Amendment of 04 document templates attached to Circular 20 on specially controlled drugs in Vietnam

Amendment of 04 document templates attached to Circular 20 on specially controlled drugs in Vietnam
Duong Chau Thanh

On November 1, 2024, the Minister of Health of Vietnam issued Circular 27/2024/TT-BYT amending Circular 20/2017/TT-BYT which provides guidance on the Law on Pharmacy and Decree 54/2017/ND-CP regarding drugs and raw materials for drugs subject to special control.

Amendment of 04 document templates attached to Circular 20 on specially controlled drugs in Vietnam

04 document templates are amended by Circular 20/2017/TT-BYT dated May 10, 2017, from the Minister of Health of Vietnam detailing certain provisions of the Law on Pharmacy and Decree 54/2017/ND-CP dated May 8, 2017, of the Government of Vietnam on drugs and drug ingredients that need special control. To be specific:

- Appendix X: Template report on imports, exports, inventory, and use of narcotic drugs, psychotropic drugs, precursor drugs, radioactive drugs, and combination drugs containing precursors.

- Appendix XIII: Template application for the supply of radioactive drugs.

- Appendix XV: Template receipt form for the application dossier for the supply of radioactive drugs.

- Appendix XX: Template minutes for reclaiming narcotic drugs, psychotropic drugs, precursor drugs.

Circular 27/2024/TT-BYT shall take effect from January 30, 2025.

The transitional provisions of Circular 27/2024/TT-BYT are as follows:

- Dossiers submitted before the effective date of Circular 27/2024/TT-BYT shall continue to be processed according to regulations at the time of dossier submission, except where the establishments propose to implement according to the regulations in this Circular.

- Export and import licenses for drugs and drug ingredients, export and import orders for drugs and drug ingredients granted before the effective date of Circular 27/2024/TT-BYT shall continue to be valid until the expiration of the license.

- Drugs and drug ingredients that have been granted circulation registration in Vietnam, drug ingredients announced for drug production according to drug registration dossiers that have circulation registration certificates in Vietnam, exported from the point of departure of the exporting country before the effective date of Circular 27/2024/TT-BYT, the importation shall be carried out according to the List of drugs and active ingredients belonging to the list of substances banned from use in certain sectors, areas according to the guiding documents effective at the time the goods are exported from the point of departure of the exporting country.

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