Eudralex Volume 4 – EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use

On 21 February 2022 the European Commission published Annex 21 of Eudralex Volume 4 EU guideline for GMP.

This Annex summarizes the GMP requirements applicable to a Manufacturing Import Authorization (MIA) holder, when importing medicinal products (human, investigational and veterinary) from outside the EU/EEA. The guidance in the main chapters and other annexes of the Guide to Good Manufacturing Practice for Medicinal Products ("the EU GMP Guide") also apply, as appropriate, for other GMP activities carried out and should be consulted for supplementary guidance. Medicinal products that enter the EU/EEA with the intention of export only and that are not processed in any form nor released for placing on the EU/EEA market, are not covered by this Annex.

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