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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2,286 disclosures

  1. Under the Freedom of Information Act 2000, I would like to request the following information held by the MHRA. 1. The total number of Yellow Card reports received since 1 January 2024 that relate, in whole or in part, to unlicensed, falsified, or 'research use only' peptide products used by humans for weight loss, muscle building, or aesthetic purposes, including but not limited to retatrutide, tirzepatide (where recorded as unlicensed or counterfeit), BPC-157, and similar compounds. 2. A breakdown by year and, where recorded, by outcome (e.g. hospitalisation, fatality, non-serious). I am not requesting any personal data, case narratives, or information that would identify an individual reporter or patient.

    Published: 8 September 2026

  2. Under the Freedom of Information Act I would like the following: 1. All information - paper, reports, research, minutes of meetings and electronic documents including emails an letters, regarding the symptoms of Protracted Antidepressant Withdrawal Syndrome (PSSD, PAWS etc). 2. All information - paper, reports, research, minutes of meetings and electronic documents including emails an letters, related to changes in brain function following the long term use of antidepressants. 3. All information - paper, reports, research, minutes of meetings and electronic documents including emails an letters, related to Emotional Blunting following the long term use of antidepressants.

    Published: 8 September 2026

  3. Under the FOI Act 2000, please provide, for 2019 to present: 3. The number of complaints/cases the MHRA has received concerning the advertising or promotion of cannabis-based medicinal products or the 4. services of medical-cannabis clinics to the public. 8. Of those, how many were investigated, how many upheld, and what action resulted (e.g. voluntary withdrawal, corrective statement, referral, 9. enforcement). 13. Any cases involving promotion via social-media influencers or celebrity endorsement of medical-cannabis clinics or products. 17. Any guidance the MHRA has issued specific to advertising by medical-cannabis clinics.

    Published: 8 September 2026

  4. I hope you are well. Please consider this a freedom of information request, in regard 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; * PL number * OLS applied to the license * Date OLS applied to the license * MAH * Active substance(s) * Dose form

    Published: 8 September 2026

  5. I would like data showing adverse reactions following BCG vaccination in late 2008 - 2009. at the John Radcliffe Hospital, Oxford, UK. My daughter (now 18) has just been told that she may have cutaneous TB, caused by the BCG she had at the JR Hospital. At the time of the vaccination, she had a severe lymph reaction, etc. I would like to know if other children experienced the same problems and if they went on to develop TB.

    Published: 8 September 2026

  6. Under the Freedom of Information Act 2000, I am requesting the following information held by the MHRA. 1. The number of adverse incident reports received by the MHRA relating to continuous subcutaneous insulin infusion (CSII) pumps or automated insulin delivery (AID) / hybrid closed loop systems, where the reporting organisation or patient location was in Northern Ireland, for the period 1 January 2019 to the date of this request, broken down by year and by outcome severity (death, serious harm, other). 2. Where the outcome was recorded as death, whether the report identifies the suspected cause as device malfunction, software/algorithm fault, or user error, where this classification is recorded. 3. Whether any of these reports relate to devices also the subject of a Field Safety Notice or recall during the same period, and if so, please identify which notice(s).

    Published: 8 September 2026

  7. See attached

    Published: 8 September 2026

  8. See attached

    Published: 8 September 2026

  9. Please provide the recorded clinical and regulatory basis for the highest authorised doses of: Estradot 100 micrograms/24 hours — PL 04416/1723 Evorel 100 — PL 49105/0008 Oestrogel Pump-Pack — PL 28397/0002 For each product, please provide the relevant redacted clinical assessment/expert report, the studies supporting the current Section 4.2 dosage, any recorded rationale for selecting the highest dose, and whether higher doses were submitted or assessed. If complete documents cannot be disclosed, please provide relevant non-exempt extracts and study identifiers. Electronic PDF format is preferred.

    Published: 8 September 2026

  10. I am writing to request information under the Freedom of Information Act (2000). I understand that the MHRA has said that doctors should report all suspected inaccuracies caused by AI tools used in clinical practice to the regulator’s yellow card scheme. I would like to know: 1. To date, how many times the MHRA has been made aware of inaccuracies or concerns caused by AI tools used in clinical practice. 2. How many of these (issues flagged) were related to AI-enabled ambient scribing products 3. Please give the details of each issue flagged - including the name of the product used, the details of who contacted the MHRA (e.g. GP surgery name or Trust) and details of what the concern was. 4. Is the MHRA sent hazard reports related to AI-enabled ambient scribing products, collated by medical practices? If so, please supply all the hazard reports which have been received since April 2025. If you are unable to answer any part of this request please move on to the next question and provide as much information as you can. I would like to receive this information in the form of an email reply. If this request is too wide or unclear, I would be grateful if you could contact me as I understand that under the Act you are required to advise and assist requesters. If any of this information is already in the public domain, please can you direct me to it, with page references and URLs if necessary. I understand that you are required to respond to my request within the 20 working days after you receive this letter. I would be grateful if you could confirm in writing that you have received this request.

    Published: 8 September 2026