Circular No. 14/2022/TT-BYT abolishes certain regulatory legal documents issued by the Minister of Health, jointly issued.

CIRCULAR

Repealing certain regulatory legal documents issued by the Minister of Health,

jointly issued

Pursuant to the Law on Issuing Legal Documents dated June 22, 2015 and the Law Amending and Supplementing Certain Provisions of the Law on Issuing Legal Documents dated June 18, 2020;

Pursuant to Decree No. 34/2016/NĐ-CP dated May 14, 2016 of the Government detailing some provisions and measures for implementing the Law on Enacting Regulatory Legal Documents; Decree No. 154/2020/NĐ-CP dated December 31, 2020 of the Government amending and supplementing some articles of Decree No. 34/2016/NĐ-CP dated May 14, 2016 of the Government detailing some provisions and measures for implementing the Law on Enacting Regulatory Legal Documents;

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 Department of Legal Affairs, the Director of the Department of International Cooperation, the Director of the Department of Medical Equipment and Construction, the Director of the Food Safety Administration, the Director of the Drug Administration, the Director of the Environmental Health Administration, the Director of the Science, Technology and Training Administration,representatives from healthcare, the Director of the Food Safety Agency, the Director of the Drug Management Agency, the Director of the Healthcare Environment Management Agency, the Director of the Science, Technology, and Training Agency,

The Minister of Health issues this Circular to repeal certain regulatory legal documents issued by the Minister of Health, jointly issued.

Article 1. Repealing entirely five (05) regulatory legal documents issued by the Minister of Health, jointly issued

1. Decision No. 36/2006/QĐ-BYT dated November 14, 2006 of the Minister of Health on issuing the "Regulations on Clinical Trials of Medical Devices."

2. Decision No. 19/2008/QĐ-BYT dated May 30, 2008 of the Minister of Health promulgating the operational regulations of the Ministry of Health.

3. Decision No. 38/2008/QĐ-BYT dated December 11, 2008 of the Minister of Health on issuing the "Maximum Limit of Melamine Cross-Contamination in Foods."

4. Circular No. 09/2013/TT-BYT dated March 29, 2013 of the Minister of Health guiding the organization and management of international health conferences in Vietnam.

5. Joint Circular No. 48/2014/TTLT-BYT-BTNMT dated December 22, 2014 of the Ministry of Health and the Ministry of Natural Resources and Environment guiding the coordination in state management of environmental protection for healthcare facilities.

Article 2. Repealing part of the provisions of two (02) Circulars issued by the Minister of Health

1. Circular No. 26/2019/TT-BYT dated August 30, 2019 of the Minister of Health on the list of rare drugs: Repeal Article 9 and the phrase "and update the Decision amending and supplementing the List of Rare Drugs on the Ministry of Health's website and the Drug Administration's website within three days from the date the Minister of Health signs the decision" in Clause 1, Article 10.

2. Circular No. 14/2020/TT-BYT dated July 10, 2020 of the Minister of Health on certain contents in medical equipment tendering (hereinafter referred to as Circular No. 14/2020/TT-BYT): Repeal Clause 3, Article 8.

Article 3. Effectiveness

1. This Circular takes effect from February 1, 2023.

2. Clause 2, Article 2 of this Circular takes effect from the date of issuance of this Circular.

Article 4. Transitional provisions for the provisions at Clause 2, Article 2 of this Circular

1. From the date Clause 2, Article 2 of this Circular takes effect, the determination of the bid package price for medical equipment procurement shall be carried out according to the Bidding Law No. 43/2013/QH13 dated November 26, 2013, Decree No. 63/2014/NĐ-CP dated June 26, 2014 of the Government detailing some provisions of the Bidding Law on selecting contractors (hereinafter referred to as Decree No. 63/2014/NĐ-CP) and related guiding documents on bid package pricing issued by the Ministry of Finance and the Ministry of Planning and Investment.

2. For bid packages for medical equipment procurement that have approved contractor selection plans with bid package prices implemented according to Clause 3, Article 8 of Circular No. 14/2020/TT-BYT before the date Clause 2, Article 2 of this Circular takes effect, healthcare facilities shall continue to implement according to the approved contractor selection plan or proceed with procedures to adjust the bid package price according to the Bidding Law No. 43/2013/QH13 dated November 26, 2013, Decree No. 63/2014/NĐ-CP, and related guiding documents on bid package pricing issued by the Ministry of Finance and the Ministry of Planning and Investment.

Article 5. Responsibilities for Implementation

The Head of the Office of the Ministry, the Inspector General, the Director of the Legal Affairs Department; Directors, Heads, and General Directors of Departments, Administrations, and General Administrations under the Ministry of Health, and relevant agencies, organizations, and individuals are responsible for implementing this Circular./.