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Medicines regulator seeks views on plan for no-deal Brexit

Will consultation regulation following a no-deal Brexit lead to more certainty?


The Medicines and Healthcare Products Regulatory Agency (MHRA) has opened a consultation on how it should continue to operate its regulatory processes if the UK leaves the EU with a ‘no-deal’.


The agency said it believes a deal between the EU and the UK would be in the best interests of everyone but it and the government have a responsibility to prepare for all outcomes.


If there was a no deal, the MHRA would work alone as the medicines and medical devices regulator, making decisions and carrying out tasks currently taken by the EU.


The agency said the government would ensure patients are not disadvantaged in the case of a no-deal Brexit. The MHRA would continue to protect the interests of patients and strengthen the UK life sciences industry, it said.


The consultation includes an online survey which seeks views on the regulation of medicines, medical devices and clinical trials and ends on 1 November.


The Association of the British Pharmaceutical Industry said the best way to protect patients and public health is to agree future co-operation between the MHRA and the European Medicines Agency on the regulation of medicines.


The association said it would study the MHRA’s proposals and submit a response in due course.


Further information

PharmaTimes: MHRA consults on new regulatory framework for ‘no-deal’ scenario  MHRA EU Exit no-deal contingency legislation for the regulation of medicines and medical devices