Category: Sickness absence and disability · Reviewed by Mark Fox, Broker · Renewals · Last reviewed 2026-06-10
The Yellow Card scheme is the United Kingdom’s national reporting system for suspected adverse drug reactions, adverse incidents involving medical devices, defective medicines, and counterfeit medicines and devices. It is operated by the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care. Yellow Card data is reviewed by the MHRA and Commission on Human Medicines, and may lead to changes in product information, safety warnings or product withdrawal.
Category: Sickness absence and disability Also known as: ADR reporting, MHRA Yellow Card Operator: Medicines and Healthcare products Regulatory Agency (MHRA) Related concepts: Mental health absence, Group IP definitions
Yellow Card reports may be submitted by patients, healthcare professionals, or pharmaceutical companies. The scheme dates from 1964, following the thalidomide tragedy. It is relevant to group risk underwriting and claim assessment where a medication may have contributed to incapacity — although group IP claim adjudication is normally based on functional capacity rather than on Yellow Card data.
The scheme is established under the Medicines Act 1968 (as amended) and the Human Medicines Regulations 2012 (SI 2012/1916). Pharmaceutical companies have a statutory duty to report adverse drug reactions; healthcare professionals and patients submit reports voluntarily.
Yellow Card reports inform UK and EU/EEA drug safety monitoring (the EMA EudraVigilance system received UK reports until the end of the Brexit transition period; the UK now operates independently). MHRA publishes monthly Drug Safety Updates and an annual review of pharmacovigilance activity.
A patient suffers severe side-effects from a prescription medication and submits a Yellow Card report. The MHRA collates the report with others; if a pattern emerges, the product information may be updated to add a new warning or contraindication. In group IP context, where the side-effects cause incapacity, the claim is assessed on functional capacity criteria regardless of whether a Yellow Card report was submitted.
This entry is part of the Apex Insurance Wiki. Last reviewed by Matt Bartlett on 2026-06-10. Next review: 2026-12-10.
Apex Insurance Brokers Limited. Authorised and regulated by the Financial Conduct Authority, FRN 724952. Registered in England and Wales, Companies House 07014570. This entry provides general information about UK insurance concepts and is not regulated advice. Consult your insurance broker on your specific position.
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