CATimelineAuthorisation object

General timespan (max nr days)

60

Mode of approval (General)

Tacit (Silent)

Clock-stop possible if complementary information requested

Yes

Additional Information

If the study is a post-market trial (CE-marked use within label, class I, IIa and IIb) only a notification of the start to CA is required (no timelines apply).

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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