CATimelineAuthorisation object

General timespan (max nr days)

60 (21 days without involvement of special authorities; max. 50 days including process of special authorities)

Mode of approval (General)

The study can be started if the CA do not have any written objection within 60 days after official receipt of application

Additional Information

Applications should be sent in 2 identical copies to the CA (HRTC/ENKK) at least 20 days prior to the next TUKEB meeting (timetable of TUKEB meeting provided on website) that sends one of them to the TUKEB (acting as special authority). TUKEB has 50 days.
NB: There is no possibility for preliminary opinion of TUKEB!

Combination studies (MD+ IMP): A second Special authority (NIPN) is involved. It has 50 days to express its opinion. (Please note that this interval starts when NIPM receives the application and HRTC will continue its procedure when the opinions of Special authorities arrive).

The general rule is one single submission to the authority that sends the relevant documents to the EC for opinion.

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