About Yellow Card
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 and 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.
The scheme collects information on suspected problems or incidents involving
- side effects (also known as adverse drug reactions or ADRs)
- medical device adverse incidents
- defective medicines (those that are not of an acceptable quality)
- counterfeit or fake medicines or medical devices
- safety concerns for e-cigarettes or their refill containers (e-liquids)
Side effects to a medicine, vaccine, herbal or complementary remedy
All medicines can cause side effects (commonly referred to as adverse drug reactions or ADRs by healthcare professionals).
Side effects reported on Yellow Cards are evaluated, together with additional sources of information such as clinical trial data, medical literature or data from international medicines regulators, to identify previously unknown safety issues. These reports are assessed by a team of medicine safety experts made up of doctors, pharmacists and scientists who study the benefits and risks of medicines. If a new side effect is identified, the safety profile of the medicine in question is carefully looked at, as well as the side effects of other medicines used to treat the same condition. The MHRA assesses the balance of risks and benefits of all medicines at the time of initial licensing and throughout their use in clinical practice. Where appropriate, the MHRA seeks advice from the independent Commission on Human Medicines (CHM). The MHRA takes action, whenever necessary, to ensure that medicines are used in a way that minimises risk, while maximising patient benefit.
A short video is available for patients on how to report a suspected side effect from a medicine. Please note that there is no audio in this video
More information about the reporting of suspected side effects or adverse drug reactions is also available on the MHRA website:
- what happens to my Yellow Card after reporting a side effect?
- what to include in your Yellow Card of an adverse drug reaction
- specific areas of interest for reporting suspected adverse drug reactions
- black triangle (additional monitored) medicines (▼)
- pharmacovigilance – how MHRA monitors the safety of medicines
- contribution of Yellow Cards to identifying safety issues and case studies
- interactive Drug Analysis Profiles - numbers of side effects reported to the MHRA
- guidance for healthcare professionals
- guidance on adverse drug reactions
- Continuing Professional Development (CPD) modules for healthcare professionals
- other languages: Information about reporting side effects
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. At the moment account details are not syncronised between this website and the app, so you need to create separate accounts. We are also considering ways to report medical device adverse incidents, defective medicines and counterfeit products through the app.
See our animation below, developed as part of an EU wide social media campaign from the Strengthening Collaborations to Operate Pharmacovigilance in Europe (SCOPE) Joint Action project. It can also be viewed on MHRA's YouTube channel here: https://youtu.be/3et5LdYLc8M.
Help raise awareness about reporting suspected side effects to the MHRA by sharing the animation on social media:
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.
An adverse incident is an event that caused, or almost caused, an injury to a patient or other person, or a wrong or delayed diagnosis and treatment of a patient.
Examples of problems:
- faulty brakes on a wheelchair
- a faulty ear thermometer giving a low reading
- a faulty batch of test strips for a blood glucose meter giving wrong readings
- labelling or instructions on the device are not clear
- unsafe design
- quality issues that impact safety
If your equipment has a safety issue you should let us know as soon as you can. Please do not send your device to the MHRA. Hold onto it once you have reported it to us. The manufacturer may need it to investigate your report.
A short video is available for patients on how to report a suspected problem with a medical device. Please note that there is no audio in this video.
Useful safety information relating to devices can be found here.
Defective medicines (those that are not of an acceptable quality)
Defects in medicines may relate to quality issues with the product itself, the packaging, e.g. carton and blister or other packaging components such as the patient information leaflet. Yellow Card reports of defective medicines are submitted to the defective medicines report centre (DMRC). The role of the DMRC is to minimise the hazard to patients arising from the distribution of defective medicines by providing an emergency assessment and communication system between manufacturers, distributors, regulatory authorities and users.
Where a defective medicine is considered to present a risk to public health, the company or manufacturer as appropriate, is responsible for recalling any affected batch(es) or, in extreme cases, removing all batches of the product from the market. DMRC normally supports this action by issuing a drug alert notification to healthcare professionals. Other regulators and countries may be notified of a recall by the issue of a Rapid Alert notification.
If a member of the public has reason to believe that their medicine is not of an acceptable quality they should, in the first instance, consult with their doctor or a pharmacist who may then decide to refer the matter to the MHRA.
Further information about defective medicines can be found within the guide to defective medicinal products
Counterfeit healthcare products
The MHRA makes sure that the UK has systems in place to prevent counterfeit or fake healthcare products entering the supply chain. If counterfeit products become available, we make sure we detect counterfeits early and take action to protect the public.
When medicines and medical devices are bought on the internet the source of these products is sometimes difficult to trace and it is highly unlikely that the manufacturers of these products conform to European standards of safety and effectiveness. This means there can be a significant risk of harm to the patient or person using the product.
Yellow Card counterfeit reports are investigated in accordance with the terms of the Human Medicines Regulations 2012 and Consumer Protection Act 1987, and associated legislation.
The MHRA has statutory powers to enter business and private property to seize products suspected of being in breach of the relevant Regulations. Investigations concerning counterfeits can be complex, involving networks of companies and countries, banks, international law enforcement agencies, solicitors, financial investigators, crime analysts, internet investigators, disclosure officers, test purchasers, and specialists in the use of the Regulation of Investigatory Powers Act 2000.
The MHRA can work with manufacturers to resolve any potential issues and problems. However, where necessary, the MHRA has the powers to take formal enforcement action against individuals and organisations. Offenders can be prosecuted under various regulations and Acts which can result in fines and often imprisonment. Civil injunctions are also given, where appropriate.
Further information about counterfeits can be found on the counterfeit medicines and devices pages on the MHRA website
Blood factors and immunoglobulin products
Blood factor and immunoglobulin products, such as factors I to XIII or Anti-D (RHO) immunoglobulin, are considered medicines. Suspected side effects to these products should be reported using the Yellow Card side effect form
The Tobacco Products Directive came into effect in the UK on the 20th of May 2016 and introduces new rules for e-cigarettes and their refill containers. These rules ensure that there are minimum standards for the safety and quality of all e-cigarettes and refill containers. The MHRA is the competent authority for enforcing these rules and as part of this safety concerns for these products from healthcare professionals and members of the public are now being collected by the MHRA through the Yellow Card scheme. For further information please visit the MHRA webpage