Initially the validity of GMP certificates for manufacturing sites of API’s located outside the Economic European Area (EEA) was automatically extended until the end of 2023 without the need for further action from the holder of the certificate due to the pandemic crisis. The EEA authorities have now announced another extension until the end of 2024.
Here, the link to the official EMA announcement: EUDRA website.
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The validity of GMP certificates for manufacturing sites of API’s located outside the Economic European Area (EEA) are automatically extended until the end of 2023 without the need for further action from the holder of the certificate, unless the issuing/supervisory authority takes any action that affects the validity of the certificate.
This automatic extension is applied in the same manner as for certificates of manufacturing sites located within the EU. Please also refer to the COVID notification on the official EUDRA website.
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