CATimelineAuthorisation object
General timespan (max nr days)
60
Mode of approval (General)
Tacit (Silent)
ATMP/GMO trials (max nr days)
Other
Xenogeneic cell therapy (max nr days)
No time limit
Mode of approval (Xenogeneic cell therapy)
Explicit
Clock-stop possible if complementary information requested
No
Timespan counted from
Confirmation of formal completeness
National legal framework in place
Yes
Additional Information
The CA has 10 days to validate the application documentation and to notify the applicant on the decision.
In case of any formal deficiencies communicated by the CA, the sponsor has 10 days to correct them. (Art 5. Regulation (UE) n.º 536/2014)
NB! CA authorization is only possible provided that the EC’s favourable opinion has been issued before the deadline.
There is NO clock stop if further information or clarification is requested from sponsor (as opposed to REC assessment).
Considering this, it is advisable that the CTA is submitted to the EC(s) at least 2.3 weeks prior to the date of submission to the CA!
