EMA Progresses on Brexit Plans

The European Medicines Agency (EMA) updated its Management Board on preparations for the United Kingdom’s withdrawal from the European Union at its June 2017 meeting. The agency is preparing for relocation of the agency, redistribution of workload, and guidance regarding any changes to marketing authorization. EMA presented the board with a business continuity plan, which the board endorsed.

In a press release, the agency stated it is proceeding under the assumption that the UK will no longer be part of the EU as of March 30, 2019. “This is without prejudice to the outcome of the withdrawal negotiations. The UK fully participates in the activities of EMA; it continues to participate in all formal meetings and retains its speaking and voting rights,” the agency stated in the release.

Some of the preparations EMA is working on to ensure continued processes during Brexit include finding a new location for the agency, which is currently located in London. EMA is currently conducting impact assessments to prepare for the move and is hoping to retain as many staff as possible. The European Council is expected to make a decision about the new location in October 2017.

EMA’s Management Board has endorsed a working methodology to redistribute work involved in the evaluation and monitoring of medicines. Two working groups will review options for redistribution and streamlining of work across the EU regulatory network.

At the meeting, the Management Board expressed appreciation for the agency’s actions to prepare for Brexit. It also highlighted other accomplishments the agency made in 2016 including the launch of the PRIority MEdicines, an initiative to target unmet medical needs; the completion of the parallel scientific advice with health technology assessment bodies; and the global response to antimicrobial resistance.

Source: EMA