News about GMP/cGMP

01.10.2021

EMA: Validity of GMP and GDP certificates extended

EMA: Validity of GMP and GDP certificates extended

The European medicines regulatory network has announced the automatically applied extension of the validity of GMP and GDP certificates for sites in the EEA (European Economic Area) until the end of 2022, unless there are restrictions on the validity period stated in the clarifying remarks of the certificate. This extension also applies to time-limited manufacturing and import and wholesale authorisations.


The Q&A guidance document has been adapted, accordingly:

Question 2.2 concerning the extension of certificates was updated, three new questions 4.2-4.4 regarding pharmacovigilance activities were added.


Source:

EMA: COVID-19, latest updates


 

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