Chương V Thông tư 16/2023/TT-BYT: Hiệu lực thi hành

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.

Article 20. Transition clause

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.

2. The Drug Administration of Vietnam shall consider temporary suspension or revocation of medication declaration under lists of contract manufactured medicine, medicine of technology transfer on their website and on “Sức khỏe và Đời sống” Newspaper in accordance with Clause 1 of this Article on the basis of Council advice when:

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:

7. The Drug Administration of Vietnam shall return labels and package insert of contract manufactured medicine, medicine of technology transfer to applicants in accordance with Point m Clause 1 Article 48 of Circular No. 08/2022/TT-BYT and publicize medicinal ingredients of contract manufactured medicine, medicine of technology transfer on their website in accordance with Point n Clause 1 Article 48 of Circular No. 08/2022/TT-BYT.

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./.