Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the capacity requirements for the Medicines and healthcare products regulatory agency after the UK leaves the EU.

The Medicines and Healthcare products Regulatory Agency has assessed the capacity that will be required in both a deal and a ‘no deal’ European Union exit scenario. This is based on scrutiny of resource and careful assessment of the Agency’s ability to support the pharmaceutical and medical device industries.

Any gaps in resource have been identified by the agency, and sufficiently addressed. In the case of a ‘no deal’ scenario, the Agency has developed and is prepared to implement a new IT system that will sufficiently support industry to continue to operate in a smooth transition. The Agency continues to engage industry to ensure any concerns are addressed and that appropriate transparency is maintained.