The government has published contingency legislation that is designed to protect the UK’s healthcare sector in the event that the country leaves the EU without a deal in place.
Under this new legislation, the Medicines & Healthcare products Regulatory Agency (MHRA) will assume responsibility for the regulatory processes for human medicines and devices. At present, this work is carried out by the European Medicines Agency, as well as other bodies.
Three regulations were set out in parliament earlier this month, one relating to human medicines, one to medical devices and one to clinical trials for medicines designed for human use.
Where medical devices are concerned, the MHRA has been named the “designated competent authority”, which means it “administers and enforces the law on medical devices in the UK”, the government explained.
As a result it now also has “a range of investigatory and enforcement powers to ensure their safety and quality”.
There are a number of concerns about what could happen in the event of a no-deal Brexit, especially if the deadline is not extended beyond the end of March. Hospital Healthcare Europe recently reported on health secretary Matt Hancock’s comments about the continuity of supply of medication.
He told the Health and Social Care Committee that medicines would be prioritised over food in the event of disruptions to imports at the UK border. His comments came as a number of UK supermarkets warned that they will face a shortage of fresh produce in a no-deal scenario, while consumers would see prices increase significantly.
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