Disclaimer: Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

This document was prepared in collaboration with the UK Medicines & Healthcare products Regulatory Agency (MHRA) and was available for public consultation between May and August 2017. As of 1 January 2021 the UK is no longer a member of the European Union. Therefore, the MHRA published a national guideline on reporting serious breaches. Similarities in different sections can be identified between the UK and EU documents.


© European Medicines Agency, 2021

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