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EMA: Concept Paper on GMP and Marketing Authorisation Holders

On 4 October 2016, EMA published an interesting Concept Paper on Good Manufacturing Practice and Marketing Authorisation Holders (MAH). The document aims at giving clarity and a better understanding as to what the responsibilities of MAHs actually are in their  totality, and what they mean at a practical level.


The responsibilities for MAHs are spread over various chapters and annexes of the EU GMP Guide. They range from a responsibility to perform a task (e.g.  review  of periodic  quality  review), to acting at the interface with manufacture and control of the medicinal product (e.g. provision of current dossier information to facilitate the manufacturer’s compliance with the marketing authorisation). However, the disparate places within the GMP Guide that cite the various responsibilities make it rather complicated to keep an adequate overview.

The concept paper aims at outlining the existing requirements in a concise way, in one place and adequately explained. It is not intended to introduce any new responsibilities on MAHs. The 5-page document presents a proposal for how this could be achieved.

This work should be of interest to Marketing Authorisation Holders, manufacturers of medicinal products and active substances as well as GMP inspectors.

The public consultation is open until end of November 2016.



EMA: Concept Paper on GMP and MAHs

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