-
We have reviewed the MHRA's updated warning about the risk of botulism following botulinum toxin treatment. Could you please advise whether you can share: * The latest aggregated Yellow Card data relating to botulinum toxin, ideally showing annual trends since 2021 * Whether cosmetic treatments can be separated from therapeutic use * The main reactions reported, including serious or fatal outcomes * Any themes involving unlicensed, counterfeit or imported products * Important limitations when interpreting the figures * The main warnings and advice that should be communicated to the public * Any existing MHRA communication materials that we could use We do not require patient-identifiable information.
Published: 13 October 2026
-
I would like to request:
-the Covid-19 vaccine analysis print for batch number AB0002 made by AstraZeneca (of the kind given in response to FOI 2024/00400).
-a breakdown of the top 50 AstraZeneca COVID-19 vaccine batches by number of ADR reports (and if possible, also showing the number of fatal reports) up to and including 25/08/2026.
-I would also like to know why the total number of reports for AB0002 was reduced from 3,182 (as per FOI 23/143 answered on 20 March 2023) to 2,857 (as per FOI 2025/00445 answered on 3 June 2025).
Published: 13 October 2026
-
Dear MHRA FOI Team, Thank you for your response to FOI2026/00830 and for your section 16 advice. I submit this as a new, refined request. It is limited to the three questions your response identified as likely capable of processing within the appropriate limit. Please provide the following recorded information: 1. The date on which MHRA received the final report of the developmental and reproductive toxicity study for Comirnaty, and the date of each interim DART dataset or report received before the final report. 2. For each of the following decisions, state the procedure under which the decision was made and the decision date: a. the Regulation 174 temporary authorisation of the Pfizer/BioNTech vaccine; b. the full marketing authorisation for Comirnaty; and c. the authorisation of Comirnaty for infants and children aged 6 months to 4 years. 3. Identify the role or post responsible for signing off an authorisation under the reliance route, and the criteria against which that decision is taken. I am not seeking a general email search, personal data, or all underlying documents at this stage. If any item is not held, please confirm that under section 1(1)(a).
Published: 13 October 2026
-
This is a refined request following your previous refusal under Section 12(2) (Ref: FOI2026/00765). Taking your Section 16 advice to narrow the scope, I have drastically reduced the timeframe. Under the FOI Act 2000, please provide the following strictly for the 6-month period between 1 January 2026 and 30 June 2026: 1. The total number of complaints received by the MHRA (via the Advertising and Borderlines departments) concerning the advertising, social media promotion, or marketing of private medical cannabis clinics or unlicensed cannabis-based medicinal products to the public. As this only requires querying the relevant inboxes or complaint-logging systems for a tight 6-month window, it should fall comfortably below the 24-working-hour cost limit.
Published: 13 October 2026
-
I would like to place a further request for assistance in relation to Annexe 24 of the EWG Report on HPT's, which refers to 235 Case Reports. The clinical detail of 28 of these 235 reports is presented in redacted form in 2 tables in Annexe 22. Could you please provide the clinical detail of the other 208 cases in similar redacted form.
Published: 13 October 2026
-
We would like to request information regarding the British Pharmacopoeia monograph for Ramipril tablets (strengths 1.25 mg, 2.5 mg, 5 mg and 10 mg). Specifically, we seek clarification on the scientific and regulatory basis used by the British Pharmacopoeia Commission to establish the impurity limits for Ramipril Impurity D + Impurity E (per strength), any other impurity, and total impurities (per strength) in the monograph. In this context, we would appreciate confirmation as to whether relevant international guidelines (e.g. ICH Q3A(R2), ICH Q3B(R2), ICH M7, EMA impurity guidance, including EMA/CHMP/4299/2026) were considered in setting these limits, and whether any toxicological evaluation formed part of the assessment. Furthermore, a summary of the approach used in establishing these limits, including any non-confidential information on the supporting data, scientific justification, or expert advisory group considerations involved in the decision-making process, would be highly appreciated. We understand that commercially confidential or proprietary data may be redacted and confirm that we are not requesting access to such information.
Published: 13 October 2026
-
I am writing as a member of the public with concerns regarding the regulatory status, clinical safety and post-market surveillance of Rapid Health Smart Triage, which is being deployed within NHS primary care. I understand that Smart Triage is software used to assess information supplied by patients and to determine or influence the urgency, routing and/or timeframe in which patients receive healthcare. I would be grateful if this correspondence could be forwarded to the MHRA team responsible for software as a medical device, medical-device compliance and post-market safety surveillance. I am not requesting confidential patient information or proprietary source code. I am seeking to understand the regulatory safeguards that apply to a system capable of influencing when patients receive clinical attention. 1. Medical-device registration Please confirm whether Rapid Health Smart Triage is currently registered with the MHRA as a medical device. If so, please provide or confirm: * the registered manufacturer; * device name; * MHRA registration/reference number; * stated intended purpose; * medical-device classification; * UKCA/CE status; and * date of registration. 2. Device classification Please explain which medical-device risk classification applies to Smart Triage and the regulatory basis for that classification. In particular, does its intended purpose encompass assessing symptoms and determining or recommending the urgency, routing or timeframe for medical attention? If so, I would be grateful for clarification as to how that functionality was taken into account when determining the appropriate device classification. 3. Nature of the technology Rapid Health and NHS material have described Smart Triage using terms including AI and automated/autonomous triage. Please advise what information the MHRA holds concerning whether Smart Triage uses: * artificial intelligence; * machine learning; * a large language model; * generative AI; * deterministic/rules-based clinical decision logic; or * another form of automated clinical decision-making. If the device is predominantly rules-based rather than machine-learning based, please explain whether this affects its regulatory classification or the clinical evidence required. 4. Clinical evidence What clinical evidence is required for software of this type to demonstrate that it performs its intended purpose safely? In the case of Smart Triage specifically, does the MHRA hold or has it reviewed evidence concerning: * sensitivity for urgent and emergency presentations; * false-negative rates; * under-triage rates; * over-triage rates; * red-flag detection; * comparison with assessment by qualified clinicians; and * performance in children, elderly patients and other vulnerable groups? If such evidence is held and can be disclosed, please identify or provide it. If the MHRA does not itself review this evidence before registration of a device of this classification, I would be grateful if you could explain this clearly and identify who is responsible for assessing it. 5. Clinical evaluation Is Rapid Health required to maintain a Clinical Evaluation Report or equivalent clinical evaluation for Smart Triage? If so, what type and level of clinical evidence is required to support the manufacturer's conclusion that the benefits of the system outweigh its clinical risks? Does the MHRA independently review that Clinical Evaluation Report? 6. Under-triage as a device safety risk I am particularly concerned about the possibility of under-triage. If software determines that a patient does not require urgent medical attention, but the patient subsequently proves to have a serious or time-critical condition, would this potentially constitute a medical-device adverse incident or near miss reportable to the MHRA? Similarly, would a failure by the software to recognise a clinically significant red flag potentially constitute a reportable medical-device incident? 7. Adverse incidents involving Smart Triage Has the MHRA received Yellow Card reports, manufacturer vigilance reports or other reports concerning Rapid Health Smart Triage? In particular, have reports concerned: * under-triage; * delayed medical attention; * incorrect urgency assessment; * failure to recognise red-flag symptoms; * incorrect routing; * emergency hospital treatment following a lower-urgency triage outcome; * serious patient harm; or * death? I appreciate that information about individual patients cannot be disclosed. However, I would be grateful if the MHRA could provide aggregate numbers and categories of reports concerning this product where legally possible. 8. Manufacturer's reporting obligations Please explain Rapid Health's obligations to report adverse incidents and safety signals concerning Smart Triage to the MHRA. In particular: * What types of under-triage incidents must be reported? * What are the applicable reporting timescales? * Is Rapid Health required to monitor trends in less serious incidents or near misses? * Is the manufacturer required to notify the MHRA when clinical decision rules are changed in response to safety incidents? 9. Post-market surveillance What post-market surveillance is required for Smart Triage? Is Rapid Health required to monitor the real-world performance of its triage system after deployment? Does that surveillance specifically need to measure or identify: * under-triage; * false negatives; * red-flag failures; * differences between automated triage and subsequent clinician assessment; and * differences in performance between patient groups? 10. Changes to clinical decision rules If Rapid Health changes the clinical rules determining urgency or patient routing, what regulatory process applies? At what point would a change to those rules constitute a significant modification requiring further clinical evaluation, regulatory assessment or notification to the MHRA? 11. Patients and Yellow Card reporting Please confirm whether a patient or member of the public can submit a Yellow Card medical-device report where they believe Smart Triage: * incorrectly assessed their urgency; * delayed access to appropriate medical care; * failed to identify serious symptoms; or * otherwise affected their diagnosis or treatment. If so, I would be grateful if you could confirm the appropriate reporting route. 12. Regulatory responsibility Finally, I would appreciate clarification of an important point of accountability. When medical-device software autonomously determines or influences the urgency with which an NHS patient receives medical attention, which organisation is responsible for demonstrating that the algorithm or clinical decision rules are sufficiently safe for that intended purpose? In the case of Smart Triage, is that determination made by: * Rapid Health as manufacturer; * the MHRA; * an Approved Body; * NHS England; * the NHS organisation deploying the software; or * some combination of these organisations? I would be particularly grateful if you could explain which organisation has actually examined the clinical performance evidence demonstrating that Smart Triage can safely distinguish patients who can wait from those requiring urgent medical attention. 13. Regulatory review Given the increasingly widespread deployment of automated triage systems within NHS primary care, has the MHRA undertaken, or does it intend to undertake, any specific review of the clinical safety of Rapid Health Smart Triage or comparable automated triage systems? If concerns about a particular deployment or patient experience should instead be submitted through the Yellow Card scheme, please advise accordingly. Thank you for considering these questions. My purpose in contacting the MHRA is to understand the regulatory chain by which software capable of influencing the urgency of NHS patient care is demonstrated to be safe, and how possible failures are detected and investigated once that software is in widespread clinical use. I would be grateful for a substantive response or for this correspondence to be forwarded to the appropriate medical-device safety and compliance team.
Published: 13 October 2026
-
I am making this request under the Freedom of Information Act 2000. I am seeking recorded information about MHRA's duty, track record and statutory powers concerning counterfeit and unlicensed medicines generally, and the unlawful substitution of licensed prescription medicines with non-MA products. 1. MHRA's duty to protect patients from counterfeit and unlicensed medicines The Novo Nordisk case shows a single manufacturer having to secure, through its own civil litigation, protection that patients might reasonably expect their medicines regulator to provide. Please provide recorded information setting out MHRA's statutory duty, objectives or public task in relation to protecting patients from counterfeit and unlicensed medicines generally — not limited to any single manufacturer's products — including the relevant legislative basis (e.g. under the Human Medicines Regulations 2012) and any published statement of MHRA's role in this area. 2. MHRA's own enforcement efforts and why they have had limited success The judgment in Novo Nordisk A/S & Anor v British Telecommunications Plc & Ors [2026] EWHC 1094 (Ch) records that “the MHRA's own efforts at closing down infringing websites have met with limited success”. Please provide any recorded information explaining what those efforts consisted of, why they have had limited success, and any internal review, assessment or lessons-learned exercise concerning this. 3. MHRA's response to the Novo Nordisk precedent for counterfeit medicines generally Please provide any recorded information — including business cases, internal assessments, correspondence, minutes or strategy documents — concerning whether MHRA intends to pursue, seek or support a court-ordered website-blocking mechanism covering counterfeit and unlicensed medicines generally, rather than leaving this protection to depend on individual manufacturers bringing their own litigation product by product. 4. MHRA's statutory powers against counterfeits and unlawful substitution The Novo Nordisk order demonstrates that website-blocking against counterfeit and unlicensed medicines is achievable through the courts. Please provide recorded information setting out what statutory powers MHRA itself holds — as opposed to relying on individual manufacturers' civil litigation — to prevent, disrupt or take enforcement action against: (a) the sale and supply of counterfeit or falsified medicines; and (b) the sale, supply, prescribing or dispensing of health/food supplements and other products without a UK marketing authorisation where they are used in place of, or presented as equivalent to, licensed prescription-only medicines. 5. Enforcement track record, 2021–2025 Against the background of the Novo Nordisk judgment's finding that “the MHRA's own efforts at closing down infringing websites have met with limited success”, for each calendar year 2021–2025, where recorded, please provide the number of enforcement actions taken by MHRA against: (a) websites or sellers of counterfeit or falsified medicines; and (b) suppliers or sellers of non-MA products used as substitutes for licensed prescription medicines — together with the nature of the action taken (e.g. website takedown request, seizure, prosecution, warning) and the outcome, where recorded. 6. Cross-agency work and future plans Following the Novo Nordisk judgment and the limitations of MHRA's own efforts that it identified, please provide any recorded information about work planned or under way, in conjunction with other bodies (e.g. GPhC, NHSBSA, police, Trading Standards, ISPs), to address counterfeit medicines and the unlawful substitution of licensed medicines with non-MA products during 2026–2030. 7. Chain of accountability — MHRA, ISPs and patient harm Where a patient is harmed by a counterfeit or unlicensed medicine bought online, accountability arguably extends along a chain: MHRA's own statutory duty and powers to prevent access to the product; the ISP or hosting provider that supplies the platform enabling the sale, and which derives commercial benefit (e.g. hosting fees, advertising revenue) from doing so; and the counterfeiter itself. Please provide any recorded information setting out MHRA's own assessment or policy position on how responsibility is distributed across this chain, including whether MHRA considers ISPs and hosting providers to bear any statutory or regulatory responsibility for illegal medicine sales conducted through their platforms, and whether MHRA has ever sought — through litigation, regulatory referral or otherwise — to hold an ISP or hosting provider to account for hosting such sales. I am seeking recorded information rather than asking MHRA to create new information or provide an opinion. Where the precise information requested is not held, please provide the closest equivalent information held. Where information is withheld, please identify the relevant FOIA exemption and provide the remainder where reasonably practicable. If any part of this request would exceed the appropriate cost limit, please identify the relevant part and provide the information that can be supplied within the limit so that I may refine the request.
Published: 13 October 2026
-
Please provide a copy of the Letter of No Objection issued by MHRA for batch EJ0553 (the Agency’s retained copy), redacted only for personal data. If you do not hold a retained copy, please confirm that as a formal “information not held” statement. If the letter is held but you consider it exempt, please identify the specific exemption and, where applicable, how the public-interest test has been applied. Please provide the information in electronic format where possible.
Published: 13 October 2026
-
Under the Freedom of Information Act 2000 I would like to request the following information held by Medicines and Healthcare products Regulatory Agency. 1. Total spend in the last complete financial year on interim, agency or contract staff working in project management, programme management, PMO, business change or ICT infrastructure roles broken down by supplier or agency where that is held. 2. The number of such interim or contract workers engaged at the date of this request, by role type. 3. The name of any framework, agency agreement or managed service provider through which those workers are engaged. If the request would exceed the appropriate cost limit, please answer part 1 alone. I would prefer to receive the response by email.
Published: 13 October 2026
