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 Last updated 22 December 2023 +show all updates
- Added glossary (see section 2). - Updated terminologies to align with Windsor Framework licensing guidance PL is now referred to as UK-wide MA.- Updated section 3 (Timelines) terminology - replaced from date of guidance with immediately. - Added new section 7 on supply of existing stock in existing packs, to provide clarity on where packs can be supplied.- Updated section 8 (Early Release to Market) to reflect that PLGB packs with UK Only labelling can be released to the GB market before 1 January 2025.- Updated section 9 (Notification Process) with new third option for initially submitting new artwork changes without an eCTD.- Added new section 11 on the packaging requirements for Traditional Herbal (THR) and Homeopathic (NR and HR) medicinal products.- Updated section 13 (Joint EU/UK Packs) on requirements for using shared inner packaging components.
Added links to Information about transitional arrangements for licences associated with the implementation of the Windsor Framework.
