Circular 14/2022/TT-BYT in Vietnam: Do the Ministry of Health decide to annul all 05 legislative documents in the health sector?
- Do the Vietnam Ministry of Health decide to annul all 05 legislative documents in the health sector?
- Do the Vietnam Ministry of Health decide to partly annul the provisions of Circular No. 26/2019/TT-BYT and Circular 14/2020/TT-BYT?
- What will legislative documents enter into effect after Clause 3, Article 8 of Circular 14/2020/TT-BYT is annulled in Vietnam?
Do the Vietnam Ministry of Health decide to annul all 05 legislative documents in the health sector?
According to the provisions of Article 1 of Circular 14/2022/TT-BYT on this content as follows:
Annul all five (05) legislative documents promulgated and jointly promulgated by the Minister of Health
1. Decision No. 36/2006/QD-BYT dated November 14, 11 of the Minister of Health on the promulgation of "Regulations on clinical trials of medical devices".
2. Decision No. 19/2008/QD-BYT dated May 30, 5 of the Minister of Health promulgating the working regulations of the Ministry of Health.
3. Decision No. 38/2008/QD-BYT dated December 11, 12, 2008 of the Minister of Health on limits of cross-contaminated melamine in food.
4. Circular No. 09/2013/TT-BYT dated March 29, 03 of the Minister of Health guiding on organization, management of international medical conferences and seminars in Vietnam.
5. Joint Circular No. 48/2014/TTLT-BYT-BTNMT dated December 22, 12, 2014 of the Ministry of Health and the Ministry of Natural Resources and Environment guiding the coordination in the implementation of the state management of environmental protection for medical facilities.
Accordingly, from December 6, 2022, the following 05 legislative documents are officially annulled:
- Joint Circular No. 48/2014/TTLT-BYT-BTNMT
Do the Vietnam Ministry of Health decide to partly annul the provisions of Circular No. 26/2019/TT-BYT and Circular 14/2020/TT-BYT?
Pursuant to Article 2 of Circular 14/2022/TT-BYT as follows:
Partial annulment of the provisions of two (02) Circulars issued by the Minister of Health
1. Circular No. 26/2019/TT-BYT dated August 30, 8 of the Minister of Health on the list of orphan drugs: Annul Article 9 and the phrase "and update the decision amending the list of orphan drugs on the websites of the Ministry of Health and Drug Administration of Vietnam no later than 03 days from the date on which the Minister of Health signs the decision" in Clause 1 of Article 10.
2. Circular No. 14/2020/TT-BYT dated July 10, 7 of the Minister of Health on medical device bidding at public health facilities (hereinafter referred to as Circular No. 14/2020/TT-BYT): Annul Clause 3, Article 8.
Thus, according to the above provisions, the provisions of Circular No. 26/2019/TT-BYT and Circular 14/2020/TT-BYT shall be partly annulled as follows:
- Circular 26/2019/TT-BYT: Annul Article 9 and the phrase "and update the decision amending the list of orphan drugs on the websites of the Ministry of Health and Drug Administration of Vietnam no later than 03 days from the date on which the Minister of Health signs the decision" in Clause 1 of Article 10.
- Circular 14/2020/TT-BYT: Annul Clause 3, Article 8.
What will legislative documents enter into effect after Clause 3, Article 8 of Circular 14/2020/TT-BYT is annulled in Vietnam?
Pursuant to Article 4 of Circular 14/2022/TT-BYT as follows:
Transitional provisions for the provisions of Clause 2, Article 2 of this Circular
1. From the effective date of Clause 2 Article 2 of this Circular, the determination of the procurement value in medical device bidding shall comply with the Law on Procurement No. 43/2013/QH13 dated November 26, 11, 2013, Decree No. 63/2014/ND-CP dated June 26, 6 of the Government detailing the implementation of a number of articles of the Law on Bidding on the selection of contractors (following this is referred to as Decree No. 63/2014/ND-CP) and relevant guiding documents on the development of the procurement value of the Ministry of Finance and the Ministry of Planning and Investment.
2. For medical device procurement packages that have approved the plan for selection of contractor and whose procurement value complies with the provisions of Clause 3, Article 8 of Circular No. 14/2020/TT-BYT before the effective date of Clause 2, Article 2 of this Circular, the medical facility shall continue to comply with the approved plan for selection of contractor; and carry out procedures for adjusting the procurement value according to the provisions of the Law on Procurement No. 43/2013/QH13 dated November 26, 2013, Decree No. 63/2014/ND-CP and relevant guiding documents on bidding package price formulation of the Ministry of Finance, Ministry of Planning and Investment.
Accordingly, after Clause 3, Article 8 of Circular 14/2020/TT-BYT is annulled in Vietnam, the following legislative documents shall enter into effect:
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