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European Medicines Agency

MHRA will lose EMA work before Brexit transition period

Despite plans to continue its close work with the EMA, the MHRA will lose involvement in evaluating medicines for the EU from March 2019.

The UK will lose its involvement in evaluating medicines for the European Medicines Agency (EMA) from the date it formally leaves the European Union in March 2019, despite plans for the UK to remain closely tied to the European Union (EU) during a transition period lasting until the end of 2020.

The EMA has appointed new rapporteurs and co-rapporteurs for 370 centrally authorised products where the UK’s Medicines and Healthcare Regulatory Agency (MHRA) and the Veterinary Medicines Directorate had co-ordinated post-authorisation work.

The new rapporteurs — who come from the other EU states plus Norway and Iceland — will take on full responsibility for the medicines on 30 March 2019, the day after the UK leaves the EU.

Despite post-Brexit transition plans the EMA said the MHRA could no longer engage in “centralised regulatory procedures” after 29 March 2019 unless another date for Brexit is agreed.

The MHRA said there has been no decision yet on the future relationship with the EMA. “We want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines and medical innovations. We are committed to continuing a close working relationship with the European Medicines Agency,” it said in a statement. “This was reiterated further by the Prime Minister in her Mansion House speech of 2 March, where she confirmed the government would like to explore with the EU the terms on which the UK could remain part of EU agencies, such as the EMA.”

It said it is considering the impact of the EMA decision, but that most of its regulatory work is national rather than EU. It would not comment on whether it had requested that that work remain with it post-Brexit.

Niall Dickson, co-chair of the Brexit Health Alliance, which includes the Academy of Medical Royal Colleges, the NHS Confederation, and the Association of the British Pharmaceutical Industry among its members, said: “Our shared approach to regulation has given patients throughout Europe faster access to treatment. The UK has been a significant player in shaping the current system and now we are leaving the EU we accept that is bound to change.

“The EMA’s decision that the UK will no longer be leading work assessing new medicines, therefore, comes as no surprise. But we very much hope that the UK and EU will reach an agreement which will enable us to participate more fully. We believe that would be in the interests of both sides.

Work on licensing and monitoring medicines has been one of the first areas to be directly affected by Brexit. In November 2017, the 27 remaining EU member states took the decision to relocate the EMA headquarters from London to Amsterdam.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20204675

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