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

The Reflection Paper concerns the responsibilities and activities of MAHs with respect to the European  Commission’s guide to GMP (Parts I, II, and its relevant Annexes) for medicines for human and  veterinary use.


Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders