EU Pharma Legislation Revision
EANM’s contributions to the European Commission’s Consultation on Revision of the EU general pharmaceuticals legislation
As part of the EU pharmaceuticals strategy, and drawing lessons from the COVID-19 pandemic, the European Commission plans to evaluate and revise the EU’s general legislation on medicines for human use to ensure future-proof and crisis-resistant medicines regulatory system.
Legal proposals to review Directive 2001/83/EC and Regulation EC/726/2004 are to be expected for the end of 2022. All stakeholders are invited to share their views and perspectives here until December 21, 2021.
The EANM’s main points of concern have been summarized in a briefing paper.