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UK pharma groups planning M&A deals ‘must get their skates on’ and begin filing now if they want to benefit from the EU’s review process before the Brexit transition period ends on 31 December.
A free trade deal needs to be negotiated in record time and UK life sciences must face up to diverging from the EU.
Latest From Brexit
The national regulator is to undergo a review in 2021 as the UK begins life as a former EU member, presenting opportunities to be seized.
In its latest communication to medical product companies, the DHSC says the biggest potential cause of disruption to supplies could be failure to prepare for border controls implemented by the EU member states after the end of the Brexit transition period.
In its latest letter to medicines and medical product companies, the UK's Department of Health and Social Care says the biggest potential cause of disruption to supplies could be failure to prepare for border controls implemented by the EU member states after the end of the Brexit transition period.
From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries.
Companies supplying into Northern Ireland now have more time to prepare for post-Brexit regulatory changes in areas like batch testing, imports and Falsified Medicines Directive requirements. UK industry association, PAGB, in a joint statement with five other pharmaceutical industry associations, including AESGP, describes it as a step in the right direction, but also warns that there is still much work to do.
The UK will have new regulatory systems for medical devices in place for when it leaves the EU at the end of this year. The Office for Life Sciences has been fielding more questions from industry on the new structures.
The Pfizer/BioNTech coronavirus vaccine results are a cause for celebration, but there is still a long way to go. Safety data are still awaited, as is more information on efficacy, and the mass rollout of the vaccine will pose significant practical challenges.
High level EU-UK negotiations have yet to deliver a free trade deal. Meanwhile, the MHRA has issued more guidance for medtechs accessing the UK market in 2021.
Incoming head of diagnostic regulation at the UK ABHI Steve Lee hopes to see more detailed MHRA guidance around product registration requirements for the post-EU national market.
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