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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