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
Report an issue with a medicine, device, vaccine, herbal or homeopathic remedy
You can report suspected side effects electronically via:
- the Yellow Card website
- the free Yellow Card app - download now from the Apple App Store or Google Play Store
- some clinical IT systems (EMIS/SystmOne/Vision/MiDatabank/Ulysses/Cerner/Medicus) for healthcare professionals
For any patients who do not have online access to report a suspected side effect to the Yellow Card scheme, call 0800 731 6789 for free, Monday to Friday between 9am and 5pm.
Medical devices adverse incidents
There are different ways for healthcare professionals to:
- report a problem with a medical device if you’re in Scotland
- report a problem with a medical device if you’re in Northern Ireland
- report a problem with a medical device if you’re in England or Wales using the Yellow Card website
For any patients who do not have online access to report an adverse incident to the Yellow Card scheme, report by email to aic@mhra.gov.uk. Adverse incidents involving medical devices cannot be reported by telephone.
Defective, fake medicines and medical devices, and e-cigarettes
Use the Yellow Card website to report information on suspected problems or incidents involving:
- a defective medicine (not of an acceptable quality)
- a falsified product (fake medicine or fake medical device)
- safety concerns associated with e-cigarettes or their refill containers (e-liquids)
Overview
The Yellow Card scheme is vital in helping the Medicines and Healthcare products Regulatory Agency (MHRA) monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and users.
Reports can be made for:
- suspected adverse drug reactions (ADRs) to all medicines including:
- vaccines
- blood factors and immunoglobulins
- herbal medicines
- homeopathic remedies
- all medical devices available on the UK market
- defective medicines (those that are not of an acceptable quality)
- fake or counterfeit medicines or medical devices
- nicotine-containing electronic cigarettes and refill containers (e-liquids)
It is important to report problems with medicines and medical devices and nicotine e-cigarette products. The reports help identify new problems with these products.
We will review the product and if necessary and take action to minimise risk and maximise benefit to patients and the public.
We are also able to investigate counterfeit medicines or devices and, if necessary, take action.
What to report
Medicines
For established medicines and vaccines you should report all serious suspected ADRs, even if the effect is well recognised.
We are particularly interested in receiving Yellow Card reports of suspected ADRs:
- in children
- in patients who are over 65
- to biological medicines and vaccines
- associated with delayed drug effects and interactions
- to complementary remedies such as homeopathic and herbal products
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You do not have to prove causality to report a suspected ADR, only a suspicion is needed.
Black triangle scheme
New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristic, together with a short sentence explaining what the triangle means. It does not mean the medicine is unsafe.
You should report all suspected ADRs for these products.
The MHRA is responsible for maintaining the list of black triangle products in the UK. The European Medicines Agency (EMA) is responsible for maintaining the list of black triangle products in Northern Ireland.
This symbol appears next to the name of a relevant product:
- in the British National Formulary (BNF)
- in the British National Formulary for Children (BNFC)
- in Monthly Index of Medical Specialties (MIMS)
- in the Association of the British Pharmaceutical Industry (ABPI) Medicines Compendium
- on advertising material
- in drug safety updates
- in summaries of product characteristics and patient information leaflets
See .
Medical devices
If a device has been involved in an incident, do not throw it away or repair it. If the police or coroner is involved in the investigation, keep the device until the MHRA contacts you. Otherwise you can make the device available to the manufacturer for analysis.
Do not send medical devices to the MHRA unless we specifically ask you.
For more information, see the Yellow Card site on reporting medical devices.
E-cigarettes and e-liquids
You should report any adverse incident involving a nicotine e-cigarette or refill container (e-liquid). We work with local trading standards bodies to ensure the safety of these products.
For more details and a video about what you can report, see What to report to the Yellow Card scheme.
How to report
You can report through the Yellow Card website.
Video guides
Guidance on what to report, how to report, what happens after you report and an overview of an account is available in these short videos about the Yellow Card Scheme.
Medicines
You can also use the free Yellow Card app available to download from Apple App Store or Google Play Store. Just search ‘Yellow Card’.
You can also send medicines Yellow Card reports by:
- writing to FREEPOST YELLOW CARD (no other address details necessary)
- emailing yellowcard@mhra.gov.uk
In some cases healthcare professionals can report using clinical IT systems, such as the MiDatabank system, SystmOne, Vision and Ulysses.
Medical devices
Report any adverse incident involving a medical device:
- in England and Wales, using the Yellow Card scheme
- in Northern Ireland, to the Northern Ireland Adverse Incident Centre
- in Scotland, to the Health Facilities Scotland online incident reporting system unless you are a private facility providing care to private clients, in which case you should report to the MHRA and the Care Inspectorate
What is being reported to the Yellow Card scheme
Interactive listings of all suspected ADRs reported by healthcare professionals and members of the public for a particular drug substance (these are called ‘Interactive drug analysis prints’) are available to view.
Further guidance and online learning
New e-learning module for doctors
We have created a new free e-learning module for doctors to learn about the importance of reporting suspected adverse drug reactions (ADRs).
The European Accreditation Council for Continuing Medical Education (EACCME), part of the European Union of Medical Specialists (UEMS), has given the module the highest order of accreditation. Doctors are awarded 1 EACCME credit (1 hour CPD) on completion of the 45 minute ADR e-learning module: Adverse Drug Reactions: reporting makes medicines safer.
The module was developed as part of the SCOPE Joint Action project to raise awareness levels of ADR reporting.
Please complete this short survey upon completion of the free e-learning.
E-learning modules for pharmacists
The Centre for Postgraduate Pharmacy Education (CPPE) has developed a series of 3 e-learning programmes with the Wales Centre for Pharmacy Professional Education and the MHRA. The programme has been endorsed by the Drug Safety Research Unit.
The e-learning modules should help pharmacists understand how to identify, report and prevent ADRS:
E-learning module for nurses
The Nursing Times, in close collaboration with the MHRA, has developed an e-learning module for nurses.
The module is free once you have registered and counts for 2 hours continuing professional development (CPD) credits.
Information material for patients and public
We have produced these resources to give patients and the public more information about the Yellow Card scheme, including awareness raising material and how to make a report.
They can be downloaded, printed and used as required by healthcare professionals and patient representative groups to encourage the reporting of suspected safety concerns involving healthcare products.
Leaflets, information cards and presentations
Information in other languages (note: all reports to the Yellow Card scheme must be in English)
Updates to this page
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Following the end of the transition period, updated references to EMA/EU systems.
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Updated PDF: Contribution of Yellow Cards to identifying safety issues
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Added a link to our new dedicated website to report any suspected side effects from medicines, future vaccines and incidents involving medical equipment relating to COVID-19 treatment.
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We have updated the information about reporting suspected side effects to a medicine, device, vaccine herbal or homeopathic remedy via electronic methods instead of paper.
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We have updated the messaging about reporting during the COVID-19 outbreak to include information on medical devices, defective or fake medicines/devices and e-cigarettes.
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During the Coronavirus (COVID-19) outbreak we are encouraging Yellow Card reporting to take place online, rather than paper.
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Added 2 video guides to assist with completing reports on the Yellow Card website.
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Uploaded an amended version of the Guidance on adverse drug reactions document.
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Added links to materials for patients and public groups about the Yellow Card Scheme.
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Updated the document Contribution of Yellow Cards to identifying safety issues.
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Updated survey link
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Information about new e-learning modules for doctors.
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New .pdf attachment for 'Contribution of Yellow Cards to identifying safety issues'.
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Updated Medical devices information.
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Updated to include reference to reporting issues with nicotine-containing electronic cigarettes and refill containers (e-liquids).
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Drug analysis prints renamed to Interactive Drug Analysis Profiles.
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First published.