The Supply of Medicines Across the UK – The Impact of the Windsor Framework

Synopsis

The Government of the United Kingdom (UK) introduced temporary measures to address problems with the supply of medicines to Northern Ireland in the wake of the UK’s withdrawal from the European Union (EU); both the UK and EU recognised that there were difficulties in operating the “Protocol on Ireland and Northern Ireland”, an agreement intended to protect the terms of the 1998 “Belfast Agreement” and preserve the close relationship between the Republic of Ireland and Northern Ireland.

These temporary measures (such as the Northern Ireland MHRA Authorised Route, “NIMAR”) were considered necessary by the UK, as the implementation of the Protocol on Ireland and Northern Ireland had created supply chain issues which impacted on public health in the region.

Despite these temporary measures, there was evidence that supply problems persisted – this was seen not only for medicines, but other areas of trade between Great Britain and Northern Ireland as well.

On 27 February 2023, the UK and EU published the “Windsor Political Declaration by the European Commission and the Government of the United Kingdom”, which is also known as the “Windsor Framework”. This framework, which was adopted by the EU-UK Joint Committee in March 2023, applies to trade between Great Britain and Northern Ireland whilst aiming to protect the EU market. This presentation will summarise the framework and MHRA expectations for the licensing & supply of medicines across the UK going forward.