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Medicines and Healthcare products Regulatory Agency

Role of MHRA post-Brexit undecided, reveals government guidance

The Medicines and Healthcare products Regulatory Agency has said in its technical guidance that most aspects of medicines regulations will remain unchanged until the end of 2020.

EU flags outside EU parliament in Brussels

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The EU and UK will be in a transition period post-Brexit until the end of 2020; however, the role of the Medicines and Healthcare products Regulatory Agency during that time and beyond is still being negotiated

The future role of the UK’s medicines regulator is still “a matter for further discussion with the EU”, according to a document detailing the impact of a Brexit implementation period on the life science sector.

At a European Council meeting, held on 22–23 March 2018, the UK and EU agreed the terms of an implementation period to the end of December 2020. The aim of this period is to give businesses in the UK and across the EU time to plan for life after Brexit.

In its technical guidance, published on 6 August 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) sets out what recent developments — such as agreement on the terms of an implementation period — would mean for the life sciences sector once finalised as part of the UK’s Withdrawal Agreement.

The document explains that many aspects of medicines regulation, such as market access, licensing and packaging, new market authorisation applications (MAAs) and the status of being a qualified person based in the UK, will remain unchanged until the end of the implementation period to enable businesses to trade on the same terms up until the end of 2020.

However, it adds that while the MHRA and Veterinary Medicines Directorate (VMD) may attend European Medicines Agency (EMA) and EU committees, and any groups where there is a UK interest during the implementation period, “the exact nature of this participation is a matter for further discussion”.

According to the guidance, the MHRA reached an agreement with the EU that the UK was to be treated as a member state for the purposes of international agreements, including mutual recognition agreements, for the duration of the implementation period to minimise disruption to existing relationships.

However, although under the terms of the implementation period new MAAs will take effect in the UK, the UK will not be able to participate as a ‘lead member state’ and will not have a vote in any decision making, the guidance explains.

Sheuli Porkess, deputy chief scientific officer for the Association of the British Pharmaceutical Industry, welcomed the guidance but said there were still some unanswered questions.

“Pharmaceutical companies need as much clarity as possible so they can continue to supply medicines to patients as the UK leaves the EU,” she said.

“We are clear that there needs to be an implementation period, but whether there will be one is still subject to negotiation. The document also states that the future role of the MHRA, whose expertise is vital, is also still being discussed.”

Porkess said the industry will continue to plan for all scenarios, including a ‘no deal’ Brexit.

“We believe that the best way to protect patients and public health is for the EU and UK to agree continued cooperation on the regulation of medicines.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205293

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