January 10, 2023
Vietnam Extends Marketing Authorization Validity for Drugs and Medicinal Ingredients

On January 9, 2023, Vietnam’s National Assembly voted to approve a draft resolution on the continued implementation of policies for the prevention and control of the Covid-19 pandemic. Under this resolution, marketing authorizations (MAs) for the following drugs and medicinal ingredients will be extended to December 31, 2024, allowing continued use in Vietnam:

  • Drugs and medicinal ingredients whose MAs expire from January 1, 2023, to December 12, 2024, and whose extension dossiers have been submitted but have not yet been approved in accordance with the Law on Pharmacy; and
  • Drugs and medicinal ingredients whose MAs have been extended as per Resolution No. 12/2021/UBTVQH15 and have not been extended in accordance with the Law on Pharmacy.

The extension does not apply to the following cases:

  • Drugs and medicinal ingredients that have been recalled by the Law on Pharmacy;
  • Drugs with signs of being unsafe for users that have been suspended from circulation/use and sealed for preservation in accordance with the Law on Pharmacy; and
  • Drugs with MAs having a validity term of three years in accordance with the Law on Pharmacy.

The Ministry of Health will announce the list of drugs and medicinal ingredients whose MAs are subject to be extended as described above.


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