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. A transition period began on 1 February 2020, during which EU pharmaceutical law remains applicable to the UK. This is due to end on 31 December 2020.
The European Medicines Agency (EMA) has made preparations to ensure it continues to deliver on its mission to protect public and animal health throughout the Brexit process.
EMA continues to operate in accordance with the timelines set by its rules and regulations throughout the Brexit process.
The UK notified the EU of its intention to leave the EU on 29 March 2017.
The withdrawal agreement establishes the terms of the UK's withdrawal from the EU, including a transition period. This began on 1 February 2020 and is due to end on 31 December 2020.
During the transition period, EU pharmaceutical law as laid out in the ‘acquis communautaire’ will be applicable to the UK. This means that pharmaceutical companies can continue to carry out activities in the UK until the end of 2020.
However, the UK no longer participates in EU institutions after its withdrawal from the EU on 31 January 2020.
For EMA, this means that as of 1 February 2020, no one who represents the UK, or is appointed or nominated by the UK can participate in any EMA scientific committee meeting, working party meeting or in the Agency’s Management Board.
EMA developed a business continuity plan to ensure operational continuity during its physical relocation and readiness for Brexit. This enabled EMA to deliver its highest priority activities, temporarily scaling back or suspending lower priority activities as required:
- Annex 1 to EMA Brexit preparedness business continuity plan - Phase 4
- EMA Brexit preparedness business continuity plan - Phase 3 implementation plan
- EMA Brexit preparedness business continuity plan (first and second phases)
The Agency is reinitiating its activities in 2020 and is no longer under business continuity measures.
In defining its work programme for 2020 and beyond, EMA focused on the core activities identified in phase four of its business continuity plan as a basis and added prioritised tasks taking into account available resources.
The Agency is still in the process of rebuilding its workforce after its relocation. It will continue to monitor staff levels and review in June 2020 whether it can relaunch additional activities.
In preparation for Brexit, the EU27 Member States and EMA redistributed the UK's portfolio of medicines to other EU Member States. This involved transferring over 370 centrally authorised products to rapporteurs and co-rapporteurs from the EU27 plus Iceland and Norway.
EMA informed the relevant marketing authorisation holders of the new (co)-rapporteurships at the end of April 2018.
In September 2018, the new (co)-rapporteurs received a knowledge transfer package for each product. This contained background on the regulatory and evaluation history of each product, including the most recent benefit-risk assessment. The transfer package also helps each national competent authority forecast upcoming workload and support the planning of resources, particularly for complex products in the portfolio.
Answers to potential questions on the supply of medicines in the EU in the context of Brexit are available in the question-and-answer document below.
The document also explains what EMA, the European Commission and national competent authorities in the Member States are doing to prevent potential medicine supply shortages due to Brexit: