Circular No. 04/2024/TT-BYT stipulates the centralized procurement list at the national level for medicines issued by the Minister of Health.

CIRCULAR

Regulations on the centralized procurement list at the national level for medicines

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

Pursuant to Decree No. 24/2024/NĐ-CP dated February 27, 2024 of the Government detailing some provisions and measures to implement the Law on Bidding regarding the selection of contractors;

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;

Upon the proposal of the Director of the Department of Planning and Finance; the Director of the Drug Administration;

The Minister of Health issues this Circular stipulating the centralized procurement list at the national level for medicines.

Article 1. Scope of Regulation

This Circular stipulates the principles, criteria for building and the centralized procurement list at the national level for medicines.

Article 2. Principles and criteria for building the centralized procurement list at the national level for medicines

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

1. Medicines purchased in large quantities with similar types at one or more agencies, organizations, or units.

2. Similar types of medicines are those with at least three registration certificates from at least three production facilities meeting technical standards group 1, group 2 as prescribed by the Minister of Health regarding bidding for medicines at public health facilities.

Article 3. Centralized procurement list at the national level for medicines

The centralized procurement list at the national level for medicines is specified in the Appendix attached to this Circular.

Article 4. Effective date

1. This Circular takes effect from April 20, 2024.

2. Circular No. 15/2020/TT-BYT dated August 10, 2020 issued by the Ministry of Health on the List of Biddable Medicines, the List of Nationally Centralized Biddable Medicines, the List of Medicines Subject to Price Negotiation, and Article 2 of Circular No. 15/2022/TT-BYT dated December 9, 2022 issued by the Minister of Health amending and supplementing certain provisions and the Appendix of Circular No. 03/2019/TT-BYT dated March 28, 2019 issued by the Minister of Health on the List of Domestic Medicines Meeting Treatment Requirements, Medicine 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 Biddable Medicines, the List of Nationally Centralized Biddable Medicines, and the List of Medicines Subject to Price Negotiation shall be repealed from the date this Circular takes effect.

State-owned enterprises that have been assigned by the Ministry of Agriculture and Rural Development to conduct offshore wind power project surveys before the effective date of this Circular shall continue to implement according to the assigned documents; any new matters arising after the effective date of this Circular shall be implemented in accordance with the provisions of this Circular.

1. Units assigned the task of centralized procurement at the national level are responsible for:

a) Implementing centralized procurement at the national level for medicines listed in the Centralized Procurement List at the National Level issued together with this Circular;

b) Issuing written notifications:

- Regarding the list of medicines planned to be centrally procured in the next centralized bidding cycle before March 15 of the notification year;

- Regarding the absence or lack of results in selecting contractors within a maximum period of 20 days from the date of the document confirming the absence or inability to select a contractor.

2. Units and localities are responsible for proactively organizing the selection of contractors to purchase medicines according to the provisions of the law based on the notification of the unit assigned the task of centralized procurement at the national level as stipulated in point b, Clause 1, Article 1 of this Circular.

3. Within a maximum period of two years, based on actual circumstances and the principles and criteria for building the list stipulated in Article 2 of this Circular, the Ministry of Health will amend and supplement the centralized procurement list at the national level for medicines.

Article 6. Responsibility for Implementation

The Head of the Ministry's Office, the Director of the Department of Planning and Finance, the Director of the Drug Administration, the Heads of units assigned the task of centralized procurement at the national level, the Heads of units, and other related organizations and individuals are responsible for implementing this Circular. In the course of implementation, if there are difficulties, they are requested to promptly report to the Ministry of Health for consideration and resolution.

In the course of implementation, if there are difficulties, they are requested to promptly report to the Ministry of Health for consideration and resolution./.

ANNEX

NATIONAL CENTRALIZED PROCUREMENT LIST FOR MEDICINES
(Attached to Circular No. 04/2024/TT-BYT dated April 20, 2024 issued by the Minister of Health)

Note:

1. Regarding the recording of active ingredient names of medicines:

- If the name recorded in Column (2) differs from the active ingredient name in Column (2) but is recorded in pharmaceutical literature (such as the Pharmacopoeia, National Pharmaceutical Dictionary, and other materials), it still falls within the scope of the list (Example: Paracetamol or Acetaminophen; Acyclovir or Aciclovir; Cefuroxime or Cefuroxim; Sodium or Natri; Hydrochloride or Hydroclorid...).

- If the active ingredient in Column (2) is not recorded in its salt form, medicines with different salt forms of this active ingredient, when converted to the base form, have the same concentration - content in Column (3) (if they have the same indication and treatment dose) still fall within the scope of the list.

2. Bidding for medicines with a different formulation than that recorded in Column (4) shall be carried out in accordance with the regulations on bidding for medicines.

3. For the formulations of medicines recorded in Column (4):

- The formulations "Tablet" and "Injectable" recorded in Column 4 are standard formulations (Tablet: Tablets, Capsules; Injectable: Injectable solution, Injectable suspension, Injectable emulsion).

- Units and healthcare facilities shall develop plans for selecting contractors for drugs with special formulations or drugs with bioavailability different from conventional formulations (e.g., enteric-coated tablets, controlled-release tablets, fast-dissolving tablets, effervescent tablets, sublingual tablets; freeze-dried injectables, liposome/nano/lipid-complex injectables, intraocular injectables, extended-release injectables, pre-filled dose-specific injectables...).