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Importation of medicinal products in EU and new Annex 21

The new Annex 21 Importation of medicinal products to the EU Good Manufacturing Practice (GMP) guidelines that has been published on February 21st, 2022, will enter into force on August 21st 2022. Document summarises the GMP requirements for Manufacturing Import Authorisation (MIA) holders when importing medicinal products (human, investigational and veterinary) from outside the EU/EEA.

When importing medicinal products into the EU following EU regulations apply:

  • Article 88 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC;
  • Article 40 (3) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use;
  • Article 61 of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC;
  • Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01).

Some regulatory expectations:

  • imported product must be physically imported before it can be certified by the Qualified Person (QP);
  • the site where batch certification occurs and the site that physically receives the imported product, if different, requires an MIA;
  • unless there are appropriate arrangements in place between the Union and the third country (e.g. Mutual Recognition Agreement (MRA)), it is required to test each batch of medicinal product upon importation into the EU before certification by a QP. GMP certificate of laboratory must include testing of imported medicinal products;
  • Annex 16 Certification by a Qualified Person and Batch Release gives detailed guidance on aspects such as sampling, interconnection of multiple manufacturing sites and QP oversight of the supply chain.

Important to remember:

  • Importation is defined as the action of physically bringing a medicinal product, from outside the territory of EEA/EU; fiscal transactions are not part of Annex 21.
  • medicinal products that enter the EU/EEA with the intention of export only and that are not processed in any form nor released for placing on the EU/EEA market, are not covered by this Annex.
  • Qualified Person (QP) certification or confirmation, as appropriate, of a batch of a medicinal product takes place only after physical importation and custom clearance into the customs territory of an EU/EEA State.
  • financial procurement, supply and export of medicines requires authorisation under a Wholesale Distribution Authorisation (WDA). Financial importation does not require authorisation by the national competent authorities

More detailed explanation on requirements of new Annex 21 with some practical examples can be found on the website of Irish Health Products Regulatory Authority (HPRA) – Annex 21 – Importation of Medicinal Products.