Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

On 23 July 2021 the EMA published the reflection paper on GMP and the responsibilities of MAHs.

This Reflection Paper is focussed on the GMP-related responsibilities that apply to Marketing Authorisation Holder (MAH) companies. While it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products themselves, the current European Commission (EC) Guide to GMP (hereafter referred to as the ‘GMP Guide’) refers, in several places, to MAHs and their responsibilities in relation to GMP.

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