Any substantial amendments (e.g . to trial protocol or its appendices)
“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.
By silent (implicit) approval
Silent approval procedure if no further information are requested, but a positive EC vote must be obtained before implementation.