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)


External expert advice required (max nr days)

+ 90

Xenogeneic cell therapy (max nr days)

No time limit

Clock-stop possible if complementary information requested


Timespan counted from

Date of submission of valid application