Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
Documents
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.
Last updated 5 April 2024 + show all updates
-
Updated section 12 (Parallel Import Packs) to reflect guidance on UK Parallel Import Licences Following Agreement of the Windsor Framework.
-
Update to section 15.
-
- 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.
-
First published.