MHRA updates guidance on warning statements for medicine labels and leaflets

2nd July 2026

Summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance setting out the warning statements that should be included on the labels and patient information leaflets of specific medicines to support their safe use. The guidance covers both general and medicine-specific warnings, including advice for marketing authorisation holders on implementing appropriate wording. While the recommended text does not need to be reproduced verbatim, the MHRA advises that any alternative wording should remain clear, consistent and easy for patients to understand. The guidance also reflects current UK regulatory requirements and was updated on 1st July 2026.

Link: https://www.gov.uk/government/publications/warning-statements-for-labels-and-leaflets-of-certain-medicines

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