A Comprehensive Study on Impact of Brexit on Medical Device Application for Europe & United Kingdom

Abstract

On 29 March 2017, the UK notified the EU of its intention to withdraw from the EU, an event that became known as Brexit. the UK formally left the EU on 31 January 2020. A transition period began on 1 February 2020 and was due to end on 31 December 2020. During this period, the UK withdrew from participating in EU institutions, including the European Medicines Agency (EMA), but the EU pharmaceutical law remained in effect in the UK. Since 1 January 2021, EU pharmaceutical law is no longer in effect in the UK, except for Northern Ireland, based on the Protocol on Ireland/Northern Ireland. The Protocol is part of the withdrawal agreement between the EU and UK that established the terms of the UK's withdrawal from the EU. The Protocol is a part of the EU-UK separation agreement, which outlined the conditions of the UK & exit from the EU. The UK-EU is in the II scenario, as the first scenario requires applicants to send their dossier to the EU Competent Authority rather than the UK Competent Authority because Northern Ireland is part of the EU Union.