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Please provide me with the following information under the Freedom of Information Act. 1. How many erectile dysfunction pills have been seized by the MHRA in the first five months of 2026 (January to May?) 1a) Of these, how many were legitimate pills/brands and how many were deemed to be fake pills/brands? If it is not possible to provide some of the data requested, I would be grateful if you could provide whichever elements of this FOI request are eligible for release.
Published: 6 July 2026
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Specifically, I request: Any internal progress reports, RAG status assessments, or milestone tracking documents relating to objective 2.7 produced between July 2023 and the date of this request Any minutes or papers from the Executive Committee or Board that reference objective 2.7 by name or by subject matter (generic medicines regulatory reform) Any defined criteria or framework developed under objective 2.7 for determining where regulator involvement adds most value in generic medicines regulation
Published: 6 July 2026
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Under the Freedom of Information Act 2000, I am requesting copies of all MHRA Good Manufacturing Practice (GMP) inspection reports conducted from 1 January 2025 to the present for the following NHS organisations: * Imperial College Healthcare NHS Trust * Royal Free London NHS Foundation Trust * Royal Devon University Healthcare NHS Foundation Trust * South Tees Hospitals NHS Foundation Trust * Barking, Havering & Redbridge University Hospitals NHS Trust * Barts Health NHS Trust * Manchester University NHS Foundation Trust * St George's University Hospitals NHS Foundation Trust * London North West University Healthcare NHS Trust * NHS Greater Glasgow and Clyde For each organisation, please provide: * Full MHRA GMP inspection reports (2025–present) * Any associated deficiency reports, CAPAs, or compliance letters * Any follow‑up correspondence relating to inspection outcomes
Published: 6 July 2026
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Please can you provide the historic Patient Information Leaflets for: Sertraline film-coated tablets 50mg Crescent Pharma Limited PL 20416/0214 I am asking to find out what was written in the leaflets in the boxes I took from July 2024 - September 2025, so the leaflets from 2021 - 2025 (as there may have been a delay in the boxes being produced to me getting them). I am asking as the interaction with alcohol, and the warning(s), are relevant to an employment tribunal claim.
Published: 6 July 2026
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I'd like to request the following information about the Ministry of Justice / HM Prison & Probation Service programme under which adults convicted of sexual offences are prescribed chemical suppressant medication to address problematic sexual arousal — originally piloted in four prisons in the south-west of England and announced for expansion to twenty prisons by the Lord Chancellor (the Rt Hon David Lammy MP) at the second reading of the Sentencing Bill. The request is about the programme only; it does not seek individual-level patient information. Where data are held in aggregate or anonymised form, please supply those. Time period: from the start of the original four-prison pilot (or 1 January 2020 if the start date is not on file) through today. 1. MEDICATIONS USED. The active substances prescribed under the programme (anti-androgens, GnRH agonists / antagonists, progestins, SSRIs, SNRIs and any others); the recorded indication and UK marketing-authorisation status of each (on-label vs off-label); the prescribing algorithm, formulary or stepped-care model in use; aggregate (anonymised) numbers of people prescribed each medication per year and per site; and the names of the four original and twenty expansion prisons with the date the original pilot began and the planned / actual go-live date in each of the twenty. 2. EXPECTED EFFECT, MECHANISM AND PERSISTENCE. For each medication in (1), the recorded mechanism of action; the magnitude and character of the expected effect on libido, erectile, ejaculatory and orgasmic function during treatment; how long that effect is expected to persist after the last dose; whether full sexual function is expected to return after discontinuation, and within what timeframe; and any other expected effects considered (mood, suicidality, bone density, fertility, gynaecomastia, cardiovascular and metabolic). 3. MANUFACTURER / SUPPLIER CORRESPONDENCE AND EFFICACY EVIDENCE. All recorded correspondence with the manufacturers, marketing-authorisation holders, suppliers or wholesalers of the medications in (1) — including SSRIs and SNRIs — concerning their use in this programme; any clinical-effectiveness or efficacy evidence supplied or relied upon; and any safety material supplied or relied upon (PSURs, RMPs, SmPCs, post-marketing-surveillance summaries). 4. CONSENT FORM AND PARTICIPANT-INFORMATION MATERIAL — WHAT INDIVIDUALS ARE TOLD AND ASKED TO AGREE. The model consent form (blank copy); the patient-information leaflet, decision aid or equivalent given before consent; any verbal-consent script or counselling protocol; the specific risks, side effects and post-treatment effects disclosed (including any wording about persistent post- treatment sexual dysfunction, mood, suicidality, bone density, fertility, gynaecomastia, cardiovascular and metabolic effects); the refusal / withdrawal-of-consent pathway and any consequences for declining or withdrawing; and how capacity to consent is assessed and by whom. 5. ADVERSE-EFFECT REPORTING AND POST-TREATMENT FOLLOW-UP. Arrangements (if any) for follow-up after the medication is stopped, including monitoring of post-treatment sexual function, mood and suicidality; the channels through which adverse effects are reported within the programme and onward to the MHRA Yellow Card scheme; and aggregate (anonymised) numbers of adverse-effect reports generated by the programme since inception, by year and by medication. If the responsive material is voluminous, please first provide an inventory (titles, dates, identifiers) so I can prioritise. Rolling / interim disclosure is welcome — in particular any pre-existing programme manual, briefing or summary responsive to (1) ahead of the rest, if readily identifiable. PDF and/or .csv / .xlsx as appropriate. Electronic delivery to the email address below is preferred. If complying with the request as drafted would exceed the cost limit, please let me know — I'm happy to narrow it (for example to categories 1 and 4 in the first instance).
Published: 6 July 2026
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We would like to Request Public Assessment Report for Prednisolone 5mg Suppository PL36301/0055. We would like to seek confirmation of the legal basis under which product PL36301/0055 has been approved.
Published: 6 July 2026
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I request information under the Freedom of Information Act 2000 relating to MHRA’s assessment of the Löwenstein prisma SMART max (WM090TD), specifically the statement communicated to me that the foam/material is “not the same” as that implicated in the Philips PE-PUR recall. This request is limited to recorded information held by MHRA at the date of search. 1) Basis and timing of MHRA’s “not the same foam” position Please provide any recorded information that states or explains: * the basis for MHRA’s conclusion that the foam/material in WM090TD is not the same as the Philips PE-PUR foam; and * the date(s) when this position was formed, reviewed, or communicated internally. This may include internal notes, summaries, emails, or correspondence referring to that conclusion. 2) Evidence relied upon Please provide any recorded information identifying the type of evidence MHRA relied upon to reach that conclusion, for example: * manufacturer statements or declarations; * notified body statements; * material descriptions or datasheets; * test evidence identifiers (e.g., ISO 18562 reports), if referenced. (Where documents are exempt in full, please provide titles/identifiers and dates, with redactions as appropriate.) 3) Assessment scope (device-specific vs model-level) Please confirm whether MHRA holds any recorded information showing that: * the assessment was device-specific (e.g., linked to a serial/lot/UDI-PI), or * the assessment was conducted at model/family level only. If held, please provide the recorded confirmation. 4) Foam/material change timing and implementation In light of information indicating a material/foam change (e.g. Polyester-polyurethane to Polytethylene-polyurethane) around late September 2024, please confirm whether MHRA holds any recorded information on: * change-control initiation/approval date(s); * implementation/effective date(s); * affected serial/lot/UDI-PI ranges; * any statement of from which point in 2024 devices would contain the new material. If held, please provide the recorded information (redacted as necessary). 5) Inter-regulator communications Please confirm whether MHRA holds any recorded correspondence or notes of communication with other regulators (including the Therapeutic Goods Administration) relating to: * the foam/material used in WM090TD; or * the assessment that it is “not the same” as Philips PE-PUR. If held, please provide such records (with appropriate redactions). 6) Market actions relating to earlier material configuration Please confirm whether MHRA holds any recorded information indicating: * whether devices with any earlier foam material configuration (prior to the 2024 change), that had the same foam or similar from the same or similar manufacturer of the foam, as a result of Philips CPAP medical devices recall due to PE-PUR Foams were withdrawn, restricted, or subject to corrective action in the UK; and * if not, any recorded rationale for no withdrawal/restriction in the context of industry concerns about foam degradation. 7) Breathing gas pathway / ISO 18562 evidence (identifiers only) Please confirm whether MHRA holds recorded identifiers for any ISO 18562 (or equivalent) evidence relied upon for this device family, including: * report title/identifier and date/version; * whether the evidence related to WM090TD specifically or a representative model; * whether the test boundary was device-only or system-level (device + tubing/mask/interface). (I am not requesting full confidential reports, only identifiers/scope information where held.)
Published: 6 July 2026
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Under the UK Freedom of Information Act 2000, I am writing to request information held by the MHRA regarding records from Eli Lilly of faulty Mounjaro pens. Specifically, I would like to request: 1. Any records of the number of Mounjaro pens reported to be faulty to Eli Lilly from 1st April 2025 to 31st March 2026 2. The number of monetary refunds for faulty pens 3. The number of new pens issued as means of a refund.
Published: 6 July 2026
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We request copies of, or summaries of, inspection findings from GCP inspections conducted by MHRA between 01/01/2018 and 30/03/2026, where the clinical trial documentation (including protocol or title) contains the term ‘basket trial’. We are happy to receive this information in summary form where full reports cannot be disclosed. If this request is likely to exceed the cost limit, we would be grateful for advice on how it could be refined.
Published: 6 July 2026
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Reference: FOI2026/00061 Subject: UK Yellow Card reports concerning electroconvulsive devices (ECT) from 1 January 2018 up to and including 2 February 2026 I am taking up this FOI request on behalf of Mr. Brian Daniels (in copy). Thank you for providing attached documents (reference: FOI2026/00061) in response to our query. I would like to follow up on the results presented in Table_01 (attached) provided by MHRA. There are three deaths cited under IMDRF code F02, although one of these seems to be a duplicate, so for our purposes let us assume two deaths in the period from 1 January 2018 up to and including 2 February 2026. We have been able to determine the total number of patients (England-wide) receiving ECT treatment during abovementioned period ( this data can be downloaded here; as an example for year 2024-2025 see : https://digital.nhs.uk/data-and-information/publications/statistical/hospital-admitted-patient-care-activity/2024-25) All procedures Finished consultant episodes Admissions 2018 2019 2396 572 380 2019 2020 1840 550 336 2020 2021 1263 443 276 2021 2022 1681 543 366 2022 2023 1357 415 250 2023 2024 1433 397 239 2024 2025 1365 579 407 total 2254 Looking at the table, we see that there were 2254 total admissions to such treatment between 2018 and 2024. For two deaths, this would suggest, roughly, a 1 in 1000 chance of death under this treatement. To put this in perspective: A 1 in 1,000 chance of death (0.1%) is considered extremely high risk by everyday standards. Looking at actuarial statistics on we find at 0.1% chance of death corresponds to * Front-line combat exposure over a limited period * Early experimental medical trials with significant unknowns * Unregulated extreme adventure activities (historically) From an institutional perspective: * Public safety regulators: unacceptable * Workplace safety standards: catastrophic * Medical ethics: far beyond acceptable risk for non-therapeutic benefit * Insurance: typically uninsurable without massive premiums We looked further into where 1 in 1,000 begins to appear: * Aggressive chemotherapy in advanced cancer * High-risk cardiac or neurosurgery * Organ transplantation (peri-operative period) * Experimental or compassionate-use treatments * Severe trauma or ICU-level interventions The above is considered acceptable only if: * The patient faces near-certain death or severe disability without treatment * There is no safer alternative * Fully informed consent is obtained What is the MHRA's risk assessment for ECT treatment, and is it consistent with the Yellow Card reporting since 2018. Please provide documentation if available. If we have misinterpreted the data shown in the table above, we are happy to be corrected.
Published: 6 July 2026
