In May 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a dedicated Yellow Card reporting site for healthcare products that are used in coronavirus (COVID-19) treatment to be easily reported: coronavirus-yellowcard.mhra.gov.uk.
Healthcare professionals, patients and carers are asked to report all suspected side effects to medicines, vaccines and medical device adverse incidents related to COVID-19 treatment and prevention. This also includes medicines that patients and healthcare professionals are using off-label to treat COVID-19. Reporting for clinical trials should be in line with the trial protocols.
Reporting will enable the MHRA to rapidly identify new and emerging side effects and medical device issues which may not have been previously known about, including diagnostic tests for COVID-19. This includes any medicines taken by patients to manage long-term, or pre-existing conditions that may influence the disease or have any potential interactions. The MHRA is closely monitoring any new or emerging safety signals in relation to medicines and medical devices used in patients with COVID-19.
Any healthcare product used in the treatment of COVID-19 can be reported, this includes medical devices such as ventilators and respiratory support devices, testing kits, certain protective personal equipment that are classified as medical devices, as well as medicines that are being used in COVID-19 treatment.
For more information on what to report please go to: coronavirus-yellowcard.mhra.gov.uk.
The MHRA are encouraging all patients, care givers and healthcare professionals to submit reports of suspected side effects using the Yellow Card Scheme electronically rather than by paper, during the current outbreak.
This is because the MHRA, following government advice are working remotely. Yellow Card reports of suspected side effects can be much more easily managed when submitting through the website, app or clinical systems than as paper reports.
You can report suspected side effects electronically via:
For any patients who do not have online access to report a suspected side effect to the Yellow Card scheme, call 0800 731 6789 for free, Monday to Friday between 9am and 5pm.
You can leave a message outside of these hours and one of the team will get back to you.
See full MHRA Guidance for further details.