Cases of addition or replacement of package inserts in Vietnamese language after customs clearance in Vietnam

Cases of addition or replacement of package inserts in Vietnamese language after customs clearance in Vietnam

According to the amendments to Clause 2, Article 5 of Circular 01/2018/TT-BYT, importers shall be granted customs clearance in order to add or replace package inserts in Vietnamese language in the following cases:

Importers shall be granted customs clearance in order to add or replace package inserts in Vietnamese language in Vietnam in the following cases:

- Imported drugs which have been granted the marketing authorization in Vietnam and have the package inserts in Vietnamese language contained in their commercial packages but have been not yet updated with compulsory information as regulated the Ministry of Health of Vietnam, except the following cases where package inserts are exempted:

+ Drugs produced or prepared according to traditional remedies or prescriptions as regulated in Clause 1 Article 70 and Clause 2 Article 85 of the Law on Pharmacy 2016 for use or retail according to prescriptions at health facilities;

+ Drugs prepared and retailed at drugstores in accordance with regulations in Point b Clause 1 Article 47 of the Law on Pharmacy 2016;

+ Drugs which have been not yet granted the Certificate of registration in Vietnam but are imported to serve the purpose of bioequivalence study, bioavailability assessment, use as specimens for registration, testing or scientific research, or display at a fair or exhibition;

+ Drugs imported in accordance with regulations in Point b Clause 1 Article 68 of the Decree 54/2017/ND-CP;

- Imported drugs which are not yet granted marketing authorization in Vietnam and do not have the package inserts in Vietnamese language contained in their commercial packages, except the cases where package inserts are exempted above

- Imported drugs which have been granted marketing authorization by the Ministry of Health of Vietnam for national defense and security, epidemic prevention and control, disaster or calamity recovery purpose and do not have the package inserts in Vietnamese language contained in their commercial packages.

More details can be found in Circular 23/2023/TT-BYT taking effect on January 15, 2024.

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