CATimelineAuthorisation object

General timespan (max nr days)

30

Clock-stop possible if complementary information requested

Yes

Timespan counted from

Confirmation of formal completeness

Applicable national legal framework/ Reference

Art. 33-34, 36 KlinV/ClinO

Additional Information

The CA shall notify the sponsor of receipt of application or of any formal deficiencies within 7 days.

Authorisation timelines: Extension to 60 days possible in specific cases: first-in-man trials, manufacturing using a new procedure, devices capable of emitting ionising radiation

Swissmedic notifies relevant ECs and other concerned CAs of its decision.

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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