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You asked for a specific list of the substances to respond to my request. Could you please send me the details I requested for the following substances: BOTOX: Azzalure Bocouture Alluzience Letybo Dysport Nuceiva FILLERS: Juvéderm Restylane Revolax Belotero Teosyal STEROIDS: Testosterone (Enanthate / Cypionate / Propionate) Nandrolone Decanoate (Deca-Durabolin) Trenbolone Sustanon 250 Stanozolol (Winstrol) PEPTIDES: Reta(Retatrutide) GHK-Cu MOTs-C BPC157 TB500
Published: 1 October 2026
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Please treat this correspondence as a request for recorded information under the Freedom of Information Act 2000. This request concerns the medicines-distribution regulatory history of the NHS Supply Chain logistics site described publicly as Gorsey Point / Mersey Gateway, Widnes, including Wholesale Distribution Authorisation for Human Medicines (WDA(H)), Good Distribution Practice (GDP) / inspection records, and the transition from Unipart to GXO. For clarity, I am not asking the MHRA to determine any individual’s eligibility under the Immigration Health Surcharge reimbursement scheme, to define “NHS setting” or “health and care setting”, or to characterise the site for DHSC policy purposes. I am seeking held regulatory records and objective authorisation history. Time period 1 September 2023 to the date of this request. Earlier records may be included only where necessary to identify the authorisation or certificate in force at the start of that period. Information requested 1. Site-specific WDA(H) history Please provide the recorded WDA(H) / wholesale-distribution authorisation history for the site known as Gorsey Point / Mersey Gateway, Widnes, including: - authorisation holder; - authorisation number; - relevant site address; - effective/addition/removal dates; and - material variations during the period. 2. Authorisation and GDP documents Please provide copies of the WDA(H) authorisations, annexes, GDP certificates or equivalent public/regulatory documents held by MHRA that identify the Gorsey Point / Mersey Gateway site during the relevant period, including superseded versions where held. 3. Unipart historical coverage Please identify whether Unipart Group Limited, Unipart Logistics or any related Unipart entity held, was named on, or operated under any WDA(H), GDP certificate or other MHRA wholesale-distribution authorisation covering the Gorsey Point / Mersey Gateway site between 1 September 2023 and the transfer of NHS Supply Chain logistics operations to GXO in 2025. If so, please provide: - the relevant authorisation/certificate number(s); - site address(es); - effective dates; and - copies of the relevant records. 4. GXO WDA(H) 15148 site-addition history For GXO Logistics UK Limited WDA(H) 15148, please identify the date on which the Mersey Gateway / Gorsey Lane, Widnes site was first added to the authorisation, and provide any superseded authorisation versions or variation records showing that addition or subsequent material change. 5. Inspection and GDP history Please provide the dates of MHRA GDP / wholesale-distribution inspections concerning the Gorsey Point / Mersey Gateway site during the relevant period, together with: - any GDP certificate issued; and - any non-exempt recorded outcome classification or summary, for example Critical, Major or Other findings, that can reasonably be disclosed. 6. Provider-transition regulatory records Please provide any reasonably retrievable recorded regulatory material showing a change of authorised logistics provider or authorisation-holder arrangements for this site in connection with the transition from Unipart to GXO, limited to WDA(H), GDP, site-registration or regulatory-variation records. Commercial tender or pricing material is not sought. 7. Site/address identity control The NHS Supply Chain public locations page identifies “Runcorn (Gorsey Point)” at Henry Road, Widnes, WA8 0SQ, while current MHRA WDA(H) 15148 lists “Mersey Gateway, Gorsey Lane, Widnes, WA8 0RP”. Please provide any recorded MHRA information that identifies whether these descriptions/addresses refer to: - the same regulated logistics site; - connected parts of the same site; or - separate sites, insofar as MHRA holds such information. Format and handling Where responsive information is already publicly available, please identify the exact document title, version/date and location rather than giving only a general reference to the MHRA website. If any material is withheld, please identify the specific FOIA exemption relied upon and disclose all reasonably severable material. If a numbered item is not held, please state clearly that it is not held. If section 12 may apply, please provide advice and assistance under section 16 on how the request could be refined. If refinement is required, my priority order is: 1, 3, 4, 2, 5, 7, 6.
Published: 1 October 2026
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Dear MHRA Freedom of Information Team, I am requesting information held by the MHRA concerning suspected adverse drug reactions reported through the Yellow Card Scheme for the MMRV vaccines Priorix-Tetra and ProQuad. I would like the information below for reports received from 1 January 2026 up to the latest date for which data are available. Please provide the following separately for: 1. Priorix-Tetra 2. ProQuad For each vaccine, please provide: • The total number of UK Yellow Card reports received. • The total number of suspected adverse reactions recorded within those reports. • The number of reports/reactions coded as: • Febrile convulsion • Febrile seizure • Convulsion • Seizure • Pyrexia/fever • Loss of consciousness • Encephalitis/encephalopathy • Meningitis • Other serious neurological adverse reactions • The number of reports classified as serious. • The number of reports involving hospitalisation. • The number of reports involving death, if any. • The number of reports in children aged approximately 12–24 months, if this age-specific information is held. I would also like to request the relevant Vaccine Analysis Print (VAP), or equivalent underlying Yellow Card data extract, for Priorix-Tetra and ProQuad covering the period above. Please provide the data in a form that allows the adverse-reaction terms to be identified separately, rather than providing only an overall adverse-event total. Please also state: • The precise reporting cut-off date used for the data. • Whether the figures represent UK reports only or include reports from outside the UK. • Whether a single Yellow Card report can contain multiple adverse-reaction terms and, if so, whether the reaction figures represent reports or individual reaction records. • Whether any reports have been excluded, for example because they were duplicates. • Whether the data include reports submitted by members of the public as well as healthcare professionals and pharmaceutical companies. I understand that Yellow Card reports are reports of suspected adverse reactions and do not, by themselves, establish causation. I am therefore not asking MHRA to determine whether the vaccine caused any reported event. I am specifically requesting the number of reports/reactions recorded in the Yellow Card database. If any part of this request is considered too broad, please provide the information that can be released and advise which specific part would need to be narrowed, rather than treating the entire request as a refusal. If the requested information is already publicly available, please provide the specific URL, dataset, table or VAP containing the figures, rather than a general link to the Yellow Card website.
Published: 1 October 2026
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This is a request for information under the Freedom of Information Act 2000. I would like to request information on the AI Assisted Discharge Summary (AADS) tool that’s hosted on the Federated Data Platform (FDP). This tool was piloted at Chelsea and Westminster Hospital NHS Foundation Trust and was recently certified by the MHRA as a Class I medical device (GMDN Code: 61087) for official use as an NHS tool. 1) In the latest minutes from the NHS England Data Transformation Check and Challenge Group, published in April 2026, it was reported that “The group reviewed the FDP action log and noted progress across several areas. It was confirmed that the DPIA for the AI Assisted Discharge Summary remained on track but could not be finalised until the product reaches pilot stage” Can you please provide me with the DPIA for the AADS. Source for Q 1: https://www.england.nhs.uk/long-read/tra... 2) Can you please provide me with the registration/certification date for the AADS device by the MHRA? Can you also please provide me with the dates the tool was being oficially piloted at Chelsea and Westminster. 3) In regards to the self certification of the AADS the manufacturer would have compiled technical documentation, implemented a Quality Management System (QMS) and created a Declaration of Conformity. The manufacturer must also must prove their device meets the Essential Requirements (ERs) of the UK Medical Devices Regulations 2002. Can you please provide me with this technical documentation, including the Quality Management System (QMS) documentation which may consist of policies, standard operating procedures, risk assessments, approval procedures, decision logs, software validation, and post-market surveillance procedures. Can you also please provide me with the Declaration of Conformity, and the proof that the manufacturer met the Essential Requirements (ERs) of the UK Medical Devices Regulations 2002.
Published: 1 October 2026
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I am writing to make a formal request under the Freedom of Information Act 2000. Please provide the total cumulative number of suspected Adverse Drug Reaction (ADR) reports received via the Yellow Card Scheme regarding meningiomas (including intracranial and spinal meningiomas) associated with the use of medroxyprogesterone acetate (specifically including the brand name Depo-Provera, as well as generic formulations). To help narrow the scope, please provide: 1. The total number of completed Yellow Card reports for this pairing up to the most recent available date. 2. A breakdown of these reports by year of submission. 3. If possible, a breakdown of patient age categories and the reported duration of drug use (e.g., under 1 year, 1–4 years, 5+ years). I understand that Yellow Card data represents suspected side effects and does not inherently prove direct causation. I look forward to your response within the statutory 20 working days.
Published: 1 October 2026
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I am requesting recorded information under the Freedom of Information Act 2000. I note that in FOI2024/00264 the MHRA confirmed that Manufacturer's "Specials" Licences are not published online, and disclosed a copy of an MS licence redacted for personal data under section 40(2) and limited commercially sensitive material under section 43(2). This request follows the approach taken in that response. 1. Please provide a copy of the current Manufacturer's "Specials" Licence (all sections, including Section 1, the Section 2 variation history, and Section 3/Annex 1 site information including the authorised-operations and dosage-form schedules and any Part 2 importation authorisations) held by Rokshaw Limited of Sunderland, redacted as necessary in line with the approach taken in FOI2024/00264. 2. Please confirm the date on which the licence, or any predecessor licence subsequently subject to a change of ownership, was first granted. We are not requesting personal data, batch or product-specific information, customer information, or any commercial terms. The dosage-form authorisation schedule of an MS licence is structural information of the same character already disclosed in FOI2024/00264, in which the MHRA identified no commercial harm arising from its release.
Published: 1 October 2026
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Please could you supply me with the summary of product characteristics or any evidence of efficacy that has been submitted to support the use of 70% to 75% isopropyl alcohol or ethanol wipes? I am thinking of the individually packed wipes that might be used to clean injection sites or hard surfaces.
Published: 1 October 2026
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I am requesting information relating specifically to Oestrogel/Estrogel, PL 28397/0002. In response to my previous FOI request, the MHRA advised that an electronic clinical overview addendum is available for Oestrogel/Estrogel (PL 28397/0002) and suggested submitting a new request limited to this specific PL reference. Please provide a copy of that electronic clinical overview addendum. I am particularly interested in any sections relating to the authorised dosage in Section 4.2, including the evidence or rationale supporting the highest authorised dose and any discussion or assessment of higher doses, where contained within the document. If any information is exempt from disclosure, please provide the remaining non-exempt sections or relevant redacted extracts. Electronic PDF format is preferred.
Published: 1 October 2026
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Under the Freedom of Information Act 2000, please provide: 1. The number of adverse incident reports received by the MHRA relating to defibrillators, including automated external defibrillators, manual defibrillators and monitor-defibrillators, in each of the calendar years 2023 to 2025 inclusive. Please state which field or device category was used to identify them. 2. Of those reports, the number in which the patient outcome was recorded as death. 3. Anonymised summaries of the first 10 of those reports in each year, to the level of detail routinely provided in response to similar requests, with nothing identifying the patient, the reporter or the organisation. 4. If the MHRA holds a breakdown by fault type, the number of reports attributed to battery or power failure, and the number attributed to missing or expired consumables such as defibrillation pads, then please provide this as well broken down by calendar year. If any part of this request would exceed the appropriate limit, please say which part and answer the remainder.
Published: 30 September 2026
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I am writing to request information under the Freedom of Information Act 2000 regarding the MHRA Drug Safety Update published on 22 January 2024 titled: "Fluoroquinolone antibiotics: must now only be prescribed when other commonly recommended antibiotics are inappropriate." https://www.gov.uk/drug-safety-update/fluoroquinolone-antibiotics-must-now-only-be-prescribed-when-other-commonly-recommended-antibiotics-are-inappropriate The published update states that MHRA reviewed the effectiveness of previous measures to reduce the risk of disabling, long-lasting or potentially irreversible side effects from systemic fluoroquinolones, sought advice from the Commission on Human Medicines, and then took additional regulatory action to update the indications for systemic fluoroquinolones. Please provide the following recorded information. 1. The MHRA review referred to in the Drug Safety Update Please provide the full review, report, briefing paper, evidence assessment, safety assessment, or equivalent document that supported the January 2024 regulatory action. 2. Terms of reference, scope and methodology Please provide any documents setting out the scope, terms of reference, methodology, inclusion/exclusion criteria, data sources, date ranges, analytical methods, or review questions used for the MHRA review. 3. Evidence on the effectiveness of the 2019 restrictions Please provide the evidence used to assess whether the 2019 restrictions had been effective. This should include, where held, prescribing data, trend analyses, audit data, Yellow Card reporting trends, healthcare-professional awareness data, compliance assessments, or any other evidence used to judge the effectiveness of the 2019 measures. 4. Commission on Human Medicines advice Please provide the CHM papers, minutes, recommendations, advice, briefing notes, slides, annexes or decision records relating to fluoroquinolone safety and the January 2024 restriction. I am happy for personal data to be redacted. 5. Basis for the estimated frequency of serious reactions The update states that disabling and potentially long-lasting or irreversible adverse reactions are estimated to occur in at least between 1 and 10 people per 10,000 patients, while also stating that the frequency cannot be estimated precisely. Please provide the analysis, data sources, calculations, assumptions and denominator information used to derive this estimate. 6. Case definitions and classification criteria Please provide any documents defining or classifying terms such as "disabling," "long-lasting," "potentially irreversible," "serious adverse reaction," "multi-system," and "fluoroquinolone-associated disability," if such terms were used in the review. 7. Drug-specific and route-specific analyses Please provide any analyses, tables or summaries comparing risks across individual fluoroquinolones, including ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin and delafloxacin, and across routes of administration, including oral, injection and inhaled use. 8. Risk-factor analysis Please provide any evidence or analyses used to support the warnings relating to older age, renal impairment, solid-organ transplantation, corticosteroid coadministration, prior serious adverse reactions, treatment duration, dose, indication, or other patient-level risk factors. 9. Mechanistic evidence Please provide any literature reviews, briefing notes or evidence summaries considered by MHRA relating to proposed mechanisms of fluoroquinolone toxicity, including tendon injury, mitochondrial dysfunction, oxidative stress, neuropathy, psychiatric effects, sensory effects, connective-tissue injury or delayed adverse reactions. 10. Patient evidence and stakeholder input Please provide any summaries of patient reports, patient-group submissions, stakeholder consultation, expert submissions, qualitative evidence, meeting notes or correspondence that informed the review, particularly evidence relating to long-lasting disability and patient reports of not being adequately acknowledged by healthcare professionals. 11. Decision rationale and benefit-risk assessment Please provide the documents explaining the rationale for the final wording that systemic fluoroquinolones must now only be used when other commonly recommended antibiotics are inappropriate. Please include any benefit-risk assessment, options appraisal, regulatory impact assessment or implementation assessment. 12. Implementation and communication planning Please provide any documents relating to the implementation of the January 2024 restrictions, including communication plans, updates to product information, Dear Healthcare Professional communications, engagement with NICE, NHS England, professional bodies, GP prescribing systems, antimicrobial stewardship teams, patient-facing materials, or monitoring plans. 13. Correspondence with marketing authorisation holders Please provide correspondence, instructions, assessment reports or variation documents sent to or received from marketing authorisation holders concerning the January 2024 fluoroquinolone indication changes and safety information updates. 14. Conflicts of interest Please provide any declarations of interest, conflict-of-interest summaries or management plans for committee members, experts or external contributors involved in the review and decision-making process. Please provide the information electronically, preferably in PDF, Word, CSV or Excel format where appropriate. For numerical data, I would prefer machine-readable tables rather than scanned documents. I am not requesting personal data of patients or members of the public. Please redact personal data where necessary and disclose the remaining information. If any information is withheld, please identify the exemption relied upon and provide the reasoning and public-interest test where applicable. Please also provide a schedule of withheld documents where possible. I would be grateful if you could acknowledge receipt of this request. I understand that public authorities normally respond to FOI requests within 20 working days.
Published: 18 September 2026
