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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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.
Clusters of excellence, competition as well as co-operation, Brexit, and aiming high. Danish Medicines Agency head Thomas Senderovitz talks national agencies and engagement in an interview with the Pink Sheet.
EU member state regulators have issued updated advice for marketing authorization holders wanting to change their reference member state for medicines evaluated through the mutual recognition and/or decentralized procedures. The document notes that Brexit is now an accepted reason for a switch of CMS, and explains how to make the switch in cases where all the strengths of the drug are not approved in any concerned member state.