Thùy Trang
On January 9, 2023, the National Assembly of Vietnam approved Resolution No.
80/2023/QH15 on the continuation of the implementation of several policies on COVID-19 prevention and control and the use of Marketing Authorizations of drugs and medicinal ingredients that expire during the period from January 1, 2023 to December 31, 2024.
According to the Resolution, Marketing Authorizations of drugs and medicinal ingredients may continue to be used from their expiration date to the end of December 31, 2024 if:
- The Marketing Authorization of drugs and medicinal ingredients expires during the period from January 1, 2023 to December 1, 2024 and the holder has applied for renewal;
- Their implementation time may be extended according to Clause 5 Article 6 of Resolution No. 12/2021/UBTVQH15, but renewal has not been promptly granted according to the Law on Pharmacy;
Excluding the following cases:
- Drugs or medicinal ingredients that are recalled according to laws on pharmacy;
- Drugs that threaten safety of users and are suspended from business and use and sealed for preservation according to laws on pharmacy;
- Drugs with 3-year Marketing Authorizations according to laws on pharmacy.
The Ministry of Health of Vietnam shall disclose the list of drugs and medicinal ingredients with Marketing Authorizations that may continue to be used.
See more details in Resolution No. 80/2023/QH15, which comes into force as of January 9, 2023.
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Above are the summary and notification of new documents for customers of THU VIEN PHAP LUAT. For more information, please send an email to [email protected].
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