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BSRBR-RA Register — SCE Rheumatology MCQ

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HardRheumatology PharmacologyBSRBR-RA RegisterSCE Rheumatology

A clinician suspects a serious previously unrecognized adverse reaction to a newly marketed biological medicine. What UK pharmacovigilance action is appropriate?

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Correct answer: C — An MHRA Yellow Card report

The best answer is “An MHRA Yellow Card report”. The Yellow Card scheme collects suspected adverse reactions, especially serious, unusual or new events; proof of causality is not required before reporting. Manufacturer confirmation and prior listing are unnecessary, and local documentation does not replace national pharmacovigilance reporting.

Reference: MHRA Yellow Card reporting guidance: https://www.gov.uk/guidance/the-yellow-card-scheme-guidance-for-healthcare-professionals-patients-and-the-public