CAAmendment object

Notification mandatory for

Any amendments - HRTC (CA) will decide whether it is a substantial or not

Authorisation mandatory for

Any substantial amendments

Timeline for approval of SA (max nr days)

60

Applicable national legal framework/ Reference

Art 35 Executive Decree No 235/2009

Additional Information

Timeline for the acceptance of a non substantial amendment: max. 21 days (has to be reported, but no fee! the study can be continued without interruption)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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