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No-Deal Brexit – MHRA consultation

The MHRA have launched a consultation on legislative proposals for a no-deal exit from the EU.

The consultation document proposes that “the overall approach in no-deal is for the MHRA to be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level. This would include decisions on Marketing Authorisation (MA) applications which are currently authorised through the Centralised Procedure, paediatric investigation plans and orphan status, as well as pharmacovigilance responsibilities.”

The no-deal Brexit consultation closes at 11:45pm on 1 November 2018