Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
KoBridge Co Ltd
Seoul, Korea, Lausanne, Switzerland
We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.
IMed Consultancy Ltd
United Kingdom, Ireland
Helping medical device and in-vitro diagnostic companies with CE marking, quality management systems, auditing, and global registrations.
April 21, 2025
Approximately 5 minutes
The Yellow Card Scheme: Guidance for Healthcare Professionals and the Public in the UK
The Yellow Card Scheme: Guidance for Healthcare Professionals and the Public in the UK
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Purpose of the Yellow Card Scheme The Yellow Card scheme is run by the Medicines and Healthcare products Regulatory Agency (MHRA) and acts as the UK’s primary system for identifying and monitoring safety concerns with healthcare products. It allows the MHRA to collect information on suspected side effects or adverse drug reactions (ADRs), medical device incidents, and concerns involving defective or counterfeit medicines. By reporting, individuals help the MHRA to take action to protect public health. Source: The Yellow Card scheme: guidance for healthcare professionals, patients and the public
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What to Report Anyone can report a suspected safety concern. This includes:
Medicines: Side effects to all medicines, including prescription, over-the-counter, herbal remedies, and those used during pregnancy.
Vaccines: Side effects associated with any vaccination.
Medical Devices: Incidents involving devices, ranging from blood glucose monitors and pacemakers to hospital beds and wheelchairs.
Defective or Fake Products: Reporting medicines that are not of acceptable quality or are suspected to be counterfeit.
Vaping Products: Side effects or safety concerns related to e-cigarettes and refills. Source: The Yellow Card scheme: guidance for healthcare professionals, patients and the public
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Reporting for Healthcare Professionals Healthcare professionals have a professional responsibility to report suspected adverse reactions, especially those that are serious, result in hospitalisation, or involve 'black triangle' (▼) medications. The black triangle symbol denotes medicines that are being intensively monitored by the MHRA. Professionals should report even if they are not certain that the product caused the reaction. Source: The Yellow Card scheme: guidance for healthcare professionals, patients and the public
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Reporting for Patients and the Public Patients, parents, and caregivers are encouraged to report side effects directly. You do not need a medical professional to report on your behalf. Reporting provides a unique patient perspective on how medicines and devices affect daily life, which is invaluable for safety monitoring. Source: The Yellow Card scheme: guidance for healthcare professionals, patients and the public
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How to Submit a Report Reports can be submitted through several channels:
Online: Using the Yellow Card website.
Mobile App: Available for iOS and Android devices.
Clinical Systems: For healthcare professionals, via integrated systems like SystmOne or EMIS.
Phone: A dedicated reporting line is available for those unable to use digital services. Source: The Yellow Card scheme: guidance for healthcare professionals, patients and the public
- What Happens After Reporting Every report is evaluated by a team of scientists, pharmacists, and doctors at the MHRA. They look for 'signals'—previously unknown side effects or a change in the frequency of known effects. If a safety issue is confirmed, the MHRA may:
Issue safety warnings.
Update the product's Information Leaflet.
Restrict how a medicine is used or, in rare cases, remove it from the market. Source: The Yellow Card scheme: guidance for healthcare professionals, patients and the public
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