The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use


The final version of Annex 21 to the EU-GMP Guidelines (“Importation of medicinal products”) has been published in EudraLex Vol. 4. 

The new Annex will come into operation on 21 August 2022.


This Annex summarizes the GMP requirements applicable to a Manufacturing Import Authorisation (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.