EU GMP Guide Update

As of 21.08.2022, a new Annex 21 "Imports of medicinal products" of the European Guide to Good Manufacturing Practice (EU GMP Guide) comes into force. According to Annex 21, once a batch of a medicinal product has been physically imported in a EU/EEA country, including clearance by the custom authority of the entrance territory, it is subject to the Qualified Person (QP) certification or confirmation. For more details on this update please follow this link: https://ec.europa.eu/health/latest-updates/eudralex-volume-4-eu-guidelines-good-manufacturing-practice-medicinal-products-human-and-veterinary-2022-02-21_en