MHRA publish UK-wide licensing for human medicines: supplementary guidance

Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.

UK-wide licensing for human medicines: supplementary guidance

Details

The Windsor Framework introduces a UK-wide licensing regime, meaning that the same medicinal products, in the same packs with the same packaging will be available across the whole UK. The Medicines and Healthcare products Regulatory Agency (MHRA) will license all medicines across the UK, including novel medicines, which under the original Northern Ireland Protocol had to be authorised for Northern Ireland by the European Commission.

This information is to help understand the main changes affecting the licensing of medicines for human use in the UK, introduced by the Windsor Framework's medicines arrangements which came into effect on 1 January 2025.