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
Clock-stop possible if complementary information requested
Yes
Timespan counted from
Date of submission of valid application
Applicable national legal framework/ Reference
Art 37 (l-p) of Pharmaceutical Law 2001 (en)/ Dz.U. 2008 nr 45 poz. 271 (pl)
Additional Information
In case that supplementary information is requested from sponsor/ investigator: Up to 90 days for providing the information.
NB! A positive opinion issued by the concerned EC is a prerequisite for trial authorization by the CA.
