EU Regulatory Network Reaches ‘Point Of No Return,’ German Official Says Of Brexit
A senior German regulator says that changes the EU medicines regulatory network has been making since the UK announced it was leaving the EU means that nothing will ever be the same again irrespective of whether the UK is allowed to remain in network as part of a Brexit deal.
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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.
The UK prime minister Theresa May says that the UK will seek “associate membership” of the European Medicines Agency after Brexit, an announcement that has been welcomed by the UK life sciences industry. However, it remains to be seen what this would entail in terms of UK regulatory input, and whether the EU will agree to negotiating such a status for a departing member state.
Members of the European Parliament are heading to the Netherlands to see whether the European Medicines Agency’s relocation process is going according to plan. The move follows Italian criticisms that the Dutch provided “incomplete” information about their readiness to host the agency.