MHRA Guidance on Substantial Amendments to a Clinical Trial

This guidance describes the information about when substantial amendments need to be submitted to a clinical trial including changes to the trial sponsor or legal representative, investigational medicinal product certification and importation.

From 1 January 2021 either the sponsor or the legal representative of a clinical trial must be established in the UK or in a country on an approved country list. This list includes EU/European Economic Area (EEA) countries.