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I am writing following correspondence from the Office for Product Safety and Standards (OPSS), who have stated that MHRA was the lead regulator for the contaminated consumer wet wipes associated with Burkholderia stabilis and linked to fatalities. OPSS has directed all questions of regulatory responsibility, enforcement, recall, and accountability to MHRA. Accordingly, I now request the following information under the Freedom of Information Act 2000 and/or the Environmental Information Regulations 2004 (EIR). If MHRA considers any part of this request to fall under EIR rather than FOIA, please process it under the correct regime without delay. 1. MHRA’s role as “lead regulator” Please provide: • The date on which MHRA formally determined that these wipes were medical products. • Any classification documents, internal assessments, or regulatory determinations relating to these wipes. • Whether MHRA had classified these products as medical devices before the contamination incident. • Any pre‑market or post‑market surveillance undertaken by MHRA relating to these products. • Any concerns previously raised by MHRA about categorisation, labelling, or marketing. If MHRA did not classify these wipes as medical products until after the contamination was discovered, please confirm this explicitly. 2. Regulatory responsibility and potential regulatory gap OPSS has stated that these contaminated wipes were outside their regulatory scope. Please provide: • MHRA’s formal position on whether it understood itself to be the sole regulator responsible for these consumer‑sold wipes. • Any internal MHRA documents assessing regulatory responsibility for these products. • Any MHRA assessments of whether a regulatory gap existed between MHRA and OPSS. • Any internal reviews, lessons‑learned documents, or evaluations of how contaminated wipes reached the market and remained on sale. 3. Investigation into manufacturer, supply chain, and production environment OPSS states that MHRA was responsible for all investigations relating to the manufacturer and supply chain. Please provide: • All MHRA investigation reports relating to the manufacturer, supply chain, or production environment. • Any findings relating to systemic failures in manufacturing or quality control. • Any enforcement notices, sanctions, compliance actions, or regulatory decisions issued by MHRA. • Any correspondence with manufacturers or distributors relating to contamination. If MHRA took no enforcement action, please provide the reasoning and any internal decision records. 4. Product recall decisions OPSS states that manufacturers undertook voluntary recalls and that MHRA did not mandate a recall. Please provide: • Any MHRA assessments of whether a mandatory recall was considered. • Any risk assessments relating to the adequacy of voluntary recalls. • Any MHRA verification that contaminated products were fully removed from the market. • Any internal or external correspondence relating to recall decisions. 5. Coordination with UKHSA and OPSS OPSS states that MHRA and UKHSA led the incident response. Please provide: • MHRA’s role in the UKHSA incident management team. • Any MHRA instructions, guidance, or risk assessments issued to OPSS. • Any MHRA evaluations of cross‑regulator coordination. • Any minutes, notes, or records of meetings involving MHRA, UKHSA, and OPSS. 6. Accountability for regulatory failure OPSS has stated that accountability for regulatory failure is a matter for MHRA. Please provide: • MHRA’s formal position on whether contaminated consumer wipes reached the market under its regulatory oversight. • Any MHRA internal reviews, investigations, or lessons‑learned documents relating to fatalities. • Any planned or completed regulatory reforms arising from this incident. • Any documents assessing MHRA’s own performance or regulatory effectiveness. 7. Documents requested under FOIA/EIR To avoid ambiguity, I request disclosure of: • Classification documents • Risk assessments • Incident reports • Internal briefings • Enforcement notices • Recall assessments • Correspondence between MHRA, OPSS, and UKHSA • Any internal reviews or lessons‑learned documents
Published: 2 June 2026
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Please disclose 1. Written notice (.issued sometime between 20 August 2025 and 9 October 2025) of the grounds for non-acceptance by the MHRA of the puberty blockers trial protocol proposed by Kings College London. 2. Minutes of the extraordinary meeting of the CHM which took place on on 18 September 2025 which were disclosed to the claimants in the judicial review on the puberty blockers trial on 30 January 2026.
Published: 2 June 2026
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Please treat this as a formal request under the Freedom of Information Act 2000. Please provide copies of SmPC documents for fluoxetine held by the MHRA between 1 January 2011 and 31 December 2019. Please include all versions, including historical versions. This request does not seek any information that could expose patient identity. Where information is exempt, I request that related, non-exempt material be disclosed.
Published: 2 June 2026
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I would like to know the percentage of people in the UK that suffer from pain? How many of this percentage take over the counter medication? How many of the pain precentage take medication relief regularly on perscription? Out of 10 how much do the anti-pain medication help with the pain? What is the statistics to each individual medication that is available in the UK? I would be grateful if you can provide as much information as you have available.
Published: 2 June 2026
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I write to you to submit a Freedom of Information Request. Please can you furnish me with the following information: How many different patients have submitted Yellow Card Reports which have been categorised using the MedDRA code 10086208 (Post-SSRI sexual dysfunction)? Can you please break the data down by a) year of first report per patient and b) medication.
Published: 2 June 2026
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Published: 2 June 2026
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Could you please provide copies of the MHRA Good Clinical Practice (GCP) inspection reports relating to the following 3 inspections: Leo Pharma - Insp GCP 43/32961802-0002Takeda - Insp GCP 16189/19142243-0002GSK - Insp GCP 19494/37251014-0002 If any of the requested information is exempt from disclosure, I would be grateful if you could: • Provide the non-exempt information that can be disclosed, and • Clearly identify the exemption(s) relied upon for any information withheld.
Published: 2 June 2026
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I want to obtain the Clinical Study Report including all appendixes on Pfizer's Zoloft study 91CK21-0550. I would like to obtain the Clinical Study Reports fully, without any parts being removed.
Published: 2 June 2026
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1. Failure to Address Current Statutory Duties. While the MHRA may not hold the historical 1963 files, the Agency assumed statutory responsibility for the safety, efficacy, and quality of medicines in 2003. Regulation is a continuous act, not a historical event. I therefore request a review of why the following current information was not disclosed: • The Scientific Evidence Review or Rationale held by the MHRA post-2003 that justifies the continued regulatory "gold standard" status of T4-monotherapy, despite published evidence regarding deiodinase (DIO2) polymorphism and T3-conversion failure. • The Marketing Authorisations (Product Licences) currently held by the MHRA for Levothyroxine products, specifically the sections outlining the clinical trials or grandfathered data used to validate T4-monotherapy as an exclusive first-line treatment.
Published: 2 June 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 Melatonin 1 mg/ml oral solution, MAH: Glenmark Pharmaceuticals Europe Ltd, (PL 25258/0402).
Published: 2 June 2026
