Final Annex 21 published

The final version of Annex 21 to the EU-GMP Guidelines (“Importation of medicinal products”) has been published in EudraLex Vol. 4. The draft was already published for comments in March 2020. Approximately 200 comments were received from 17 stakeholder organisations. The new Annex will come into operation on 21 August 2022.

What is the purpose of this new Annex?

The Union legislation addresses all actors in the supply chain and sets out their roles to ensure the integrity of the supply chain of medicinal products. The importation of medicinal products is subject to GMP requirements in the light of Article 40(3) of Directive 2001/83/EC. In addition to the requirements contained in the main chapters and annexes of the EU-GMP Guidelines, it has become necessary to summarise and publish specific requirements explaining the application of GMP principles to the import of medicinal products. This Annex 21 to the EU-GMP Guidelines now sets out the principles and requirements applicable to a Manufacturing and Import Authorisation (MIA) holder importing medicinal products (human and veterinary) across EU/EEA borders. Requirements from other parts of the EU GMP Guidance on activities around import activities continue to apply and are not repeated in full in the new Annex 21.

What has changed from the draft?

Besides editorial changes and adaptations to Annex 16, there were a few important additions and clarifications:

  • Explicitly included are now Investigational Medicinal Products (IMPs). Advanced Therapeutic Medicinal Products (ATMPs) and medicinal products that do not have a marketing authorisation in the EU/EEA and are directly re-exported were not included.
  • Fiscal transactions” (where the product physically remains in the EU but changes ownership to a third country or vice versa) remain explicitly excluded.
  • The complete batch documentation must be available to the MIA holder responsible for QP certification or batch confirmation at the time of certification or batch confirmation. In the draft, this was still stated as “should have access”.
  • For QP certification or batch confirmation, a packing list, freight documentation or a customs import declaration, is now also required. The certification of a batch can therefore only take place after physical importation and customs clearance.