CATimelineAuthorisation object
General timespan (max nr days)
60 calendar days; however, the CA aims to give grounds for non-acceptance or grant authorisation within 30 working days counted from receipt of a valid application.
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
No
Timespan counted from
Date of submission of valid application
