CATimelineAuthorisation object
General timespan (max nr days)
60
Mode of approval (General)
Tacit (Silent)
Explicit approval possible before expiration of time period
Timespan counted from
Date of submission of valid application
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.
