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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1,011 disclosures

  1. I am currently doing a PhD looking at Self administration of medicines in hospitals. I was hoping to find any data related to the uptake of SAM schemes by UK hospitals . Do you have any documents that you can share?

    Published: 23 July 2025

  2. This is an information request relating to flights taken by staff in your organisation. Please include the following information for the following financial years 2022/23,2023/24 and 2024/25: * A list of all flights taken by employees and board members, including the following details: * The airline * The class (e.g. economy, business, first) * The departure airport and destination * The cost * The dates of travel * The name of the hotels stayed at, if possible * The cost of any other expenses.

    Published: 23 July 2025

  3. This is an information request relating to staff expenses. Please include the following information for the last four financial years, 2021-22, 2022-23, and 2023-24: * The total amount claimed in expenses by senior staff annually. * A breakdown of expenses by category (e.g., travel, accommodation, meals, hospitality, subsistence, training, etc.). * The total amount claimed by the most expensive individual claimant (job title only) in each of those years. * If available, a breakdown of expenses for members of the senior leadership team (e.g., Chief Executive, Directors), including job titles and total expenses per individual per year. If it is not possible to provide the information requested due to the information exceeding the cost of compliance limits identified in Section 12, please provide advice and assistance, under the Section 16 obligations of the Act, as to how I can refine my request.

    Published: 23 July 2025

  4. Requesting information regarding Ditropan 2.5 mg and 5 mg tablets. Were these approved Europe wide and via a centralized or a MRP and is or was Northern Ireland listed as an concerned member state.

    Published: 23 July 2025

  5. Please provide enough of the iatroX registration file (MHRA reference 2025042201417535) (https://www.iatrox.com/) to show the type and level of evidence the manufacturer relied upon to demonstrate the device’s safety and performance at the time of self-declaration. To protect any genuinely confidential material, I am asking only for summary-level information or suitably redacted extracts, namely — Clinical evaluation / performance evidence A synopsis (or redacted copy) of the Clinical Evaluation Report (CER) or Performance Evaluation Report that identifies: the kinds of data reviewed (e.g. published literature, bench testing, post-market data, clinical studies) and their relative weighting; any pivotal clinical investigations, including study design and subject numbers (titles and protocols may be redacted if necessary); the manufacturer’s overall conclusion on clinical safety and performance and any residual risks accepted. Essential safety and performance requirements evidence map The table or matrix that links each essential requirement of the UK MDR 2002 to the evidence cited (test reports, standards, literature, etc.). A redacted version showing document titles and evidence types, with confidential details removed, would be sufficient. Post-market surveillance (PMS) approach A brief description or summary table of the PMS activities the manufacturer committed to (e.g. complaints trend analysis, periodic safety update reports, user surveys). Applied standards and intended purpose The list of harmonised or designated standards applied; the intended purpose statement and rule(s) used to justify Class I classification. Registrant details Name and address of the legal manufacturer and UK Responsible Person (if different).

    Published: 23 July 2025

  6. I would like to request a Borderline Classification Letter for Vagisil Daily Soothe & Protect Cream with Prebiotic Oatmeal (product code 802618), including confirmation that it is classified as a cosmetic under EC 1223/2009 (as retained in UK law SI 2013/1478).

    Published: 23 July 2025

  7. Please find a request under the Freedom of Information act to provide data from the MHRA imports database. List of NOl applications to import unlicensed medicines to include 1. Date of NOI 2. Name of the medicinal product 3. Name of importer 4. NOl status (ie was the notification of import objected) 5. If the justification for import was a UK shortage (Y/N) 1. Please provide the data on a monthly basis for the time period 2020 - 2024 inclusive, in excel format. 2. Note, no commercially sensitive information is requested - for example the importers supply chain or the volume of medicine requested within the NOl - only equivalent information to that published by the MHRA for Parallel Import licences. I have checked the MHRA FOl disclosure log and have no found any equivalent requests. Information on product and importer has been provided previously for the product Co-proxamol - FOI 21/376 & FOl 21/465 and the MHRA previously published detailed information of importations including listing products and importers as Quarterly reports https://www.gov.uk/government/statistics/quarterly-reports-on-the-import-of-unlicensed-medicines (ceased and has not been resumed since 2018).

    Published: 23 July 2025

  8. Thanks for your reply, I would like to narrow the scope of my request to these 15 vaccines as you have described then: * Infanrix hexa 6-in-1 vaccine * Vaxelis 6-in-1 vaccine * Rotarix Rotavirus vaccine * Bexsero MenB vaccine * Pneumovax pneumococcal vaccine * Prevenar 13 pneumococcal vaccine * Menitorix Hib/MenC vaccine * MMRVaXPro MMR vaccine * Priorix MMR vaccine * Cell-based quadrivalent influenza vaccine * Boostrix IPV 4-in-1 vaccine * Repevax 4-in-1 vaccine * Gardasil 9 HPV vaccine * Revaxis Td/IPV vaccine * MenQuadfi MenACWY vaccine

    Published: 23 July 2025

  9. Under the Freedom of Information Act 2000, I am requesting the following: • A complete list and summary of all documented side effects, adverse reactions, or complications associated with the anthrax vaccine administered by or on behalf of the UK government or military, covering the years 1990 - 2024. • Any internal reports, memos, or safety assessments related to the vaccine’s safety profile. Please provide this information in electronic format. If any part of this request is unclear or too broad, I would appreciate your assistance in refining it.

    Published: 23 July 2025

  10. Please consider this a freedom of information request, in regards to own label suppliers. Could you please share which own label suppliers are applied to marketing authorisations in the UK. Other associated linking meta data that would also be useful to reference the OLS please; 1. PL number 2. OLS applied to the license 3. Pack size 4. Manufacturing batch release site on the leaflet

    Published: 6 July 2025