This decentralization is implemented according to the provisions of new Decrees issued in 2025 such as: Decree No. 163/2025/ND-CP (guiding the implementation of the Law on Pharmacy), Decree No. 217/2025/ND-CP (on specialized inspection), Decree No. 42/2025/ND-CP (on the organization of the Ministry of Health ) and other relevant regulations.
According to the Circular, the Drug Administration Department is assigned the authority to comprehensively carry out 32 administrative procedures related to licensing the import and export of drugs and drug ingredients, including drugs subject to special control such as: addictive drugs, psychotropic drugs, precursor drugs, radioactive drugs, aid drugs, etc.; appraise and submit for issuance of all types of certificates of eligibility for pharmaceutical business, pharmacy practice certificates in the form of examinations; license drug advertising content, handle adjustment and correction contents; manage drug prices, including publication, re-publication and recommendation of wholesale prices of prescription drugs.
In addition, the Department is also responsible for appraising clinical trial records, scientific research, drug testing, purchase and sale of special raw materials... Notably, many procedures that previously required consultation at the Ministry level are now directly received, processed and decided by the Department of Drug Administration, contributing to shortening the processing time as well as increasing the initiative of professional agencies.
In parallel with the implementation of the new process, the Department of Drug Administration is assigned the responsibility to continue handling administrative procedures submitted before July 1, 2025 according to the old regulations in Decree 54/2017/ND-CP, Decree 155/2018/ND-CP and Decree 88/2023/ND-CP.
Source: https://baohaiphong.vn/bo-y-te-phan-cap-chi-tiet-mot-so-thu-tuc-hanh-chinh-linh-vuc-duoc-521844.html
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