Italy: Publication of annex 21 of the guidelines on good manufacturing practices for the importation of medicinal products

In short

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

Key points to remember

  • Annex 21 sets out the principles and requirements applicable to manufacturing and import authorization holders when they intend to import medicinal products for human, experimental or veterinary use from a third country into the EU . Conversely, medicinal products which enter the territory of the EU for the sole purpose of being exported and which are not transformed into any form or placed on the EU market are not covered by the annex.
  • With regard to the content of Annex 21, the document first sets out some general principles, including that requiring that all manufacturing steps of imported medical products that are carried out in third countries be carried out in accordance with the guidelines of EU GMP or other equivalent standards. , in accordance with the marketing authorization, the clinical trial and the corresponding quality agreement, if applicable.
  • Other provisions contained in Annex 21 are those devoted to the “Pharmaceutical Quality System”, with which all sites carrying out import activities must be equipped in accordance with Chapter 1 of the GMP guidelines, and to “Premises and equipment”, according to which the imported products the medicinal products should be stored in quarantine in separate areas until they are released for further processing or until the affected batches are certified by the qualified person.

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Jacob L. Thornton