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Published: 15 October 2026
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Thank you for your response of 19 May 2026 (ref FOI2026/00435), and in particular for the advice under section 16 that a request restricted to Questions 1 and 2 would fall below the section 12 cost limit. I am acting on that advice. This is a new, narrowed request. Question 3 — the pre-submission and scientific-advice counts — is withdrawn in full. That question was the sole stated cause of the cost estimate, since it would have required opening every meeting record. Nothing below requires that work. I would also like to address the section 21 exemptions you raised, because I think the position has changed since your letter. Request 1 — Rx-to-OTC reclassifications, 1 January 2015 to date I have obtained and am using the published register (Reclassifications_Approved_1991_-_01-3-2026.xlsx). It is genuinely useful and I am grateful it exists. For approved reclassifications I therefore withdraw the request entirely — section 21 plainly applies. What that register does not carry is the date the application was received alongside the grant date. I request only that single additional field for the entries already published in it, if it is held. I am not requesting information on refused or withdrawn applications, so the section 41 and section 43 concerns in your letter fall away. Request 2 — one machine-readable extract of the legal-status register This is the substance of my request, and it is one query against one table: PL number · product name · active substance(s) · ATC code · legal status (POM / P / GSL) · MA holder · date of first authorisation for all currently authorised human medicines, as a single CSV or Excel file. Your letter cited section 21 for this, pointing to the Marketing authorisations: lists of granted licences collection. Having worked with that collection, I would ask you to reconsider whether it makes this information reasonably accessible for the purpose stated: It is published as PDF, in fortnightly instalments. It is a notice of what was granted, not an extract of the register, and it cannot be read as a dataset without re-keying thousands of entries by hand. It runs substantially in arrears. As at 8 September 2026 the most recent instalment on the 2026 page covers 15–31 March 2026, and the page records that the 1–14 March list was added on 3 September 2026 — a lag of approximately five months. It is incremental, not cumulative. It shows what was granted in a fortnight. It does not give the current legal status of the authorised portfolio, which is what I have asked for and what Products.MHRA.gov.uk presents one record at a time with no download. I do not say this to be difficult. I say it because a single export of a table the Agency already maintains is, I believe, far less work for you than the alternative, and it is the only form in which the information is usable for the stated purpose. Why this matters, briefly I am building a consumer-healthcare intelligence platform covering the national medicines registers of Europe. Twenty-three EU member states publish exactly this data as a downloadable extract — the Netherlands, Spain, France, Belgium, Ireland and others — and it is incorporated. The United Kingdom is the significant omission, not because MHRA withholds it, but because the published form cannot be processed. The practical consequence is that UK legal-status data in my platform currently ends in April 2026 while comparable EU markets are current to within days. I would much rather represent the UK accurately. Format and cost CSV or Excel preferred; any machine-readable format is welcome. I am content to receive a point-in-time snapshot rather than anything ongoing, and I make no request for commercially sensitive or unpublished information — only regulatory-decision metadata of the kind routinely published by other European national registers. If any part of this still approaches the cost limit, I would ask that Request 2 be treated as the priority and Request 1 set aside. I am grateful for the Agency's time, and for the section 16 advice that made this narrower request possible.
Published: 15 October 2026
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I am requesting documentation indicating when MHRA first received trial data from Astra Zeneca, Moderna and Pfizer about its Covid-19 vaccine and for how many weeks and months afterwards continuing trial data was received by MHRA prior to authorisation of the vaccine for general use
Published: 15 October 2026
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We hereby request any information you hold and can provide regarding the adverse effects of Roaccutane, in particular in relation to mental health, including depression, mood and suicide, including reports regarding same from 2016 onwards.
Published: 15 October 2026
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Please could you tell us how many devices used in beauty and aesthetics the MHRA has inspected since 2020? Of those machines inspected, please could you tell me how many have not been compliant with the MHRA standards? For clarification, by devices we are using your guidelines (below): ◦ Class I, Ila, Ilb or III devices you have manufactured ◦ Class I, Ila, Ilb or III devices you have refurbished or re-labelled with your own name ◦ any system or procedure pack containing at least one medical device ◦ custom-made devices ◦ IVDs you have manufactured ◦ IVDs undergoing performance evaluation
Published: 15 October 2026
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MHRA GMP Inspection Reports from 2023 - 2025 for Pharmaceutical Companies The reports can be in PDF or Word formats.
Published: 15 October 2026
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This request is for MHRA PV inspection reports from 2022-2025. I did not see these reports in the FOIA website.
Published: 15 October 2026
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Under the Freedom of Information Act 2000, I hereby request the disclosure of information held by the Medicines and Healthcare products Regulatory Agency (MHRA) regarding the illegal importation, border detention, chemical testing, and reported adverse health events associated with the investigational peptide "Retatrutide" (also known as LY3437943). Please provide responsive records covering the period from 1 January 2024 to the date of processing, specifically addressing the following three areas: 1. BORDER DETENTIONS & ENFORCEMENT SEIZURES (Criminal Enforcement Unit): a. The total number of seizures, detentions, or postal intercepts executed by or referred to the MHRA Criminal Enforcement Unit (CEU) involving products labelled, marketed, or suspected to be "Retatrutide" or novel triple-agonist (GLP-1/GIP/glucagon) peptides. b. For each recorded seizure/intercept (in an anonymised table or line listing): - Date of seizure/detention. - Total quantity seized (e.g., number of vials, ampoules, or weight of bulk powder). - Declared country of export/origin (where known). - Transit channel (e.g., air cargo, international mail hub, or courier consignment). - Deceptive customs descriptions utilised (e.g., "cosmetics," "research chemicals," "glassware"). 2. LABORATORY TESTING & DEFECT PROFILING: a. Summaries or final analytical certificates of any laboratory analysis, potency testing, or purity screening conducted on seized or test-purchased vials labelled as "Retatrutide." b. Specifically, records indicating whether tested samples contained: - The declared active pharmaceutical ingredient (retatrutide) vs. alternate substances (e.g., semaglutide, tirzepatide, or inactive filler). - Dosage variances (sub-potent or super-potent concentrations). - Microbiological contamination, endotoxins, heavy metals, or unlisted preservatives/bacteriostatic agents. 3. YELLOW CARD & ADVERSE REACTION REPORTS: a. A de-identified line listing of all suspected Adverse Drug Reaction (ADR) reports received via the Yellow Card scheme where the suspect drug was recorded as "Retatrutide," "LY3437943," or an unspecified/unlicensed weight-loss peptide. b. For each report, please provide: - Date of report. - Patient age group and sex (where recorded). - Reported adverse reaction terms (MedDRA preferred terms, e.g., tachycardia, pancreatitis, severe vomiting, injection site abscess). - Reported outcome (e.g., resolved, hospitalisation, life-threatening). - Product source or formulation noted (e.g., "purchased online," "reconstituted powder," "aesthetic clinic"). HANDLING EXEMPTIONS & SECTION 12 COST LIMIT: - Section 40 (Personal Data): This request specifically excludes direct personally identifiable information (PII) of patients, clinicians, and agency staff below Senior Civil Service level. All patient-identifying details and names of targets in active investigations may be redacted without consultation. - Sections 30 & 31 (Law Enforcement & Investigations): If specific ongoing investigations cannot be disclosed, please segregate and release all aggregate statistics, finalized test certificates, closed enforcement summaries, and Yellow Card pharmacovigilance data, which carry a strong public interest in protecting public health from counterfeit injectables. - Section 12 (Cost Limit): If you estimate that retrieving any specific sub-part of this request will exceed the statutory £450 / 18-hour limit, please contact me immediately and prioritize sections 1(a), 2(a), and 3(a) before refusing the request in its entirety. Pursuant to Section 10(1) of the Act, I look forward to receiving your response within 20 working days.
Published: 15 October 2026
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I am writing to ask how often the MHRA has employed people using an Aliens' Certificate in the last five years? If it would not result in any deanonymisation please break this down by civil service grade. What exercises were undertaken to ensure that: * there is no suitably qualified UK national available for employment in that post; or * the alien possesses exceptional qualifications or experience for employment in that post.
Published: 15 October 2026
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Finally, you were able to share the median and average time taken from validation to decision on IRP applications. I was wondering if you could kindly also specify how many applications met the published IRP target timelines (60 days for Route A, 110 for Route B)?
Published: 15 October 2026
