Brexit: the United Kingdom's withdrawal from the European Union
The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. During a?transition period from 1 February to 31 December 2020, EU pharmaceutical law continued to apply to the UK. From 1 January?2021, EU pharmaceutical law?applies to the UK in respect of Northern Ireland only.?
EMA continued?to operate in accordance with the timelines set by its rules and regulations?throughout the Brexit?process and its relocation.
The EU-UK Trade and Cooperation Agreement?concluded between the EU and the UK provisionally?applies since 1 January 2021, pending the completion of ratification procedures.?
The agreement contains a specific annex on medicinal products ('Annex TBT 2 - Medicinal Products'), which covers the recognition of good manufacturing practice (GMP) inspection outcomes carried out by EU and UK authorities.?
For more information, see:?
As of 1 January 2021, EU pharmaceutical law as laid out in the ‘acquis communautaire’ applies to and in the UK in respect of Northern Ireland only.
This is?based on the Protocol on Ireland / Northern Ireland. The?Protocol?forms?part of the withdrawal agreement?concluded by the EU and the UK?that established the terms of the UK's withdrawal from the EU.
For details on the impact of the?Protocol, see?Brexit-related guidance for companies.?
The withdrawal agreement also established?a transition period, which ran from 1 February to 31 December 2020.?During this?period, EU pharmaceutical law as laid out in the ‘acquis communautaire' continued to apply to whole of the UK.
As of 1 February 2020, no one representing, appointed by or nominated by the UK can participate in any EMA scientific-committee or working-party meetings, or in the Agency’s Management Board.?This is because the UK stopped participating in EU institutions after it left?the EU on 31 January 2020.
EMA, the European Commission (EC) and national competent authorities in?Member States have been working?closely together to minimise the impact of Brexit on the supply of medicines?since May 2017.
This has included advising?companies on how to apply for and implement the necessary changes, and encouraging?them?to plan and take action early.
More information?on the supply of medicines in the EU in the context of?Brexit?is available in this document:
In preparation for Brexit, the EU27 Member States and EMA redistributed?the?UK's portfolio of medicines?to rapporteurs and co-rapporteurs in other EU Member States,?Iceland and Norway. This involved over 370 centrally authorised medicines.?After receiving a detailed?knowledge transfer package?for each medicine, the new rapporteurs and co-rapporteurs were fully responsible for all of these medicines by July 2019.
In parallel, all marketing authorisation holders?for centrally authorised?medicines previously?based in the UK?were based in?an EU Member State by November 2020.
EMA supported these activities with a?Brexit-preparedness survey?in 2018. This gathered information from marketing authorisation holders on their preparedness for Brexit, and on the timelines for submission of necessary regulatory changes. It also aimed to identify any centrally authorised medicines at potential risk of supply shortages.
EMA followed its?business continuity plan to ensure it remained continually operational during the Brexit process and?its?relocation to Amsterdam. This enabled?EMA to deliver its highest priority activities, temporarily scaling back or suspending lower priority activities as required: