EC adopts acts on Good Manufacturing Practices for medicines

30 October 2017

The European Commission adopted two legal acts aimed at improving patient safety in the EU through good manufacturing practices (GMP) that ensure the highest quality of medicines for human use. The first act is Commission Directive (EU) 2017/1572 that sets out principles and guidelines of GMP in medicines where the manufacture or import is subject to a manufacturing authorization.
The second act is a Commission Delegated Regulation (EU) 2017/1569 that sets out GMP for investigational medicinal products. The principles and guidelines for GMP set out in these acts take into account recent updates to the well-established EU rules on the safety of medicines (European Commission, 18 September 2017).
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Click here for Commission Directive (EU) 2017/1572.
Click here for Commission Delegated Regulation (EU) 2017/1569.
Click here for more information about the NVC project Pharmaceutical Packaging Innovation.
Click here for more information about the NVC E-Course Pharmaceutical Packaging.

This news item is also included in our monthly overview, the NVC Members-only Update. If you have any questions, please contact us: info@nvc.nl, +31-(0)182-512411.