The
European Medicines Agency has released a “Concept paper on Good Manufacturing
Practice and Marketing Authorisation Holders.”
The
current EU Guide to GMP refers in several places to Marketing Authorisation
Holder (MAH) companies and their responsibilities in relation to GMP ensuring
that the manufacturing authorisation holder can comply with GMP. These 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). These
responsibilities for MAHs are spread over various chapters and annexes of the
Guide, and are quite numerous. There appears, however, to be a lack of clarity
and understanding as to what these responsibilities actually are in their totality,
and what they mean for MAHs at a practical level.
Posted by Dr. Tim Sandle