In brief

On 16 February 2022, the European Commission published the final version of Annex 21 to the Good Manufacturing Practice (GMP) Guidelines governing the importation of medicinal products, which will enter into force on 21 August 2022.

Key takeaways

  • Annex 21 sets out the principles and requirements applicable to holders of manufacturing and import authorizations when they intend to import medicinal products for human, investigational, or veterinary use from a non-EU country into the EU. Conversely, medicinal products that enter the EU territory with the intention of export only and that are not processed in any form nor released for placing on the EU market are not covered by the Annex.
  • With regard to the content of Annex 21, the document firstly sets out some general principles, including one requiring that all manufacturing stages of imported medical products that are carried out in third countries should be conducted in accordance with the EU GMP Guidelines or other equivalent standards, in conformance with the marketing authorization, the clinical trial and the relevant quality agreement, as applicable.
  • Further provisions contained in Annex 21 are those dedicated to the “Pharmaceutical Quality System,” which all sites conducting importation activities should be equipped with in accordance with Chapter 1 of the GMP Guidelines, and to the “Premises and Equipment”, according to which imported medicines must be stored in quarantine in segregated areas until they are released for further processing or until the relevant batches are certified by the qualified person.