Important information for clinical trial applicants concerning the coming into force of Regulation No 536/2014 and the possibilities of its practical application

With regard to the growing number of cases where applicants submitting clinical trials refer to Regulation No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (hereinafter referred to as “Regulation No 536/2014”), sponsors, monitors, CRO representatives, and anyone working in the field of clinical trials on medicinal products are hereby notified that Regulation No 536/2014 will come into force only after the roll-out of the EU portal and database, which scheduled for 31 January 2022. Until then, it is not possible to refer to Regulation No 536/2014 or apply it in practice.

1 June 2021

Department of Clinical Trials on Medicinal Products