Draft EU GMP Annex 21: Importation issued for consultation

The European Commission has published the long-awaited draft Annex 21 on Importation of medicinal products. This is now open for stakeholder consultation until 20-Jun-2020. If you would like to feed comments in via PQG, then please email webmaster@pqg.org by end April.

The document is only short (140 lines). It focusses on the action of physically bringing product from outside the EEA/EU into the customs territory of an EU/EEA state. Imported dosage forms and intermediates which undergo further manufacturing operations are included within scope. Medicinal products which enter EU/EEA for export only and which are not processed or released for the EU/EEA market are out of scope. It is not explicit about whether Investigational Medicinal Products are in scope or not, but there is reference in one place to the Clinical Trial Authorisation. Responsibilities of the Marketing Authorisation Holder, Manufacturing/Importation Authorisation Holder and the Qualified Person are highlighted.