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GMP Guideline, Annex 21

Annex 21 GMP Guideline (“Importation of medicinal products”) – what goes around comes around?


As of 16.02.2022, Annex 21 “Importation of medicinal products” of Volume 4 of the EU GMP Guidelines has finally been published. It will enter into force as a new Annex on August 21, 2022, i.e. 6 months after publication, and sets out the principles and requirements applicable to a Manufacturing and Import Authorization (MIA) holder who wishes to import medicinal products (human and veterinary) from outside the EU/EEA into the EU/EEA.

Why “finally”?

Many years have been spent working on and discussing this Annex. Already in 2015, a concept paper (“Concept Paper” EMA/238299/2015) was published addressing the issue of import of medicinal products with the aim to establish an additional Annex. Thus, it took about seven years until publication. “Finally” perhaps also because the question of whether the “financial” import (“fiscal transactions”), i.e. the physical remaining of the product in the EU but change of ownership in a third country and vice versa, will be conclusively regulated in Annex 21, hovered like a sword of Damocles over one or the other international group. With the publication of Annex 21, it is clear that “fiscal transactions” are not regulated in this document.

So what does this final Annex 21 say?

This Annex summarizes the GMP requirements that apply to Manufacturing and Importation Authorization (MIA) holders when importing medicinal products (human, investigational and veterinary) into the EU/EEA. Explicitly included here are clinical investigational medicinal products while medicinal products that do not have a marketing authorization in the EU / EEA (i.e. are directly re-exported) are not regulated by the new Annex 21. The requirements already existing in the GMP Guideline regarding activities around import are still valid, the new Annex 21 is rather an addition.

The following locations are defined as responsible for import and require authorization (MIA):

(a) the site of physical importation; and

(b) the site of QP certification of imported drug products or QP confirmation for bulk or intermediate products that are further processed.

In the section “Pharmaceutical Quality System”, it is again made clear that the importer must be able to demonstrate a GMP-compliant quality management system. The preparation of Product Quality Reviews (PQRs) is also required here. These should pay particular attention to appropriate quality agreements and also compare the analytical results generated in the EU and in the third country.

In the “Premesis” section, it is made clear that imported goods must remain in quarantine prior to release by the EU QP. The most comprehensive paragraph is devoted to documentation. It explains, among other things, that the QP must have the complete batch documentation for certification or confirmation of the batch. From the fact that a packing list, shipping documents or an import customs declaration are also required, it follows that the certification of a batch can only take place after the physical import and customs clearance.

Finally, reference is made to the QP’s responsibility with regard to “Ongoing Stabilities”, safety features and reference and reserve samples, and compliance with Chapter 8 of the GMP Guideline (complaints and recalls) is required.

All in all, the annex has been developed over a long period of time and contains rather few new findings and requirements, most of which have already been implemented in practice.


TentaConsult will be happy to answer any questions you may have on this topic or to assist you in the import of your medicinal products.
Please contact us!


Your contact:

Alheidis Merschel TentaConsult

Alheidis Merschel
Senior Consultant / Qualified Person

+49 251 928715-69

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