CATimelineAuthorisation object
General timespan (max nr days)
15 (for monocentric Phase I trials)
28
Mode of approval (General)
Tacit (Silent)
ATMP/GMO trials (max nr days)
+ 30
(up to 90 days if the Belgian Biosafety Advisory Council has to be asked for advice)
Xenogeneic cell therapy (max nr days)
No time limit
Clock-stop possible if complementary information requested
Yes
Additional Information
The order of submission to the EC and CA is not defined. The trial cannot start until both instances have given a positive reaction.
In case of questions to the applicant: One clock-stop of maximum one month for supplementary information is possible
