EU GMP: new Annex 21 on the Way

Recommendation

14-16 May 2025
Vienna / Schwechat, Austria

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The GMP/GDP Inspectors Working Party is planning to implement a new Annex to the EU GMP Guidelines with a concept paper on new guidance for importers of medicinal products.

Medicinal products, which are manufactured in third countries and imported into the EU, can only be imported into the EU if the importer holds a manufacturing authorisation (MIA). Those products need to be tested and then certified by an EU Qualified Person. Both are defined being a manufacturing step. Here an MIA is needed as well. As a consequence, more than one licence might be needed, if various sites are involved. The new Annex 21 now wants to give more detailed guidance on these activities.

Another issue that might need further clarification is the term 'import' and what goes along with it.

So the main goal of such a new annex is to "provide additional guidance on the GMP requirements that are of particular relevance to importers and on the extent those requirements apply to the different entities involved in importation activities".

Stakeholders are now welcome to give their opinion on the concept paper. End of consultation (deadline for comments) is 29 August 2015. Comments should be sent to adm-gmdp@ema.europa.eu. However, ECA will conduct a survey amongst its members to provide a consolidated feedback.