Brexit Already Affecting UK Regulator’s Role In Marketing Authorizations
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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If Brexit means the UK no longer plays a part in the EU drug regulatory system, responsibility for the ongoing oversight of almost one in four of all the human medicines that have ever been approved under the centralized procedure will have to be reassigned from the UK to other member states. What Brexit means for the UK’s role as a key player in the regulatory system in the meantime is the subject of speculation.
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