Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, for what reason his Department held a public consultation for only three weeks on changes to the Human Medicines Regulation 2012 in relation to supply and the UK’s withdrawal from the EU.

The Medicines and Healthcare products Regulatory Agency (MHRA) ran a four-week public consultation on changes to the Human Medicines Regulations 2012 in preparation for the United Kingdom’s withdrawal from the European Union in the event of a ‘no deal’, from 4 October to 1 November 2018.

Preparations to ensure the UK will be ready for EU exit in all scenarios, including a potential ‘no deal’ outcome, requires contigency legislation to be made before 29 March 2019 to allow for an orderly exit. There was no statutory obligation to consult on these changes, but the MHRA applied the principles of best practice and consulted stakeholders publicly for as long as was feasible. This public consultation followed informal consultation with industry and the third sector on the proposed changes.