Freedom of information (FOI) releases from MHRA

This is a disclosure log of Medicines and Healthcare products Regulatory Agency's responses to freedom of information (FOI) or environmental information regulations (EIR) requests that might be of wider public interest.

If you can't find the information you're looking for, you can make a new FOI request.

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514 disclosures

  1. CEC 201928 Bed grab bars

    I was wondering if you could provide further information regarding the number of deaths and injuries specifically related to bed grab bars rather than the combined with the figures including bed rails as is detailed in the guidance document

    Published: 20 November 2024

  2. FOI- Revolade 25 mg, 50 mg and 75 mg film-coated tablets

    hereby submits the following Freedom of Information request with regards to the Marketing Authorisations for Revolade 25 mg, 50 mg and 75 mg film-coated tablets (PLGB 00101/1126-1128-1129) held by Novartis Pharmaceuticals UK Limited. The details of the request are as follows: * The Environmental Risk Assessment document named Revolade(r) (eltrombopag olamine) 25 and 50 mg film coated tablets Environmental Risk Assessment and associated study/chemical testing reports that are currently registered in module 1.6 for the following Product Licences (PLGB 00101/1126, PLGB 00101/1128, PLGB 00101/1129) In accordance with the Heads of Medicines Agencies/European Medicines Agency (HMA/EMA) guidance on transparency, the environmental risk assessment information within module 1.6 requested is considered releasable, as outlined in pages 5 and 25 of the HMA/EMA guidance.

    Published: 20 November 2024

  3. Gardasil 9 vaccine analysis print

    Thank you for providing the document. Can you please clarify - earliest reaction date - data lock date - report run date - total reports (not total reactions)

    Published: 20 November 2024

  4. Freedom of information request

    Could I please request a list of the Dental Laboratories in Scotland who are registered with the MHRA.

    Published: 20 November 2024

  5. Validation of submission DC-Vax

    I'm writing you regarding DC-Vax from Northwest Biotherapeutics. It seems as if people contacting you guys about validation has gotten two different answers. They submitted for approval in December 2023, they got a validation of submission from MHRA on 24th of January 2024. After that they got a confirmation of validation on the 7th of March. Now the question is when the clock starts, apparently you answered to one guy that it was the date in January and another that it was the date in March? Hope you will take your time to be specific about the date that the clock on for submission started.

    Published: 20 November 2024

  6. MHRA Yellow Card Contact Us Form Submission

    Where can I find Vaccine reports for the influenza vaccines, specifically those used in last years flu vaccination program? I only see reports for COVID vaccines and medicines. Also, the data Table view for COVID-19 Vaccine Pfizer/BioNTech bivalent does not show any values for 2023, but the graph shows doses were given. I do not see anywhere the total number of doses given? Without it interpretation of the ADRs is impossible.

    Published: 20 November 2024

  7. FOI Covid ADR data

    Can you clarify the total amount of adverse reactions so far submitted and what are the 10 most common reactions reported?

    Published: 20 November 2024

  8. PHARMARON MANUFACTURING SERVICES (UK) LTD Inspection Reports

    Please provide a copy of the MHRA GMDP Inspection Report arising from the 21 Feb 2022 inspection of the following site: PHARMARON MANUFACTURING SERVICES (UK) LTD, WINDMILL INDUSTRIAL ESTATE, SHOTTON LANE, CRAMLINGTON, NE23 3JL, UNITED KINGDOM The corresponding GMP Certificate is: UK API 22857 Insp GMP 22857/36790-0008 (The site was previously owned by Rosemont)

    Published: 20 November 2024

  9. FOI Request - Correspondence with the Civil Aviation Authority

    Please can you send me copies of all emails (including attachments) since 1 January 2023 between the MHRA and the Civil Aviation Authority (CAA) which relate to the safety of the Covid vaccines where Dame June Raine or Dr Alison Cave (or their personal assistants/secretaries) are either the originator or on the distribution list.

    Published: 20 November 2024

  10. FOI vaccines

    I am also writing to request information under the Freedom of Information Act regarding the safety monitoring of the Repevax vaccine in the UK, with the yellow card reporting scheme. Specifically, I would like to know how many cases of chorioamnionitis have been reported through the Yellow Card Scheme associated with the use of Repevax since its introduction in the UK and how many cases of facial paralysis has been reported through the Yellow card scheme also since its introduction. Please provide any relevant data, reports, or summaries that detail the number of reported cases, as well as any information regarding the investigation or assessment of these reports by the MHRA. I am looking for reports on the whooping cough vaccines such as Repevax, Boostrix and Adacel. Would you kindly tell me where I can find all reports on this subject please?

    Published: 20 November 2024