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Unease Mounts Over Brexit Drug Shortage Risk

Executive Summary

Not enough is known about how industry is preparing for Brexit when it comes to drugs approved via Europe’s mutual recognition and decentralized procedures. National regulators are urging companies to get their house in order.

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Big Share Of EU Decentralized Procedures Still Seeking Post-Brexit Home

Progress is being made with redistributing UK rapporteurships for non-centrally approved medicines, but companies need to keep up the momentum if all procedures are to be reallocated to other EU countries by the Brexit date of March 29, 2019.

‘We’ll Manage,’ Danish Medicines Agency Head’s View On Brexit

He’d rather Brexit weren’t happening, but senior European regulator Thomas Senderovitz says the national medicines agencies across the EU are on track to cope with the expected loss of the UK – a key player – from the EU pharmaceutical regulatory network. There’s no alternative, and they’re putting lots of work into preparing for it, he tells the Pink Sheet.

Germany Heads List Of EU Countries Taking On UK’s RMS Roles

Companies still need to replace the UK as their reference member state for around 6,000 products in Europe’s decentralized and mutual recognition procedures. Of the switches that have been completed so far, many have gone to Germany.

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