CATimelineAuthorisation object
General timespan (max nr days)
60
ATMP/GMO trials (max nr days)
90
External expert advice required (max nr days)
+ 90
Xenogeneic cell therapy (max nr days)
No time limit
Clock-stop possible if complementary information requested
Yes
Timespan counted from
Date of submission of valid application
Additional Information
In case of incompleteness of the application dossier the sponsor has 30 days to submit the missing information/ documentation.
Submission to the national CA is anytime possible.
NB! There is no parallel application process to CA and EC(s) in Serbia. A positive vote of the EC is a prerequisite for CA application and approval.
