Circular 03/2024/TT-BYT List of drugs manufactured by at least 3 domestic manufacturers on pharmaceutical production lines meeting EU-GMP principles

CIRCULAR

Promulgating the List of drugs manufactured by at least 3 domestic manufacturers on pharmaceutical production lines meeting EU-GMP principles and standards or equivalent and meeting the Ministry of Health’s technical criteria as well as quality, price and supply capacity criteria

Pursuant to April 6, 2016 Law No. 105/2016/QH13 on Pharmacy;

Pursuant to June 23, 2023 Law No. 22/2023/QH15 on Bidding;

Pursuant to the Government’s Decree No. 95/2022/ND-CP of November 15, 2022, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration of Vietnam,

The Minister of Health promulgates the list of drugs manufactured by at least 3 domestic manufacturers on pharmaceutical production lines meeting EU-GMP principles and standards or equivalent and meeting the Ministry of Health’s technical criteria as well as quality, price and supply capacity criteria.

Article 1. Scope of regulation

This Circular provides principles and criteria for formulation, promulgation and announcement of the list of drugs manufactured by at least 3 domestic manufacturers on pharmaceutical production lines meeting EU-GMP principles and standards or equivalent and meeting the Ministry of Health’s technical criteria as well as quality, price and supply capacity criteria (below referred to as the Drug List).

Article 2. Principles and criteria for formulation of the Drug List

To be included in the Drug List, a drug must fully meet the following principles and criteria:

1. It is accompanied by at least 3 (three) circulation registration certificates of at least 3 (three) domestic manufacturers meeting EU-GMP principles and standards or equivalent and meeting technical criteria for drugs of group 1 or group 2 specified in the Minister of Health’ Circular on bidding for procurement of drugs at public medical facilities.

2. The price of the drug, for domestically produced drugs (the average bid-winning price calculated by the average method) must not exceed the price of an imported drug with equivalent technical criteria (in accordance with the Bidding Law’s provisions on preferences for domestically produced drugs).

3. The manufacturer is capable of supplying the drug to medical facilities.

Article 3. Promulgation and publishing of the Drug List

1. To promulgate together with this Circular the List of 93 drugs manufactured by at least 3 domestic manufacturers on pharmaceutical production lines meeting EU-GMP principles and standards or equivalent and meeting the Ministry of Health’s technical criteria as well as quality, price and supply capacity criteria.

2. To publish the List of 93 drugs provided in the Appendix to this Circular on the Ministry of Health’ Portal and the Drug Administration of Vietnam’s Website.

Article 4. Updating of the Drug List

Within 2 (two) years, based on the principles and criteria for formulation of the Drug List specified in Article 2 of this Circular and information on the average bid-winning price of drugs in the preceding year, the Drug Administration of Vietnam shall formulate and submit to the Minister of Health a circular on updating of the Drug List for promulgation.

Article 5. Effect

1. This Circular takes effect on the date of its signing.

2. The Minister of Health’s Circular No. 03/2019/TT-BYT of March 28, 2019, promulgating the List of domestically produced drugs meeting medical treatment, drug pricing and supply capacity; and Article 1 of the Minister of Health’s Circular No. 15/2022/TT-BYT of December 9, 2022, amending and supplementing a number of articles of, and Appendix to, the Minister of Health’s Circular No. 03/2019/TT-BYT of March 28, 2019, promulgating the List of domestically produced drugs meeting medical treatment, drug pricing and supply capacity, and the Minister of Health’s Circular No. 15/2020/TT-BYT of August 10, 2020, promulgates the List of drugs subject to bidding, the List of drugs subject to centralized bidding, and the List of drugs eligible for price negotiation, cease to be effective on the date this Circular takes effect.

Article 6. Transitional provisions

Bidding packages for which contractor selection plans have been approved and bidding dossiers or dossiers of requirements have been issued before the effective date of this Circular must comply with the regulations issued before the effective date of this Circular and still in effect, except cases in which medical units and facilities voluntarily apply this Circular from the effective date of this Circular.

Article 7. Implementation responsibility

1. The Chief of the Office, Director of the Drug Administration of Vietnam, Director of the Planning-Finance Department, and heads of related units shall implement this Circular.

2. Any problems arising in the course of implementation of this Circular should be promptly reported to the Ministry of Health (the Drug Administration of Vietnam) for consideration and settlement.-

For the Minister of Health
Deputy Minister
DO XUAN TUYEN

* The Appendix to this Circular is not translated.