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Guidance: Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework

Medicines Healthcare Products Regulatory Agency

July 28
14:00 2023

Details

This guidance is designed to provide information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.

The Windsor Framework 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) , with medicines using the same packaging and labelling across the UK, and provides for the disapplication of European Union (EU) Falsified Medicines Directive (FMD) requirements for medicines marketed and supplied in Northern Ireland.

Published 28 July 2023

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