CATimelineAuthorisation object

General timespan (max nr days)

60

Mode of approval (General)

Tacit (Silent)

Clock-stop possible if complementary information requested

Yes

Applicable national legal framework/ Reference

Art 45 & 46 Medical Device Act 2010 (en) / Dz.U. 2010 nr 107 poz. 679 (pl)

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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