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Under the Freedom of Information Act, I would like to request the following information within the 20 days timeframe: The number of complaints you have had on pharmacies breaking advertising laws by advertising the below named medicines for weight loss directly to the public over the past two years (July 2024 to July 2026), giving figures by quarters. I would also like the name and address of the pharmacy a complaint has been made against. The drugs I would like information on are: • Wegovy (semaglutide) – subcutaneous injection • Wegovy (semaglutide) – tablet • Mounjaro (tirzepatide) – subcutaneous injection NB: Please supply the number of complaints made for each of the three medicines mentioned above, unless this work would exceed the appropriate time limit outlined in Section 12 of the FOI Act, in which case it would be acceptable to provide the number of complaints as a total across all three medicines. I am happy for you to supply the information in a way that is most convenient for you but is also as clear as possible.
Published: 9 October 2026
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Published: 9 October 2026
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I am currently conducting an academic study on the evolution of semaglutide consumption across European countries. I would like to request annual data for semaglutide (ATC A10BJ06) for United Kingdom/England, for the period 2019 to 2025, where available. In particular, I would be grateful if you could provide: * annual consumption or sales volume of semaglutide; * total annual consumption expressed in Defined Daily Doses (DDD); * annual consumption expressed as DDD per 1,000 inhabitants per day (DDD/1,000 inhabitants/day; DHD/DID); * where available, the physical volume sold or dispensed, such as number of tablets, pens/injections, packs, or total quantity of active substance. If possible, I would also appreciate the data being distinguished by presentation, including: * oral versus parenteral semaglutide; * product/brand where available; * strength and pharmaceutical presentation; * quantity of active substance or number of units dispensed/sold. For interpretation and comparison with other European datasets, I would also be grateful if you could clarify: * whether the data cover England only or the whole United Kingdom; * whether they include only NHS-funded prescriptions/dispensing or also private/self-pay sales; * whether they include only community/primary care or also hospital/secondary care; * the population denominator used to calculate DDD/1,000 inhabitants/day; * the methodology and WHO DDD values used for semaglutide, particularly the distinction between oral and parenteral formulations. If annual DDD/DHD values are not directly available, aggregated annual sales or dispensing quantities by presentation would also be extremely useful, as I can calculate the DDD and DHD values for the academic analysis. I am only requesting aggregated annual data, with no patient-level information. If these data are already available through an official database, report or publication, I would also be grateful if you could indicate the relevant source.
Published: 9 October 2026
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I am requesting information under the Freedom of Information Act concerning third-party submissions or communications relating to Northwest Biotherapeutics’ Marketing Authorisation Application (MAA) for DCVax-L, submitted on 20 December 2023. I am particularly interested in whether individuals, patient groups, healthcare professionals, companies, organizations, or other third parties have submitted questions, concerns, objections, or other substantive representations concerning DCVax-L to the MHRA, including in connection with the MHRA’s 2025 consultation concerning individualised cancer immunotherapies. Specifically, I would like to know: 1. Whether the MHRA received any substantive third-party submissions concerning DCVax-L or Northwest Biotherapeutics’ MAA during the period 20 December 2023 to the present. 2. If so, the approximate number of such submissions and, where disclosure is possible, the broad category of the source (for example: patient/patient group, healthcare professional, academic, competing commercial interest, industry organization, or other). 3. Whether any such third-party submissions were provided to, referred to, or otherwise considered by the MHRA team responsible for assessing the DCVax-L MAA. 4. Whether any such third-party information or concerns resulted in, contributed to, or were associated with additional questions or Requests for Information (RFIs) being sent to Northwest Biotherapeutics. 5. If the answer to (4) is yes, the number and approximate dates of those RFIs and a general description of the subject matter, excluding commercially confidential or personally identifiable information. 6. Whether the MHRA maintains records specifically identifying third-party communications that were considered material to the regulatory assessment of the DCVax-L MAA. I am not requesting personal information, confidential identities, commercially sensitive material, or the contents of confidential regulatory correspondence. If any portion of the information requested is exempt from disclosure, I would appreciate disclosure of the remaining non-exempt information, including aggregate numbers, dates, categories of sources, and general subject matter where possible. If the request is considered too broad, please identify the specific part that creates the difficulty and advise how it could be narrowed rather than treating the entire request as refused.
Published: 9 October 2026
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I am requesting recorded information concerning the assessment of national marketing authorisation applications, particularly innovative/biological medicinal products submitted before 3 April 2025 and remaining under assessment after that date. I am not requesting the contents of any applicant’s regulatory dossier, RFI questions or responses, confidential clinical/manufacturing information, assessor opinions, or commercially confidential information. Where a question below is phrased as a question, please treat it as a request for any recorded guidance, policy, SOP, work instruction, data, correspondence template, or other information held by MHRA that answers it. 1. Procedure applicable to legacy applications Please provide any recorded guidance, SOP, transitional instruction or policy explaining which assessment procedure applies to a national MAA that: was submitted and validated before 3 April 2025; and remained under active MHRA assessment after 3 April 2025. In particular, did such applications remain under the former 150-day national assessment procedure, transition to the National Assessment Procedure published on 3 April 2025, or follow another transitional procedure? 2. Meaning of second and subsequent RFIs under the procedure applicable to those legacy applications Please provide any recorded information explaining: a. the circumstances in which a second RFI would be issued; b. whether a second RFI could contain unresolved major objections which, if unresolved, would preclude marketing authorisation, or whether second RFIs were ordinarily/reserved for minor or otherwise resolvable outstanding matters; c. the circumstances in which a third or subsequent RFI could be issued; d. whether there was any maximum or usual number of RFIs; e. when unresolved issues would instead result in consultation with the Commission on Human Medicines and/or a CHM letter concerning possible non-approvability; and f. whether satisfactory resolution of a second/subsequent RFI would ordinarily be followed by final compliance checks before grant. 3. Historical outcome data by number of RFIs For completed national MAAs for innovative medicines, new active substances, biological products, ATMPs or vaccines assessed under the former national/150-day procedure, preferably covering 1 January 2021 through 2 April 2025, please provide, if held in readily retrievable form: number receiving zero RFIs and final outcome: grant / refusal / withdrawal; number receiving one RFI and final outcome: grant / refusal / withdrawal; number receiving two RFIs and final outcome: grant / refusal / withdrawal; number receiving three or more RFIs and final outcome: grant / refusal / withdrawal. If MHRA does not hold this exact table but holds an existing dataset from which these fields can readily be extracted, please provide that dataset or the closest existing aggregate information rather than creating new analysis. 4. Historical outcome data for unusually prolonged reviews For the same class of completed applications, if readily held, please provide counts by final outcome (grant / refusal / withdrawal) for applications whose elapsed time from validation/procedure start to final disposition exceeded: 12 months; 18 months; 24 months. If MHRA instead records duration in clock-on assessment days, clock-stop periods, or another measure, please provide the closest existing information. I am particularly interested in whether very prolonged reviews historically have materially different grant/refusal/withdrawal outcomes. 5. Historical outcome following CHM concern If readily available, for the same period please provide the number of national innovative/biological MAAs that received a CHM letter indicating a provisional view that authorisation might not be granted, broken down by eventual outcome: subsequently granted; refused; withdrawn. 6. Meaning of MHRA terminology Please provide any recorded definition or guidance concerning the phrases: “initial regulatory review” “first regulatory decision” when used in relation to a pending MAA. In particular, does “first regulatory decision” ordinarily refer to the ultimate initial decision to grant or refuse an application, rather than an RFI, clock stop, CHM consultation, provisional CHM opinion, or other intermediate review step? 7. Limited procedural metadata concerning DCVax-L / murcidencel Finally, insofar as the following can be disclosed without revealing confidential scientific or commercial information, please provide the following limited procedural metadata concerning the publicly acknowledged DCVax-L (murcidencel) MAA submitted by Northwest Biotherapeutics in December 2023: a. Which procedural framework currently governs this application: the former 150-day procedure, the post-April-2025 National Assessment Procedure, or another/transitional procedure? b. How many RFIs have been issued to date? c. The month and year only in which each RFI was issued. d. The month and year only in which MHRA received a complete response to each RFI. e. Whether any CHM letter communicating a provisional view that the application might not be approvable has been issued. f. Whether MHRA has notified the applicant that the application has entered final compliance checks. I expressly do not request the substance of any RFI, applicant response, assessment report, CHM deliberation, clinical or CMC issue, regulatory recommendation, or other confidential dossier material. If any portion of question 7 is considered exempt under sections 41, 43 or another provision of FOIA, please disclose any separable non-exempt procedural metadata and identify the exemption relied upon for each withheld item rather than withholding question 7 in its entirety. Similarly, if fulfilling all of questions 3–5 would exceed the Section 12 cost limit, please prioritize the request in the following order: (1) Question 1 (2) Question 2 (3) Question 3 (4) Question 7 (5) Question 5 (6) Question 4 (7) Question 6 If any requested statistical breakdown is not held in exactly the form requested, I would be grateful for the closest existing aggregate data, management information or underlying readily extractable data rather than requiring MHRA to create new information. Please also provide advice and assistance under Section 16 of FOIA if narrowing any element would permit disclosure that otherwise could not be provided.
Published: 9 October 2026
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Under the Freedom of Information Act 2000, I would like to request aggregated product-level information from the MHRA Import Notification System relating to unlicensed human medicinal products notified for import into Great Britain. Please provide data for the calendar years 2024 and 2025, together with 2026 year-to-date, containing the following fields where held: 1. Active ingredient or generic product name 2. Brand name, where recorded 3. Strength 4. Pharmaceutical form 5. Pack size 6. Source country 7. Number of import notifications for each product 8. Total number of packs or units notified for import, where recorded 9. Notification outcome, including accepted, no objection, objected to, withdrawn or any equivalent classification 10. The clinical speciality or broad therapeutic category, where recorded 11. Whether the product was imported from within the EEA or from outside the EEA 12. Whether the import arose in connection with a recognised UK supply shortage, where recorded. Please provide the information in Excel or CSV format, with one row for each product, strength, pharmaceutical form, source country and reporting period combination. I am not requesting: * patient-identifiable information; * individual prescriber information; * commercially confidential pricing information; or * any information that would compromise patient confidentiality. If the identities of importers or suppliers are considered commercially sensitive, please omit those identities and provide the remaining aggregated product-level information. If pack or unit quantities cannot be disclosed, please provide the number of notifications for each product. If exact figures are considered sensitive, I would be grateful for volume bands, for example: * 1–10 notifications * 11–50 notifications * 51–100 notifications * More than 100 notifications. Please also let me know if an existing report, dataset or previous FOI response contains substantially equivalent information.
Published: 9 October 2026
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Please can you provide the Public Assessment Report, or any equivalent assessment documentation held by the MHRA for PL 46302/0163 – Elidel 10 mg/g Cream, held by Viatris Products Limited, Station Close, Potters Bar, EN6 1TL, United Kingdom. Our aim is to obtain any documentation that may confirm the historical regulatory relationship between the UK and EU reference products, including details relating to the original MRP approval and the subsequent maintenance of the license following Brexit.
Published: 9 October 2026
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I am writing to request information under the Freedom of Information Act 2000. I have checked the MHRA's published advertising investigations series and the MHRA FOI disclosure log and have not been able to locate the information below, so I do not believe section 21 applies. For each of the periods 1 January to 31 December 2023, 1 January to 31 December 2024, 1 January to 31 December 2025, and 1 January to 26 August 2026, please provide the number of occasions on which the MHRA took each of the following steps in relation to the advertising or promotion of a medicinal product indicated for weight loss or weight management, or of a service supplying such a product (e.g., Voy, Juniper etc): (a) issued a notice under the statutory determination procedure described in chapter 9 of the Blue Guide (that is, a notice informing a person that the MHRA is minded to make a determination, and inviting written representations); (b) made, or asked Health Ministers to make, a determination as to whether a breach of the advertising provisions of the Human Medicines Regulations 2012 had occurred; (c) referred a matter to, or received an application to, an Independent Review Panel; (d) applied for, or sought counsel's advice on applying for, an injunction; (e) required or requested an advertiser to publish a corrective statement; (f) required an advertiser to submit future advertising to the MHRA for vetting; (g) referred a case to the MHRA's Inspection, Enforcement and Standards Division for consideration of legal action, as contemplated by Appendix 6 of the Blue Guide; (h) referred a case to another regulator, and if so to which regulator. Where the figure for any item is nil, please confirm that it is nil rather than omitting the item. If any part of this request would exceed the cost limit in section 12, please tell me which part, and I will narrow it. I would be grateful for your assistance under section 16 in identifying a form of the request that can be answered within the limit. If you consider any part of the information exempt, please disclose the remainder.
Published: 9 October 2026
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I request the following recorded information under the Freedom of Information Act 2000 concerning oral ivermectin tablets for human use. 1. Historical UK authorisations Please provide details of any UK marketing authorisation (MA) or historic product licence for oral ivermectin tablets granted before PL 23218/0227 on 11 April 2023, including: * product name and strength; * licence number and holder; * date and legal basis of authorisation; and * current status or date of withdrawal. Please specifically confirm whether Stromectol 3 mg Tablets, Mectizan or any other oral ivermectin tablet was ever authorised in the UK before 11 April 2023. 2. Current UK reference medicinal product Please provide any record held by MHRA identifying a UK-authorised ivermectin 3 mg tablet currently eligible to be cited as the reference medicinal product (RMP) for a new UK-wide generic application under Regulation 51B. If MHRA does not designate or maintain a list of such products, please confirm whether MHRA records identify any currently eligible UK RMP for ivermectin 3 mg tablets. For each currently authorised generic or hybrid ivermectin tablet, please also provide: * the legal basis of the application; * the RMP cited; * its MA number, holder, country or UK territory and initial authorisation date; and * the identity and authorised market from which the bioequivalence (BE) comparator was sourced. Please distinguish between the legal RMP and the comparator used in the BE study. 3. PL 40546/0266 and PL 40546/0267 The published SmPCs identify the following products, held by Aristo Pharma GmbH, as first authorised on 5 August 2026: * Ivermectin 3 mg Tablets - PL 40546/0266; and * Ivermectin 6 mg Tablets - PL 40546/0267. For each product, please provide: * the legal basis and application type; * the regulatory procedure or assessment route; * the original submission and validation dates; * whether any transitional arrangements relating to applications submitted by 31 December 2024 applied; * the cited RMP and BE comparator, if it was a generic or hybrid application; * whether it was an informed-consent or duplicate application and, if so, the product name and PL number of the source or parent authorisation; and * whether the 6 mg strength was supported by a separate BE study or an additional-strength biowaiver. Please also provide the Public Assessment Reports for these two authorisations or confirm when they are expected to be published. I am not requesting commercially confidential dossier contents. Where information is withheld, please provide the remaining non-exempt information and identify the applicable exemption. If necessary to remain within the cost limit, please prioritise section 3, followed by confirmation of whether any oral ivermectin tablet was authorised in the UK before 11 April 2023.
Published: 9 October 2026
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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
