ECTimelinesEthicalReview object
60
60
90
+ 90
No time limit
Yes
Date of submission of valid application
Yes
Art 37t, 37n, 37p, 37x Pharmaceutical Law 2001 (en)/ Dz.U. 2008 nr 45 poz. 271 (pl)
In case that supplementary information is requested from sponsor or investigator: 90 days max for providing the information.
The EC shall communicate its opinion to the sponsor or the (coordinating) investigator and to the CA.
The sponsor and the (coordinating) investigator have the right to appeal against an unfavourable opinion to the Bioethics Committee of Appeal. The sponsor or coordinator has 14 days from receiving the opinion of the local EC to apply for Appeal Bioethics Committee. The Appeal Bioethics Committee respond with its decision within 2 months from receiving the complete documentation.
Art. 37u oft he Pharmaceutical Law and Art. 29 of the Physicians’ Act