After the ‘Meaningful Vote’, MHRA guidance in event of a no-deal Brexit scenario

Following the ‘Meaningful Vote’ on the 15th of January, in which MPs voted down the Prime Minister Theresa May’s Brexit Deal, Aptus Clinical would like to reiterate the updated guidance from the MHRA in the event of a no deal Brexit.

The guidance states that the UK would continue to recognise existing approvals so organisations would not need to re-apply. The sponsor or legal representative of a clinical trial would be required to be in the UK or a country on an approved country list, which would initially include both EU and EEA countries.  Official guidance also states that the UK would be aligning with the EU Clinical Trials Regulation, when it applies.

Steve McConchie, CEO of Aptus Clinical said:
“The MHRA has worked closely with the government to ensure the safe regulation of clinical trials, despite whichever deal is reached with the European Union. We are pleased that this enables us to re-assure our clients that in the event of a no deal Brexit we will be able to continue to seamlessly conduct their clinical trials in the UK and Europe for the benefit of patients.”

https://www.gov.uk/government/news/mhra-releases-response-to-consultation-on-eu-exit-no-deal-legislative-proposals

January 16 2019 0 comments

Comments

There are no comments on this post yet. Be the first to leave a comment.