Thông tư 15/2021/TT-BYT sửa đổi Thông tư 15/2019/TT-BYT

• Số hiệu: 15/2021/TT-BYT
• Loại văn bản: Thông tư
• Nơi ban hành: Bộ Y tế
• Người ký: Trương Quốc Cường
• Ngày ban hành: 24/09/2021

MINISTRY OF HEALTH -------	SOCIALIST REPUBLIC OF VIET NAM Independence-Freedom-Happiness -----------------
No.: 15/2021/TT-BYT	Hanoi, September 24, 2021

CIRCULAR

PROVIDING AMENDMENTS TO CERTAIN ARTICLES OF CIRCULAR NO. 15/2019/TT-BYT DATED JULY 11, 2019 OF MINISTER OF HEALTH PRESCRIBING BIDDING FOR SUPPLY OF DRUGS FOR PUBLIC HEALTH FACILITIES

Pursuant to the Law on Bidding dated November 26, 2013;

Pursuant to the Pharmaceutical Law dated April 06, 2016;

Pursuant to the Government’s Decree No. 63/2014/ND-CP dated June 26, 2014 providing guidelines for the Law on bidding regarding contractor selection;

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on pharmacy;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of Director of Vietnam Administration of HIV/AIDS Control and Director of Legal Department,

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Article 1. Amendments to certain Articles of Circular No. 15/2019/TT-BYT dated July 11, 2019 of Minister of Health 

1. Clause 7 Article 1 is abrogated.

2. Clause 1 Article 43 is amended as follows:

“1. Aggregating demands for use of drugs in the list of drugs procured through price negotiation:

a) The national centralized drug procurement center shall develop plan and aggregate demands for drugs in the list of drugs procured through price negotiation according to Clause 1 Article 40 of this Circular;

b) With regard to antiretroviral drugs included in the list of drugs procured through price negotiation, Vietnam Administration of HIV/AIDS Control shall take charge of and cooperate with the national centralized drug procurement center in providing guidelines for planning and aggregating demands for drugs.”

3. Clause 5 Article 46 is amended as follows:

“5. Supervising and regulating the performance of framework agreements:

a) The national centralized drug procurement center shall supervise and regulate the supply and use of drugs procured through price negotiation under the signed framework agreements according to Clause 13 Article 40 of this Circular;

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- If the demand for drugs of a health facility under the management of the provincial government, or a health facility under the management of the Ministry of Health or another supervisory Ministry located in the province or city (hereinafter referred to as “health facility”) exceeds the quantity of drugs to be supplied as specified in the framework agreement by 20%, the health facility shall notify such demand to the provincial HIV/AIDS control agency for aggregating and regulating the quantities of drugs supplied between local health facilities provided that the quantity of drugs to be regulated shall not exceed 20% of total quantity of drugs distributed to local health facilities under the signed framework agreements. Within 10 days from the receipt of the written request for regulation of drugs from the health facility, the provincial HIV/AIDS control agency must give a written response to the health facility.

- If the demand for drugs of local health facilities exceeds the regulating capacity of the provincial HIV/AIDS control agency or the demand for drugs of a health facility is not aggregated in the plan for drug supplier selection, such cases must be reported to Vietnam Administration of HIV/AIDS Control for consideration. Within 05 days from the receipt of the written request for regulation of drugs from the health facility, the provincial HIV/AIDS control agency shall submit a report which is made using the form in Appendix 12 enclosed herewith to Vietnam Administration of HIV/AIDS Control.

Within 10 days from the receipt of the written request for regulation of drugs from the provincial HIV/AIDS control agency, Vietnam Administration of HIV/AIDS Control must give its written response.

Total quantity of drugs to be regulated by Vietnam Administration of HIV/AIDS Control shall not exceed 30% of total quantity of drugs specified in the approved plan for drug supplier selection. Drugs in the List of drugs procured through price negotiation shall be regulated according to guidelines given by the Ministry of Health.”

Article 2. Effect

This Circular comes into force from November 15, 2021.

Article 3. Responsibility for implementation

Director of Vietnam Administration of HIV/AIDS Control, Director of Legal Department, Chief of the Ministry's Office, the Ministry’s Chief Inspector, General Directors/ Directors of Departments/ General Departments affiliated to the Ministry of Health, and relevant authorities, organizations and individuals shall implement this Circular./.

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PP. MINISTER
DEPUTY MINISTER




Truong Quoc Cuong