BREXIT – No extension to the transition period

It seems that Brexit is on course for 1st January 2021….

The 30th June 2020 came and the legal deadline for agreeing to an extension of the transition period has passed with no request from the UK. Therefore the Brexit trade deal transition phase will come to an end on the 31st December 2020. At this stage there will be one of two possible outcomes:The next important dates are the 15-16th October (European Council Meeting) and 26th November (penultimate plenary session of 2020. European lawmakers have stated that a trade deal must be negotiated, checked, translated and presented to the European Parliament by this date if the transition period is to end by 31 December 2020). If the UK exits without a trade deal, trade between the UK and EU will change immediately on the 1st January 2021 (i.e. Hard Brexit).

The European Commission (EC), European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have recently reminded clinical trial sponsors that they must comply with EU clinical trial rules following the Brexit transition period that expires on 31 December 2020 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/brexit_technicalnotice_ct_en.pdf

The UK Government launched a major new public information campaign to give everyone the facts that they will need to be ready for 1 January 2021. A straightforward checker tool at gov.uk/transition will help identify some of the specific steps any business or individual needs to take to be ready, and will allow companies to sign up for bespoke updates.

To keep up to date with all EMA advice on Brexit please refer to the following: https://www.ema.europa.eu/en/about-us/brexit-united-kingdoms-withdrawal-european-union

For more detailed information about how 2020 currently looks with regard to Brexit please see: https://www.ivowen.com/brexit-everything-stays-the-same-for-2020/

If you require any assistance for UK products please contact us: info@ivowen.com

Written by Emily Fletcher

Emily Flecther

 

Posted in BREXIT, Clinical trials, News from National Competent Authorities and tagged , , , , .