Circular No. 16/2023/TT-BYT stipulates the registration for circulation of processed drugs and technology transfer drugs in Vietnam.

CIRCULAR

PROVISIONS ON THE REGISTRATION FOR CIRCULATION OF DOMESTICALLY PROCESSED DRUGS AND TECHNOLOGY TRANSFER DRUGS IN VIETNAM

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

Pursuant to the Government Decree No. 81/2018/NĐ-CP dated May 22, 2018, detailing the Trade Law on trade promotion activities;

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

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

Pursuant to the Government's Decree No. 54/2017/NĐ-CP dated May 8, 2017 detailing certain provisions and measures for implementing the Drug Law;

Pursuant to the Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions within the scope of management of the Ministry of Health;

Pursuant to Decree No. 69/2018/NĐ-CP dated May 15, 2018 of the Government detailing certain provisions of the Law on Foreign Trade Management;

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

At the proposal of the Director of the Drug Administration Department;

The Minister of Health issues this Circular on the registration for circulation of domestically processed drugs and technology transfer drugs in Vietnam.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. This Circular provides general regulations on the registration for circulation of domestically processed drugs and technology transfer drugs produced in Vietnam; the dossier, procedures for issuing, extending, amending, supplementing, and revoking the drug circulation registration certificate for domestically processed drugs and technology transfer drugs (chemical drugs, vaccines, biological products, traditional medicine) in Vietnam.

2. This Circular applies to domestic and foreign agencies, organizations, and individuals related to the activities of processing drugs and transferring drug production technology in Vietnam.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Processing drugs means the activity of producing drugs under a processing contract in accordance with the law, where the processing entity implements one, several, or all stages of the drug production process according to the requirements of the entity placing the order for processing and receives payment.

2. Transfer of drug production technology means the activity of transferring ownership rights or granting usage rights of drug production technology from the entity with the right to transfer technology to the entity receiving the technology to implement one, several, or all stages of the drug production process according to the contract between both parties in compliance with the law.

3. Entity placing orders for drug processing is the party providing part or all of the raw materials, materials, production processes, technical files proving the quality, safety, and efficacy of the drug to the processing entity to place orders for drug processing according to the processing contract between both parties.

4. Processing entity is the party using part or all of the raw materials, materials, production processes, and technical files of the entity placing orders for drug processing to implement one, several, or all stages of the drug production process according to the requirements of the entity placing orders for drug processing and receives payment according to the processing contract between both parties.

5. Entity transferring drug production technology is the party owning or having the right to use drug production technology in accordance with the law, which transfers ownership rights or grants usage rights of drug production technology to the entity receiving transferred drug production technology for application in one, several, or all stages of the production process.

6. Entity receiving transferred drug production technology is the party accepting ownership rights or usage rights of drug production technology from the entity transferring drug production technology according to the contract between both parties for application in one, several, or all stages of the production process.

7. Drug placed for processing is a drug that already has a registration certificate for circulation in Vietnam or does not yet have a registration certificate for circulation in Vietnam, which is placed for production by the entity placing orders for drug processing at the processing entity according to the processing contract between both parties.

8. Processed drug is a drug produced by the processing entity for the entity placing orders for drug processing according to the processing contract between both parties.

9. Pre-transfer technology drug is a drug that already has a registration certificate for circulation in Vietnam or does not yet have a registration certificate for circulation in Vietnam, which is transferred by the entity transferring drug production technology to the entity receiving transferred drug production technology for application in one, several, or all stages of the production process.

10. Transferred technology drug is a drug produced by the entity receiving transferred drug production technology from the entity transferring drug production technology according to the contract between both parties.

Chapter II

GENERAL PROVISIONS ON THE REGISTRATION FOR CIRCULATION OF DOMESTICALLY PROCESSED DRUGS

Article 3. Rights and responsibilities of the entity placing drug manufacturing on commission, the entity registering drugs for commission

In addition to the rights and obligations stipulated in Article 181 of the Commercial Law and Clause 1 of Article 42 of Decree No. 69/2018/ND-CP dated May 15, 2018 of the Government detailing certain provisions of the Law on Management of Foreign Trade (hereinafter referred to as Decree No. 69/2018/ND-CP), the entity placing drug manufacturing on commission has specific rights, obligations, and responsibilities as follows:

1. Rights of the entity placing drug manufacturing on commission:

a) The right to authorize an entity with sufficient conditions to stand in the name of registering drugs in accordance with the law;

b) The right to stand in the name of registering commissioned drugs in any of the following cases:

- Having a certificate of qualification for business operations in one of the forms of business: production, wholesale trade, export, import of drugs, raw materials for drugs for Vietnamese entities placing drug manufacturing on commission;

- Having legal documents issued by competent authorities abroad allowing the implementation of at least one of the following forms of business: production, wholesale trade, export, import of drugs, raw materials for drugs and a representative office establishment permit in Vietnam for foreign entities placing drug manufacturing on commission.

2. Responsibilities of the entity placing drug manufacturing on commission:

a) An entity placing drug manufacturing on commission standing in the name of registering commissioned drugs shall be responsible for complying with the provisions of Article 3 of Circular No. 08/2022/TT-BYT dated September 5, 2022 of the Minister of Health on the registration for circulation of drugs and raw materials for drugs (hereinafter referred to as Circular No. 08/2022/TT-BYT);

b) Providing to the entity receiving drug manufacturing on commission:

- A portion or all of the raw materials, materials, technical files including production processes, quality standards, and testing methods of initial raw materials, semi-finished products, finished products, excipients of the commissioned manufacturing process;

- Other relevant files and documents related to the registration for circulation of commissioned drugs and drug manufacturing on commission;

c) Being responsible for the legality and honesty regarding the intellectual property rights of commissioned drugs, raw materials, materials, production processes, technical files transferred to the entity receiving drug manufacturing on commission;

d) Cooperating with the entity registering drugs to update the quality standards of drugs and raw materials for drugs according to Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Minister of Health on the quality of drugs and raw materials for drugs, and Circular No. 03/2020/TT-BYT dated January 22, 2020 of the Minister of Health amending and supplementing some articles of Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Minister of Health on the quality of drugs and raw materials for drugs;

d) Inspecting and supervising the entity receiving drug manufacturing on commission regarding the implementation of commissioned drug production in accordance with the raw materials, materials, files, and documents transferred, the approved drug registration files to ensure compliance with the agreements in the manufacturing commission contract and adherence to Good Manufacturing Practices (GMP) for drugs and raw materials for drugs;

e) Being responsible for the quality, safety, and efficacy of commissioned drugs;

g) Reporting or cooperating with the entity registering commissioned drugs (in case the entity placing drug manufacturing on commission is not the entity registering drugs) to report monitoring and evaluating the safety and efficacy of commissioned drugs according to Clause 2 of Article 5 of Circular No. 08/2022/TT-BYT;

h) Being responsible for notifying the entity receiving drug manufacturing on commission, the entity registering commissioned drugs in the following cases:

- When there are issues related to the safety and efficacy of commissioned drugs;

- When there are changes or supplements to the technical files of commissioned drugs during circulation;

- When there is a decision to revoke the registration for circulation of commissioned drugs in any country in the world;

3. The entity registering commissioned drugs shall be responsible for coordinating with the entity placing drug manufacturing on commission, the entity receiving drug manufacturing on commission to notify the Drug Administration Department in writing within thirty days from the date of the decision to revoke the registration for circulation of commissioned drugs in any country in the world (within the validity period of the registration for circulation of commissioned drugs) and performing other responsibilities prescribed in Article 3 of Circular No. 08/2022/TT-BYT;

4. Performing other rights, obligations, and responsibilities as prescribed by relevant laws.

Article 4. Rights and responsibilities of the entity receiving drug manufacturing on consignment

In addition to the rights and obligations stipulated in Article 181 of the Commercial Law and Clause 2 of Article 42 of Decree No. 69/2018/NĐ-CP, the entity receiving drug manufacturing on consignment has specific rights, obligations, and responsibilities as follows:

1. Rights of the entity receiving drug manufacturing on consignment:

a) To accept consignment manufacturing for producing drugs within the scope of business as stated in the certificate of eligibility for pharmaceutical business operations, applicable when the entity receiving drug manufacturing on consignment is a production facility in Vietnam that has been issued such a certificate;

b) To accept consignment manufacturing for producing drugs within the scope of activities as stated in the Good Manufacturing Practice (GMP) certification, applicable when the entity receiving drug manufacturing on consignment is a facility engaged in activities but not for commercial purposes as specified in Point a, Clause 1, Article 35 of the Drug Law;

c) To be named in the registration of consigned drugs upon authorization from the entity placing the drug manufacturing on consignment.

2. Responsibilities of the entity receiving drug manufacturing on consignment:

a) To fulfill the responsibilities of a drug manufacturing facility as prescribed in Article 4 of Circular No. 08/2022/TT-BYT;

b) To only accept consignment manufacturing for producing drugs within the scope of business as stated in the certificate of eligibility for pharmaceutical business operations already issued or within the scope of activities as stated in the GMP certification for facilities engaged in pharmaceutical activities but not for commercial purposes as specified in Point a, Clause 1, Article 35 of the Drug Law;

c) To carry out consignment manufacturing for drugs strictly according to raw materials, materials, production processes, technical files transferred by the entity placing the drug manufacturing on consignment, and ensure drug quality in accordance with the drug registration file, complying with GMP requirements and the requirements of the entity placing the drug manufacturing on consignment in the consignment contract. To retain all relevant files, documents, and samples related to the production process of consigned drugs and provide these files to competent state management authorities upon request;

d) To only implement changes related to drug formulation; production processes; raw material quality standards; finished product quality standards; trade names for consigned drugs in compliance with the provisions of Point a, Clause 1, this Circular when corresponding changes to the placed drug have been approved by the competent authority, and such changes can only be implemented at the request of the entity placing the drug manufacturing on consignment, and must be approved by the Department of Drug Management for these changes;

đ) To comply with regulations concerning production, transportation, import/export, circulation, use, disposal, receipt/delivery, reporting, records, and retention of documents and materials related to drugs and raw materials for special control drugs as stipulated in Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and measures to enforce the Drug Law (hereinafter referred to as Decree No. 54/2017/NĐ-CP), Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to investment and business conditions under the Ministry of Health's jurisdiction (hereinafter referred to as Decree No. 155/2018/NĐ-CP), Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health detailing certain provisions of the Drug Law and Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government regarding special controlled drugs and raw materials (hereinafter referred to as Circular No. 20/2017/TT-BYT) and other relevant regulations for special controlled drugs;

e) To follow procedures for applying for a consignment manufacturing permit to conduct consignment manufacturing for drugs for foreign traders as stipulated in Clause 4, Article 38 of Decree No. 69/2018/NĐ-CP.

3. To perform other rights, obligations, and responsibilities as prescribed by relevant laws.

Article 5. Processing Contract

In addition to complying with the contents prescribed in Article 39 of Decree No. 69/2018/NĐ-CP, contracts for processing pharmaceuticals must include the following contents:

1. Agreement on the supply of raw materials and materials. The provision of technical files from the entity placing the processing of pharmaceuticals to the entity undertaking the processing of pharmaceuticals shall include: production process, quality standards, initial raw material testing methods, semi-finished product, finished product, excipient, and other documents related to the processing of pharmaceuticals.

2. Rights and responsibilities of the entity placing the processing of pharmaceuticals, the entity undertaking the processing of pharmaceuticals, and the entity registering pharmaceuticals (if applicable):

a) For each stage of the pharmaceutical processing production process regarding the production process, quality inspection, storage, transportation of initial raw materials, semi-finished products, finished products, excipients, packaging process, printing or labeling of processed pharmaceuticals, and defining the responsibility of the entity signing the batch test report for finished products and the dispatch report for processed pharmaceuticals.

b) Regarding the retention of records on production, quality inspection, distribution, circulation of pharmaceuticals, sample retention, resolution of issues related to quality, complaints, and product recalls on the market.

3. Responsibilities of the entity placing the processing, the entity undertaking the processing, and the entity registering pharmaceuticals (if applicable) concerning intellectual property issues related to processed pharmaceuticals.

4. Inspection and supervision procedures for production facilities.

5. The phased implementation of processing stages of the pharmaceutical production process in Vietnam and the responsibilities of the parties involved for processed pharmaceuticals as stipulated in Clause 2 of Article 6 of this Circular.

6. Circumstances for terminating agreements and liabilities arising from breaches of agreements.

Article 6. Registration for Circulation of Processed Pharmaceuticals

1. Processed pharmaceuticals when registering for circulation are classified as follows:

a) Processed pharmaceuticals having the same content as the pharmaceuticals placed for processing, including: drug formulation; production process; raw material quality standards; finished product quality standards; trade name;

In cases where the pharmaceuticals placed for processing are original brand drugs, reference biological products that have been announced by the Ministry of Health, and the processed pharmaceuticals differ from the pharmaceuticals placed for processing in at least one of the criteria mentioned herein (excluding changes in trade name) or other changes related to quality, these changes must be approved by the drug regulatory authority of the producing country or the authority specified in Clause 9 of Article 2 of Circular No. 08/2022/TT-BYT which has granted permission for the circulation of such pharmaceuticals, or the registering entity must provide data proving that the processed pharmaceuticals are equivalent in quality to the pharmaceuticals placed for processing.

b) Other processed pharmaceuticals not falling under the provisions of point a of this clause.

2. For processed pharmaceuticals with a phased implementation plan for production stages in Vietnam, annually from the date of registration approval, the entity registering processed pharmaceuticals or the entity undertaking the processing of pharmaceuticals as stipulated in point a of Clause 1 of this Article must report the progress of implementing the processing stages of the finished product production process in Vietnam to the Ministry of Health (Department of Drug Management) according to Form 04/TT Appendix 1 issued together with this Circular.

3. The validity of the registration certificate for the circulation of processed pharmaceuticals is implemented according to Clause 1 and Clause 2 of Article 8 of Circular No. 08/2022/TT-BYT.

4. The time limit for submitting applications to extend the registration certificate for the circulation of processed pharmaceuticals is carried out according to Clause 4 of Article 8 of Circular No. 08/2022/TT-BYT.

Chapter III

GENERAL PROVISIONS ON REGISTRATION FOR CIRCULATION OF TECHNOLOGY TRANSFER PHARMACEUTICALS

Article 7. Rights and Responsibilities of Entities Transferring Pharmaceutical Production Technology, Entities Registering Technology Transfer Pharmaceuticals

In addition to the rights and obligations stipulated in Clause 1 and Clause 2 of Article 25 of the Law on Technology Transfer, entities transferring pharmaceutical production technology have specific rights, obligations, and responsibilities as follows:

1. Rights of entities transferring pharmaceutical production technology:

Have the right to register technology transfer pharmaceuticals if they fall into one of the following cases:

a) Hold a business license for pharmaceuticals with one of the business forms: production, wholesale, export, import of pharmaceuticals, raw materials for pharmaceuticals for domestic entities transferring pharmaceutical production technology;

b) Hold legal documents issued by competent authorities abroad allowing the implementation of at least one of the following business forms: production, wholesale, export, import of pharmaceuticals, raw materials for pharmaceuticals, and establishment of a representative office in Vietnam for foreign entities transferring pharmaceutical production technology.

2. Responsibilities of entities transferring pharmaceutical production technology:

a) Entities transferring pharmaceutical production technology that register technology transfer pharmaceuticals have the responsibility to comply with the provisions of Article 3 of Circular No. 08/2022/TT-BYT;

b) Provide to the entity receiving the transfer of pharmaceutical production technology:

- Technical files including the production process, quality standards, and testing methods for initial raw materials, semi-finished products, finished products, excipients of the technology transfer stage;

- Other documents and materials related to the registration for circulation of technology transfer pharmaceuticals and the transfer of pharmaceutical production technology;

c) Be responsible for the legality, honesty, and intellectual property rights of the transferred documents and materials to the entity receiving the transfer of pharmaceutical production technology;

d) Be responsible for notifying the entity receiving the transfer of pharmaceutical production technology and the entity registering technology transfer pharmaceuticals in the following cases:

- When there are issues related to pharmaceuticals before technology transfer regarding safety and efficacy;

- When there are changes or additions to the technical files of pharmaceuticals before technology transfer during circulation;

- When there is a decision to revoke the registration certificate for circulation of pharmaceuticals before technology transfer in any country in the world;

3. The technology transfer drug registration basis shall be responsible for coordinating with the technology transfer drug production entity and the technology transfer drug receiving entity to notify the Drug Administration Department in writing within thirty days from the date of the decision to revoke the drug circulation registration certificate before technology transfer in any country while the technology transfer drug registration certificate remains valid, and to fulfill other responsibilities as stipulated in Article 3 of Circular No. 08/2022/TT-BYT.

4. Performing other rights, obligations, and responsibilities as prescribed by relevant laws.

Article 8. Rights and Responsibilities of the Technology Transfer Drug Production Receiving Entity

In addition to the rights and obligations prescribed in Article 26 of the Law on Technology Transfer, the technology transfer drug production receiving entity shall have specific rights, obligations, and responsibilities as follows:

1. Rights of the Technology Transfer Drug Production Receiving Entity:

a) To receive technology transfer to produce drugs in accordance with the scope of business stated in the certificate of adequate conditions for pharmaceutical business operations, in cases where the technology transfer drug production receiving entity is a domestic production entity that has been issued a certificate of adequate conditions for pharmaceutical business operations;

b) To receive technology transfer to produce drugs in accordance with the scope of activities stated in the Good Manufacturing Practice (GMP) certificate, in cases where the technology transfer drug production receiving entity is a non-commercial pharmaceutical activity entity as defined in point a, Clause 1, Article 35 of the Medicine Law;

c) To be named as the registrant of the technology transfer drug or to be authorized by an entity with sufficient conditions to be named as the registrant of the technology transfer drug in accordance with the provisions of the law, except in cases where the parties have agreed otherwise.

2. Responsibilities of the Technology Transfer Drug Production Receiving Entity:

a) To fulfill the responsibilities of a drug manufacturing facility as prescribed in Article 4 of Circular No. 08/2022/TT-BYT;

b) Only to produce technology transfer drugs in accordance with the scope of business stated in the certificate of adequate conditions for pharmaceutical business operations that has been issued, or in accordance with the scope of activities stated in the GMP certificate for entities engaged in pharmaceutical activities but not for commercial purposes as defined in point a, Clause 1, Article 35 of the Medicine Law;

c) To carry out the production of technology transfer drugs according to the production procedures, technical files, and ensure drug quality in accordance with the drug registration files, comply with GMP requirements, and the requirements of the technology transfer drug production transferring entity as stipulated in the technology transfer contract. To store related files, documents, and samples of the technology transfer drug production process, and provide these files to the competent state management agency when requested;

d) Only to implement changes related to the drug formulation; production processes; raw material quality standards; finished product quality standards; brand name for technology transfer drugs in compliance with the provisions at point a, Clause 1, Article 10 of this Circular, when corresponding changes to the pre-transfer drugs have been approved by the competent authority, and only to implement changes and supplements to technology transfer drugs upon notification from the technology transfer drug production transferring entity and approval from the Drug Administration Department for such changes and supplements;

đ) To comply with regulations on production, transportation, import/export, circulation, use, destruction, receipt/delivery, reporting, records, and retention of documents and materials related to drugs and drug raw materials for technology transfer drugs that are special controlled drugs as stipulated in Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP, Circular No. 20/2017/TT-BYT, and other relevant regulations concerning special controlled drugs;

e) To complete the technology transfer registration procedures in accordance with Article 31 of the Law on Technology Transfer and Article 5 of Decree No. 76/2018/ND-CP dated May 15, 2018 of the Government detailing and guiding the implementation of certain provisions of the Law on Technology Transfer.

3. To perform other rights, obligations, and responsibilities as prescribed by relevant laws.

Article 9. Technology Transfer Contracts

In addition to complying with the contents stipulated in Article 23 of the Law on Technology Transfer, technology transfer contracts for pharmaceutical production must include the following contents:

1. Agreement on the provision of technical documentation from the technology transferring entity for pharmaceutical production to the technology receiving entity, including: production processes, quality standards, initial raw material testing methods, semi-finished product testing methods, finished product testing methods, excipient testing methods, and other relevant documents related to the technology transfer for pharmaceutical production.

2. Responsibilities of the technology transferring entity for pharmaceutical production, the technology receiving entity for pharmaceutical production, and the drug registration entity regarding intellectual property issues related to the transferred technology drugs.

3. The schedule for transferring technology for each stage of the pharmaceutical production process in Vietnam and the responsibilities of the parties involved as specified in Clause 2 of Article 10 of this Circular.

4. Circumstances for terminating agreements and liabilities arising from breaches of agreement.

Article 10. Registration for Circulation of Transferred Technology Drugs

1. Transferred technology drugs when registering for circulation are classified as follows:

a) Transferred technology drugs that have the same content as the drugs before technology transfer, including: drug formulation; production process; raw material quality standard; finished drug quality standard; trade name;

If the drug before technology transfer is a basic drug or reference biological product announced by the Ministry of Health, and the transferred technology drug has changed compared to the drug before technology transfer in at least one of the criteria mentioned herein (excluding changes in trade name) or other changes related to drug quality, these changes must be approved by the drug regulatory authority of the producing country or the authority specified in Clause 9 of Article 2 of Circular No. 08/2022/TT-BYT which has granted circulation permission for the drug, or the registration entity must provide data proving that the transferred technology drug is equivalent in quality to the drug before technology transfer.

b) Other transferred technology drugs not falling under the case specified in point a of this clause.

2. For transferred technology drugs with a schedule for transferring technology stages of production in Vietnam, annually from the date of obtaining the registration certificate for circulation, the registration entity for transferred technology drugs or the technology receiving entity specified in point a of Clause 1 of this Article must report the progress of transferring technology stages of the finished drug production process in Vietnam to the Ministry of Health (Drug Administration Department) according to Form 04/TT - Appendix 1 issued together with this Circular.

3. The validity of the registration certificate for circulation of transferred technology drugs shall be implemented in accordance with Clause 1 and Clause 2 of Article 8 of Circular No. 08/2022/TT-BYT.

4. The time limit for submitting applications to extend the registration certificate for circulation of transferred technology drugs shall be carried out in accordance with Clause 4 of Article 8 of Circular No. 08/2022/TT-BYT.

Chapter IV

DOCUMENTS AND PROCEDURES FOR ISSUING, EXTENDING, MODIFYING, SUPPLEMENTING, AND REVOKING THE REGISTRATION CERTIFICATE FOR CIRCULATION OF COMPOUNDED DRUGS AND TRANSFERRED TECHNOLOGY DRUGS IN VIETNAM

Article 11. Provisions on the registration dossier for processed drugs and technology transferred drugs

1. Language used in the registration dossier: The registration dossier for processed drugs and technology transferred drugs must be written in Vietnamese or English. The drug usage instructions and product characteristics summary must be written in Vietnamese.

2. The registration dossier for processed drugs and technology transferred drugs shall be prepared according to the model issued together with this Circular: Cover page (Model 01/TT - Appendix 1) and arranged in accordance with the correct sequence of the table of contents (Model 05/TT Appendix 1). The following documents must be compiled into separate parts and accompanied by one application form:

a) Bioequivalence research documentation;

b) Preclinical and clinical documentation.

3. The registration dossier must bear the confirmation stamp of the registering entity or the processing drug manufacturing entity, the technology receiving entity for drug production (the drug manufacturing entity) at the first page of each part throughout the entire dossier (acceptance of the representative office stamp for foreign registering entities).

For documents provided by the entity placing orders for processed drugs or the entity transferring technology for drug production, such documents must bear the confirmation stamp of that entity. In cases where the entity placing orders for processed drugs or the entity transferring technology for drug production does not use stamps as required by the local regulations, the registering entity for processed drugs or the registering entity for technology transferred drugs must affix their confirmation stamp on these documents, commit to the fact that the local regulations of the entity placing orders for processed drugs or the entity transferring technology for drug production do not require the use of stamps, and assume responsibility for the authenticity of these documents.

4. Drugs may be registered in the same dossier when they share the following common factors: drug name; dosage form; route of administration; drug quality standards; name and address of the manufacturer (processing drug manufacturing entity or technology receiving entity for drug production); same formulation, wherein:

a) Solid dosage forms with divided doses: Having the same active ingredient content per dose unit;

b) Solid dosage forms without divided doses, liquid or semi-solid dosage forms having the same concentration or active ingredient content; injectable or infusion dosage forms having the same concentration or active ingredient content and direct contact packaging material.

5. Provisions for documents in the dossier requesting issuance, extension, change, or supplementation of the drug circulation registration certificate for processed drugs and technology transferred drugs shall be implemented in accordance with Article 22 of Circular No. 08/2022/TT-BYT.

6. Quantity of documents to be submitted in the dossier requesting issuance, extension of the drug circulation registration certificate, specifically as follows:

a) One complete set of dossier in accordance with Article 12 of this Circular;

b) In addition to the documents under point a of Clause 6 of this Article, an additional one complete copy of the dossier is required for vaccines and biological products, and two copies of the documents including the application form, quality standards, and testing methods for other cases;

c) Two sets of sample drug labels and drug usage instructions intended for circulation, bearing the confirmation stamp of the registering entity (acceptance of the representative office stamp for foreign registering entities) or the manufacturing entity. Drug labels are attached and designed on A4 size paper. In case of online submission, the entity only needs to submit one set of sample drug labels and drug usage instructions.

7. Quantity of documents to be submitted in the dossier requesting changes or supplements to the drug circulation registration certificate;

a) One complete set of documents in accordance with Article 15 of this Circular;

b) Two sets of sample drug labels and drug usage instructions proposed for changes in the case of label or usage instruction changes, bearing the confirmation stamp of the registering entity (acceptance of the representative office stamp for foreign registering entities) or the manufacturing entity. Drug labels are attached and designed on A4 size paper. In case of online submission, the entity only needs to submit one set of sample drug labels and drug usage instructions.

8. Provisions on the application of online dossiers:

The application of online dossiers shall be carried out in accordance with Clause 6 of Article 6 of Circular No. 08/2022/TT-BYT.

9. Drug registration fee: The registering entity for processed drugs and technology transferred drugs must pay the fee in accordance with current laws on fees and charges.

10. Verification of the authenticity of legal documents in the registration dossier for processed drugs and technology transferred drugs shall be carried out in accordance with Article 12 of Circular No. 08/2022/TT-BYT.

Article 12. Documents for Application to Obtain a Registration Certificate for Processed Medicines and Technology Transfer Medicines

1. Documents for Application to Obtain a Registration Certificate for Processed Medicines and Technology Transfer Medicines in cases where the processed medicines or pre-transfer technology medicines have an existing valid registration certificate in Vietnam at the time of submission:

a) Administrative documents

- Application form according to Model 02A/TT - Appendix 1 issued together with this Circular;

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

- Documents specified in Point e Clause 1 Article 23 of Circular No. 08/2022/TT-BYT for foreign registering entities;

- Documents specified in Point đ Clause 1 Article 23 of Circular No. 08/2022/TT-BYT for domestic registering entities;

- Documents specified in Point h Clause 1 Article 23 of Circular No. 08/2022/TT-BYT, except in cases where only processing or only technology transfer of packaging steps is involved;

- Processing contract or technology transfer contract;

In cases where the processing entity and the receiving entity are not the registering entity, the processing contract must be signed by the legal representative of the processing entity, the registering entity, and the receiving entity;

- Permit for foreign traders to process medicines as specified in Point e Clause 2 Article 4 of this Circular for applications for processed medicines;

- Certificate of registration for technology transfer as stipulated in Clause 1 Article 31 of the Law on Technology Transfer for applications for technology transfer medicines;

- Processing schedule for processed medicines as specified in Clause 2 Article 6 or technology transfer schedule for technology transfer medicines as specified in Clause 2 Article 10 of this Circular according to Model 03/TT - Appendix 1 issued together with this Circular.

b) Quality documents:

- Quality documents for chemical medicines, vaccines, and biological products as provided for in Article 13 of this Circular;

- Quality documents for herbal medicines as provided for in Article 14 of this Circular.

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

Requirements for clinical data to ensure safety and efficacy and criteria for determining cases exempt from trials or certain trial phases, and medicines that must undergo Phase 4 clinical trials in Vietnam as stipulated in Chapter II of Circular No. 08/2022/TT-BYT.

d) Documents of processed medicines or pre-transfer technology medicines:

Reports on monitoring and evaluating safety and efficacy; usage situation of medicines according to Model 2/TT issued together with Circular No. 08/2022/TT-BYT for processed medicines or pre-transfer technology medicines that require monitoring and evaluation reports on safety and efficacy as stipulated in Clause 2 Article 5 of Circular No. 08/2022/TT-BYT.

2. Documents for Application to Obtain a Registration Certificate for Processed Medicines and Technology Transfer Medicines in cases where the processed medicines or pre-transfer technology medicines do not have a registration certificate in Vietnam or the registration certificate has expired at the time of submission.

a) Administrative documents:

- Application form according to Model 02A/TT - Appendix 1 issued together with this Circular;

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

- Documents specified in Point e Clause 1 Article 23 of Circular No. 08/2022/TT-BYT for foreign registering entities;

- Documents specified in Point đ Clause 1 Article 23 of Circular No. 08/2022/TT-BYT for domestic registering entities;

- Processing contract or technology transfer contract;

In cases where the processing entity and the receiving entity are not the registering entity, the processing contract must be signed by the legal representative of the processing entity, the registering entity, and the receiving entity;

- Permit for foreign traders to process medicines as specified in Point e Clause 2 Article 4 of this Circular for applications for processed medicines;

- Certificate of registration for technology transfer as stipulated in Clause 1 Article 31 of the Law on Technology Transfer for applications for technology transfer medicines;

- Processing schedule for processed medicines as specified in Clause 2 Article 6 or technology transfer schedule for technology transfer medicines as specified in Clause 2 Article 10 of this Circular according to Model 03/TT - Appendix 1 issued together with this Circular.

b) Quality documents:

- Quality documents for chemical medicines, vaccines, and biological products as provided for in Article 13 of this Circular;

- Quality documents for herbal medicines as provided for in Article 14 of this Circular;

c) Preclinical and clinical documents for new chemical medicines, vaccines, and biological products as provided for in Articles 25 and 26 of Circular No. 08/2022/TT-BYT, except in cases where the processed medicines or pre-transfer technology medicines are new chemical medicines already having preclinical and clinical documents submitted under Point đ Clause 2 of this Article;

Requirements for clinical data to ensure safety and efficacy and criteria for determining cases exempt from trials or certain trial phases, and medicines that must undergo Phase 4 clinical trials in Vietnam as stipulated in Chapter II of Circular No. 08/2022/TT-BYT.

đ) Safety and efficacy documents for herbal medicines as provided for in Article 29 of Circular No. 08/2022/TT-BYT;

đ) Documents of processed medicines or pre-transfer technology medicines:

- Documents as specified for applications for registration certificates for new chemical medicines, vaccines, and biological products under Points b, c, d Clause 1 Article 27 of Circular No. 08/2022/TT-BYT or generic medicines under Point b Clause 2 Article 27 of Circular No. 08/2022/TT-BYT or herbal medicines under Points b, c Clause 1 Article 30 of Circular No. 08/2022/TT-BYT;

- Product Certification (CPP) of processed medicines or pre-transfer technology medicines as specified in Point c Clause 4 Article 22 of Circular No. 08/2022/TT-BYT in cases where the processed medicines or pre-transfer technology medicines are foreign medicines.

3. Documents for Application to Obtain a Registration Certificate for Processed Medicines with Technology Transfer of Medicine Production from the Processing Entity to the Receiving Entity:

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

b) Technology transfer contract;

c) Certificate of registration for technology transfer as stipulated in Clause 1 Article 31 of the Law on Technology Transfer.

Article 13. Provisions on quality documents in the registration dossier for processed drugs, technology transfer drugs that are chemical drugs, vaccines, biological products.

Quality documents in the registration dossier for processed drugs, technology transfer drugs that are chemical drugs, vaccines, biological products shall be implemented according to the guidance in Part II-ACTD or Section 3-ICH-CTD, as stipulated in Clauses 1, 2, 3, and Clause 5, Article 24 of Circular No. 08/2022/TT-BYT, and the following documents:

1. Quality documents of the drug to be processed or the drug before technology transfer in cases where the drug to be processed or the drug before technology transfer has not been granted a registration certificate for circulation in Vietnam: shall be implemented according to the guidance in Part II-ACTD as stipulated in Appendix I issued together with Circular No. 08/2022/TT-BYT or Section 3-TCH-CTD.

2. Detailed comparison table of changes (if any) between the drug to be processed and the processed drug or between the drug before technology transfer and the technology transferred drug, and technical documents according to the guidance in Appendix II issued together with Circular No. 08/2022/TT-BYT.

3. The active substance dossier part of the processed drug provided by the processing drug receiving entity or of the technology transferred drug provided by the technology transferring drug receiving entity when there is a change in the active substance manufacturing site compared to the drug to be processed or the drug before technology transfer.

4. The finished product dossier part of the processed drug carried out by the processing drug receiving entity or of the technology transferred drug carried out by the technology transferring drug production receiving entity, including:

a) Production process specifications for the processed drug or technology transferred drug;

b) Production process validation report (for production stages carried out at the processing drug receiving entity or technology transferring drug receiving entity);

c) Suitability evaluation report of the analytical procedure (which may be replaced by the analytical procedure transfer dossier jointly conducted by the processing drug placing entity and the processing drug receiving entity or by the technology transferring drug production placing entity and the technology transferring drug production receiving entity);

d) Batch analysis data, Finished Product Test Report;

đ) Stability data: submit stability research data for the registered drug according to Point 4.7.9 of the ASEAN Guidelines on Drug Stability Research - Part II Appendix I issued together with Circular No. 08/2022/TT-BYT.

In cases where the drug to be processed or the drug before technology transfer does not have stability data in Region IVb: submit stability research data for the registered drug in Region IVb according to the ASEAN Guidelines on Drug Stability Research as stipulated in the ASEAN Guidelines on Drug Stability Research - Part II Appendix I issued together with Circular No. 08/2022/TT-BYT;

e) Bioequivalence study report documentation of the processed drug, technology transferred drug proposed to be classified as original brand-name drug, bioequivalent drug (including: drugs required to submit a bioequivalence study report according to Circular No. 07/2022/TT-BYT dated September 5, 2022, of the Minister of Health on drugs requiring bioequivalence testing and requirements for bioequivalence data reporting dossiers in drug circulation registration in Vietnam, drugs not required to submit a bioequivalence study report according to the Minister of Health's regulations but the registration entity requests classification as an original brand-name drug, bioequivalent drug). The registration entity may replace this with a dissolution equivalence study report between the processed drug and the drug to be processed or between the technology transferred drug and the drug before technology transfer if they meet the following conditions simultaneously:

- The drug to be processed, drug before technology transfer has been granted a registration certificate for circulation in Vietnam and has been announced as an original brand-name drug, bioequivalent drug or has requested classification as an original brand-name drug, bioequivalent drug; the drug to be processed, drug before technology transfer has not been granted a registration certificate for circulation in Vietnam and has requested classification as an original brand-name drug, bioequivalent drug when registering the drug;

- The processed drug, technology transferred drug have the same formulation, production process, raw material quality standards, finished product quality standards with the drug to be processed, drug before technology transfer. In cases where there are changes related to these contents and such changes fall within levels not requiring submission of a bioequivalence study report of the drug, the registration entity must submit appropriate dossiers and documents for each change according to the guidance on scale-up batches and post-approval changes for solid oral dosage forms of US-FDA (SUPACs).

5. For processed drugs, technology transferred drugs involving secondary packaging stages, there is no requirement for documents as stipulated in Point đ, e Clause 4 of this Article.

Article 14. Provisions on quality documents in the application dossier for processing and technology transfer of medicinal drugs

Quality documents in the application dossier for processed drugs and technology transferred drugs that are medicinal drugs shall be implemented in accordance with Article 28 of Circular No. 08/2022/TT-BYT and the following documents:

1. Quality documents of the drug to be processed or the drug before technology transfer in cases where the drug to be processed or the drug before technology transfer has not been granted a registration certificate for circulation in Vietnam: shall be implemented in accordance with Article 28 of Circular No. 08/2022/TT-BYT.

2. A detailed comparison table of changes (if any) between the drug to be processed and the processed drug or between the drug before technology transfer and the technology transferred drug, and technical documents according to the guidance provided in Appendix II issued together with Circular No. 08/2022/TT-BYT.

3. Dossier carried out by the entity receiving the drug processing or the entity receiving the technology transfer production:

a) Raw materials: herbal medicine test report or semi-finished herbal medicine test report, herbal extract test report;

b) Finished products: finished product test report; stability research report according to the stability research guidance specified in Part II of Appendix I issued together with Circular No. 08/2022/TT-BYT.

Article 15. Dossier for requesting changes and supplements to the registration certificate for circulation of processed drugs and technology transferred drugs

1. Request form for changes and supplements according to Form 02C/TT - Appendix I issued together with this Circular.

2. The dossier for requesting changes and supplements to the registration certificate for circulation of processed drugs and technology transferred drugs shall be implemented in accordance with the provisions at Appendix II of Circular No. 08/2022/TT-BYT.

For changes related to the technical dossier of processed drugs and technology transferred drugs, the entity registering the processed drug or the entity registering the technology transferred drug must provide evidence that the contents of the changes for the drug to be processed or the drug before technology transfer have been approved by the competent authority.

For vaccines from the same manufacturing entity or owner of the drug circulation permit, changes in the location of the manufacturing facility within the same country or outside the country where the registration certificate for circulation was granted are acceptable.

3. Changes related to the entity placing the drug for processing

a) Change of name and address of the entity placing the drug for processing, update information related to the entity placing the drug for processing (the entity placing the drug for processing does not change): The dossier shall be implemented in accordance with the regulations on changing the name and address of the registered company (MiV-N1) Section 7 of Appendix II issued together with Circular No. 08/2022/TT-BYT;

b) Change of the entity placing the drug for processing:

Documents and materials to be submitted;

- Document showing the transfer of rights and responsibilities between the old entity placing the drug for processing and the new entity placing the drug for processing in the implementation of the processing contract submitted in the drug registration dossier;

- Document of the new entity placing the drug for processing committing that the location of the drug processing manufacturing facility will not change and committing to continue performing the rights and responsibilities of the entity placing the drug for processing according to the drug processing registration dossier already granted a registration certificate for circulation in Vietnam.

4. Changes related to the entity transferring technology for drug production

a) Change of name and address of the entity transferring technology for drug production, update information related to the entity transferring technology for drug production (the entity transferring technology for drug production does not change); The dossier shall be implemented in accordance with the regulations on changing the name and address of the registered company (MiV-N1) Section 7 of Appendix II issued together with Circular No. 08/2022/TT-BYT;

b) Change of the entity transferring technology for drug production

Documents and materials to be submitted:

- Document of the entity transferring technology for drug production changing announcing the continued implementation of the technology transfer contract for drug production with the previous entity;

- Certificate of registration for technology transfer change (if any).

Article 16. Documents for Application to Extend the Drug Registration Certificate for Contract Manufacturing Drugs and Technology Transfer Drugs

1. Application form according to Model 02B/TT - Appendix 1 issued together with this Circular.

2. Contract for contract manufacturing or technology transfer contract.

3. Chemical drugs, vaccines, biological products: The application for extending the drug registration certificate for contract manufacturing drugs and technology transfer drugs shall be carried out in accordance with the provisions of Clause 3, Article 27 of Circular No. 08/2022/TT-BYT.

4. Herbal drugs: The application for extending the drug registration certificate for contract manufacturing drugs and technology transfer drugs shall be carried out in accordance with the provisions of Clause 2, Article 30 of Circular No. 08/2022/TT-BYT.

5. Progress report on the implementation of the contract manufacturing schedule for contract manufacturing drugs as stipulated in Clause 2, Article 6 or progress report on the implementation of the technology transfer schedule for technology transfer drugs as stipulated in Clause 2, Article 10 according to Model 04/TT - Appendix 1 issued together with this Circular.

Article 17. Procedures for Issuing, Extending, Amending, and Supplementing the Drug Registration Certificate for Contract Manufacturing Drugs and Technology Transfer Drugs

1. Procedure for issuing the drug registration certificate for contract manufacturing drugs and technology transfer drugs in cases where the drugs to be manufactured under contract or transferred technology already have a valid registration certificate in Vietnam at the time of submission of the application:

a) Within three months from the date of receipt of all documents, the Drug Administration of Vietnam shall issue the drug registration certificate for contract manufacturing drugs and technology transfer drugs. In case of non-issuance or delay in issuance, the Drug Administration of Vietnam shall provide a written response stating the reasons. The time limits for each step are specified as follows:

- Within eight working days from the date of receiving the application, the Drug Administration of Vietnam shall review and classify the documents and send them to the experts or units for assessment. Within one month from the date of receiving the documents from the Drug Administration of Vietnam, the experts or units for assessment must complete the assessment record and submit it to the Drug Administration of Vietnam for consolidation and conclusion in accordance with Clause 4, Article 35 of Circular No. 08/2022/TT-BYT;

- Within twelve working days from the date of receiving the assessment record, the Drug Administration of Vietnam shall provide a written response to applications that do not meet the requirements and state the reasons. For applications proposed for issuance, non-issuance, or requiring further assessment and consultation from the Advisory Council for Drug Registration and Raw Materials (hereinafter referred to as the Council), the Drug Administration of Vietnam shall transfer the documents to the Council's Office to organize a meeting of the Council;

- Within six working days from the date of receiving the documents from the Drug Administration of Vietnam, the Council's Office shall organize a meeting of the Council and submit the minutes of the meeting to the Drug Administration of Vietnam;

- Within eighteen working days from the date of receiving the minutes of the meeting, the Drug Administration of Vietnam shall issue a decision to grant the drug registration certificate for contract manufacturing drugs and technology transfer drugs for applications that meet the requirements; the Drug Administration of Vietnam shall provide a written response based on the Council's conclusions for applications that do not meet the requirements and state the reasons.

b) Within thirty-six months for cases requiring additional preclinical and clinical data, bioequivalence data, stability study data, or within twelve months for other additional data, from the date of the Drug Administration of Vietnam's notification, the applicant must submit the additional data as required. After this period, if the applicant does not submit the additional data, the submitted application will lose its validity.

The applicant may update information related to the safety and efficacy of the drug or legal documents of the applicant, drug manufacturer, and raw material supplier compared to the previously submitted documents by providing written notice to the Drug Administration of Vietnam during the assessment period.

The time from the date of the Drug Administration of Vietnam's notification to the date the applicant submits additional data shall not be included in the time limit stipulated in Point c, Clause 5, Article 56 of the Drug Law.

c) Within three months from the date of receipt of all additional documents, the Drug Administration of Vietnam shall issue a decision to grant the drug registration certificate for contract manufacturing drugs and technology transfer drugs for applications that meet the requirements; the Drug Administration of Vietnam shall provide a written response based on the Council's conclusions for applications that do not meet the requirements and state the reasons.

The procedures and time limits for reviewing additional documents shall be carried out in accordance with the provisions of Point a, Clause 1 of this Article.

2. Procedure for issuing the drug registration certificate for contract manufacturing drugs and technology transfer drugs in cases where the drugs to be manufactured under contract or transferred technology do not have a registration certificate in Vietnam or the registration certificate has expired at the time of submission of the application:

a) Within a maximum of nine months from the date of receipt of all documents, the Drug Administration of Vietnam shall issue the drug registration certificate for contract manufacturing drugs and technology transfer drugs. In case of non-issuance or delay in issuance, the Drug Administration of Vietnam shall provide a written response stating the reasons. The time limits for each step are specified as follows:

- Within two months from the date of receiving the application, the Drug Administration of Vietnam shall review and classify the documents and send them to the experts or units for assessment. Within four months from the date of receiving the documents from the Drug Administration of Vietnam, the experts or units for assessment must complete the assessment record and submit it to the Drug Administration of Vietnam for consolidation and proposal on the assessment record in accordance with Clause 4, Article 35 of Circular No. 08/2022/TT-BYT;

- Within one month from the date of receiving the assessment record, the Drug Administration of Vietnam shall provide a written response to applications that do not meet the requirements and state the reasons. For applications proposed for issuance, non-issuance, or requiring further assessment and consultation from the Council, the Drug Administration of Vietnam shall transfer the documents to the Council's Office to organize a meeting of the Council;

- Within one month from the date of receiving the documents from the Drug Administration of Vietnam, the Council's Office shall organize a meeting of the Council and submit the minutes of the meeting to the Drug Administration of Vietnam;

- Within one month from the date of receipt of the minutes of the Council meeting, the Drug Administration shall issue a decision to grant the drug registration certificate for processed drugs and technology transfer drugs for applications that meet the requirements; the Drug Administration shall provide a written response according to the Council's conclusion for applications that do not meet the requirements, and clearly state the reasons.

b) Within thirty-six months for cases requiring additional preclinical and clinical data, bioequivalence data, stability study data, or within twelve months for other additional data, from the date of the Drug Administration of Vietnam's notification, the applicant must submit the additional data as required. After this period, if the applicant does not submit the additional data, the submitted application will lose its validity.

The applicant is permitted to update in writing to the Drug Administration about the submitted registration dossier and the dossier currently under review in cases where information related to the safety and efficacy of the drug or legal documents of the applicant, the drug manufacturer, and the raw material supplier differ from the previously submitted dossier.

The time from the date of the Drug Administration of Vietnam's notification to the date the applicant submits additional data shall not be included in the time limit stipulated in Point c, Clause 5, Article 56 of the Drug Law.

- Within four months from the date of receipt of all supplementary documents, the Drug Administration shall issue a decision to grant the drug registration certificate for processed drugs and technology transfer drugs for applications that meet the requirements, or provide a written response for applications that do not meet the requirements according to the Council's conclusion, or provide a written response for applications that have not met the requirements and clearly state the reasons. The time frame for processing each step is specified as follows:

- Within twelve working days from the date of receiving the dossier, the Drug Administration shall conduct a review, classification, and send the dossier to the experts or units for assessment. Within one month from the date of receipt of the dossier from the Drug Administration, the experts or units for assessment must complete the assessment report and submit it to the Drug Administration for consolidation and recommendation on the assessment report in accordance with Clause 4, Article 35 of Circular No. 08/2022/TT-BYT.

- Within one month from the date of receipt of the assessment report, the Drug Administration shall provide a written response for applications that do not meet the requirements and clearly state the reasons. For applications proposed by the Drug Administration to be granted, not granted, or require the Council's opinion and advice, the Drug Administration shall transfer them to the Council Office for the Council to convene a meeting.

- Within one month from the date of receipt of the documents from the Drug Administration, the Council Office shall organize a Council meeting and send the Council meeting minutes back to the Drug Administration.

- Within ten working days from the date of receipt of the Council meeting minutes, the Drug Administration shall issue a decision to grant the drug registration certificate for processed drugs and technology transfer drugs for applications that meet the requirements; the Drug Administration shall provide a written response according to the Council's conclusion for applications that do not meet the requirements, and clearly state the reasons.

3. The procedure for granting the drug registration certificate for processed drugs with technology transfer from the drug commissioning entity to the drug processing entity shall be carried out in accordance with the provisions of Clause 1 of this Article if the commissioned drug has an existing valid drug registration certificate in Vietnam at the time of submission of the application, or in accordance with the provisions of Clause 2 of this Article if the commissioned drug does not have a drug registration certificate in Vietnam or the drug registration certificate has expired at the time of submission of the application.

4. The drug registration certificate for processed drugs and technology transfer drugs shall be issued jointly for the drugs specified in Point a, Clause 4, Article 11 of this Circular, or separately for multiple drug registration certificates for the drugs specified in Point b, Clause 4, Article 11 of this Circular.

5. The procedures for extending, changing, and supplementing the drug registration certificate for processed drugs and technology transfer drugs shall be implemented in accordance with the regulations stipulated in Articles 37 and 38 of Circular No. 08/2022/TT-BYT.

6. The authority to grant, extend, change, and supplement the drug registration certificate for processed drugs and technology transfer drugs shall be implemented in accordance with the provisions of Article 34 of Circular No. 08/2022/TT-BYT.

7. General provisions regarding the procedures for granting, extending, changing, and supplementing the drug registration certificate for processed drugs and technology transfer drugs shall be implemented in accordance with the provisions of Article 35 of Circular No. 08/2022/TT-BYT.

Article 18. Revocation of registration certificates for circulation, suspension of acceptance of applications for issuance and extension of registration certificates for processed drugs and technology transfer drugs

1. The authority to revoke and the responsibility to notify revocation of registration certificates for circulation shall be implemented in accordance with the provisions of Clause 1, Article 40 of Circular No. 08/2022/TT-BYT.

2. The procedures for revoking registration certificates for circulation of processed drugs and technology transfer drugs shall be implemented in accordance with the provisions of Article 40 of Circular No. 08/2022/TT-BYT.

3. Cases of suspension of acceptance of applications for issuance and extension of registration certificates for processed drugs and technology transfer drugs shall be implemented in accordance with the provisions of Article 41 of Circular No. 08/2022/TT-BYT.

Chapter V

EFFECTIVE DATE

Article 19. Effective Date

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

2. Circular No. 23/2013/TT-BYT dated August 13, 2013, guiding the operation of drug processing issued by the Minister of Health shall cease to be effective from the date this Circular takes effect.

Article 20. Transitional Provisions

1. Applications submitted before the date this Circular takes effect shall continue to be processed in accordance with the regulations at the time of submission, except where the registering entity requests otherwise in a supplementary document or voluntarily requests to follow the new regulations from the date of issuance of this Circular.

2. Processed drugs and technology transfer drugs that have been granted registration certificates under previous regulations prior to the effectiveness of this Circular and which require publication according to Clause 1, Article 22 of this Circular must submit new application forms for registration certificates in accordance with the provisions of this Circular for review, assessment, and issuance of registration certificates.

Article 21. Reference Provisions

In cases where referenced documents in this Circular are replaced or amended, they shall be applied in accordance with the replaced or amended documents.

Article 22. Implementation organization

1. The Drug Administration Department is responsible for publishing on its official website and the Health and Life newspaper, in accordance with Appendix 2 attached to this Circular, the following lists:

a) List of processed drugs (without technology transfer for drug production) that have been issued or extended registration certificates in compliance with point a, Clause 1, Article 6 of this Circular;

b) List of processed drugs (with technology transfer for drug production) that have been issued or extended registration certificates in compliance with point a, Clause 1, Article 6 of this Circular;

c) List of technology transfer drugs that have been issued or extended registration certificates in compliance with point a, Clause 1, Article 10 of this Circular.

2. The Drug Administration Department will consider suspending or revoking the publication of processed drugs and technology transfer drugs on its official website and the Health and Life newspaper, in accordance with Clause 1 of this Article, based on the advisory opinions of the Council in the following circumstances:

a) Failure to report progress on the implementation of the processing route for processed drugs as stipulated in Clause 2, Article 6 or the technology transfer route for technology transfer drugs as stipulated in Clause 2, Article 10 of this Circular;

b) Drugs not meeting the processing route for stages of the drug production process in Vietnam or the technology transfer route for stages of the drug production process in Vietnam as submitted in the application for registration certificate;

c) Drugs no longer meeting the requirements set out in point a, Clause 1, Article 6 of this Circular for processed drugs or in point a, Clause 1, Article 10 of this Circular for technology transfer drugs.

3. Labeling of processed drugs and technology transfer drugs shall be carried out in accordance with Circular No. 01/2018/TT-BYT dated January 18, 2018, of the Minister of Health regarding labeling of drugs, raw materials for drugs, and instructions for use.

4. For processed drugs produced under contracts with foreign traders for circulation in Vietnam, after the processed drugs are granted registration certificates in accordance with the regulations, the relevant import and export procedures for processed drugs shall be carried out in accordance with Decree No. 69/2018/NĐ-CP.

5. Foreign-invested enterprises participating in drug processing activities shall implement the right to import and distribute drugs in accordance with Clause 10 and Clause 11, Article 91 of Decree No. 54/2017/NĐ-CP.

6. Each processed drug or technology transfer drug granted a registration certificate will have a drug registration number structured in accordance with Appendix VI of Circular No. 08/2022/TT-BYT. For processed drugs involving technology transfer for drug production, the drug group code in Appendix VI is defined as follows:

7. The Drug Administration Department shall return labels and instructions for use of processed drugs and technology transfer drugs to the registering entities in accordance with point m, Clause 1, Article 48 of Circular No. 08/2022/TT-BYT and publish the sources of raw materials for these drugs on its official website in accordance with point n, Clause 1, Article 48 of Circular No. 08/2022/TT-BYT.

8. For other matters related to the registration and circulation of processed drugs and technology transfer drugs in Vietnam not covered by this Circular, they shall be implemented in accordance with the relevant provisions of Circular No. 08/2022/TT-BYT.

Article 23. Responsibility for Implementation

1. The Drug Administration Department is responsible for guiding the implementation of the provisions of this Circular; it shall take the lead or coordinate with the Ministry of Health's Inspectorate and relevant departments and units to inspect and audit the implementation of this Circular by pharmaceutical production and trading units nationwide.

2. Provincial Departments of Health under central cities are responsible for inspecting and auditing the implementation of this Circular by pharmaceutical production and trading units within their jurisdiction.

3. Units under the Ministry of Health, Vietnam Pharmaceutical Corporation, and pharmaceutical production and trading units are responsible for implementing this Circular.

During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals should reflect them to the Ministry of Health (Drug Administration Department) for consideration and resolution./.