What contents are included in the drug manufacturing contracts from 01/10/2023 in Vietnam?

What contents are included in the drug manufacturing contracts from 01/10/2023 in Vietnam?

From 15/8/2023, the Minister of Health promulgates the Circular 16/2023/TT-BYT on marketing authorization registration of contract manufactured medicine and medicine of technology transfer in Vietnam. 

Pursuant to Article 5 of the Circular 16/2023/TT-BYT, from 01/10/2023, in addition to satisfying provisions under Article 39 of Decree 69/2018/ND-CP, drug manufacturing contracts must contain:

- 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.

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

+ 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;

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

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

- Procedures for inspecting, supervising contract facilities.

- 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 of the Circular 16/2023/TT-BYT.

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

How to classify contract manufactured medicine for the purpose of registration for marketing authorization in Vietnam?

Pursuant to Clause 1 Article 6 of the Circular 16/2023/TT-BYT stipulating registration for marketing authorization of contract manufactured medicine as follows:

- 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 the Circular 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.

- Other contract manufactured medicine that does not fall under above cases.

What is the deadline for applying for extension of marketing authorization of contract manufactured medicine in Vietnam?

Pursuant to Clause 4 Article 6 of the Circular 16/2023/TT-BYT stipulating deadline for applying for extension of marketing authorization of contract manufactured medicine in Vietnam as follows:

Registration for marketing authorization of contract manufactured medicine

...

3. Effective period of marketing authorization of contract manufactured medicine shall conform to Clause 1 and Clause 2 Article 8 of Circular 08/2022/TT-BYT.

4. Deadline for applying for marketing authorization of contract manufactured medicine shall conform to Clause 4 Article 8 of Circular 08/2022/TT-BYT.

Pursuant to Article 8 of the Circular 08/2022/TT-BYT stipulating deadline for applying for extension of marketing authorization of contract manufactured medicine in Vietnam as follows:

Validity periods, symbols of marketing authorization and deadline for renewal; quantity of marketing authorization of drugs having same active ingredients or herbal ingredients, dosage form, route of administration, content or concentration in a dosage unit

...

4. Renewal deadline: Within 12 months before the expiration date of the marketing authorization, an application for renewal must be submitted.

As regulations above, the deadline for applying for extension of marketing authorization of contract manufactured medicine in Vietnam is within 12 months before the expiration date of the marketing authorization.

Best regards!