MHRA Seeks Views on ‘No-Deal’ Brexit Legislation and Procedural Changes

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation to seek views on how legislations and procedures of the agency may need to be modified should there be a ‘no-deal’ Brexit scenario. As stated on the Department of Health & Social Care website, the consultation period will run for four weeks from Oct. 4 to Nov. 1, 2018.

Through a series of questions, the MHRA will address no-deal proposals that cover medicines, clinical trials, and medical devices. The overall approach is for the agency to be a standalone medicines and medical devices regulator that decides upon and performs any functions currently carried out at the EU-level, including decisions on marketing authorisation applications.

Following the announcement, the Association of the British Pharmaceutical Industry (ABPI) revealed that it will be studying the proposals in great detail with a view to submitting a response in due course. In a press release, Dr Sheuli Porkess, deputy chief scientific officer at the ABPI said, “It is important that the UK puts plans in place for a ‘no deal’ Brexit. Pharmaceutical companies continue to plan for all possible outcomes from the negotiations and we will continue to work closely with the government on their plans.

“But we have been very clear that the best way to protect patients’ and public health in the UK and in the EU is to agree future cooperation between the MHRA and the EMA on the regulation of medicines.”  

“We continue to urge both the UK and EU negotiators to rapidly agree the terms of the UK’s withdrawal and a future relationship based on cooperation to protect public health, control infectious diseases, and manage medicine safety.”

Sources: Department of Health & Social Care and ABPI