No time limit
Date of submission of valid application
Art 37 (l-p) of Pharmaceutical Law 2001 (en)/ Dz.U. 2008 nr 45 poz. 271 (pl)
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.