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May I please request for the Public Assessment report for the below stated product- GLYCOPYRRONIUM UNICORN PHARMA 320 MICROGRAMS /ML ORAL SOLUTION MAH- UNICORN PHARMACEUTICALS LIMITED PL- 58713/0032
Published: 28 October 2026
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I would like to see the full review of MHRA's request for Eli Lilly to investigate post marketing reports of persistent sexual dysfunction following discontinuation of fluoxetine and other SSRIs. All reviews of published literature, case reports, consumer internet reports, and incidental research findings discussing persistent sexual dysfunction following SSRI discontinuation. Lilly identified six published articles containing 14 case reports involving prolonged or persistent sexual dysfunction after discontinuation of SSRIs, including three reports involving fluoxetine. After this review, Lilly proceeded to update Prozac labels in the United States to warn of the risk of persistent sexual dysfunction The text is included here, and the FDA document is attached. " Page 1 Regulatory Response 6. Persistent Sexual Dysfunction 6.1. Overview This addendum is provided to support a labeling supplement for Prozac (fluoxetine). The purpose of this labeling supplement is to update Section 6.1 Clinical Trial Experience of the Prozac USPI arising from a review requested by the MHRA in August 2010. The review was completed and submitted to the MHRA by Lilly in November 2010, and the CDS was updated in November 2010. 6.2. Background Lilly received a request from the MHRA on 31 August 2010 for a cumulative review of adverse reactions related to sexual dysfunction suspected to be associated with fluoxetine use, with a particular focus on those cases that have persisted long term after treatment with fluoxetine has been discontinued. This was to aid the MHRA's evaluation of the potential signal of sexual dysfunction which may persist after treatment with an SSRI has been stopped. Following clarification with the MHRA, Lilly defined the term "persistent" to mean at least 3 months after discontinuation of fluoxetine treatment, which is based on the half-life of fluoxetine and its active metabolite, norfluoxetine. There is a high incidence of sexual dysfunction in the general population, and the occurrence of sexual dysfunction is consistently higher in patients with depression than in the general population (Kennedy and Rizvi 2009). Most antidepressants have side effects related to sexual functioning, and it has been estimated that up to 60% of patients receiving SSRIs report some form of treatment-emergent sexual dysfunction (Kennedy and Rizvi 2009). In recent years there have been several publications (reviews, commentaries, case reports, consumer-provided internet-based information, and incidental research findings) that discussed persistent sexual dysfunction following SSRI discontinuation. Six articles reported 14 case reports of patients experiencing prolonged or persistent sexual dysfunction following discontinuation of several SSRIs, including fluoxetine (3 reports), paroxetine, citalopram, and sertraline. The exact mechanisms for persistent sexual side effects after SSRI discontinuation discussed in the literature are unclear, and only mechanistic hypotheses have been suggested." Please include Eli Lilly's discussion of clinical trial evidence for persistent sexual dysfunction and the MHRA's identification of persistent sexual dysfunction as a long-term risk.
Published: 28 October 2026
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Thank you for your response to FOI2026/00903. Three follow-up questions, please, as a new request under the Freedom of Information Act 2000: 1. Does GMDN code CT269 or CT299 capture monitor-defibrillators? If not, please provide the equivalent figures under the correct code. 2. Please provide the IMDRF Annex A breakdown, by year, for all 86 fatal reports 2023–2025 – not just the first 10 reports per year. 3. Are the 2025 figures (336 reports; 29 fatal) final, or still provisional?
Published: 28 October 2026
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This is a Freedom of Information request. Section 5 of the Government Efficiency Framework requires departments to have central data monitoring processes in place and to report efficiency savings to HM Treasury on a quarterly basis. Please provide a copy of the efficiency savings report submitted by your organisation to HM Treasury or DHSC for the most recently completed reporting quarter.
Published: 28 October 2026
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I am requesting any recorded information held by the MHRA relating to the use of lemon and menthol leaf imagery on the packaging of the following products: PL 00129/0349 Vicks Cold, Flu & Cough All In One 500 mg/200 mg/10 mg Powder for Oral Solution PL 00129/0347 Vicks Cold & Flu Max Strength 1000 mg/12.2 mg Powder for Oral Solution Specifically, I request: Any assessment reports, review documents, approval records, or correspondence relating to the acceptability of lemon and menthol leaf imagery on the approved packaging. Any MHRA guidance, policies, assessment criteria, or regulatory requirements concerning the use of fruit, plant, herb, or leaf imagery on medicinal product packaging. Any recorded information relating to whether natural lemon-derived and/or natural menthol-derived flavouring components were considered when approving the packaging. Any documented criteria regarding the level or proportion of natural flavouring required to justify the use of lemon, menthol leaf, or other botanical imagery on medicinal products. If any of the requested information is publicly available, please provide links to the relevant sources. Electronic copies of documents are preferred.
Published: 28 October 2026
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Under the Freedom of Information Act 2000, I request the following recorded information concerning how MHRA receives, records, assesses and uses evidence arising from coroners and inquests concerning deaths involving medicinal products. The period of this request is 1 January 2018 to the date of this request. This request is limited to existing centrally held policies, procedures, datasets, aggregate information, audits, reports and governance records. I am not requesting individual patient records, individual Yellow Card reports, a manual review of individual inquests or the creation of new statistics. Sources of coronial information Please provide copies of any policies, procedures, standard operating procedures, guidance or other recorded arrangements governing MHRA's receipt or acquisition of information from: a) Prevention of Future Death reports issued under Regulation 28; b) coroners or coroners' offices outside the Regulation 28 process; c) inquest conclusions or narrative conclusions; d) post-mortem or toxicology findings supplied following an inquest; e) the Chief Coroner or Office of the Chief Coroner; f) Ministry of Justice; g) Medical Examiner offices or NHS England; h) police or other public bodies following medication-related deaths. Deaths where no Regulation 28 report is issued Please provide any recorded policy, procedure or guidance addressing how MHRA can become aware of, or obtain information from, an inquest involving a medicinal product where the coroner does not issue a Regulation 28 Prevention of Future Death report to MHRA. Please include any recorded consideration of whether reliance on Regulation 28 reports alone would fail to identify medication-related deaths relevant to pharmacovigilance. 1. Systematic data feeds or information-sharing arrangements Please provide copies or descriptions of any existing: a) information-sharing agreements; b) memoranda of understanding; c) routine data feeds; d) notification arrangements; e) database links; f) periodic reports; between MHRA and any of the following concerning medication-related deaths: * coroners; * the Chief Coroner; * Ministry of Justice; * Office for National Statistics; * NHS England; * Medical Examiner offices; * toxicology services. Recording and Coding Please provide any existing data dictionary, coding guidance or list of database fields used by MHRA to identify that safety information originated from: a) a coroner; b) an inquest; c) a Regulation 28 report; d) a post-mortem; e) toxicology; f) a Medical Examiner; g) a death involving suspected overdose or poisoning. Please also indicate through disclosure of the relevant recorded material whether such information can be searched or retrieved according to medicinal product. Aggregate information Where already centrally held, please provide for each calendar year from 2018 onwards: a) the number of Regulation 28 reports received by MHRA concerning medicinal products; b) the number of other coronial or inquest notifications received which were not Regulation 28 reports; c) the number of safety reports or pharmacovigilance cases identified as having originated from coronial or inquest information; d) the number of cases where post-mortem or toxicology findings supplied by a coroner contributed to a pharmacovigilance assessment; e) the number of Yellow Card reports, if separately identifiable, generated from or linked to coronial information. I am requesting these figures only where they already exist. I am not requesting MHRA to perform a retrospective review of individual records to create them. Signal detection and regulatory assessment Please provide any policy, procedure, guidance or governance document describing how information arising from coroners, inquests, post-mortems or toxicology is incorporated into: a) signal detection; b) signal validation; c) signal assessment; d) periodic safety review; e) benefit-risk assessment; f) regulatory action concerning a medicinal product. Audits and gap analyses Please provide copies of any audits, reviews, reports, committee papers, risk assessments or gap analyses since 1 January 2018 considering: a) whether MHRA receives sufficient information from coroners concerning medication-related deaths; b) possible under-reporting of medication-related deaths identified at inquest; c) limitations arising where no Regulation 28 report is issued; d) barriers to linking coronial, toxicological or mortality information with pharmacovigilance data; e) proposals to improve such information flows. Suicide, poisoning and medication-related deaths Please provide any national policy, guidance or governance record specifically concerning the use of coronial or toxicological information in MHRA surveillance where death involves: a) suicide; b) intentional or suspected intentional overdose; c) accidental poisoning; d) prescribed-drug toxicity; e) a combination of prescribed medicinal products. For avoidance of doubt, I am seeking the systems by which MHRA learns from these deaths, not details of individual deceased persons. If any part would exceed the appropriate cost limit, please provide the information which can be supplied within the limit and provide section 16 advice and assistance concerning any part requiring refinement. Please provide the information electronically.
Published: 28 October 2026
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I write under the Freedom of Information Act 2000 in relation to the Pfizer/BioNTech COVID-19 vaccine batch FH4751. The published case series print indicates 60 reports coded as “Dyspnoea” (shortness of breath) for this batch. I am seeking a breakdown of the underlying clinical causes or diagnoses associated with those dyspnoea reports. For the reports in which dyspnoea was recorded, please provide: 1. A breakdown of the stated or subsequently identified clinical diagnoses or medical conditions associated with the breathlessness (for example pulmonary embolism, myocarditis, cardiac arrhythmia, anaphylaxis, pneumonia, interstitial lung disease, hypersensitivity pneumonitis, heart failure, anxiety-related hyperventilation, or any other identified cause). 2. Where no specific diagnosis was identified, please confirm how many dyspnoea reports were recorded without an underlying cause being specified. 3. Please confirm whether the MHRA reviewed the dyspnoea reports for batch FH4751 to determine whether a common clinical mechanism or safety signal was present, and if so, provide the conclusion of that review. I am not requesting identifiable personal data, but a substantive breakdown of the underlying clinical causes recorded in association with the dyspnoea reports.
Published: 28 October 2026
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I am seeking information about safety incidents reported in connection with the use of AI products in healthcare. If possible, please could the MHRA provide answers to the following: 1. The number of safety incidents relating to i) SaMDs (Software as a Medical Device) and ii) AIaMDs (Artificial Intelligence as a Medical Device) reported to date through the MHRA's Yellow Card system. 2. A full list of all providers of SaMDs and AlaMDs the MHRA has registered in each of its risk based classification categories
Published: 28 October 2026
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Please provide copies of current practical materials used by the Medicines and Healthcare products Regulatory Agency for Civil Service promotion or internal selection, and where readily available equivalent materials used in the last three years, covering: 1. Candidate guidance for applications/personal statements, Success Profiles/behaviours/strengths, interviews, presentations, written exercises or assessment centres. 2. Assessor guidance, scoring descriptors, marking matrices/rubrics, interview guidance and moderation/calibration materials. 3. Sample or retired questions/exercises and associated marking guidance. 4. Example applications, statements, interview answers or other candidate responses used to train candidates or assessors, including scores/comments where held. 5. Materials used in positive-action, talent or development schemes to help staff prepare for promotion/selection, including workbooks, slides, coaching/mentoring guides, mock exercises and example answers. I am not requesting personal data or live secure question banks. Where current material cannot be disclosed, please provide retired/sample equivalents if held. Redaction is preferable to withholding whole documents. If this exceeds the cost limit, please prioritise items 2, 4 and 5.
Published: 28 October 2026
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I would like to be sent all the information submitted by Astellas to support the licensing and wording of the SmPC for Fezolinetant In regards to breast cancer as per wording in section 4.4 (as below), as well as the documentation in relation to the MHRA in how it came to agree this wording. The SmPC contains the wording below in Regards to breast cancer 4.4 Special warnings and precautions for use Known or previous breast cancer or oestrogen-dependent malignancies Women undergoing oncologic treatment (e.g., chemotherapy, radiation therapy, antihormone therapy) for breast cancer or other oestrogen-dependent malignancies have not been included in the clinical studies. Therefore, Veoza is not recommended for use in this population as the safety and efficacy are unknown. Women with previous breast cancer or other oestrogen-dependent malignancies and no longer on any oncologic treatment have not been included in the clinical studies. A decision to treat these women with Veoza should be based on a benefit-risk consideration for the individual. The SmPC contains no data to support the above and SKYLIGHY-1 and SKYLIGHT-2 excluded people with a history of breast cancer, and this is clearly stated in the wording above for both groups. I therefore wish to understand what information was submitted to the MHRA by Astellas in regards to this and how the MHRA came to make this decision in relation to the wording related to breast cancer given the referenced data in the SmPC.
Published: 28 October 2026
