Yellow Card Scheme

E55600

The Yellow Card Scheme is the United Kingdom’s national system for collecting and monitoring reports of suspected adverse reactions to medicines and medical devices to help ensure their safety.

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Statements (50)

Predicate Object
instanceOf adverse event reporting system
pharmacovigilance system
administeredBy UK Medicines and Healthcare products Regulatory Agency
surface form: Medicines and Healthcare products Regulatory Agency
appliesTo e‑cigarettes and refill containers
herbal remedies
medical devices
over‑the‑counter medicines
prescription medicines
vaccines
associatedConcept black triangle scheme
collects reports of counterfeit or fake medicines
reports of defective medicines
reports of e‑cigarette side effects and safety concerns
reports of suspected adverse incidents involving medical devices
reports of suspected adverse reactions to biological medicines
reports of suspected adverse reactions to herbal medicines
reports of suspected adverse reactions to medicines
reports of suspected adverse reactions to vaccines
country United Kingdom
dataUsedFor regulatory decisions on restrictions or withdrawal of products
signal detection of medicine safety issues
updating product information and warnings
encouragesReportingOf adverse reactions in children
adverse reactions to black triangle medicines
new or unexpected adverse reactions
serious adverse reactions
focusesOn suspected adverse reactions rather than proven causality
hasWebsite https://yellowcard.mhra.gov.uk
jurisdiction United Kingdom
language English
operatedBy UK Medicines and Healthcare products Regulatory Agency
surface form: MHRA

UK Medicines and Healthcare products Regulatory Agency
surface form: Medicines and Healthcare products Regulatory Agency
purpose collect reports of suspected adverse drug reactions
contribute to benefit–risk assessment of medicines
identify new or rare adverse reactions
monitor safety of medical devices
monitor safety of medicines
support regulatory action on medicine safety
relatedTo pharmacovigilance in the United Kingdom
reportingMethod mobile application
online form
paper form
reportsCanBeSubmittedBy carers
dentists
doctors
healthcare professionals
nurses
patients
pharmacists
supportedBy UK Medicines and Healthcare products Regulatory Agency
surface form: Commission on Human Medicines

Referenced by (1)

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