CATimelineAuthorisation object

General timespan (max nr days)

30

ATMP/GMO trials (max nr days)

60

Clock-stop possible if complementary information requested

Yes

Timespan counted from

Confirmation of formal completeness

Applicable national legal framework/ Reference

Art. 33-36 KlinV/ClinO

Additional Information

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

If the therapeutic product is to be used in persons for the first time (“first-in-man”) or manufactured using a new procedure: extension by a maximum of 30 days possible.
Trial applications with products capable of emitting ionising radiation or radiation sources: 60 calendar days (Art. 36(4) KlinV/ClinO)

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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