of Decree No. 54/2017/ND-CP.

6. Each contract manufactured medicine and medicine of technology transfer granted marketing authorization shall be assigned with a registration number whose structure conforms to Appendix VI attached to Circular No. 08/2022/TT-BYT. In regard to contract manufactured medicine that involves manufacturing technology transfer, medicine category under Appendix VI is as follows:

Medicine category
(1 digit)

8: Contract manufactured medicine with manufacturing technology transfer

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8. Other details pertaining to marketing authorization registration of contract manufactured medicine and medicine of technology transfer in Vietnam that have not been prescribed under this Circular shall conform to relevant provisions under Circular No. 08/2022/TT-BYT

Article 23. Responsibilities for implementation

1. The Drug Administration of Vietnam is responsible for providing guidelines on implementation of this Circular; taking charge or cooperating with Inspectorates of the Ministry of Health, departments and agencies in examining and supervising implementation of this Circular in pharmaceutical manufacturing and trading entities across the country.

2. Departments of Health of provinces and central-affiliated cities are responsible for examining and inspecting implementation of this Circular in local pharmaceutical manufacturing and trading entities.

3. Entities affiliated with the Ministry of Health, Vinapharm, and pharmaceutical manufacturing and trading entities are responsible for the implementation of this Circular.

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

PP. MINISTER
DEPUTY MINISTER




Do Xuan Tuyen

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