The Minister of Health has just issued Circular 39/2025/TT-BYT regulating the decentralization of the implementation of a number of tasks and handling a number of administrative procedures in the pharmaceutical sector under the authority of the Ministry of Health.
The Circular has decentralized the implementation of a number of tasks and resolved a number of administrative procedures (TTHC) in the pharmaceutical field under the authority of the Ministry of Health to the Department of Drug Administration such as:
License to import drug ingredients must be subject to special control (code TTHC 1,014071) for drug ingredients such as addictive pharmaceuticals, psychotropic pharmaceuticals, precursors used as drugs, radioactive drugs, pharmaceutical drugs in the list of drugs and pharmaceutical substances banned for use in a number of industries and fields, toxic ingredients for toxic drugs and toxic chemicals 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 pharmaceuticals without a drug circulation registration certificate in Vietnam, drugs containing medicinal herbs for first use in Vietnam (code TTHC 1,014072) for pharmaceutical chemicals, medicinal herbs, vaccines and biological products as prescribed in Clause 2, Article 62 of Decree No. 163/2025/ND-CP.
License to import drugs without a drug circulation registration certificate in Vietnam that contain pharmaceuticals with a drug circulation registration certificate in Vietnam but do not meet treatment needs, drugs containing medicinal herbs that have been used as drugs in Vietnam but do not meet treatment needs (code TTHC 1,014073) for pharmaceutical chemicals, medicinal herbs, vaccines and biological products as prescribed in Clause 2, Article 62 of Decree No. 163/2025/ND-CP.
License to import rare drugs without a drug circulation registration certificate in Vietnam (code TTHC 1,014074) for pharmaceuticals, medicinal herbs, vaccines and biological products as prescribed in Clause 2, Article 62 of Decree No. 163/2025/ND-CP.
Allow the purchase of drug ingredients such as addictive pharmaceuticals, psychotropic pharmaceuticals, and precursors used as drugs (code TTHC 1,014077) as prescribed 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 drug ingredients such as addictive pharmaceutical substances, psychotropic drugs, and precursors used as drugs (code TTHC 1,014080) as prescribed 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 import of drugs without a drug circulation registration certificate in Vietnam to meet special treatment needs (code TTHC 1,014082) for pharmaceuticals, medicinal herbs, vaccines and biological products as prescribed in Clause 5, Article 62 of Decree No. 163/2025/ND-CP.
License for export of medicinal herbs on the list of rare, endemic and precious medicinal species and varieties to be controlled (code TTHC 1,014110) for the sale of finished medicinal herbs as prescribed in Clause 1, Article 49 of Decree No. 163/2025/ND-CP....
