Search for:

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. 

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

Write A Comment