EMA produljila valjanost GMP i GDP certifikata do 2022. godine

EMA je zadnjom revizijom dokumenta Notice to stakeholders: Q&A on regulatory expectations for medicinal products for human use during the covid-19 pandemic objavila sljedeće upute:

The validity of GMP certificates for manufacturing/importing sites of active substances and/or finished products in the EEA should be extended until the end of 2022 without the need for further action from the holder of the certificate. This automatic extension does not apply where restrictions on the validity period are stated in the clarifying remarks of the GMP certificate and does not cover changes in the scope of the GMP certificate (e.g. new buildings, new medicinal products).

The validity of GMP certificates for manufacturing sites of active substances and/or finished products located outside the EEA should be extended until the end of 2022 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 does not apply where restrictions on the validity period are stated in the clarifying remarks on the GMP certificate and does not cover changes in the scope of the GMP certificate (e.g. new buildings, new medicinal products).

In light of difficulties to conduct on-site GDP inspections due to restrictions arising from the COVID-19 pandemic, the validity of GDP certificates should be extended until the end of 2022 without the need for further action from the holder of the certificate. The validity of time-limited wholesale authorisations should also be extended until the end of 2022 without the need for further action from the holder of the authorisation.8This automatic extension does not apply where restrictions on the validity period are stated in the clarifying remarks on the GDP certificate and also does not cover changes in the scope of the authorisation (e.g. type of medicinal products or authorised operations).

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