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newsBrexit and medicines - preparations by the European Medicines Agency

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.

One of the consequences of Brexit is that EMA will relocate to Amsterdam, the Netherlands, where it has to take up its operations on 30 March 2019 at the latest.

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.

Continuity of EMA activities

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.

Regulatory preparedness

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.

EMA will facilitate knowledge transfer from the UK to the new rapporteurs and co-rapporteurs, who will only take full responsibility for these products as of 30 March 2019.

In September 2018, the new (co)-rapporteurs will receive 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 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.

Business continuity plan

EMA has developed a business continuity plan to ensure operational continuity while the Agency prepares for its relocation 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:

The plan entered its second phase in January 2018.

EMA will launch a third phase of its business continuity plan on 1 October 2018 at the latest, following implementation of the first and second phases of the plan.

Activities to be scaled back or suspended in the third phase include:

  • collaboration at international level, which will be temporarily scaled back to focus primarily on product-related requests, supply-chain integrity and procedures under Article 58. In global medicine regulation, EMA will only take a reactive role. EMA's engagement in other global public health issues such as antimicrobial resistance or vaccines will be maintained as long as possible, but reviewed on a case-by-case basis;
  • development and revision of guidelines, which will be temporarily limited to those guidelines that address an urgent public or animal health need or are necessary to support and facilitate preparation for Brexit;
  • holding of non-product related working parties, which will be temporarily reduced as a consequence of the scaling back of guideline development or revision;
  • programmes and projects, where activities in relation to project governance will be reduced in line with the reduction and suspension of projects;
  • organisation and attendance at stakeholder meetings, which will be limited to Brexit-related interactions;
  • clinical data publication, for which the launch of new procedures will be temporarily suspended as of 1 August 2018. Data packages submitted for medicines until the end of July 2018 will be processed and finalised.

This will allow the Agency to safeguard core activities related to the evaluation and supervision of medicines, while it has to intensify its preparations for the physical move to Amsterdam in March 2019 and cope with significant staff loss.

Overall, EMA expects a staff loss of about 30%, with a high degree of uncertainty regarding mid-term staff retention.

EMA is developing detailed plans for the implementation of these measures. EMA will communicate these to stakeholders and the public as soon as they are available.

EMA will continuously review and adapt its business continuity plan as necessary.

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