CATimelineAuthorisation object

General timespan (max nr days)

60

Mode of approval (General)

Tacit (Silent)

Clock-stop possible if complementary information requested

Yes

Timespan counted from

Confirmation of formal completeness

Applicable national legal framework/ Reference

Art 30.2-4 of Royal Decree 1591/2009
Art 127.2-4 of Royal Decree 1616/2009

Additional Information

The CA validates the correctness and completeness of the application and notifies the applicant on the decision. In case of any deficiencies the sponsor has a maximum time span of 10 days to correct them.

For Type III MD or active implantable type IIa-IIb MD the period for approval (by affirmative administrative silence) is reduced to 15 days. If clarifications are requested by the AEMPS, the Sponsor will have to submit a reply within 15 days.

Refer to Royal Decree 1090/2015.

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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