CATimelineAuthorisation object

General timespan (max nr days)

30

Mode of approval (General)

Explicit

Timespan counted from

Confirmation of formal completeness

Applicable national legal framework/ Reference

22a-22c MPG;
Art 6-7 of MPKPV

Additional Information

The applicant will receive an official notification from the CA and from the competent EC when the application documents are regarded as complete to start approval procedure. No deadlines for submission apply.

Clinical investigations for MD and performance evaluations of in vitro diagnostic agents in Germany must be approved by the federal CA and approvingly evaluated by an EC before they may commence (according to MPG §§ 22 and 22a).

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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