EU GMP Annex 21

Annex 21 to the EU-GMP Guidelines has been published as a draft (on 20^th March 2020), titled "Importation of medicinal Products".

The Annex is aimed at Manufacturing and Importation Authorisation holders (MIA holders) who import human or veterinary medicinal products from third countries.

The Annex does not cover products that do not have a marketing authorisation in the EU/EEA and are directly re-exported.

The Annex includes:

·         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

For details, see: https://ec.europa.eu/health/sites/health/files/files/gmp/importation_medicinalproducts_draftannex21_en.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)