The Yellow Card scheme: guidance for healthcare professionals, patients and the public
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
Latest change: Updated to reflect that the Northern Ireland Adverse Incident Centre (NIAIC) incident and reporting function will be closing. From the 1st August 2025, healthcare professionals in Northern Ireland will report adverse incidents involving medical devices to the Yellow Card scheme in accordance with their organisations medical device policies and procedures.
AI Summary
This guidance document from the Medicines and Healthcare products Regulatory Agency (MHRA) outlines the procedures for reporting safety concerns regarding medicines, medical devices, vaccines, and e-cigarettes within the United Kingdom. The regulatory framework is centered on the Yellow Card scheme, a vital pharmacovigilance tool used to monitor product safety and protect public health. While no specific inspections or company violations are detailed, the document highlights the necessity of reporting suspected adverse drug reactions (ADRs), defective medicines, and falsified products. Special emphasis is placed on the 'Black Triangle' scheme, which mandates the reporting of all suspected reactions for new medicines under additional monitoring. Required actions for healthcare professionals and the public include submitting reports via the Yellow Card website, mobile app, or integrated clinical IT systems. For medical device incidents, users are instructed to preserve the device for analysis rather than disposing of it. Reporting protocols vary slightly by region, with specific channels designated for Scotland and Northern Ireland. These reports allow the MHRA to identify emerging risks, investigate counterfeit goods, and implement safety measures to minimize patient harm.
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