Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, when she will publish guidance on the future regulation of (a) medicines, (b) health technologies and (c) vaccines in Northern Ireland.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the regulation of human medicines and medical devices from 1 January 2021 in the United Kingdom. This guidance includes vaccines, which are regulated as medicines.

The MHRA has updated the guidance to reflect changes made by the European Union to its medicine legislation in relation to the Northern Ireland Protocol and the introduction of the route for the Government to ensure equity of access to medicines for patients in Northern Ireland. Any future regulatory changes will be reflected in this guidance.