The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive Agency of the Department of Health and Social Care that acts on behalf of the Ministers to protect and promote public health and patient safety, by ensuring that medicines and medical devices meet appropriate standards of safety, quality and efficacy.
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 and medical devices.
The scheme relies on voluntary reporting of suspected side effects or medical device incidents to be reported by health professionals and the public, including patients, carers and parents. Reporting helps others.
The purpose of the scheme is to provide an early warning that the safety of a medicine or a medical device may require further investigation. It is important for people to report problems experienced with medicines or medical devices as these are used to identify issues which might not have been previously known about. The MHRA will review the issue and if necessary, take action to minimise risk and maximise benefit to the patients.
Reports can be made for all medicines including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, all medical devices available on the UK market and reports of safety concerns associated with e-cigarette products . The MHRA is also able to investigate counterfeit or fake medicines or devices and if necessary, take action to protect public health.
Medical device adverse incidents
The term ‘medical device’ covers a broad range of products that are used in healthcare. They can be physical items or software which are used for the diagnosis, prevention, monitoring or treatment of illness or disability. Products reportable to the Yellow Card scheme as a medical devices will have a CE mark.
Examples of medical devices include: contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames.
Get the App
Yellow Card Mobile App: You can now receive news updates from the MHRA and report side effects to medicines via the Yellow Card app. Please download it from the Apple App Store or Google Play Store. Key features of the app include the ability to create a ‘watch list’ of medications for which you can receive news and alerts from the MHRA. You can view numbers of Yellow Cards reported to the MHRA for medicines of interest and see previous Yellow Cards you have submitted through the app.