CATimelineAuthorisation object

General timespan (max nr days)

60

Mode of approval (General)

Explicit

Timespan counted from

Confirmation of formal completeness

Applicable national legal framework/ Reference

Regulation On Medical Device Clinical Trials 2014

Additional Information

The sponsor is granted a single opportunity to resubmit amendments upon request of the Ministry.

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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