Freedom of Information request on Summaries of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) for any vaccine that is currently authorised (FOI 21-258)
Published 28 May 2021
© Crown copyright 2021
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-12-april-2021/freedom-of-information-request-on-summaries-of-product-characteristics-smpcs-and-patient-information-leaflets-pils-for-any-vaccine-that-is-current
Thank you for your email.
Please review the links to the MHRA Products index and we advise that you can search for specific for the Summaries of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) for any vaccine that is currently authorised, and these will contain a list of the ingredients. https://products.mhra.gov.uk/
Further, any vaccines that have been approved since 31 October 2005 should have Public Assessment Reports (PARs) published either on the MHRA website (through the above-linked portal) or the European Medicines Agency (EMA) website through the link below. The PARs contain the non-confidential parts of the assessment of that vaccine.
If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.
After that, if you remain dissatisfied, you may write to the Information Commissioner at; The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.
Yours sincerely
MHRA Customer Service Centre