EMA updates reflection paper on GMP responsibilities of marketing authorization holders

Regulatory NewsRegulatory News | 29 July 2021 |  By 

The European Medicines Agency (EMA) on Thursday issued an updated reflection paper specifying the good manufacturing practice (GMP) responsibilities of marketing authorization holders under the European Commission (EC) GMP guidelines and other EU legislation.
The paper replaces a draft version issued in January 2020 with only some minor revisions. (RELATED: EMA Consults on GMP Reflection Paper, Regulatory Focus, 22 January 2020).
The paper covers the responsibilities required of marketing authorization holders (MAHs) under Parts 1 and II of the GMP guide. The reflection paper also addresses activities and responsibilities laid out by the EU in GMP Directives 2003/94/EC and 91/412/EC, as well as relevant articles in Directive 2001/83/EC and Regulation (EU) 2019/6. It also covers aspects of the Falsified Medicines Directive (FMD) and its related delegated regulations. However, the reflection paper does not cover some of the advanced therapy medicinal product (ATMP) GMP requirements that are addressed in Part IV of the GMP guide.
“It is recognized that, while MAHs have a significant role in facilitating GMP and MA  compliance, their responsibilities in this area can, in some cases, be difficult to comprehend when reading the GMP Guide or the applicable legislation,” said the paper. “Notwithstanding this, such responsibilities are there and may be inferred. This reflection paper seeks to provide clarity on these.”
EMA said that the reflection paper addresses all the references in the current GMP Guide as of the April 2019 update. Yet it says that the paper “should not be taken to provide an exhaustive list of those references on an ongoing basis.” It categorizes the general GMP-related responsibilities and activities of the MAH into seven themes.
The themes include:
  • Outsourcing and technical agreements
  • Audits and qualification activities
  • Communication with manufacturing sites
  • Product quality reviews
  • Quality defects, complaints and products recalls
  • Maintenance of supply of medicinal products
  • Continual improvement activities
The paper contains a few revisions from the draft. One change adds language stating that manufacturing sites and Qualified Persons should have visibility on what is registered in the marketing authorization as well as any regulatory commitments that have been agreed with the competent authorities in the section on “two-way communication systems" between MAHs and competent authorities.
Another adds language stating that alerts on supply problems issued by wholesalers, pharmacies and hospitals should also be considered by the MAHs in reporting potential supply problems to competent authorities. This was added in the section on “reporting supply restrictions and problems.” The revised reflection paper now also includes a list of abbreviations.
EMA reflection paper


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Tags: EMA, GMPs

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