According to the Circular, supplemented regulations on the determination of effective period of GMP compliance during Covid-19 epidemic or natural disasters, epidemics and wars are as follows:
- For GMP certificates granted by drug regulatory agencies of countries in the European Economic Area:
+ In case the GMP certificate of the manufacturer is renewed according to the Notification of the European Medicines Agency (EMA) concerning plans applied to medicinal products for human use during the Covid-19 or natural disasters or epidemics, effective period of GMP compliance shall comply with the Notification of EMA;
+ In case the GMP certificate is renewed, the effective period of the renewed GMP certificate will apply;
- For GMP certificates granted by other agencies, the effective period shall be the period notified by the drug regulatory agency of the nation where the GMP certificate is granted or the period specified in the GMP certificate.
For more details, see Circular No. 12/2022/TT-BYT of the Ministry of Health of Vietnam, which will come into force from January 05, 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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