Important Information for Applicants for Clinical Trials through the Voluntary Harmonisation Procedure - Brexit and Christmas Break 2020/2021

The State Institute for Drug Control hereby informs the sponsors of clinical trials that  VHP Christmas Break 2020 will be from 22 December 2020 to 6 January 2021.  

The United Kingdom (UK) will no longer be eligible for initial VHPs and VHP-substantial amendments (VHP-SA) starting with 1 November 2020.

 

More information: https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2020_10_VHP_brexit_and_Christmas_Break.pdf

 

Department of Clinical Trials on Medicinal Products

Date: 3 November 2020