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During our first meeting with Dr June Raine CBE and the Pharmacovigilance team in August 2013 it was stated approx 20,000 babies had been affected by Valproate in pregnancy since licensing in 1973 and have constantly repeated that figure since. Therefore our FOI Question 1. Where has the figure of 20,000 affected orginated from 2. Can MHRA please provide evidence that number of affected exists. We look forward to your reply
Published: 9 September 2025
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I am writing to make a request under the Freedom of Information Act 2000. I request access to all documentation, reports, and communications held by the MHRA (and previously, the Medicines Control Agency) regarding the antihistamine drug Astemizole (e.g., under the brand name Hismanal), including but not limited to: 1. Marketing authorisation documents, applications, and approval notices. 2. Safety reviews, risk assessments, and benefit-risk analyses conducted during its approval and marketing period. 3. Adverse event reports and pharmacovigilance data related to Astemizole use in the UK. 4. Correspondence with the marketing authorisation holder (e.g., Janssen-Cilag or Johnson & Johnson) about safety signals or regulatory action. 5. Documentation or internal reviews relating to restrictions, suspensions, or withdrawal of Astemizole from the UK market. 6. Any communications with the European Medicines Agency (EMA) or other international bodies that contributed to UK decisions on Astemizole.
Published: 9 September 2025
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I am requesting further information and want all effects on Ludiomil (maprotiline). Specifically after the following Intended effects Dementia effects Side effects
Published: 9 September 2025
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We would now like to make a further freedom of information request relating to the 9 yellow cards received: MHRA answer:The first date of receipt of a Yellow Card reporting the above devices and components failing was the 27/11/20133. Our question: Who sent this yellow card to you? What was the action from the MHRA and by whom? Include dates, names of reporting organisation or person in your answer and can you provide evidence? 2. Relating to the above yellow card dated 27/11/2013, did you inform the NJR as part of your action and if so, at what date and to whom and can you provide evidence? 3. MHRA answer: The last date of receipt of a Yellow Card of the above devices and components failing in 2022 (1/1/2022 to 31/12/22) was the 06/04/22. Our question: Who was the 6/4/2022 card from? What did it report? What was the action by MHRA? Include dates and names. 4. Can you give us more specific details of who you received the 9 yellow cards from, what they reported and what action was taken by the MHRA.
Published: 9 September 2025
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I’m writing this email to submit a Freedom of Information (FOI) request for “Ocrevus (ocrelizumab)”. Requesting document is listed below and please let me know if you need additional information. Requesting documents ‘Ocrevus (ocrelizumab)’ ▶ CSR for WA21092 (Phase 3) ▶ SAP for WA21493, NCT00676715 (Phase 2) (unblinded in November 2009, first CSR) ▶ CSR body for WA21493, NCT00676715 (Phase 2)
Published: 9 September 2025
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I’m writing this email to submit a Freedom of Information (FOI) request for “Remicade (infliximab)_CSR (NCT00207675, NCT00336492)”. Requesting document is listed below and please let me know if you need additional information. Requesting documents ‘Remicade (infliximab)’ ▶ CSR for NCT00207675 (CD Pediatric Phase 3) ▶ CSR for NCT00336492 (UC Pediatric Phase 3)
Published: 9 September 2025
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We are requesting urgent clarification and traceability data regarding any Ventway Sparrow ventilators exported from the UK, particularly units that may have originated from NHS pandemic surplus stock. Our Concerns We are aware of potential unauthorised resale and attempted exportation of these devices by third parties without the knowledge, approval, or oversight of either Simulation Man Ltd or the manufacturer (Inovytec). As you will appreciate, the Ventway Sparrow is a Class IIb life-supporting ventilator, and any exports of such equipment may carry: Clinical risk if used without service history or valid warranty Regulatory consequences if exported without proper manufacturer engagement Reputational damage if UK-sourced equipment is misrepresented abroad Our Request We respectfully request that the MHRA confirm whether: Any Ventway Sparrow ventilators have been registered or declared for export from the UK since January 2023. Who the declared exporters were for each shipment. The destinations or countries these units were exported to. The serial numbers or identification of the exported devices, if available. We believe this information is critical not only for regulatory accountability, but also for ensuring that unsupported devices do not enter clinical service abroad under false assurances. Supporting Role We are fully aligned with the manufacturer and the MHRA’s mandate to uphold safety and compliance. We are happy to cooperate further with enforcement, provide technical validation, or help identify at-risk devices.
Published: 9 September 2025
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I would like to submit a Freedom of Information request for updated information regarding covid jabs and elderly deaths since 2021.
Published: 9 September 2025
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I am writing under the Freedom of Information Act 2000 to request the following information regarding the marketing authorization application for DCVax-L, a personalized dendritic cell-based vaccine submitted by Northwest Biotherapeutics: Has the MHRA accepted and validated a Marketing Authorisation Application (MAA) for DCVax-L? If so, on what date was the application validated? Is the MAA for DCVax-L being reviewed under the 150-day accelerated assessment pathway? Has the Commission on Human Medicines (CHM) reviewed or advised on the DCVax-L application? If so, please provide the dates of any relevant CHM meetings. Has the MHRA completed its assessment of the application or issued a decision regarding approval? If a decision is still pending, please provide the current status of the review. Have there been any regulatory clock stops during the DCVax-L assessment process? If so, when and for what reason? I understand that some aspects of this request may be commercially sensitive. However, I am only requesting factual status updates (e.g., dates of submission, validation, and review phases), not detailed content of the application. Thank you in advance for your time and assistance. Please do not hesitate to contact me if further clarification is required.
Published: 9 September 2025
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SCENARIO: A patient hands in a blue prescription listing only buprenorphine sublingual tablets (NOT SC), of which are not to be prescribed via supervised consumption only nor on a daily basis, with regard for the provision (via legal requirement) by the pharmacist [and not legal status of the drug itself A) What are (if any) the statutory/legislative/MHRC/ requirements that mandate by law, a pharmacist or pharmacy premises' to: do anything else different than they would otherwise when dispensing that medicine underlined above? B) What are (if any) the statutory/legislative/MHRC requirements that mandate by law, a pharmacist or pharmacy premises' to: override or disregard a disabled patients standing reasonable adjustments under the Equality Act 2010? C) What are (if any) the statutory/legislative/MHRC requirements that mandate by law, a pharmacist or pharmacy premises' to REQUIRE a collecting party to get a note, and within the note, confirmation from a "Key Worker" that confirms both: I. The fact that the patient's representative is to collect the patient's medication on that patient's behalf Ii. WHY the patient requires it collecting for them, and why they therefore cannot collect it themselves
Published: 9 September 2025
