Consultation on the Revised Annexes 1, 2 and 3 on the Clinical Trial Application Form

GMP News
9 April 2008
 

 Consultation on the Revised Annexes 1, 2 and 3
on the Clinical Trial Application Form

 
Annexes 1, 2 and 3 on the Clinical Trial Application Form, the Substantial Amendment Form and the Declaration of the end of a Clinical Trial Form to the ' Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial' have been revised.

These revised annexes will be required once the changes have been implemented in EudraCT version 7.0 on the EMEA website. It is anticipated that version 7.0 will be available towards the end of 2008. Comments on the changes introduced into the revised annexes should be e-mailed by 18 April 2008 to entr-pharmaceuticals@ec.europa.eu.

The documents (pdf format) you will find here.

Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
 

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