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 healthcare products meet appropriate standards of safety, quality and efficacy. We keep watch over medicines and devices, and take necessary action to protect the public promptly if there is a problem.
Speak to your doctor, pharmacist or to call NHS 111 if you are worried about your health as the MHRA is unable to provide medical advice.
The Yellow Card scheme
The MHRA runs the Yellow Card scheme, which collects and monitors information on suspected safety concerns involving a healthcare products, like a side effect with a medicine or an adverse medical device incident. The scheme relies on voluntary reporting of problems to a healthcare product by the public (including patients, parents and carer givers) as well as from healthcare professionals. The scheme also collects suspected safety concerns involving defective (not of an acceptable quality), falsified or fake healthcare products.
Always read the patient information leaflet, or instructions supplied with your medicine or medical device. It lists the known side effects or problems and advises you on what to do. You can report safety issues from any healthcare product to the Yellow Card scheme. Healthcare products include:
Blood factor and immunoglobulin products
Herbal products or complementary therapies such as homeopathies
Medical devices (including software, apps and artificial intelligence)
E-cigarettes including their refill containers (e-liquids)
More information on the types of reports for these healthcare products can be found here.
Aims of the scheme
It is important for people to report problems experienced with healthcare products as these are used to identify issues which might not have been previously known about. The purpose of the Yellow Card scheme is to provide an early warning that the safety of a product may require more further investigation. The scheme helps the MHRA monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and users. Reports are used alongside other safety information and help the MHRA to take action if any trends associated to the safety or efficacy of a healthcare product are identified. The MHRA will review the issue and if necessary, take action to minimise risk and maximise benefit to the patients.
The Yellow Card App
Report using the Yellow Card app available 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. Your account details can be used for the app and the website.
Use the dedicated Coronavirus Yellow Card reporting site to report suspected side effects to medicines and vaccines or medical device and diagnostic adverse incidents used in coronavirus treatment.
Anyone can report
You can report your suspicions of a safety concern or incident yourself as a patient, user, parent, or on behalf of someone you care for. Reporting is voluntary for healthcare professionals and is considered a professional responsibility. There are legal requirements for manufacturers to report problems with their healthcare products to the MHRA.
MHRA asks for all reports to be sent electronically using our website or the app instead of paper forms during the pandemic.
Your Yellow Card report
Every report counts and is important so if in doubt about reporting a suspected issue, the advice is to please report it as Yellow Card reports can help prevent future harm to others.
When you submit a report, you will receive a notification of submission which will contain your unique reference number. Your report will go onto our database after a quality check, so sometimes we may need to get in touch with you for more information.
All reports go onto our specialised database that allows us to process and analyse the reports rapidly to make them available to detect new safety issues. Every report therefore could be a potential safety issue or ‘signal’. Potential signals are evaluated and triaged to identify previously unidentified potential hazards, and new information including on recognised effects or safety issues. Your Yellow Card report will be considered in the context of all other reports received from patients or healthcare professionals.
Alongside your report, we also evaluate additional safety information available from other sources such as world-wide medical literature, the MHRA Clinical Practice Research Datalink, data from other regulatory agencies and world-wide databases, as well as the science behind the product, known information about the product and condition it is used to treat.
The MHRA may use your Yellow Card report in a range of different ways, including:
Highlighting the report as a possible safety issue on the MHRA database and keeping a close watch on the safety of the product by monitoring similar reports.
Noting the patient perspective of the effect, fault or complication, to better understand the impact on the people who use the product.
Requesting additional information from you so MHRA expert scientists and specialists can better understand the suspected potential safety issue.
Conducting a specific analysis of similar Yellow Card reports to identify potential new safety signals.
Requesting further information from other sources, including from the manufacturer(s).
Discussing the suspected side effect, adverse medical device incident or problem with other medicines regulatory agencies and experts in the field.
When we identify a new safety issue or learn more about a recognised one and if there is enough evidence, we carefully consider this in the context of the overall safety profile for the healthcare product. As no healthcare product is without risk, the MHRA investigates the safety signal further and reviews how a product can be used. This includes any warnings given to people taking, giving or using a healthcare product, for example adding information or warnings into the product information of a medicine or undertaking a field corrective notice for a medical device.
We also consider the safety issue in comparison with other products which can be used to treat the same condition and compare the risks with the benefits of the product. If a new safety issue is identified, where appropriate, the MHRA seeks advice from an independent group of expert advisors, like the Commission on Human Medicines (CHM) or the Devices Expert Advisory Committee (DEAC).
If necessary, we may take action to ensure that the product is used in a way which minimises risk, and maximises benefits to the patient or user.
We might include details of a new safety issue in the product information, change the way the product is used, or give out warnings to groups of patients, healthcare professionals, or users of the product. In rare circumstances, we may need to withdraw a product from the market, when we believe that the risks are much greater than its potential benefits.
Reporting makes a difference
Reporting has helped identify many new safety issues that were previously unknown until they were reported as a Yellow Card. For example:
Yellow Card reports of fires associated with emollients (which can be both medicines or medical devices) helped contribute to taking regulatory action for the labelling to be updated to include the risk which resulted in a communication campaign with several partners.
Warnings were added to the product information for the smoking-cessation drug varenicline after we received Yellow Cards reporting suicidal ideation.
Side effects to the former obesity drug rimonabant contributed to this drug being withdrawn - new evidence meant the risks were considered to outweigh any benefits.
A field safety corrective action (recall) by the manufacturer after several Yellow Card reports of mis-labelled femoral heads (medical device for the top part ball of the thigh bone in a hip replacement).
For more examples, see the contribution of Yellow Cards to identifying safety issues or our case studies page.
Data we gather from the Yellow Card scheme is vital in our work to protect the public, by ensuring that healthcare products continue to be used to benefit people and are used in a safe way. Yellow Cards reports are needed to continue identifying new side effects or safety issues and ways in which the risks of recognised issues can be minimised. Every report we receive contains potentially useful information - without the reports, we simply would not be able to continue this important work.
Yellow Card data transparency and access
The MHRA is transparent in the data it receives. See what types of problems are being reported to the Yellow Card scheme where you will find Interactive Drug Analysis Profiles which contain complete data for all spontaneous suspected adverse drug reactions, or side effects, which have been reported on a drug substance to the MHRA via the Yellow Card scheme from healthcare professionals and members of the public. They also include reports from pharmaceutical companies that have legal responsibilities to report to the MHRA.
We fully recognise the importance of increasing awareness and access to the Yellow Card scheme, and for anyone to be able to promptly report any concerns they have about the safety of medicines and vaccines. The MHRA is continually looking at ways to do this and has in place a strategy to promote the scheme and raise awareness amongst healthcare professionals and patients alike. The MHRA is first priority is patient safety and we regularly run public health campaigns to raise awareness about the importance of reporting, such as #MedSafetyWeek. See our campaigns and resources for more information or downloadable materials to help spread awareness and to encourage others to report.
Drug Safety Update - stay up to date with emerging news and MHRA guidance.