About this service

The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive Agency of the Department of Health and Social Care that acts on behalf of the Ministers to protect and promote public health and patient safety, by ensuring that medicines and medical devices meet appropriate standards of safety, quality and efficacy.

The MHRA runs the Yellow Card scheme which collects and monitors information on suspected safety concerns or incidents involving: medicines, medical devices, and e-cigarettes. The scheme relies on voluntary reporting of suspected safety concerns or incidents by healthcare professionals and members of the public (patients, users, or carers).

The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation. Further information about the Yellow Card scheme, including its contribution to identifying safety issues can be found on the Yellow Card website.

The MHRA is responding to the coronavirus pandemic and providing a dedicated coronavirus Yellow Card site for healthcare professionals and patients to report the following related to coronavirus treatment:

  • suspected side effects to medicines

  • suspected side effects of any future vaccines

  • incidents involving medical devices

Why should I report?

Reporting suspected side effects or faulty medical devices helps identify issues which might not have been previously known.

Patients and healthcare professionals are reminded that there are currently no medicines authorised to treat COVID-19. Whilst scientists and organisations work to develop a vaccine against coronavirus (COVID-19), several treatments authorised for other diseases including severe respiratory illnesses are being used in patients with COVID-19. This also includes medicines and medical devices used to treat the symptoms of coronavirus, provide supportive care, or to suppress virus reproduction in some cases.

We still do not know how COVID-19 interacts and behaves with medicines or medical devices used for existing conditions. By reporting through this site, patients and healthcare professionals can help gather valuable evidence to inform decisions on the safe and effective use of medicines and medical devices as the pandemic evolves.

If a medicine or a medical device is used in a different way or for a different purpose, or it is new, or brought to market faster to aid coronavirus treatment, it is especially important that it is monitored closely and any suspected incidents are quickly reported. 

What should I report?

Report suspected side effects to medicines and incidents involving medical devices including faulty equipment, used for the treatment of coronavirus. When reporting patients and healthcare professionals are encouraged to provide as much information as possible.

It is important that sponsors continue to report via the established routes for clinical trials and not via the Yellow Card scheme.

Suspected side effects

When reporting side effects to medicines the following information should be provided where available:

  • Information on the person who have experienced the side effect

  • Whether the COVID-19 infection has been confirmed through testing

  • The name of the medicine suspected to have caused the side effects

  • A description of the side effects

  • Any other medicines being taken around the same time (including non-prescription and herbal remedies)

  • Any other health condition that the person who experienced the side effect may have

Medical device incidents

When reporting adverse incidents to medical devices at least the following information should be provided:

  • Information about the person affected by the adverse medical device incident

  • Information about the medical device, including the type and where you got it from

  • A description of the incident, including whether there was an injury

  • Whether the COVID-19 infection has been confirmed through testing

To report on any other medicines or medical devices unrelated to COVID-19 please report via www.mhra.gov.uk/yellowcard