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Detailed GuideMHRA

Clinical trials for medicines: labelling

Guidance on labelling for medicinal products used in clinical trials.

First published: Jun 24, 2025Last updated: Apr 27, 2026Changes: 7

Latest change: Clarified that only one contact phone number needs to be included on the label. The amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft.

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