ECAmendment object

Ethical review mandatory for

Any substantial amendments (except related to quality of investigational medicine)

Responsible for notification of SA

Sponsor

Applicable national legal framework/ Reference

20-22 Rulebook Application 2011

Additional Information

NB! Assessment by the EC(s) is not required if the substantial amendments are related to the quality of the IMP and/or changes to the bearer of the authorization for the implementation of clinical trials for the medicine (Art 20-22 Rulebook Application 2011)

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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