The new Annex 21 (C(2022) 843 final) was published by the European Commission on 16 February 2022 and will enter into force six months after its publication on 21 August 2022. The document provides a guideline on the import of medicinal products from extra-EU countries. Its contents should be read in parallel with the EU Guide to Good Manufacturing Practice for Medicinal Products and its other annexes, as those requirements continue to apply as appropriate.
Annex 21 is applicable to human, investigational and/or veterinary medicinal products imported in the European Union and European Economic Area (EEA) by holders of a Manufacturing Import Authorisation (MIA).
Annex 21 does not apply to medicinal products entering the EU/EEA for export only, as they do not undergo any process or release aimed to place them on the internal market, nor to fiscal transactions.