United Kingdom's withdrawal from the European Union ('Brexit')
On 29 March 2017, the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU), a process known as 'Brexit'. The European Medicines Agency (EMA) is making preparations to ensure that it can continue to deliver on its mission and protect public and animal health after the UK leaves the EU on 30 March 2019, the date currently set by the timeframe provided in Article 50 of the Treaty on European Union.
The Agency continues its operations in accordance with the timelines set by its rules and regulations.
EMA is working on the scenario that the UK will become a third country as of 30 March 2019. As a consequence, the UK will no longer be able to engage as (co)-rapporteur for new marketing authorisation applications for which the centralised procedure would finish after 30 March 2019. This is without prejudice to the outcome of the withdrawal negotiations.
No Member State has previously decided to leave the EU, so there is no precedent for this situation.
EMA is essential to the functioning of the single market for medicines in the EU. The Agency's work is vital to providing EU citizens with effective, safe and high-quality medicines and to maintain a regulatory environment that fosters innovation and the development of new medicines.
The Agency is taking steps to ensure that it can continue to deliver on its mission and protect public and animal health while it prepares to relocate.
In April 2018, the EU27 Member States and EMA completed the redisribution of the UK's portfolio of over 370 centrally authorised products to rapporteurs and co-rapporteurs from the EU27 plus Iceland and Norway, in preparation for Brexit.
EMA informed the relevant marketing authorisation holders of the new (co)-rapporteurships at the end of April 2018.
In October 2018, EMA published the cut-off dates for UK (co)-rapporteur appointments for pre- and post-authorisation activities, based on the average duration of specific centralised procedures from submission to outcome:
- Cut-off dates for UK Rapporteurship appointments for pre and post authorisation procedures for centrally authorised products
In September 2018, the new (co)-rapporteurs received a knowledge transfer package for each product, containing background knowledge on the regulatory and evaluation history of each product, including the most recent benefit-risk assessment.
This will also help each national competent authority to forecast upcoming workload, to better support the planning of resources, particularly for complex products in the portfolio.
The redistribution plan covers the post-authorisation stage in a medicine's lifecycle. It takes into account the diverse expertise in the European medicines regulatory network and allows Member States to participate in EMA activities according to their capacity.
The methodology draws on Member States' expertise with a specific class of medicines and knowledge gained through prior involvement in a medicine's evaluation. For more information see:
EMA's two working groups on committees' operational preparadness developed the methodology. For more information, see:
- EMA working group on committees' operational preparedness for human medicines
- EMA working group on committees' operational preparedness for veterinary medicines
EMA first initiated discussions with the national competent authorities in April 2017 on how work related to the evaluation and monitoring of medicines will be shared between Member States in view of the UK's withdrawal from the EU.
EMA has developed a business continuity plan to ensure operational continuity while it prepares for its Relocation to Amsterdam and the UK's withdrawal from the EU. It enables EMA to deliver its highest priority activities and to temporarily scale back or temporarily suspend lower priority activities if required.
Update: The plan entered its fourth phase on 1 January 2019. This aims to ensure that EMA can continue its core activities to the same high quality while it is physically relocating to its temporary premises in the Spark building in Amsterdam and cope with the anticipated staff loss of 25% of its total workforce.
The highest priority activities EMA will focus on in the fourth phase include:
In addition, EMA has prioritised activities from its multi-annual work programme to continue in 2019, which are included in Annex 1 of the business continuity plan. EMA published this annex in January 2019, which complements the business continuity plan and the implementation plan for the third phase:
EMA will review in April 2019 which other activities from the multi-annual work plan can resume in the second half of 2019 once it has moved to its temporary building in Amsterdam.
EMA has been closely monitoring staff intention to relocate to Amsterdam. Overall, it currently expects a staff loss of about 25%
EMA will continuously review and adapt its business continuity plan as necessary.