Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

The European Medicines Agency issued an updated reflection paper specifying the good manufacturing practice (GMP) responsibilities of marketing authorization holders under the European Commission GMP guidelines and other EU legislation. In general, these responsibilities range from responsibilities that relate to outsourcing and technical agreements, to ones that require the MAH to perform certain specific tasks. These responsibilities are spread over the various chapters and annexes of the GMP Guide, and are quite numerous.
_{August 2, 2021}