News about GMP/cGMP


EMA: Reflection Paper on GMP-related responsibilities of MAHs

On 14 January 2020, the EMA published a draft Reflection Paper on the GMP-related obligations of marketing authorisation holders (MAHs). In general, these responsibilities relate to outsourcing and technical agreements. However, they are spread over the different chapters and annexes of the EU GMP Guideline and are also quite numerous. The aim of the reflection paper now is to clarify in a single document what the different responsibilities are and what they mean for MAHs at a practical level. It also addresses the legal provisions in European Directives and other Directives that relate to GMP and also affect marketing authorisation holders.

To summarize all these aspects in their totality and what they mean for MAHs at a practical level is presented under a number of different themes:

  • Outsourcing and technical agreements
  • Audits and qualification activities
  • Communication with manufacturing sites (e.g. MA dossier information, variations, regulatory 269 commitments, etc.)
  • Product Quality Reviews
  • Quality defects, complaints and product recalls
  • Maintenance of supply of medicinal products
  • Continual improvement activities.

It is intended that this 31-page Reflection Paper will provide increased clarity for MAHs in this area, and that it will serve as a useful resource for MAHs when designing (or reviewing) their internal systems as well as their interactions with manufacturing  sites.


EMA draft: Reflection Paper on GMP and Marketing Authorisation Holders