Revised version of application form for initial evaluation of human medicines available
The European Commission has published a revised version of the application form for all marketing-authorisation applications for medicines for human use. The form is for submissions to either the European Medicines Agency under the centralised procedure or to a Member State (as well as Iceland, Liechtenstein and Norway) under a national, mutual-recognition or decentralised procedure.
An electronic version of this application form is also available for use.
Applicants are advised to use the revised form (revision 10.1) from today, Monday 3 June 2013.