MHRA: Further Guidance on Windsor Framework
The MHRA has published supplementary information for international regulators: export of UK medicines and the new Windsor Framework (Northern Ireland) labelling requirements.
This guidance explains upcoming packaging changes for UK-licensed medicines, effective 1 January 2025, and confirms that these medicines can still be exported globally.
Key Points:
- The Windsor Framework, agreed in February 2023, transfers medicines authorized under EU regulations to UK law, removing the Falsified Medicines Directive safety features.
- From 1 January 2025, all UK medicines must be labelled ‘UK Only’ to prevent movement into the EU, while maintaining consistent UK packaging.
- MHRA assures that 'UK Only' labelling does not restrict exports to non-EU countries, provided local import laws are met.
- Marketing authorisation holders can export without restrictions, though export by other companies is limited during UK shortages, with a regularly updated banned export list from the Department of Health and Social Care.
- Exporting companies must comply with both UK and destination country laws.
Source:
MHRA: UK medicines export and Windsor Framework labelling requirements
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