Freedom of information (FOI) releases from MHRA

This is a disclosure log of Medicines and Healthcare products Regulatory Agency's responses to freedom of information (FOI) or environmental information regulations (EIR) requests that might be of wider public interest.

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754 disclosures

  1. Freedom of Information Request – CBD Working Group

    I am submitting a Freedom of Information (FOI) request regarding the CBD Working Group, which I understand included representation from the MHRA, FSA, and Home Office, among other government bodies. Please provide: Confirmation of the CBD Working Group’s existence – whether the MHRA participated in or was aware of such a group. The date of its formation and whether it is still active. A list of government departments and agencies involved. The stated purpose of the group – if available, any official description of its role or objectives. If the MHRA was not involved, please confirm if the department has ever received communications from the FSA, Home Office, or BEIS regarding the CBD Working Group. If any documents are withheld or redacted, please provide the reason under FOI exemptions.

    Published: 31 March 2025

  2. Question about the CHM puberty blocker report

    We are writing with a question for the authors of the CHM report on the safety implications of restricting the supply of GnRHa to minors in response to gender dysphoria: https://www.gov.uk/government/publications/chms-report-on-proposed-changes-to-the-availability-of-puberty-blockers The source text we are referring to is the PDF version of the CHM report here: https://assets.publishing.service.gov.uk/media/678e6994ea48a571517acf98/chm-advice-to-sos-on-gnrh-agonists-for_pubertal-suppression.pdf Item 16 on page 7 of the report includes the claim "One in 18 do regret the decision and may have lifelong impact from GnRH agonist use." No reference is provided, which means it is not possible to verify the veracity of that claim. Please could you supply details of the source(s) on which this claim is based.

    Published: 31 March 2025

  3. FOI Black Triangle List : Weight Loss Medication

    Please could you direct us to the latest Black Triangle list for weight loss medications? Also is it possible to access any data from black triangle reporting please as the link from the gov site takes only to yellow card info Current drugs under intensive surveillance (Black Triangle List)?

    Published: 31 March 2025

  4. Yellow Card Reports

    please let me have following information urgently. 1.The total number of adverse drug reactions and fatalities recorded under the Yellow Card Scheme for RIVAROXABAN 2 The total number of adverse drug reactions and fatalities recorded under the Yellow Card Scheme for FUROSEMIDE 3 The total number of adverse drug reactions and fatalities recorded under the Yellow Card Scheme for ZOLENDROLIC ACID 4 .The total number of adverse drug reactions and fatalities recorded under the Yellow Card Scheme for CO-TRIMOXAZOL

    Published: 31 March 2025

  5. Freedom of Information Request “ Batch FL9994 of Comirnaty (Pfizer COVID-19 Vaccine)

    I am writing to request information under the Freedom of Information Act 2000 regarding batch FL9994 of the Comirnaty (Pfizer COVID-19) vaccine. Specifically, I would like to request the following details: 1. Adverse Events Reports: Any reports of adverse reactions associated with batch FL9994. 2. Quality Assurance Data: Details of any testing, safety inspections, or quality control measures conducted on batch FL9994 before its release. 3. Batch Recall or Investigation Records: Information on whether batch FL9994 was ever flagged, recalled, or investigated for any safety or efficacy concerns. 4. Distribution Information: Geographic areas or vaccination centers where batch FL9994 was distributed in the UK.

    Published: 31 March 2025

  6. MHRA FOIA Request -Lasix 40mg tablets PAR

    We would like to request a copy of the Public Assessment report (UK PAR) and information if its Initial application of the following product under the Freedom of Information Act (FOIA) of MHRA. This product has been discontinued in UK. We would like to know if the product Lasix 40mg Tablets was authorized through a DCP route where UK was included with the Procedure? We tried to search this but could not get any information about it in the public domain. Product name: Lasix 40mg Tablets Date of 1st Authorization: March 1965 MAH name: Aventis Pharma Limited 410 Thames Valley Park Drive Reading, Berkshire RG6 1PT, UK Trading as: Sanofi Genzyme 410 Thames Valley Park Drive Reading, Berkshire RG6 1PT, UK PL number: Not available

    Published: 31 March 2025

  7. ADR data for newborn vitamin K injection

    I want to see reported adverse reactions or side effects of newborn vitamin k injection.

    Published: 31 March 2025

  8. CEC 212817 Norovirus Vaccine trial by Moderna

    I refer to the above subject and attach article published by BBC News 30 January 2025. I note there are 2,500 UK participants in the global trial. I would be grateful if you could arrange to provide me with further information regarding the messenger ribonucleic acid [mRNA] Norovirus vaccine currently under trial by Moderna.

    Published: 31 March 2025

  9. Scientific policy in drug development testing

    The Animals in Science Committee as the responsible committee for policy direction under the Carltona Principle to the Home Secretary, participated in and organised a Future Futures workshop in 2021. The published pack included various workstreams Under the area "Drug Development Crisis " the workstream stated that " One of the key challenges is the lack of a clear scientific strategy to demonstrate how the different NAMS can be pieced together to replace all the various animal tests that are currently required to test a single new drug." Ergo by the same rationale there must a clear scientific strategy using animal testing existing and in use with which to replace this with NAMS, that the Government expects and indeed must be using to regulate the process of drug development here in the UK and for sale around the world. Please could I ask under Freedom of Information request, if you could point me to the clear scientific strategy that demonstrates how and which animal tests are currently required to test a single new drug please? This must surely be available to drug development manufacturers to enable them to reach regulatory standards and to gain market approval.

    Published: 31 March 2025

  10. The MHRA and CHM pertaining CHM decision to expand the NiQuitin indication (Type II variation)

    On Wed 5, Dec 2024 Perrigo received correspondence from the MHRA to inform us that the agency and the independent experts in CHM will be reviewing the decision to expand the NiQuitin indication (Type II variation) that was approved on 17-10-2024, based on the evidence that was presented. We have been advised that this referral is necessary because it is not completely aligned with the previous decision made by the CHM some time ago. We request that all information which is held by the MHRA and CHM pertaining to this previous CHM decision is shared.

    Published: 28 March 2025