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<p>Our goal is to continue working closely with our European Union colleagues, as
we do at present, to make sure patients have access to safe and effective medicines.
As set out in the United Kingdom-EU Political Declaration, our priority is to seek
a new relationship with the EU that includes close regulatory co-operation for medicines
and medical devices. We have always been clear that we wish to explore with the EU
the UK’s on-going participation with the European Medicines Agency (EMA) and wider
regulatory network, as a part of the future relationship negotiations.</p><p>Whatever
the outcome of the negotiations, we will set up a regulatory system that protects
the best interests of patients and supports the UK life science industry to go from
strength to strength. The Medicines and Healthcare products Regulatory Agency, with
over 30 years’ experience licensing and monitoring the safety of new medicines, already
licences the vast majority of medicines on the UK market.</p><p>The Government will
ensure that patients are not disadvantaged by the future regulatory regime in order
that UK patients are able to access the best and most innovative medicines and their
safety is protected. The UK life sciences industry has much to offer in creating,
developing, trialling and commercialising medicines that will benefit UK patients
and strengthen the ability of the UK to compete internationally.</p><p>The Government
has taken pragmatic steps to ensure that patients continue to access innovative treatments
in the event that the UK leaves the EU without a deal. The Government’s stockpiling
regime will minimise any supply disruption in the weeks after leaving without a deal.
The Government has set out alternative licensing routes to incentivise companies to
continue to apply for licences with a view to approval of a licence at the same time
as the EU. This will ensure that patients, including those with the most critical
conditions, are not put at a disadvantage with regard to accessing innovative treatment.
Further to this, all centrally authorised products that are already approved by the
EMA will be converted into UK-only licences after exit unless the licence holder chooses
to opt out, ensuring continued supply of innovative treatment onto the UK market.</p>
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