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Brexit Already Affecting UK Regulator’s Role In Marketing Authorizations

Executive Summary

A recent stakeholder meeting at the EMA heard that because of Brexit, the UK will soon no longer be able to play the role of rapporteur for initial EU marketing authorization applications. Meanwhile, the EMA is working with the other 27 EU member states to ensure an “orderly redistribution” of the work currently done by the UK regulator, the MHRA.

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