Circular No. 03/2024/TT-BYT on the List of Medicines with at least three domestic manufacturers producing on drug production lines meeting EU-GMP principles, standards, or equivalent EU-GMP standards and technical criteria as prescribed by the Ministry of Health, and concerning quality, price, and supply capacity.

CIRCULAR

Issuing the list of drugs produced by at least three domestic manufacturers on drug production lines meeting EU-GMP principles and standards or equivalent EU-GMP and technical criteria set forth by the Ministry of Health regarding quality, price, and supply capacity

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

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

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 the list of drugs produced by at least three domestic manufacturers on drug production lines meeting EU-GMP principles and standards or equivalent EU-GMP and technical criteria set forth by the Ministry of Health regarding quality, price, and supply capacity. This Circular stipulates the principles, criteria for building, issuing, and announcing the list of drugs produced by at least three domestic manufacturers on drug production lines meeting EU-GMP principles and standards or equivalent EU-GMP and technical criteria set forth by the Ministry of Health regarding quality, price, and supply capacity (hereinafter referred to as the list of drugs).

Article 1. Scope of Regulation

Article 2. Principles and Criteria for Building the List of Drugs

Drugs included in the list must meet all of the following principles and criteria:

1. There must be at least three (three) registration certificates from at least three (three) domestic manufacturers meeting EU-GMP principles and standards or equivalent EU-GMP and technical criteria Groups 1 and 2 as prescribed in the Circular on bidding for drugs at public health facilities issued by the Minister of Health.

2. The price of domestically produced drugs (the average winning bid price calculated using the arithmetic mean method) must not be higher than the price of imported drugs with equivalent technical criteria (consistent with the preferential provisions for domestically produced drugs under the Bidding Law).

3. There must be the ability to supply drugs to healthcare facilities.

Article 3. Issuance and Announcement of the List of Drugs

1. Accompanying this Circular is the list of 93 drugs produced by at least three domestic manufacturers on drug production lines meeting EU-GMP principles and standards or equivalent EU-GMP and technical criteria set forth by the Ministry of Health regarding quality, price, and supply capacity.

2. Announce the list of 93 drugs attached to this Circular on the Ministry of Health's official website and the Drug Administration of Vietnam's website.

Article 4. Updating the List of Drugs

Within a maximum period of two (2) years, based on the principles and criteria for building the list of drugs as stipulated in Article 2 of this Circular and taking into account the average winning bid prices of the preceding year, the Drug Administration will develop and submit to the Minister of Health for issuance of a Circular updating the list of drugs.

2. Circular No. 03/2019/TT-BYT dated March 28, 2019, issued by the Minister of Health on the List of Domestic Drugs Meeting Treatment Requirements, Drug Prices, and Supply Capacity, and Article 1 of Circular No. 15/2022/TT-BYT dated December 9, 2022, issued by the Minister of Health amending and supplementing certain articles and appendices of Circular No. 03/2019/TT-BYT dated March 28, 2019, issued by the Minister of Health on the List of Domestic Drugs Meeting Treatment Requirements, Drug Prices, and Supply Capacity, and Circular No. 15/2020/TT-BYT dated August 10, 2020, issued by the Minister of Health on the List of Drugs for Tendering, Centralized Tendering List of Drugs, and List of Drugs Subject to Negotiated Pricing shall become invalid from the date this Circular takes effect.

Article 5. Effective Date

1. This Circular takes effect from the date of issuance.

For tender packages that have been approved for procurement plan selection and tender documents issued before the date this Circular takes effect, they may continue to be implemented according to the regulations prior to the date this Circular takes effect, except where units and healthcare facilities voluntarily implement the provisions of this Circular from the date it takes effect.

Article 6. Transitional Provisions

1. The Director of the Ministry's Office, the Director of the Drug Administration, the Director of the Planning and Finance Department, and the heads of related units are responsible for implementing this Circular.

Article 7. Responsibility for Implementation

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

- Government Office (Legal Department, Press Release Section,

ANNEX

03/2024/TT-BYT dated April
(Annexed to Circular No. 16, 2024 issued by the Minister of Health) Concentration - Content

Note:

1. Regarding the recording of the active ingredient name of the medicine:

- Medicines that are listed under a different legal name from the active substance name in Column (2), and this listing is recorded in pharmaceutical specialized documents (such as the Pharmacopoeia, National Pharmaceutical Handbook, and other documents), still fall within the list (For example: Paracetamol or Acetaminophen; Acyclovir or Aciclovir; Cefuroxime or Cefuroxim; Sodium or Natri; Hydrochloride or Hydroclorid...).

- In cases where the active substance in Column (2) is not listed in its salt form, medicines with different salt forms of this active substance, after being converted to the base form with the same concentration - quantity in Column (3) (if they have the same indication and treatment dose), still fall within the list.

2. The participation in bidding for medicines with a different preparation form from the preparation form recorded in Column (4) shall be carried out in accordance with the regulations on medicine bidding.

3. "Regarding the preparation form of medicines recorded in Column (4):

- The preparation form “Tablet”, “Injectable Medicine” recorded in Column 4 are standardized preparation forms (Tablet; Tablet, Capsule; Injectable Medicine: Injectable Solution, Injectable Suspension, Injectable Emulsion).

- Units and healthcare facilities may develop plans for selecting contractors, and in tender documents and request documents, it is specified that contractors can bid for imported medicines for special preparation forms or medicines with bioavailability different from standardized preparation forms (For example: Enteric-coated tablet, Controlled-release tablet, Fast-dissolving tablet, Effervescent tablet, Sublingual tablet; Freeze-dried injectable, Liposome/nano/lipid complex injectable, Ophthalmic injectable, Long-acting injectable, Pre-filled syringe injectable...).

4. Contractors are not allowed to bid for imported medicines for medicines with Technical Criteria Group recorded in Column (6).