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Under the Freedom of Information Act, I would like to request the clinical overview and the bioequivalence study report for: Ferrous fumarate 210 mg tablets PL 51463/0129 approved on 13 September 2024 submitted under Regulation 51B of The Human Medicines Regulation 2012, as amended (previously Article 10(1) of Directive 2001/83/EC. I understand that commercially confidential and personal data within any documents provided may be redacted and this is considered acceptable.
Published: 7 October 2026
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I am requesting from the MHRA’s viewpoint and records information to answer the following two questions, please: 1. I would like please to receive records of the policy decision making that went in to the MHRA's guidance issued online on 29th July 2026, concerning both public safety and government fiscal policy. 2. I would like in particular to understand how the UK Government funded research initiatives such as CERSI-AI and the outputs of the National Commission into the Regulation of AI in Healthcare have been considered and integrated in to the guidance, and any rationale of dismissing any findings for example in the CERSI-AI report on LLMs (which the MHRA sent contributing staff members) and the CERSI-AI and any MHRA internal initiative on borderline manual(s) regarding AI qualification and classification as a medical device.
Published: 7 October 2026
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Please provide recorded information held by the MHRA concerning the development of the strengthened valproate safety measures announced on 28 November 2023 and introduced from January 2024. I am seeking to understand the recorded chronology by which relevant safety evidence was identified, assessed, escalated and translated into regulatory action. Please provide: 1 Any chronology, timeline or equivalent document prepared for, or used during, the MHRA/Commission on Human Medicines review of valproate safety in 2022 which records when significant safety evidence or signals were first received, identified or escalated, including in relation to: * reproductive risks * risks associated with exposure during pregnancy * impaired fertility or reproductive effects in male patients * emerging evidence concerning risks associated with paternal exposure * continued prescribing notwithstanding previous safety measures. 2 The earliest internal briefing, assessment, paper or recommendation from the 2021-2023 period which considered materially strengthening the existing regulatory restrictions on valproate. 3 Copies of papers, minutes, decision records or recommendations from the Commission on Human Medicines and/or its relevant expert or implementation working groups during 2022 and 2023 which considered: * whether further restrictions on valproate prescribing were required * the options available * the proposed restriction on initiation in patients under 55 years of age * the requirement for two specialists independently to consider and document whether valproate should be initiated * the proposed timetable for implementation 4 Recorded information setting out the reasons for the timing of the strengthened regulatory measures, including any recorded consideration of: * whether action should have been taken earlier * whether stronger or weaker restrictions should be introduced * advantages, disadvantages or risks associated with alternative regulatory options * reasons for adopting the measures ultimately announced 5 The final decision or approval record authorising the regulatory measures announced on 28 November 2023 and implemented from January 2024. This request is for recorded information only. To assist in keeping the request within the appropriate cost limit, I am not requesting individual Yellow Card reports, patient-level information, routine administrative correspondence or duplicate copies of documents. Where a document is already publicly available, I am content for the MHRA to identify it by title and link. However, the request includes any underlying non-public paper, minute, briefing, recommendation or decision record which is not contained in the published material. If information within a document is exempt, I should be grateful if the exempt material could be redacted and the remainder disclosed with the exemption relied upon identified.
Published: 7 October 2026
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Please provide me with the number of Yellow Card reports recorded with the term Post-SSRI Sexual Dysfunction (MedDRA code 10086208). Please list the number of cases recoded each year.
Published: 7 October 2026
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The MHRA has approved the use of the product Syncrodin 3 mg film-coated tablets, for i.a. short-term treatment of jet-lag in adults, and treatment of insomnia in patients aged 6 to 17 years with ADHD or ASD (see PL 20243/0004). Accordingly, we hereby make a request, under the Freedom of Information Act, to receive copies of Module 2.5 (including any addendum documents) of the Common Technical Document (CTD) in relation to the abovementioned approval. Please do not hesitate to reach out should anything above be unclear or further information is required in order to handle the request. As the request is urgent, a swift handling would be highly appreciated. The information can be sent to us on email.
Published: 7 October 2026
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Thank you for your response dated 20 August 2026 in relation to FOI2026/00802. I would like to request the following further information regarding the adverse incident reports involving GMDN CT1539 – Staples and/or CT1540 – Staplers from Blackpool Teaching Hospitals NHS Foundation Trust. 1. In relation to the 12 adverse incident reports identified, please provide the month and year of each. 2. If the month and year cannot be provided, please provide a breakdown by year. 3. Please provide the same search and coding breakdown for incidents that took place between 1 January 2020 and 20 December 2023 involving GMDN CT1539 – Staples and/or CT1540 – Staplers from Blackpool Teaching Hospitals NHS Foundation Trust. Please provide the relevant IMDRF Annex codes, where available. 4. In relation to the one adverse incident report identified between 15 December 2023 and 31 January 2024, please provide the incident date associated with that report. 5. Please provide all Annex code / codes that were applied to that incident. 6. Please confirm whether any Annex F code applied to that incident is associated with death, including Annex F code F02 Death.
Published: 7 October 2026
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I am making a request under the Freedom of Information Act 2000 regarding suspected adverse drug reaction reports submitted to the MHRA Yellow Card Scheme for Pfizer-BioNTech COVID-19 vaccine batches FA1027 and FF3319. For each batch separately, please provide the following information held by the MHRA: 1. The total number of UK Yellow Card reports associated with the batch. 2. The total number of reported reactions/events associated with the following MedDRA preferred terms, or the closest equivalent terms used within the MHRA database: * Aortic dissection * Artery dissection * Aortitis * Periaortitis * Arteritis * Vasculitis * Aortic aneurysm * Iliac artery aneurysm * Iliac artery dissection * Aortic thrombosis * Arterial thrombosis * Thrombosis * Tachycardia * Sinus tachycardia * Palpitations * Exercise intolerance * Dyspnoea on exertion 1. For each of the above reaction terms, where held, please provide: * number of individual Yellow Card reports; * number classified as serious; * number resulting in hospitalisation; * number resulting in death; * patient age and sex in aggregated form where disclosure permits. 1. Please provide the dates, or at least month and year, on which reports involving aortic dissection, artery dissection, aortitis, periaortitis, arteritis or vasculitis were received for either batch. 2. Please state how many doses from batches FA1027 and FF3319 were distributed and/or administered in the United Kingdom, if this information is held. If exact administration figures are not held, please provide the closest available denominator, such as doses supplied or released. 3. Please provide any safety signal assessment, pharmacovigilance review, internal analysis or aggregate assessment specifically relating to either FA1027 or FF3319, insofar as this can be supplied within the appropriate FOI cost limit. I am not requesting individual patient-identifiable information, copies of individual Yellow Card forms or personal medical information. If some of the requested terminology does not correspond precisely with the MedDRA coding used by MHRA, please use the closest applicable Preferred Term and state which terminology was used. If any element of this request would exceed the statutory cost limit, please provide the information that can be supplied within the limit and advise me how the remaining request could be narrowed. Where practical, I would prefer the numerical information in CSV or spreadsheet format, although a table within the response is also acceptable.
Published: 7 October 2026
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We act on behalf of a client in relation to a potential claim for damages with respect to Cartiva Synthetic Cartilage Toe Implants ("the relevant product"), which were inserted into both of our client's feet, as treatment for osteoarthritis. Our client has since required revision surgery. We understand that NICE withdrew guidance (published in 2022) on the relevant product following a recall notice issued by the manufacturer Stryker on 31 October 2024. Please see attached recall notice MHRA reference: 33744394 2024/010/028/601/045 As part of our investigations into a potential damages claim we would be grateful if you would provide such relevant information/documents concerning the Regulation/Registration of the relevant product insofar as it's placing on the UK market is concerned, to include; 1. The Statutory Instrument under which the relevant product was first permitted to be placed on the UK Market (and details of any subsequent/amending Statutory Instruments) 2. The date upon which the relevant product was first registered/notified in the UK and any documents concerning its registration 3. Confirmation of the device classification of the relevant product under the relevant legislation 4. Confirmation of the conformity assessment procedure applicable to the relevant product 5. Details of the relevant Notified Body/UK Approved Body who undertook the original conformity assessment procedure on the relevant product and any subsequent change of Body 6. A copy of any Declaration of Conformity (EC/EU or UK) 7. A copy of any EC/EU Type Examination Certificate and Certificate Number (and any renewal/extension of certificates or amended Certificates) 8. Copies of any Technical Documentation relating to the relevant product 9. Confirmation as to whether there had been any change to the relevant product's Regulatory status since being first placed on the UK market 10. Documents concerning the recall notice/removal of the relevant product from the UK market Please treat this email as a Freedom of Information request.
Published: 7 October 2026
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Under the Freedom of Information Act 2000 I request the following information held in connection with the register of persons registered to import, manufacture or distribute active substances under regulation 45N of the Human Medicines Regulations 2012 (the register published at cms.mhra.gov.uk/mhra/api-reg). 1. A structured extract (CSV or Excel) of the current register, listing for each registration: registration number, registrant name, activity type (importation, manufacture, distribution), active substance name and code, and for importation entries the name and country of each third-country manufacturer and third-country distributor, as published on the public record pages. 2. For importation entries, a summary table of the number of registered importers and the number of distinct declared third-country manufacturers per active substance, broken down by country of the third-country manufacturer. 3. The number of active substance registrations (by activity type) on the register at 31 December in each year from 2019 to 2025. 4. A list of the third countries for which the MHRA currently accepts "written confirmation" of GMP equivalence for imported active substances, and any country-level waivers in force. All of this information is already in the public domain record by record; I am asking for it in aggregated, machine-readable form. If the full extract would exceed the cost limit, please provide items 2 to 4 first and tell me how item 1 could be narrowed to bring it within the limit.
Published: 7 October 2026
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Dear MHRA, I am writing to request information under the Freedom of Information Act 2000 relating to notifications of intent to import selected unlicensed medicinal products into the United Kingdom. For the period 1 January 2025 to the most recent date for which data are available, please provide information held by the MHRA relating to notifications to import the following substances: * Testosterone cypionate * Testosterone enanthate * Testosterone – other formulations * Human chorionic gonadotrophin (hCG / chorionic gonadotrophin) * Enclomifene / enclomiphene * Sermorelin * Tesamorelin * Ipamorelin * CJC-1295 * BPC-157 * Glutathione * NAD / NAD+ / nicotinamide adenine dinucleotide * Levocarnitine / L-carnitine For each notification, where held, I would be grateful if the following fields could be provided: * Non-proprietary/generic name (INN/BAN) * Proprietary/product name * Strength * Pharmaceutical form * Route of administration * Pack size * Number of packs notified for import * Country of manufacture * Country from which the product was supplied/imported * Manufacturer * Importer * Importer’s WDA(H) or Manufacturer’s “Specials” Licence number * Date or month/year of notification * Whether the MHRA raised no objection, requested further information, or objected to the importation I would preferably like the information supplied electronically in CSV or Excel format. If any individual field cannot be disclosed because an exemption applies, I would be grateful if you could provide the remaining non-exempt fields rather than refusing the request in its entirety. If providing notification-level data would exceed the appropriate cost limit under section 12 of the Freedom of Information Act, I would instead be grateful for aggregated data by substance and calendar year, including, where held: * Number of import notifications * Total number of packs notified * Countries of manufacture * Countries of supply * Manufacturers * Importers If the request would still exceed the appropriate cost limit, please advise what narrower date range, subset of substances or level of aggregation would allow the request to be fulfilled.
Published: 7 October 2026
