CRED SMPC 2024

Labelling and packaging requirements

‘UK Only’ must be on all new packs . Can appear anywhere on the packs and must be clearly legible

Stickers can be used to apply ‘UK Only’ statement for a limited time period of 6 months (until 30 June 2025)

EU FMD packaging, labelling and barcode requirements for medicines must not appear on medicines being supplied to the UK. Companies can, however, use features that have not been uploaded to the European Medicines Verification System, i.e. 2D barcodes and serialisation numbers. The use of anti-tamper devices is also encouraged.

Early implementation of labelling (i.e. before 1 January 2025) will be permitted for PLs and PLGBs

Before implementing new artwork changes, companies must notify the MHRA by 31 December 2024. Notification can be through (1) any available regulatory opportunity or (2) self-certification

Joint EU/UK packs can no longer enter the supply chain after 01/01/2025 but where already released to market, can continue to be supplied until their expiry date. Information relevant to other markets will need to be removed from packs

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Reduced labelling: Blister foils

1. Name of medicinal product i.e. licensed product name (section 1 of SPC) immediately followed by common name(s) of up to three active substances

2. Name of MA holder

3. Expiry date

4. Batch number

5. Other (e.g. calendar days)

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