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Thank you for the information you have sent me. but this is wrong. I am wanting an updated one off this please Please see the attached link.
Published: 17 August 2026
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Dear Sir/Madam, I would be grateful if you could provide the following information 1. The complete regulatory history of Chlorphenamine 2 mg/5 ml Oral Solution (PL 51463/0142) from Kent pharma , 2. A copy of the Public Assessment Report (PAR) for PL 51463/0142, if available. 3. Details of the legal basis / regulatory route under which this product was granted (for example, Article 10(1), 10(a), 10(3), or any other applicable article). 4. Confirmation as to whether PL 51463/0142,was granted following a Change of Ownership /Change of Authorisation Holder, and if so, a brief summary of the licence history, including: • Previous PL numbers (if applicable) • Dates of transfer • Names of former and current Authorisation Holders
Published: 17 August 2026
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Please disclose the unredacted numerical endotoxin (LAL) test results (including the exact values for both Drug Substance and Drug Product for the following batches and their clinical sub-batch suffixes: • Main batch EJ0553 and its clinical sub-batch EJ0553Z • Main batch EE8493 and its clinical sub-batch EE8493Y • Main batch ER9449 and its clinical sub-batch ER9449Z These batches are linked through the manufacturing genealogy and were all used as shown above as clinical trial material for the booster trial under the “EUA framework”.
Published: 17 August 2026
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Dear FOI Team, I am writing to request, under the Freedom of Information Act 2000, a copy of the discussion paper on agentic AI systems presented to the National Commission into the Regulation of AI in Healthcare at its meeting on 27 April 2026. The paper is referenced in the published summary minutes of that meeting, which describe it as exploring regulatory approaches to oversee AI systems capable of autonomously planning and taking actions with limited human supervision, and as proposing a tiered regulatory framework using levels of agent autonomy as a basis to determine what regulation and risk controls are required. I request: 1. The full discussion paper as presented to the Commission. 2. Any accompanying annexes or appendices. 3. Any cover note or briefing prepared by MHRA staff in connection with the paper. If any information is withheld in full or in part, please specify the exemption(s) relied upon, confirm whether the public interest test has been applied, and provide a schedule of withheld documents. I am happy to receive this information by email.
Published: 17 August 2026
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I am writing to make a request for information under the Freedom of Information Act 2000. Please provide copies of all Joint MHRA Health Canada pharmacovigilance inspection reports since January 2025 If the information is held electronically, I would prefer to receive it in electronic format by email. If clarification or refinement of this request would assist in processing it, please let me know as soon as possible. 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: 17 August 2026
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Thank you for your response. I have clarified my request and restated it for you below: 1) How many of the following types of peptide were seized by the MHRA during in 2024 and 2025? - Retatrutide - BPC-157 - GLP-1 - NAD+ - CJC 1295 -Ipamorelin 2) How many of the following peptide products were seized by the MHRA in the first 5 months of 2026? - Retatrutide - BPC-157 - GLP-1 - NAD+ - CJC 1295 -Ipamorelin 3) How many counterfeit peptide products were seized by the MHRA in the following periods? - the year 2024 - the year 2025 - the first five months of 2026 Please let me know if you require any further clarification. Thanks,
Published: 17 August 2026
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We've prepared a short overview below. We welcome your guidance on what would be considered in scope for a FoI. Devices in scope 1. Cardiac implants: pacemakers, implantable cardioverter defibrillators, cardiac resynchronisation therapy devices (including relevant subtypes where applicable),... 2. Neural implants: deep brain stimulation systems and spinal cord stimulation and neuromodulation systems, ... Primary request: anonymized case-level dataset We are looking for anonymized, case-level extracts from vigilance (post-market serious incident) reports for the device categories above, covering 1 January 2000 to present. If that full period is not feasible, please could you let us know what is the longest period that is feasible? Fields of interest (please could you indicate which represent data that is available): • Event date and/or date received by MORE - MHRA • Number of adverse event reports for selected AIMDs, identified by relevant GMDN codes • Device category (pacemaker / implantable cardioverter defibrillator / cardiac resynchronisation therapy device / deep brain stimulation system / spinal cord stimulation system) and device type/model fields if recorded • IMDRF annex breakdown for device problem and clinical symptoms as MHRA • Event type and seriousness • Problem / failure codes (or equivalent structured categories) • Patient sex (female/male/unknown, as recorded) • Patient age (preferably as bands) • Outcome and/or revision/explant/replacement indicator • Link to a Field Safety Corrective Action / Field Safety Notice (if recorded) • If available, any denominator/exposure proxy by sex • Any additional structured fields that are routinely available and relevant to interpreting the report Optional cross-tabulations (if feasible within FoI aggregation constraints) • year × device category × event type/seriousness × patient sex • if available: problem/failure code (or high-level failure mode) × device category × patient sex • optionally: age band × device category × patient sex • optionally: linkage to Field Safety Corrective Actions / Field Safety Notices • Sex × device category (GMDN) × severity • Sex × device issue category • Sex × clinical outcome category Finally, a simple pragmatic question, would you be providing the information as CSV or Excel (or another machine-readable format)? I look forward to your response and working with you to develop a FoI request that supports the progress of our research, whilst not excessively burdening your team. I hope that this work may even feed into your own internal reflection as to what data may, in the future, be made accessible through published summaries.
Published: 17 August 2026
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I am making this request under the Freedom of Information Act 2000. This request concerns dopamine agonist medicines, including but not limited to pramipexole, ropinirole, rotigotine, bromocriptine, cabergoline and apomorphine. Please provide the following recorded information: 1. The total number of UK Yellow Card reports received for each dopamine agonist since 1 January 2005 that include reports of: * impulse control disorder; * pathological gambling; * compulsive gambling; * hypersexuality; * compulsive sexual behaviour; * compulsive shopping or spending; * compulsive eating or binge eating; * punding or repetitive compulsive behaviours; * dopamine agonist withdrawal syndrome (DAWS); * suicide, suicidal ideation or suicide attempts where a dopamine agonist was recorded as a suspected medicine. 1. Any internal reviews, safety assessments, benefit-risk assessments or expert reports produced since 2005 concerning these adverse effects. 2. Copies of any meeting minutes, briefing papers or decision papers discussing whether additional warnings or prescribing restrictions should be introduced for dopamine agonists. 3. Copies of correspondence between the MHRA and pharmaceutical manufacturers concerning impulse control disorders or behavioural adverse effects associated with dopamine agonists. 4. Copies of correspondence between the MHRA and: * NHS England; * NICE; * the Commission on Human Medicines; * other UK health departments, 1. concerning the risks of impulse control disorders associated with dopamine agonists. 2. Copies of any communications issued to healthcare professionals, GP practices, pharmacists or NHS organisations concerning these risks, including any Drug Safety Updates or equivalent communications not already publicly available. 3. Any recorded information explaining why current prescribing advice does or does not recommend enhanced monitoring for patients considered potentially more vulnerable to impulse control disorders. 4. Any recorded information held regarding whether neurodevelopmental conditions, including ADHD or autism, have been considered as potential factors influencing susceptibility to dopamine agonist-induced impulse control disorders. 5. The dates on which the MHRA first became aware of evidence linking dopamine agonists with impulse control disorders, and the dates on which significant regulatory actions or safety communications were subsequently issued. 6. Any equality impact assessments, patient safety assessments or regulatory reviews concerning whether existing patient information sufficiently communicates the risk of impulse control disorders. If any part of this request exceeds the appropriate cost limit, please treat each numbered item separately and provide advice and assistance under section 16 of the Freedom of Information Act 2000 so that the request may be refined.
Published: 17 August 2026
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5. Requests for PIP-Specific Surveillance Data Please provide the following PIP-specific statistics from the current surveillance frameworks: a. The total number of PIP-specific adverse incident reports received by the MHRA to date, broken down by year and type of adverse event. b. The exact number of these reports that specifically involve rupture, gel leakage, silicone migration, lymph-node involvement, or systemic inflammatory/autoimmune symptoms, BIA-ALCL, other implant cancer, or malignancy, including BIA-SCC. c. The total headcount of historically PIP-exposed women currently recorded within the BCIR. d. The specific data fields held for those PIP-exposed entries in the BCIR (e.g., original batch, model numbers, current rupture status). e. A statement clarifying whether the current BCIR contains historical PIP records from before 2016/2017, does if it hold data from later revision surgeries? If it cannot map the historic PIP cohort, please clarify the answer to Question 7(a). 6. Clarification on "Multiple Exposure" and BIA-ALCL Tracking An MHRA presentation regarding Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) note that as of December 2023, 48 out of 117 confirmed UK cases occurred in women who had "previous breast implants". Please disclose how the MHRA records and evaluates these sequential histories: - What is the MHRA’s official operational definition of "multiple exposure" in its adverse event tracking? - If a woman had a PIP implant, underwent explantation, and later received a different textured brand (e.g., PIP > explant > Allergan), does the MHRA record this complete sequence? If the Agency only records the specific brand present at the time of cancer diagnosis, explain how multiple exposure risk is accurately assessed. - Out of the confirmed UK BIA-ALCL reports, how many of those patients had a documented history of prior PIP exposure?
Published: 17 August 2026
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I also request, under the freedom of information acts, to receive all materials related to that application, from filing an application of medical device approval, and up untill receiving an actual medical device approval by MHRA. Should any other documents exists, with regard to Ayla, the new entity Aylacare, or the former owners Brain+, or the former brandname "Your CST Assistant," then this is kindly also asked for being handed over, for me to review this data. I can supplement the request, with a brand name, that was tolled, when Brain+ in september 2023, said it had received protection, where the brand name was, "CST-Therapist Companion", so perhaps MHRA may have provided approval, for that brand name, wich today is known as Ayla.
Published: 17 August 2026
