Vietnam’s list of drugs manufactured by at least 3 domestic drug companies meeting EU-GM standards

Vietnam’s list of drugs manufactured by at least 3 domestic drug companies meeting EU-GM standards
Quốc Tuấn

On April 16, 2024, the Minister of Health of Vietnam promulgated Circular No. 03/2024/TT-BYT on promulgating the list of drugs manufactured by at least 3 domestic drug companies in processes that meet EU-GMP principles and standards or equivalents and technical specifications in accordance with regulations of the Ministry of Health concerning quality, price, and availability.

Vietnam’s list of drugs manufactured by at least 3 domestic drug companies meeting EU-GM standards

The Minister of Health of Vietnam promulgated the list of 93 drugs manufactured by at least 3 domestic drug companies in processes that meet EU-GMP principles and standards or equivalents and technical specifications in accordance with regulations of the Ministry of Health concerning quality, price, and availability enclosed with Circular No. 03/2024/TT-BYT.

The list of 93 drugs in the Appendix enclosed with Circular No. 03/2024/TT-BYT is disclosed on the web portal of the Ministry of Health of Vietnam and the website of the Vietnam Drug Administration. 

Within 2 (two) years, Vietnam Drug Administration shall, based on principles and criteria for compiling the list of drugs and information on average successful bids of drugs of the immediately preceding year, compile the list and submit it to the Minister of Health of Vietnam promulgating Circulars on the update on the list of drugs. 

Specifically, each drug included in the list must satisfy all of the following principles and criteria:

- There are at least 3 (three) Marketing Authorization Approval Certificates of at least 3 (three) domestic drug companies meeting EU-GMP principles and standards or equivalents and technical specifications of Category 1 and/or Category 2 in accordance with regulations in Circular prescribing bidding for supply of drugs for public health facilities promulgated by the Minister of Health of Vietnam.

- The domestic drug price (arithmetic mean of successful bids) must not exceed the price for imported drugs with equivalent specifications (in conformity with regulations of the Law on Bidding on incentives for domestically manufactured drugs).

- This drug must be adequate for health facilities.

See more details in Circular No. 03/2024/TT-BYT, effective as of April 16, 2024. Circular No. 03/2019/TT-BYT and Article 1 of Circular No. 15/2022/TT-BYT and Circular No. 15/2020/TT-BYT shall be annulled as of April 16, 2024. 

If the contractor selection plan is approved and the request for proposals/bidding documents of a bidding package is issued before April 16, 2024, the regulations that are applicable before the effective date of this Circular may be applied unless the health facility or procuring unit voluntarily applies the regulations of Circular No. 03/2024/TT-BYT from the effective date thereof.

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