CRED SMPC 2024

Labelling requirements (3/3)

13. Batch number

14. General classification for supply (legal status)

15. Instructions for use (OTC medicines only)

16. Information in Braille

17. Unique identifier - 2D barcode *

18. Unique identifier - human readable data *

* For Northern Ireland until 01/01/2025

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Windsor framework labelling requirements

All new packs for licensed medicines placed on the UK market on or after 1 January 2025 must include the statement ‘UK Only’. Any stock in existing packaging already placed on the market (in Great Britain and Northern Ireland) can continue to be supplied to patients in the relevant territory until the date of expiry. ‘UK only’ application: • must be conspicuous and clearly legible, at least 7-point font and in line with Article 5 of EU Regulation 2023/1182, current MHRA expectations and best practice guidance. • may be located anywhere on the outer packaging Before implementing any new artwork changes, companies must notify the MHRA and have until 31 December 2024 to do so. Further guidance can be found via the following link: https://www.gov.uk/government/publications/labelling-and-packaging-of-medicinal-products-for human-use-following-agreement-of-the-windsor-framework/labelling-and-packaging-of medicinal-products-for-human-use-following-agreement-of-the-windsor-framework

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