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EU Guidelines for Good Manufacturing Practice for Medicinal Products

As part of the manufacturing import authorisation (MIA) process, the Annex outlines the GMP requirements that must be followed when importing medicinal products (human, investigational, and veterinary) from outside the EU/EEA.

The purpose of this annex, the term importation refers to the action of physically bringing a medicinal product, from outside the territory of EEA/EU.


It covers topics such as GMP compliance and the role of the Qualified Person (QP), before going into details about QMS, premises and equipment, operations, documentation, and handling complaints.


The guidelines now cover investigational medicinal products, as well as human and veterinary medicines, and principles specify that fiscal transactions in which a product changes ownership but remains in the EU are excluded.


Click this LINK to know more on Annex 21: Importation of medicinal products

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