Thông tư 04/2024/TT-BYT quy định về danh mục mua sắm tập trung cấp quốc gia đối với thuốc do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

PRESCRIBING LIST OF DRUGS PROCURED THROUGH NATIONAL CENTRALIZED PROCUREMENT

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

Pursuant to the Government’s Decree No. 24/2024/ND-CP dated February 27, 2024 on elaboration of and measures for implementation of the Bidding Law regarding contractor selection;

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

At the request of the Director General of the Department of Planning and Finance; the Director General of the Drug Administration of Vietnam;

The Minister of Health hereby promulgates a Circular prescribing the list of drugs procured through national centralized procurement.

Article 1. Scope

This Circular provides for rules and criteria for compiling the list of drugs procured through national centralized procurement and the list of drugs procured through national centralized procurement.

Article 2. Rules and criteria for compiling the list of drugs procured through national centralized procurement

A drug to be included in the list must fully adhere to the rules and criteria below:

1. The drug is procured in a large quantity and is of a similar category to serve demands of one or more authorities, organizations and units.

2. Drug of a similar category is a drug that is granted at least 03 marketing authorizations by at least 03 manufacturers and meets group 1 and group 2 technical standards according to the regulations on bidding for supply of drugs to public health facilities issued by the Minister of Health.

Article 3. List of drugs procured through national centralized procurement

The list of drugs procured through national centralized procurement is specified in the Appendix to this Circular.

Article 4. Effect

1. This Circular comes into force from April 20, 2024.

2. The Circular No. 15/2020/TT-BYT dated August 10, 2020 of the Ministry of Health promulgating the List of drugs procured through bidding, List of drugs procured through centralized bidding, and List of drugs procured through price negotiation and Article 2 of the Circular No. 15/2022/TT-BYT dated December 09, 2022 of the Minister of Health amending certain Articles and Appendices of 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 Circular No. 15/2020/TT-BYT dated August 10, 2020 of the Ministry of Health promulgating the List of drugs procured through bidding, List of drugs procured through centralized bidding, and List of drugs procured through price negotiation shall cease to have effect from the effective date of this Circular.

Article 5. Implementation

1. The unit assigned to organize national centralized procurement shall:

a) procure drugs on the list of drugs procured through national centralized procurement enclosed with this Circular through national centralized procurement;

b) issue a notification of:

- The list of drugs expected to be procured through national centralized procurement in the next period of national centralized procurement before March 15 of the year of notification;

- Availability or unavailability of the supplier selection result within 20 days from the date of obtaining a written confirmation that a supplier is yet to be selected or fails to be selected.

2. Units and local authorities shall proactively select drug suppliers as prescribed by law according to the notification issued by the unit assigned to organize national centralized procurement as specified in point b clause 1 of this Article.

3. Within 02 years, the Ministry of Health shall, according to current situation, rules and criteria for compiling the list specified in Article 2 of this Circular, amend the list of drugs procured through national centralized procurement.

Article 6. Responsibility for implementation

Chief of the Ministry Office, Director General of Department of Planning and Finance, Director General of Drug Administration of Vietnam, head of unit assigned to organize national centralized procurement, heads of other units, agencies, organizations and individuals concerned are responsible for the implementation of this Circular.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Health for consideration./.

APPENDIX

LIST OF DRUGS PROCURED THROUGH NATIONAL CENTRALIZED PROCUREMENT
(Enclosed with the Circular No. 04/2024/TT-BYT dated April 20, 2024 of the Minister of Health)

Note:

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”, “Injections” written in Column 4 are conventional dosage forms (Pills: Tablets, Capsules; Injections: Solution for injection, Suspension for injection, Emulsion for injection).

- Procuring units and health facilities are permitted to develop their own supplier 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 injections, Liposomal/nano/lipid complex injections, Intraocular injections, Long-acting injections, Metered-dose injection applicators, etc.).