ECTimelinesEthicalReview object
General timespan for single-centre studies (max nr days)
15
General timespan for multi-centre studies (max nr days)
15
ATMP/GMO trials (max nr days)
60
Additional Information
Submission is possible anytime.
The sponsor is granted a single opportunity to resubmit amendments upon request of the Ministry (Regulation on Clinical Trials of Medicinal and Biological Products 2014).
Approval from the EC for Bioavailability-Bioequivalence Studies will be obtained within 7 days after notification date
