Freedom of Information request on the Yellow Card Scheme (FOI 22/362)
Published 31 May 2022
© Crown copyright 2022
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-31-january-2022/freedom-of-information-request-on-the-yellow-card-scheme-foi-22362
FOI 22/362
2nd February 2022
Dear,
Thank you for your FOI request dated 21st January 2022.
It may be helpful if I firstly describe the role of the Medicines and Healthcare products Regulatory Agency (MHRA) and the work that we do. The MHRA is a government agency that has responsibility for the regulation of medicines and medical devices. The MHRA, together with independent expert advice from the Commission on Human Medicines (CHM), is responsible for ensuring that the overall balance of benefits in terms of effectiveness, and risks of medicines is positive at the time of licensing and remains so thereafter.
The Yellow Card Scheme, which is run by the MHRA, is the UK program for collecting experiences of side effects from healthcare professionals and patients and is used to monitor the safety profile of all medicines, including those from prescriptions, over-the-counter or general retail sales. It is a voluntary scheme for healthcare professionals and members of the public; however there is a legal requirement for pharmaceutical companies to report side effects that they have received to the scheme.
Information related to the number of myocarditis and pericarditis cases is not held by the MHRA. Reports received through our Yellow Card scheme include some where myocarditis or pericarditis were a suspected adverse reaction following COVID-19 vaccination and these can be viewed by following the link below:
Reports to the Yellow Card Scheme of myocarditis/ pericarditis following use of other medicinal products can be accessed using the link below:
https://yellowcard.mhra.gov.uk/iDAP/
I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division