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UK drugs regulator plays down Brexit disruption threat

UK drugs regulator plays down Brexit disruption threat

LONDON: Britain’s drugs regulator said on Tuesday it would work to minimise disruption caused by the country leaving the European Union as it tried to allay some of the worst fears of pharmaceutical companies.

The highly regulated drugs industry is concerned about Brexit fallout as the European Medicines Agency (EMA) relocates from London to Amsterdam, creating uncertainty about drug approvals after 2019.

The Medicines and Healthcare products Regulatory Agency (MHRA) said in an update on its website that it hoped to have a continuing relationship with the EMA after Brexit, but if this did not happen it would be “pragmatic” in setting UK drug rules.

“There would be no sudden changes to the UK regulatory framework … we would give adequate notice and ensure that companies had sufficient time to implement any changed requirements,” it said.

The agency also noted that London and Brussels agreed last month that “goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labeling”.

The Association of the British Pharmaceutical Industry said it welcomed the MHRA’s pragmatism but warned that planning for a scenario where Britain had a separate regulatory system required further detail, highlighting the need for a realistic Brexit implementation period.

Pharmaceutical companies are used to decade-long product development cycles. Maintaining timely approvals for new drugs is crucial both for getting new medicines to patients and ensuring financial returns.

(Reporting by Ben Hirschler; Editing by Raissa Kasolowsky and Alexander Smith)

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