The European Medicines Agency (EMA) this week released a draft reflection paper for consultation outlining the good manufacturing practice (GMP) responsibilities applicable to marketing authorization holders (MAHs) under European Commission (EC) GMP guidelines and other EU legislation.
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.


Reflection paper on Good Manufacturing Practice and  Marketing Authorisation Holders