Eudralex Volume 10 Annex 1 revised: Clinical Trial Application Form

Eudralex Volume 10 Annex 1 revised: Clinical Trial Application Form

Annex 1 revised

Please note: Recent changes in the regulatory framework for pharmaceuticals and clinical trials in the EU (mainly consequences of the paediatrics legislation and the legislation on advanced therapies) have required changes to the clinical trials application form. This is the revised version of the clinical trials application form. It will become applicable in the course of the first half of 2010, and is published in advance to allow stakeholders time for preparation. A precise date for applicability is going to be published on this website.