Simplification of submission of applications for centrally authorised medicines

15/03/2013

Simplification of submission of applications for centrally authorised medicines

The European Medicines Agency has simplified the process of submission of applications for centrally authorised medicines, reducing the number of applications companies now need to submit.

The new requirements are outlined in a newly published table of dossier requirements for centrally authorised products. They have been revised with the aim of simplifying the process of submissions and aligning it with the implementation of the pharmacovigilance legislation, the creation of the Pharmacovigilance Risk Assessment Committee (PRAC) and the possibility of electronic submission throughout the European network.