CATimelineAuthorisation object
General timespan (max nr days)
30
Mode of approval (General)
Silent approval. Nevertheless, normally a written approval is sent to the sponsor
ATMP/GMO trials (max nr days)
90
External expert advice required (max nr days)
180
Xenogeneic cell therapy (max nr days)
No time limit
Mode of approval (Xenogeneic cell therapy)
Explicit
Timespan counted from
Date of submission of valid application
National legal framework in place
Yes
