Updated Assessment Procedure of Documentation When Submitting Changes to Clinical Trials
State Institute for Drug Control (SUKL) posted the following update on December 02, 2020:
The SUKL / Department of Clinical Trials of Medicinal Products announces that the assessment procedure of documents (part of regulatory submissions) will change from 01 January 2021. The minor changes should be implemented and notified to SUKL along with the substantial changes as it will not be possible to add a minor change to the EU Portal / CTIS. The contracting authority is obliged to comply with the statutory deadline (35 days) after notification of the facts and implementation of substantial changes.