January Brexit Update
MHRA & HPRA Brexit Updates
The MHRA open the year with a position statement on Brexit and the progression to the second stage of negotiations [1 & 2]. But what is new?
This notification is a statement of intent, but it is difficult to see what couldn’t have been said earlier, unless withheld due to negotiating strategy. The statement does align with messages that have been stated by MHRA in conferences and off line. MHRA reiterate that the UK continues to bid for EMA work and expects those bids to be considered on merit. “On merit” requires that the departure of the UK from the EU must be taken into consideration. So, it seems likely that the UK’s share of workload would be significantly reduced compared to previous experience.
What is welcome in this update is the formal acknowledgement that MHRA will be pragmatic with regards to the evolution of the UK regulatory framework and the implementation of continuity plans, license maintenance and availability of medicines. But the negotiations still have a long way to go and much clarification will be required at the appropriate time.