Industry and other reporting guidance
Side effects from medicines
Patients, carers, parents and healthcare professionals in the UK are encouraged to report suspected suspected side effects, or suspected adverse drug reactions using the Yellow Card scheme using this website, the app or through some healthcare professional IT clinical systems (EMIS, SystmOne, Vision, MiDatabank, and Ulysses).
See our guidance on what to report. For more information about side effects from medicines, vaccine, herbal products or complementary remedies see here. For information about e-cigarettes see here.
Healthcare professionals can report suspected side effects where harm occurs as a result of a medication error as a Yellow Card or through their local risk management systems that feed into the National Reporting and Learning System (NRLS). If reported to the NRLS, these will be shared with the MHRA. If the NRLS is not available and harm occurs, report using a Yellow Card.
There is a legal requirement for pharmaceutical companies to report suspected adverse drug reactions directly to the MHRA for their products. See here for more information on their submission.
Medical device adverse incidents
Medical devices adverse incident reporting links:
for a healthcare professional in Northern Ireland or Scotland (additionally please also report the incident to your employer's local risk management system).
Anyone else should use the Yellow Card scheme. For more information about medical device adverse incidents see here.
If you are reporting a defective product as a manufacturer, marketing authorisation holder, or other (e.g. university, clinical trial sponsor), please send details of your report via email: email@example.com
Falsified (Fake) medicines
Falsified reporting links:
for industry, please report via email: firstname.lastname@example.org
Anyone else should use the Yellow Card scheme. For example, if you are a member of the public or identify yourself as reporting from non-healthcare setting (Her Majesty's Revenue and Customs, UK Border Force, from Law Enforcement (e.g. Home Office, Police, National Crime Agency or other), Trading Standards) please use the Yellow Card scheme.