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I request the following information held by the Medicines and Healthcare products Regulatory Agency (MHRA): 1. Oncology-Related Risk Assessments Please confirm whether the MHRA conducted, commissioned, or received any internal risk assessment, briefing paper, or expert review between January 2019 and December 2023 concerning potential interactions between SARS-CoV-2 spike protein expression (including mRNA or adenovirus vector platforms) and: • p53 pathway modulation • BRCA1/BRCA2 pathways • DNA damage response mechanisms • tumour suppressor gene regulation • immune surveillance impairment • cancer progression or recurrence If such documents exist, please provide: a) The title of each document b) The date of creation c) The authoring department or committee d) Any executive summary or conclusion section If no such assessment was conducted, please confirm that fact. 2. Comparative Platform Safety Assessment Please confirm whether the MHRA conducted any comparative safety assessment between: • mRNA vaccine platforms • Adenovirus vector platforms • Inactivated whole-virus platforms Specifically in relation to long-term oncological risk or tumour-suppressor interaction. If such comparative assessments were conducted, please provide: a) The title and date of the assessment b) Minutes of any committee meeting where comparative oncological safety was discussed c) Any formal risk classification outcome If no comparative oncological assessment was conducted, please confirm that fact. 3. Cancer Patient Guidance Consideration Please confirm whether the MHRA formally considered issuing guidance specific to cancer patients or oncology consultation prior to administration of COVID-19 vaccines. If such consideration occurred, please provide: a) Records of internal discussions b) Committee minutes c) Draft guidance documents d) Any risk-benefit analysis specific to oncology patients If no such consideration occurred, please confirm that fact. Clarification and Cost Limit This request is limited to formal assessments, briefing papers, committee minutes, or executive summaries. It does not require a full keyword search across all correspondence. If you consider any part of this request likely to exceed the appropriate cost limit under Section 12, please advise under your duty pursuant to Section 16 how the request may be refined to fall within statutory limits.
Published: 31 March 2026
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Please can you provide the data provided in Marketing Authorisation which supports the clinical assessment for Promazine 2.5 and 5mg/5ml (PL 40546/0178-0179) MAH Aristo Pharma GmbH. We are particularly interested in the request made from the CHM for the clinical package and how this was addressed by the MAH or Modules 2.5 in order to satisfy the WEU legal basis.
Published: 24 March 2026
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• Were HSCNI notified that prescription only medicines were being supplied to their harm reduction contracts from unlicensed premises?
Published: 24 March 2026
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I would like to request for Module 2.4, Module 2.5, Module 2.6 and Module 2.7 submitted for Ketoconazole 2% Shampoo, MAH: Curagenix Life Sciences Limited, (PL 59154/0004).
Published: 24 March 2026
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Would it be possible to also have the information in the first PDF (Total Number of Yellow Card Reports Recevied after the 1st of January 2016 associated with Apixaban, Edoxaban, Warfarin, Dabigatran and Rivaroxaban broken down by hospital) be broken down by month (or year, if month is not available)? I understand I did not initially ask for this information, although it would be of great help. Many thanks for any help you can provide.
Published: 24 March 2026
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I would like to see any and all information related to this study and it's endpoints specifically reduced behavioral reactivity and reproductive functional impairment. All email correspondence between regulators and stakeholders or discussion with regulators regarding clinical relevance. Here is the full study. Any information you have would be greatly appreciated. "Beck MJ. 2004. A study in young CD(IGS) rats administered fluoxetine hydrochloride (LY110140) orally by gavage to evaluate general, reproductive and behavioral toxicity, study. Document ID WIL-353039. Eli Lilly and Company. Peforming laboratory: WIL Research Laboratories."
Published: 24 March 2026
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I would like to submit a freedom of information request regarding the drug analysis print for immunoglobulin normal. There is aggregated data on drug analysis prints, however I am looking for more granular data. Specifically, I please request a breakdown of the type and frequency of all different adverse events reported within skin and subcutaneous tissue for all subcutaneous immunoglobulin brands, broken down by brand, in the UK since 1st January 2015 to the most current date available reported via the yellow card system and pharmaceutical industry. Route of administration to include: - 'intravenous bolus; subcutaneous' - 'other; subcutaneous' - 'subcutaneous'. The output should include - all sexes - age groups - reporter types - severity.
Published: 24 March 2026
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Further to your response to our initial request, we would request copies of the latest approved Clinical / Non-Clinical / Quality overviews from the just for Vancomycin Morningside Healthcare, 125mg, Capsules, hard, PL 20117/0149.
Published: 24 March 2026
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I shall be grateful if you will provide information as follows: 1) Is Dysport licensed for use in hernia surgery in the UK? 2) In the event it is licensed please outline the conditions for its use in hospitals. 3) Are all hospitals able to use it? In the event the use is limited which ones are allowed to do so? 4) Has the MHRA been notified of any side effects it has? Have any patients deaths been reported following use of Dysport?
Published: 24 March 2026
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I would like to request the following information: Re “The Commission on Human Medicines CHM advises ministers on the safety, efficacy and quality of medicinal products: - As the CSM was replaced by CHM during October 2005 my request may be held in CSM documents. Please can you supply all the information you supplied to minsters on the safety and efficacy regarding the following drugs prior to the Anne Begg Co-proxamol debates in parliament during 2005 and 2007. • Co-proxamol • Oxycodone • Buprenorphine • Codeine • Tramadol In my 'Annotation for Reference' the FDA report clearly shows: - The FDA report produced between 1969 and 2005 there were 10671 more adverse event reports, 3256 more overdose reports, 437 more suicide reports, 5041 more abuse & dependence reports, and the total number of death reports increased by 5059 when Oxycodone was compared with Propoxyphene (Co-proxamol)! The highest number of all adverse events was reported for oxycodone followed by tramadol. Despite this information being available prior to the announcement of the ban on Co-proxamol (2005), the MHRA continued issuing additional 'Marketing Authorisations’ for Oxycodone, Fentanyl and Buprenorphine'. Between 2005 and 2015 MHRA issued 298 additional ‘Marketing Authorisations’ for the more dangerous opiates. MA Increases: Oxycodone +138, Fentanyl (Including Fentanyl Citrate) +75 and Buprenorphine + 85. As CSM/CHM are required to inform and advise Ministers on the safety, efficacy and quality of drugs what advice was given to the Minister regarding these drugs which replaced Co-proxamol?
Published: 24 March 2026
