EU GMP Annex 21 finally published

On 20 March, after some delays, the new Annex 21 to the EU-GMP Guidelines was published as a draft. The document is entitled "Importation of medicinal Products". The "Concept Paper" was already published on 13 May 2015 (EMA/238299/2015) and the consultation phase ended in August 2015. The first draft for regulatory consultation was published in November 2016. Since then, no further activities or versions have been issued.

The Guidance is aimed at Manufacturing and Importation Authorisation holders (MIA holders) who import human or veterinary medicinal products from third countries. It does not cover products that do not have a marketing authorisation in the EU/EEA and are directly re-exported. The following points are to be regulated by the new Annex:

  • Physical transfer from the third country to the EU/EEA
  • Certification by the Qualified Person (QP) (link with the requirements of Annex 16)
  • Requirements for equipment and facilities
  • Required documentation
  • GMP requirements for manufacturers and exporters in third countries
  • Qualification and audits under the responsibility of the importing company and the Qualified Person (QP)
  • Import testing
  • Contractual regulations between all companies or persons involved in the import

The issue of "fiscal import" is no longer addressed in the current draft. Consultation phase is 20 March 2020 to 20 June 2020. The deadline for coming into operation still needs to be determined.

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