Decentralization of handling some administrative procedures in the pharmaceutical field

(Chinhphu.vn) - The Minister of Health has just issued Circular 39/2025/TT-BYT regulating the decentralization of performance of a number of tasks and settlement of a number of administrative procedures in the pharmaceutical field under the authority of the Ministry of Health.

Decentralization of handling some administrative procedures in the pharmaceutical field

Decentralization of handling of some administrative procedures in the pharmaceutical field under the authority of the Ministry of Health to the Department of Drug Administration

Circular decentralizing the performance of a number of tasks and handling of a number of administrative procedures in the pharmaceutical field under the authority of the Ministry of Health to the Department of Drug Administration such as:

Granting licenses for the import of pharmaceutical ingredients subject to special control (TTHC code 1.014071) for pharmaceutical ingredients that are addictive drugs, psychotropic drugs, precursors used to make drugs, radioactive substances, pharmaceutical ingredients in the list of drugs, pharmaceutical ingredients in the list of substances banned from use in certain industries and fields, toxic ingredients for making drugs except for toxic medicinal ingredients as prescribed in Article 67 of Decree No. 163/2025/ND-CP.

License to import drugs without a drug circulation registration certificate in Vietnam containing pharmaceutical ingredients without a drug circulation registration certificate in Vietnam, drugs containing medicinal ingredients used for the first time in Vietnam (TTHC code 1.014072) for chemical drugs, herbal drugs, vaccines and biological products according to regulations in Clause 2, Article 62 of Decree No. 163/2025/ND-CP.

License to import drugs that do not have a certificate of drug circulation in Vietnam containing pharmaceutical ingredients that have a certificate of drug circulation in Vietnam but do not meet the treatment needs, drugs containing medicinal herbs that have been used as drugs in Vietnam but do not meet the treatment needs (TTHC code 1.014073) for chemical drugs, herbal drugs, vaccines and biological products according to the provisions of Clause 2, Article 62 of Decree No. 163/2025/ND-CP.

Granting licenses to import rare drugs that do not have a drug circulation registration certificate in Vietnam (TTHC code 1.014074) for chemical drugs, herbal drugs, vaccines and biological products as prescribed in Clause 2, Article 62 of Decree No. 163/2025/ND-CP.

Permission to purchase pharmaceutical ingredients that are addictive drugs, psychotropic drugs, and precursors used to make drugs (TTHC code 1.014077) according to regulations in Point a, Clause 1 and Clause 2, Clause 3, Clause 4, Clause 5, Article 39 of Decree No. 163/2025/ND-CP.

Allowing the transfer of pharmaceutical ingredients that are addictive drugs, psychotropic drugs, and precursors used to make drugs (TTHC code 1.014080) according to the provisions of Point a, Clause 1 and Clause 2, Clause 3, Clause 4, Clause 5, Article 39 of Decree No. 163/2025/ND-CP.

License to import drugs without a drug circulation registration certificate in Vietnam to meet special treatment needs (TTHC code 1.014082) for chemical drugs, herbal drugs, vaccines and biological products as prescribed in Clause 5, Article 62 of Decree No. 163/2025/ND-CP.

Granting license to export medicinal herbs in the list of precious, rare, and endemic medicinal species and varieties that must be controlled (TTHC code 1.014120) for semi-finished medicinal herbs as prescribed in Clause 1, Article 49 of Decree No. 163/2025/ND-CP....

Decentralization of handling 27 administrative procedures in the pharmaceutical field under the authority of the Ministry of Health to the Department of Traditional Medicine and Pharmacy Management

The Circular clearly states that the implementation of a number of tasks and the settlement of a number of administrative procedures in the pharmaceutical field under the authority of the Ministry of Health is delegated to the Department of Traditional Medicine and Pharmacy Management, such as:

Granting licenses to export medicinal herbs in the list of precious, rare, and endemic medicinal herb species and varieties that must be controlled (TTHC code 1.014120) for medicinal herbs as prescribed in Clause 1, Article 49 of Decree No. 163/2025/ND-CP.

License to import rare drugs without a drug circulation registration certificate in Vietnam (TTHC code 1.014074) for traditional drugs according to regulations in Clause 2, Article 62 of Decree No. 163/2025/ND-CP.

License to import drugs without a drug circulation registration certificate in Vietnam to meet special treatment needs (TTHC code 1.014082) for traditional drugs according to regulations in Clause 5, Article 62 of Decree No. 163/2025/ND-CP.

Licensing for the export of specially controlled drugs that have been licensed for import to serve humanitarian medical examination and treatment activities but are not fully used (TTHC code 1.014094) for traditional medicines as prescribed in Clause 1, Article 49 of Decree No. 163/2025/ND-CP.

Issuing a certificate of confirmation of drug advertising content (except for drug advertising through the means of organizing seminars, conferences, and drug introduction events) (TTHC code 1.014093) for traditional drugs according to the provisions of Clause 1, Clause 2, Clause 3, Clause 4, Clause 6, Clause 7, Clause 8, Article 108 of Decree No. 163/2025/ND-CP.

Issuing a certificate of confirmation of drug advertising content through the organization of seminars, conferences, and drug introduction events (TTHC code 1.014095) for traditional drugs according to the provisions of Clause 1, Clause 2, Clause 3, Clause 4, Clause 6, Clause 7, Clause 8, Article 108 of Decree No. 163/2025/ND-CP.

License to import drugs without a Certificate of Circulation Registration in Vietnam for display at exhibitions and fairs (TTHC code 1.014106) for traditional drugs according to regulations in Clause 5, Article 62 of Decree No. 163/2025/ND-CP.

Granting import license for special controlled drugs with drug circulation registration certificate in Vietnam (TTHC code 1.014079) for traditional drugs according to regulations in Article 67 of Decree No. 163/2025/ND-CP....

Decentralize the task of publishing the list of clinical trial drugs under the authority of the Ministry of Health to the Department of Science, Technology and Training.

The focal unit shall coordinate with the Ministry's Office to publish the list of drugs used for clinical drug trials based on the clinical trial research outline approved by the Ministry of Health for customs clearance upon import on the Ministry of Health's electronic information portal and the electronic information page of the Department of Science, Technology and Training as prescribed in Clause 3, Article 82 of Decree No. 163/2025/ND-CP and Form No. 50, Appendix III issued with Decree No. 163/2025/ND-CP.

Minh Hien

Source: https://baochinhphu.vn/phan-cap-giai-quyet-mot-so-thu-tuc-hanh-chinh-trong-linh-vuc-duoc-102250924100631858.htm