Thông tư 03/2024/TT-BYT về Danh mục thuốc có ít nhất 03 hãng trong nước sản xuất trên dây chuyền sản xuất thuốc đáp ứng nguyên tắc, tiêu chuẩn EU-GMP hoặc tương đương EU-GMP và đáp ứng tiêu chí kỹ thuật theo quy định của Bộ Y tế và về chất lượng, giá, khả năng cung cấp

CIRCULAR

PROMULGATING LIST OF DRUGS MANUFACTURED BY AT LEAST 03 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, AVAILABILITY

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;

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

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

At the request of the Director General of Traditional Medicine Administration (TMA);

The Minister of Health hereby promulgates a list of drugs manufactured by at least 03 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, availability.

Article 1. Scope

This Circular provides for principles and criteria of compiling, promulgating and disclosing the list of drugs manufactured by at least 03 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, availability (hereinafter referred to as “list of drugs”).

Article 2. Principles and criteria of compiling the list of drugs

Each drug included in the list must satisfy all the principles and criteria bellows:

1. There are at least 03 (three) Marketing authorization approval certificates of at least 03 (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.

2. 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).

3. This drug must be adequate for health facilities.

Article 3. Promulgation and disclosure of the list of drugs

1. The list of 93 drugs manufactured by at least 03 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, availability is enclosed herewith.

2. The list of 93 drugs is disclosed in the Appendix enclosed herewith on the Web portal of the Ministry of Health and the website of the Traditional Medicine Administration.

Article 4. Update of the list of drugs

Within 02 (two) years, on the basis of principles and criteria for compiling the list of drugs specified in Article 2 of this Circular and information on average successful bids of drugs of the immediately preceding year, the Traditional Medicine Administration shall compile the list and submit it to the Minister of Health promulgating this Circular for update of the list of drugs.

Article 5. Effect

1. This Circular comes into force from the day on which it is signed.

2. The Circular No. 03/2019/TT-BYT dated March 28, 2019 of the Minister of Health promulgating list of domestically manufactured drugs meeting treatment requirements, drug prices and availability and Article 1 of Circular No. 15/2022/TT-BYT dated December 09, 2022 of the Minister of Health amending certain Articles and Appendices of Circular No. 03/2019/TT-BYT and Circular No. 15/2020/TT-BYT shall be invalid from the effective date of this Circular.

Article 6. Transitional provisions

If the contractor selection plan is approved and the request for proposals/bidding documents of a bidding package is issued before the effective date of this Circular, 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 this Circular from the effective date thereof.

Article 7. Implementation responsibilities

1. The Chief of the Ministry Office, the Director General of Traditional Medicine Administration, the Director of Department of Planning and Finance, Heads of relevant units are responsible for implementation of this Circular.

2. Agencies, organizations and individuals should report difficulties that arise during the implementation of this Circular to the Ministry of Health (via the Traditional Medicine Administration) for consideration and settlement./.

APPENDIX

LIST OF 93 DRUGS MANUFACTURED BY AT LEAST 03 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, AVAILABILITY
(enclosed with Circular No. 03/2024/TT-BYT  dated April 16, 2024 of the Minister of Health)

Notes:

1. Regarding names of active ingredients of drugs:

- If the name of a drug is different from the name of the active ingredient (chemical name) in Column (2) and is written in specialized pharmaceutical documents (such as Pharmacopoeia, National Pharmacopoeia and other documents), the drug still belongs to the list (E.g. Paracetamol or Acetaminophen; Acyclovir or Aciclovir; Cefuroxime or Cefuroxim; Sodium or Natri; Hydrochloride or Hydroclorid, etc.).

- If the salt base of an active ingredient in Column (2) is not specified, different salts of this active ingredient, after being converted into bases with the same concentrations and content in Column (3) (with the same indications and dosage) still belong to the list.

2. The bidding for a drug whose dosage form is different from that written in Column (4) shall comply with regulations on drug bidding.

3. “Regarding dosage forms written in Column (4):

- Dosage forms "Tablets/capsules", "Injectables" written in Column 4 are conventional dosage forms (Pills: Tablets, Capsules; Injectables: Solution for injection, Suspension for injection, Emulsion for injection).

- Procuring units and health facilities are permitted to develop their own contractor selection plans in which bidding documents and request for proposals permit bidders to offer imported drugs with special dosage forms or drugs with bioavailability that is different from conventional dosage forms (E.g. Enteric-coated tablets/capsules, Controlled-release tablets/capsules, Fast disintegrating tablets/capsules, Effervescent tablets, Sublingual tablets; Lyophilized injectables, Liposomal/nano/lipid complex injectables, Intraocular injectables, Long-acting injectables, Metered-dose injection applicators, etc.)”.

4. Imported drugs that fall into the Categories in Column (6) must not be offered.

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