On June 18, according to information from the Ministry of Health , Deputy Minister of Health Do Xuan Tuyen has just signed and issued a Decision on promulgating abolished administrative procedures in the pharmaceutical sector under the management of the Ministry of Health as prescribed in Circular No. 11/2025/TT-BYT of the Minister of Health.
Accordingly, the Ministry of Health promulgates with this Decision 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.
The list of 13 abolished administrative procedures includes 7 central-level administrative procedures and 6 local-level administrative procedures.
7 Central-level administrative procedures include: Assessment of compliance with Good Storage Practices for drugs and pharmaceutical ingredients for pharmaceutical businesses; Assessment of maintenance of compliance with Good Storage Practices for drugs and pharmaceutical ingredients for pharmaceutical businesses; 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 of Circular 36/2018/TT-BYT; 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.
Assess 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 of Circular 36/2018/TT-BYT; Assess 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; Control changes when there are changes in one of the cases specified in Points d, dd, and e, Clause 1, Article 11 of Circular 03/2018/TT-BYT.
6 local administrative procedures include: Assessment of compliance with Good Distribution Practices for drugs and pharmaceutical ingredients; Assessment of compliance with Good Distribution Practices for drugs and pharmaceutical ingredients for non-commercial business establishments; Assessment of maintenance of compliance with Good Distribution Practices for drugs and pharmaceutical ingredients; Assessment of compliance with Good Retail Practices for drug retail establishments; Assessment of maintenance of compliance with Good Retail Practices for drug retail establishments; Control of changes when there are changes in one of the cases specified in Points c and d, Clause 1, Article 11 of Circular 02/2018/TT-BYT./.
Source: https://www.vietnamplus.vn/bo-y-te-bai-bo-13-thu-tuc-hanh-chinh-trong-linh-vuc-duoc-pham-post1044874.vnp
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