Brexit - What will the impact be?
With less than 100 days to go to Brexit what should the UK Pharmaceutical industry expect?
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UK vote to leave the EU opens the prospect of years of negotiations over the union's future relationship with one of its most valued member states.
Guidance from the UK’s MHRA on post-Brexit arrangements relevant to the off-patent industry has been welcomed by local industry body the BGMA. However, it has warned that time is short to prepare for the end of the UK-EU transition period, with new guidance in certain areas “critical.”
Although the EU MDR and IVDR will fall outside the scope of new post-Brexit medtech regulations for Great Britain in 2021, the UK MHRA says it has the chance of developing its own world-leading regulatory regime.
The Medicines and Healthcare products Regulatory Agency has put procedures in place to renew UK marketing authorizations that are grandfathered from the EU system after the Brexit transition period ends.
With time running out on the UK-EU trade deal negotiations, the UK life sciences industry looks at the fine print of the new guidance on medicines regulation and explains why a mutual recognition agreement is urgently needed.
The UK’s approach to pharmacovigilance system requirements in the post-Brexit transition period will allow companies to leverage some of the existing structures put in place for EU systems.
June 24 was a seismic day, in more ways than one. The UK's decision to withdraw from the EU may have elated more than half of the voting public, but it has caused deep disappointment, anxiety and anger among many millions more in the UK, Europe and around the world.
Securing a favorable post-Brexit free trade agreement with the US is the principal aim of the UK’s Department for International Trade, and the UK medtech industry is pressing its case for closer business links with its largest non-EU trading partner.
Work has started on UK-only regulations for the medtech and medicines sectors, to ensure that the regulatory framework not only functions but can also react swiftly to needs after the UK leaves the EU. This article is part two of two.
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