CATimelineAuthorisation object
General timespan (max nr days)
60
Mode of approval (General)
Explicit
ATMP/GMO trials (max nr days)
90
Mode of approval (ATMP/GMO trials)
Explicit
External expert advice required (max nr days)
+ 90
Xenogeneic cell therapy (max nr days)
No time limit
Additional Information
NB! The applicant has the right to supplement the application once if additional information or material is requested from applicant.
Questions from CA will come after 30-35 days. The applicant has to respond within 45 days if the 60 days response time should apply. If the applicant does not respond within timelines CA will consider to start from scratch again.
