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I am requesting the following information under the Freedom of Information Act 2000. Please provide documents held by MHRA from the period 2020-2025 relating to psychiatric risks of the following treatments used for headache or migraine, particularly in patients with a diagnosis of bipolar disorder or other psychiatric conditions: 1. Any safety alerts, drug safety updates, internal guidance, or prescribing advice issued by MHRA regarding: * The use of steroid-containing nerve blocks (e.g. local anaesthetic + corticosteroid injections) in patients with bipolar disorder * The use of amitriptyline or nortriptyline for migraine prevention in patients with psychiatric histories 1. Any Yellow Card data (summary-level, no personal data) relating to psychiatric adverse events such as mania, psychosis, or suicidal ideation, following: * Steroid-based nerve blocks for headache/migraine * Low-dose tricyclic antidepressants used for migraine prevention 1. Any internal briefings, policy discussions, or pharmacovigilance reviews where MHRA considered psychiatric risk or contraindications in relation to: * Migraine preventatives prescribed to patients with bipolar disorder or psychosis * The need for clinicians to disclose psychiatric risks before administering steroids or tricyclics If available, please also include any advice MHRA has provided to prescribers or the public about the importance of discussing psychiatric risk (e.g. mania induction) when prescribing these treatments. If this request risks exceeding the cost limit under Section 12, please advise me how to refine it under your Section 16 obligations. I prefer the information in digital format.
Published: 6 February 2026
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The CHM Annual Report for 2024 (see attached pages 13-14) summarises briefly several reclassification applications which CHM advised on. The CHM has considered a POM to P reclassification of melatonin indicated in adults for short-term treatment of jet lag. We would like to request further details including the proposed Pharmacy conditions requested e.g. product format and strength, indication, age limit, posology including maximum daily dose and maximum pack size. We would also like to request details of the CHM advice given and any requests for further information shared with the MHRA reclassification group and applicant.
Published: 6 February 2026
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In the document titled 'ClinicalAR PL 00065-5086R - 0029 (S.40 redacted).pdf' there are two references to tables, but the tables themselves appear to be missing. Are you able to provide these, or clarify if these are the ones present in PLVariation02 and PLVariation01?
Published: 5 February 2026
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Dear Medicines and Healthcare Products Regulatory Agency, please provide me with reports of myocarditis and pericarditis outcome (death or other) after exposure to COVID-19 mRNA vaccine PrifzerBioNTech Comirnaty from licensing in 2021 to the end of 2024. We are sure you hold this information as both conditions are a recognised harm of the vaccine. We would like to see your follow up of this important issue, augmented by the Yellow Card Reports show.
Published: 5 February 2026
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Dear Medicines and Healthcare Products Regulatory Agency, please provide me with reports of lymphopenia by duration after exposure to COVID-19 mRNA vaccine PrifzerBioNTech Comirnaty from licensing in 2021 to the end of 2024. We know you hold the data for a subset of 216 participants of registration trial BNT162b1 and the dataset includes lymphocyte count reported by dose, age (old or young), and assessment date. To facilitate your work the relevant clinical study report file is 125742 S1 M5 5351 Bnt162 01 Interim3 Lab Measurements (1) We would like to see your follow up of this important issue, augmented by the Yellow Card Reports show.
Published: 5 February 2026
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I am concerned that overdosing has occurred due to incorrect dosage information on Calpol and Nurofen. 2.5 ml on the syringe is actually 5ml on the spoon
Published: 5 February 2026
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Please treat this as a request for recorded information under the Freedom of Information Act 2000. This request concerns regulatory expectations around record keeping, data protection and privacy notices for pharmacies, clinics and manufacturers supplying unlicensed medicines under the “specials” framework, with particular reference to cannabis-based products for medicinal use in humans (CBPMs). I am not requesting any patient-level data. I am interested only in policies, guidance, statistics and correspondence. Guidance and expectations for “specials” licence holders and CBPM suppliers 1.1 Please provide copies of any current internal guidance, SOPs, inspector training materials or policy documents which set out MHRA’s expectations regarding: a) Record keeping and data retention for the manufacture, supply and distribution of unlicensed medicinal products (“specials”), including unlicensed CBPMs. b) How holders of Manufacturing “Specials” (MS) licences and other suppliers using patient-facing portals or online forms are expected to describe their data processing in privacy notices or patient information, particularly where health data and controlled drug information is collected directly from patients. If no such documents exist, please confirm this. Risk assessments and internal discussion of CBPM clinic and pharmacy data risks 2.1 Since 1 January 2018, please provide copies of any internal MHRA briefing notes, risk assessments, or policy papers that: a) Discuss data protection, record keeping or information governance risks associated with specialist CBPM clinics or distance-selling pharmacies in the private sector, and b) Refer specifically to unlicensed CBPMs supplied under the “specials” framework. Liaison with other regulators about data protection at CBPM suppliers 3.1 Since 1 January 2018, please confirm whether MHRA holds records of any referrals, notifications or correspondence with: a) The Information Commissioner’s Office (ICO), b) The General Pharmaceutical Council (GPhC), or c) NHS England or its predecessor bodies, where the subject matter includes concerns about data protection, privacy notices, record keeping or patient-facing portals operated by manufacturers, pharmacies or clinics involved in supplying unlicensed CBPMs. 3.2 For each regulator listed above, please provide, by calendar year, the number of such referrals or items of correspondence held, and copies of any documents you are able to disclose, redacted as necessary to remove personal data. Inspection findings: records, IT systems and privacy notices 4.1 For each calendar year from 2018 to 2025, please provide: a) The number of MHRA inspections of Manufacturing “Specials” licence holders where the scope included the manufacture, importation or supply of unlicensed CBPMs. b) For those inspections, the number which recorded deficiencies or observations (of any grading) in relation to: i. Record keeping or traceability of supply, ii. IT systems or data security, iii. The accuracy or adequacy of patient-facing privacy information or consent processes. If you do not hold these statistics in a pre-compiled form, please confirm whether any internal summaries, dashboards or reports exist that aggregate inspection findings in a way that would answer this question. Records specifically mentioning IPS Pharma 5.1 IPS Pharma publicly states that it is a manufacturer and supplier of unlicensed medicines and “specials” and operates patient-facing services via its website and portal. Its published privacy notice, as accessed in 2025, still carries 2018 implementation wording and transitional GDPR language, despite the later launch of a patient portal that collects detailed medical and payment information. Without requesting any patient data, please provide: a) Copies of any inspection reports, deficiency letters, warning letters, or other enforcement correspondence issued by MHRA to IPS Pharma Limited (or associated entities trading as IPS) since 1 January 2018 where data governance, record keeping, privacy notices, portals or information provided to patients are mentioned. b) Copies of any internal MHRA emails, memos or briefing notes since 1 January 2018 in which IPS Pharma is discussed in the context of information governance, privacy notices or patient portals, redacted as required to remove personal data or legally privileged content. If you consider that any of the requested information is exempt from disclosure, please: Specify which exemptions you are relying on for each withheld item, and Explain, where applicable, how the public interest test has been considered.
Published: 5 February 2026
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I am making a request under the Freedom of Information Act 2000 regarding the oil-based contrast agent Myodil (Pantopaque) and similar agents (e.g., oil-based contrast media used for myelography) Please could you confirm: 1. Whether Myodil, Pantopaque, or oil-based contrast media were licensed or in clinical use in the UK in 1986. 2. When their use ceased or was formally discontinued or discouraged in the UK. 3. Whether the MHRA or its predecessor bodies issued guidance (including archived or superseded guidance) describing specific procedural requirements for their use, such as post-procedure patient positioning (for example, being kept upright or advised not to lie flat). This request is limited to regulatory status and guidance held by the MHRA or its predecessor bodies and does not seek patient- or hospital-specific information.
Published: 5 February 2026
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Dear Medicines and Healthcare Products Regulatory Agency, Under the Freedom of Information Act 2000, I request the following held information from 1 July 2024 to the present: 1. Any internal or external correspondence, meeting notes, assessments, or reports discussing the potential recommendation or qualification of **liver-on-a-chip** (or liver microphysiological systems) as a recommended or complementary tool alongside animal testing for preclinical hepatotoxicity assessment (e.g., drug-induced liver injury prediction) in regulatory submissions. 2. Details of any MHRA engagement with international developments on non-animal methods, including: - The US FDA Modernization Act 2.0 (2022) and 2025 FDA roadmap promoting microphysiological systems. - The EU Proposal for a Regulation on Biotechnology and Biomanufacturing (adopted December 2025). - Ongoing ICH discussions on new approach methodologies (NAMs) or non-animal alternatives in safety guidelines. 3. Any identified barriers, plans, or timelines for the MHRA to recommend or qualify liver-on-a-chip platforms in line with the UK Government's November 2025 strategy on replacing animals in science. This request follows a previous unhelpful FOI response earlier in 2025. Please exclude information already provided in that response and focus on post-July 2024 material. If needed, advise on refining to stay within cost limits. I prefer electronic format.
Published: 5 February 2026
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Under the Freedom of Information Act, on behalf of Medicines and Healthcare Products Regulatory Agency, I would request you to respond to questions included in the attachment. For any reason if you are unable to open the attachment do let me know. I can then send the questions within the email itself. Please note: If you do not have records relating to the questions in the attachment, please pass on this request to your IT department to provide us with the required information.
Published: 5 February 2026
