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<p>The Medicines and Healthcare products regulatory Agency (MHRA), as with all of
Government has been working hard to ensure that the United Kingdom is fully prepared
for European Union exit under any circumstance. The potential effect that the UK leaving
the EU without a deal will have on the regulatory processes for new medicines for
rare conditions is being mitigated with clear guidance and close engagement with industry
to ensure plans are relevant and fit for purpose.</p><p>Following a public consultation
last year, the MHRA has legislated to ensure a smooth transition to national provisions
for human medicines, including those for rare diseases. Indeed, for medicines for
rare diseases the UK will offer incentives, some fees will be waived, with others
fully or partially refunded, to encourage the development and marketing of such medicines.</p>
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