CAAmendment object

Authorisation mandatory for

Any substantial amendments (e.g . to trial protocol or its appendices)

Responsible for submission of SA


Standard notification form

“Substantial Amendment Notification Form” available on the European Commission website EudraLex - Volume 10 Clinical trials guidelines – Chapter I: Application and Application Form.

The forms may be filled in electronically on the EMA website, but Fimea requires submission of signed paper printouts.

Timeline for approval of SA (max nr days)

By silent (implicit) approval

Applicable national legal framework/ Reference

Section 9 of Regulation 2/2012

Additional Information

Silent approval procedure if no further information are requested, but a positive EC vote must be obtained before implementation.