The reflection paper also addresses the activities and responsibilities set out by the EU in the GMP Directives 2003/94/EC and 91/412/EC, as well as the relevant articles of Directive 2001/83/EC and Regulation (EU) 2019/6. In addition, aspects of the Falsified Medicines Directive and its delegated regulations are addressed. Not included are the GMP requirements for advanced therapy medicinal products (ATMPs), which are covered in Part IV of the GMP Guide.
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:
However, EMA states that the document is not intended to be an all-inclusive continued "reference list". This paper considers all reference documents up to and as of April 2019. It should serve as a useful resource for MAHs when designing (or reviewing) their internal systems as well as their interactions with manufacturing sites.
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