CATimelineAuthorisation object

General timespan (max nr days)


Mode of approval (General)

Tacit (Silent)
Explicit approval possible before expiration of time period

Timespan counted from

Date of submission of valid application

Applicable national legal framework/ Reference

Art 21 Regulation no. 934/2010

Additional Information

60-d period applies to Class IIa,b and III MD.
Class I: Authorisation may be granted immediately after the date of notification, given that the relevant EC has issued its favourable opinion.

NB! During summer holidays no clinical trial applications will be confirmed. The holidays are published on the IMA website in section Home > Licences > Clinical Trials > Application.