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
Timespan counted from
Date of submission of valid application
Applicable national legal framework/ Reference
Art 8 modified RGD 2005
