Windsor Agreement on the supply of medicines into Northern Ireland

This summer the Government announced the Windsor Framework, which sets out the long-term arrangements for the supply of medicines into Northern Ireland.

It will ensure that medicines can be approved and licensed on a UK-wide basis by the Medicines and Healthcare products Regulatory Agency (MHRA) and provides for the disapplication of European Union (EU) Falsified Medicines Directive (FMD) requirements for medicines marketed and supplied in Northern Ireland.

To preclude onward movement of these medicines into any part of the European Union (EU), while ensuring medicines use the same packaging and labelling across the UK, all medicines on the UK market must be labelled as ‘UK Only’.

The measures will commence on 1 January 2025. Relevant information, exceptions and caveats on the agreement and its commencement can be found in the MHRA guidance on the labelling and packaging of medicinal products for human use following the agreement of the Windsor Framework and related FAQs.

 

Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework – GOV.UK (www.gov.uk)

Medicines and Healthcare products Regulatory Agency (filecamp.com)

 

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