Amendment to Regulation (EC) No 1394/2007 (+4 more) on Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
COMCMT1R-EP1R-C2R-EPCNCADO
Updated 26d ago
This procedure updates the rules for approving and overseeing medicines for human use across the EU. It aims to ensure medicines are safe and effective, and streamlines the process through the European Medicines Agency.
It affects patients, healthcare professionals, and the pharmaceutical industry by setting clear standards for drug authorisation and supervision, and repealing older, related regulations.