CATimelineAuthorisation object
General timespan (max nr days)
60
Mode of approval (General)
Tacit (Silent)
ATMP/GMO trials (max nr days)
90
Mode of approval (ATMP/GMO trials)
Explicit (written)
External expert advice required (max nr days)
+ 90
Xenogeneic cell therapy (max nr days)
No time limit
Clock-stop possible if complementary information requested
No
Timespan counted from
Date of submission of valid application
Additional Information
In case of further clarification asked by the CA: Any requests for clarification must be made in writing within the respective time span.