Reporting to the MHRA
The Yellow Card scheme run by the MHRA is the UK system for collecting and monitoring information on safety concerns such as suspected side effects or adverse incidents involving medicines including vaccines, and medical devices and e-cigarettes. The scheme relies on voluntary reporting by healthcare professionals and the public, including patients, carers and parents.
For healthcare professionals the MHRA request that we report:
- All reactions to new drugs, which have an inverted black triangle next to them in the BNF or in their SmPCs. (You can read more about the MHRA's approach to monitoring of black triangle drugs and the current list of these drugs is here.)
- Any serious reaction to all other drugs including prescription and OTC medicines, vaccines, blood factors, immunoglobulins and herbal products.
Patients, carers, or parents are asked to report any side effect that they, or a person in their care, may have experienced from a medicine.
There is a separate website for reporting suspected side effects to coronavirus medicines, vaccines, medical devices and test kit incidents.
Yellow cards may be completed via the MHRA’s dedicated Yellow Card website, on the mobile app or via the MiDatabank software that all Medicines Information centres in the UK use – ask your tutor or your MI pharmacist to show you how this works.
Quick clinical question
Can you report harmful incidents caused by medical devices to the Yellow Card scheme? ➔ Consider, then click for answer.
Can you report harmful incidents caused by medical devices to the Yellow Card scheme? ➔ Consider, then click for answer.
You can report incidents related to (1) medical devices, (2) defective medicines, and (3) counterfeit medicines via the Yellow Card scheme.
