What are the GMP Responsibilities of the Marketing Authorisation Holders?

Recommendation
17/18 September 2025
Building a Knowledge Framework in GMP
The GMP/GDP Inspectors Working Group of the European Medicines Agency (EMA) has published a concept paper to summarise the GMP responsibilities of the Marketing Authorisation Holders (MAH). It is not intended to introduce any new responsibilities on MAHs but to document existing requirements in a better way.
The current EU GMP-Guidelines define in several chapters and annexes GMP tasks and responsibilities of the MAH. However, there seems 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. All these tasks and responsibilities have now been summarised in this concept paper:
- Chapter 1: responsibility to evaluate the results of the PQR review
- Chapter 7: responsibility to put contracts in place
- Chapter 8: responsibilities concerning quality defects, risk-reducing actions and notification of possible disruption in supply
- Annex 2: responsibility to put contracts in place
- Annex 12: obligations to approve the design of irradiation cycles, and agreeing the location for retention of irradiation cycle records.
- Annex 16: requirement to identify the site and QP responsible for certifying each batch (in the case of multiple sites authorised to manufacture / import / certify the same product) and the statement that the "ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy" lies with the MAH
- Annex 19: responsibilities for ensuring that reference and retention samples are taken, and stored.
The GMP/GDP Inspectors Working Group thinks that the issues outlined above "are not without important consequences. The way in which MAHs are expected to interact with the manufacturing sites registered in a marketing authorisation is not sufficiently clear, given the diverse ways in which the various MAH responsibilities are set out in the EC Guide to GMP, and differing (often complex) supply chains."
So what is next?
According to the Concept Paper, "It is recommended that the GMP/GDP Inspectors Working Group (GMP/GDP IWG) should produce a reflection paper intended for Part III of the EU GMP Guide or in another appropriate location (e.g. as proposed by the GMP/GDP IWG). This would capture all of the responsibilities that apply to MAH companies to enable manufacturers to comply with GMP. It would also result in a more complete picture of the regulatory environment with respect to GMP in which the MAH operates."
The deadline for comments on the concept paper is end of November 2016. Comments should be sent to adm-gmdp@ema.europa.eu.
Related GMP News
03.09.2025Is QP Release possible after deviating In-Process Controls?
20.08.2025What is the FDA Post-Warning Letter Meeting?
20.08.2025European Pharmacopoeia: New Online-only Platform
20.08.2025Events in an Audit Trail and Determination of GMP-Relevant Data in the Audit Trail
20.08.2025The Importance of Knowledge Management in GMP
13.08.2025FDA assesses economic Benefits of investing in Quality Management