Yellow Card extended to include devices, counterfeits and defective medicines

We have simplified our medicine and device incident report systems by bringing them all under the Yellow Card Scheme.

You can now report any of the following on a Yellow Card:

  • suspected adverse drug reactions
  • medical device incidents
  • defective medicines
  • suspected counterfeit medicines

Please continue to report all suspected adverse drug reactions that are:

  • serious, medically significant, or result in harm - serious reactions are any of the following:
    • fatal
    • life-threatening
    • a congenital abnormality
    • disabling or incapacitating
    • those that result in or prolong hospitalisation
  • associated with new drugs and vaccines (denoted by a ▼); see list of black triangle medicines

Report via Yellow Card at www.gov.uk/yellowcard.

We have simplified our medicine and device incident report systems by bringing them all under the Yellow Card Scheme. Please report any of the following on a Yellow Card:

  • suspected adverse drug reactions (including those caused by medication errors) to medicines, vaccines, and herbal or homeopathic remedies
  • medical device incidents
  • defective medicines (ie not of an acceptable quality or not working as it should)
  • suspected counterfeit medicines

We will review and seek feedback on these changes from people who use the website and update the website accordingly.

Further information

Further guidance on what to report.

MHRA press release

Article citation: Drug Safety Update volume 8 issue 6 January 2015: 6

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