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Making medicines and medical devices safer

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.

For medication errors, healthcare professionals can report suspected side effects where harm occurs as a result of a medication error are reportable as an MHRA Yellow Card or via a local risk management system (LRMS). In England, medication errors reported via a LRMS are uploaded to the national Learning From Patient Safety Events service (LFPSE);  if a LRMS is not available, medication errors can also be reported directly via the LFPSE online service. If incidents are uploaded into LFPSE, these will be shared with the MHRA. If LFPSE 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 industry,

  • 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.

Defective medicines

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:

Falsified (Fake) medicines

Falsified reporting links:

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.