Brexit and UK Regulatory System
With a provisional trade deal between the UK and EU having been agreed, Diamond continue to provide thoughts on the emerging standalone UK regulatory system and give insights into regulatory strategy considerations for 2021. Despite a trade deal having been agreed, significant changes to the regulation of medicines in the UK and EU have been taking place and it is undertood that the UK will be a third country on 1st January 2021. This requires that pharmaceutical companies continue to prepare for the imminent deadline.
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The deal is now being assessed by all concerned parliaments and it is anticipated that this will trigger discussion through the Christmas and New Year period. Through our ongoing interactions with MHRA, we understand that further guidance will be announced that will be tailored to the nature of the deal agreed. We will update these pages as the details emerge and when the 2000+ pages of the agreement are scrutinised and the consequences are understood fully.
[last updated 15.30 GMT 24Dec2020]