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MHRA to consult on potential for no-deal Brexit

Published on 05/10/18 at 10:00am

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on how its legislation and regulatory processes would be impacted by a no-deal Brexit.

The agency have said in a statement that although they “remain committed” to the negotiation of an agreement with the European Union, they believe “a responsible government should prepare for all potential outcomes, including the unlikely scenario in which no mutually satisfactory agreement can be reached.”

The agency noted that: “As part of this contingency planning it is necessary to make sure the UK’s regulatory processes for medicines, clinical trials and medical devices are legally coherent on exit day.”

The statement comes after American life sciences company Recardio halted clinical trials in the UK due to uncertainties surrounding Brexit.

Dr Ian Hudson, Chief Executive Officer at the MHRA commented: “Our position on medicines and medical devices regulation remains clear. We want to retain a close working partnership with the EU to make sure patients continue to have timely access to safe medicines and medical devices. However, it is important for the UK to prepare for all scenarios and this consultation is a key part of that. I therefore strongly encourage anyone that has an interest to share their comments.

The MHRA’s vision for the future of medicines and medical devices regulations is underpinned by three clear principles, that patients should not be disadvantaged, that innovators should be able to get products to the UK market as quickly and simply as possible, and that the UK continues to play a leading role promoting public health.

In the unlikely event of a no-deal scenario, the UK will strive to be at the forefront of regulatory innovation and processes. For example, looking at ways to reduce the length of time required to approve new medicines.”

Louis Goss

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