New GMP Guidance for Marketing Authorisation Holders

After long discussions, the European Medicines Agency EMA has published a Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders (EMA/457570/2019).

The document focusses on good manufacturing practice (GMP) responsibilities applicable to Marketing Authorization Holders (MAH). Business models have been changing over the years and many companies hold the MA, but contract many or all GMP related activities out.  For some of them it is not easy to understand all their responsibilities for the product, which can, "in some cases, be difficult to comprehend when reading the GMP guide or the applicable legislation". "Responsibilities are spread over the various chapters and annexes of the GMP guide, and are quite numerous", EMA points out in the introduction. And Annex 16 to the EU-GMP guidelines states that the "ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder (MAH)."  Although certain activities may be delegated to a contract acceptor, the "MAH retains the responsibilities which are outlined in this paper".

How this Reflection Paper sets out the various MAH responsibilities

In section 5 of the paper, each GMP requirement that applies to the MAH is outlined, with its key message stated or summarised. These are:

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

In addition to those, Chapter 6 discusses FMD-related responsibilities for MAHs, including responsibilities for safety features, repositories systems, serialisation data uploading and unique identifier decommissioning.

GDP-related responsibilities that may apply to MAHs are not directly addressed in the paper. Nevertheless, "MAHs do need to understand the type of interfaces that may need to be in place with the wholesalers they employ or engage."

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