CATimelineAuthorisation object

General timespan (max nr days)

15 (for monocentric Phase I trials)

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


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