EU rules will no longer apply to most of the UK from 31st December 2020.
But it’s not that simple!
The MHRA have been holding a series of webinars to inform the industry of regulatory and pharmacovigilance procedures in the UK following the end of the transition period. They are also publishing information on their website on the Gov.UK site here. Polls taken during the webinars give the impression that many pharmaceutical companies are not fully prepared for the end of the transition period.
After 31st December 2020, Great Britain (GB, which comprises England, Scotland and Wales) will follow UK rules. Things are a bit more complicated in Northern Ireland (NI), as an agreement between the United Kingdom (UK, which comprises GB and NI) and European Union allows for NI to remain aligned with specific EU rules.
Contact us at Agos Pharma for help if needed or email our team.