12-14 March 2024
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.
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.
Besides editorial changes and adaptations to Annex 16, there were a few important additions and clarifications: