EC: Final Annex 21 on Importation of Medicinal Products
The EU GMP Annex 21: Importation of medicinal products has finally been published on February 21, 2022, and will enter into force on August 21, 2022. The 6-page new Annex summarises the GMP requirements for Manufacturing Import Authorization (MIA) holders of human, investigational, and veterinary medicinal products from outside the EU/EEA. Medicinal products entering the EU/EEA for export only and are neither processed in any way nor released for placing on the EU/EEA market, are not covered by this Annex.
The draft document dating back to the year 2020 (we reported) has not fundamentally changed, but some details have been specified:
- Investigational medicinal products, regulated by Regulation (EU) 536/2014 (we reported), have been added to the scope.
- The section on principles now includes a sentence stating that "fiscal transactions" are not part of the Annex. Thus, this topic, which was part of the concept paper, is definitely off the table. Certification by a qualified person (QP) or certification of a batch of a medicinal product will only take place once the physical import and customs clearance into the customs territory of an EU/EEA state is carried out.
- Imported bulkware (newly included) and intermediate products may undergo further manufacturing activities, as appropriate, prior to certification or confirmation by the QP, provided they are in compliance with the marketing authorization or clinical trial authorization.
- The QP "must" ensure that all imported, human, investigational, and veterinary medicinal products from third countries, have been manufactured to standards recognized in the EU. Imported products must be tested upon importation if they do not originate from a third country with MRA or ACAA. For this purpose, Annex 16 and also the new Annex 13 on GMP for test specimens are mentioned as reference documents.
- If sampling of an imported product is done in a third country, a confidence assessment of this sampling should be done as part of the quality review. Nonconformities and OOTs should be investigated and documented.
- The site responsible for certification by the QP must have access to all documents necessary for clearance. These must be evaluated periodically and on a risk basis.
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