Accordingly, the Ministry of Health announced 13 administrative procedures abolished in the pharmaceutical sector under the management of the Ministry of Health in Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health amending and supplementing a number of articles of Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health regulating good practices for drug retail establishments; Circular No. 03/2018/TT-BYT dated February 9, 2018 of the Minister of Health regulating good practices for distribution of drugs and pharmaceutical ingredients; Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health regulating good practices for preservation of drugs and pharmaceutical ingredients.
This Decision comes into force from July 1, 2025.
List of 13 administrative procedures in the pharmaceutical sector at the central and local levels abolished:
STT | Number of administrative procedure records | Name of administrative procedure | Name of the legal document regulating the abolition of administrative procedures | Field | Implementing agency |
A. Central level administrative procedures | |||||
1 | 1.008443 | Assessment of compliance with Good Storage Practices for Drugs and Pharmaceutical Ingredients for Pharmaceutical Business Establishments | Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health | Pharmaceuticals | Department of Drug Administration; Department of Traditional Medicine Administration - Ministry of Health |
2 | 1.008444 | Assessment of maintaining compliance with Good Storage Practices for drugs and pharmaceutical ingredients for pharmaceutical business establishments | Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health | Pharmaceuticals | Department of Drug Administration; Department of Traditional Medicine Administration - Ministry of Health |
3 | 1.008445 | Assessment of compliance with good storage practices for drugs and pharmaceutical ingredients when there are changes in the cases specified in Point a, Clause 1, Article 11, Circular 36/2018/TT-BYT | Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health | Pharmaceuticals | Department of Drug Administration; Department of Traditional Medicine Administration - Ministry of Health |
4 | 1.008446 | Assessment of compliance with good storage practices for drugs and pharmaceutical ingredients when there are changes in the cases specified in Point b, Clause 1, Article 11 of Circular 36/2018/TT-BYT | Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health | Pharmaceuticals | Department of Drug Administration; Department of Traditional Medicine Administration - Ministry of Health |
5 | 1.008447 | Assessment of compliance with good storage practices for drugs and pharmaceutical ingredients when there are changes in the cases specified in Point c, Clause 1, Article 11, Circular 36/2018/TT-BYT | Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health | Pharmaceuticals | Department of Drug Administration; Department of Traditional Medicine Administration - Ministry of Health |
6 | 1.008448 | Assessment of compliance with good storage practices for drugs and pharmaceutical ingredients when there are changes in the cases specified in points d, dd, e, Clause 1, Article 11 of Circular 36/2018/TT-BYT | Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health | Pharmaceuticals | Department of Drug Administration; Department of Traditional Medicine Administration - Ministry of Health |
7 | 1.008445 | Change control when there is a change in one of the cases specified in points d, dd and e, Clause 1, Article 11, Circular 03/2018/TT-BYT | Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health | Pharmaceuticals | Department of Drug Administration; Department of Traditional Medicine Administration - Ministry of Health |
B. Local administrative procedures | |||||
1 | 1.002258 | Assessment of compliance with Good Distribution Practices for drugs and pharmaceutical ingredients | Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health | Pharmaceuticals | Health service |
2 | 1.002339 | Assessment of compliance with Good Distribution Practices for drugs and pharmaceutical ingredients for non-commercial business establishments | Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health | Pharmaceuticals | Health service |
3 | 1.002292 | Assessment of maintenance of compliance with good distribution practices for drugs and pharmaceutical ingredients | Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health | Pharmaceuticals | Health service |
4 | 1.003001 | Assessment of compliance with Good Pharmacy Practice | Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health | Pharmaceuticals | Health service |
5 | 1.002952 | Assessment of maintaining compliance with good retail pharmacy practices | Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health | Pharmaceuticals | Health service |
6 | 1.002934 | Change control when there is a change in one of the cases specified in points c and d, Clause 1, Article 11, Circular 02/2018/TT-BYT | Circular No. 11/2025/TT-BYT dated May 16, 2025 of the Minister of Health | Pharmaceuticals | Health service |
Source: https://baochinhphu.vn/bai-bo-13-thu-tuc-hanh-chinh-ve-duoc-102250618180314111.htm
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