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
External expert advice required (max nr days)
180
Xenogeneic cell therapy (max nr days)
No time limit
Mode of approval (Xenogeneic cell therapy)
Explicit
Timespan counted from
Confirmation of formal completeness
Additional Information
In case of any deficiencies in the application, the sponsor is granted one opportunity to submit supplementary information within 30 days.
Explicit approval must also be obtained for clinical trials on active ingredients or components that are biological products of human or animal origin.