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I would be interested in your product database https://products.mhra.gov.uk/. As it is very difficult to download the information from the website, I was wondering if you collect it in another format such as Excel, this could be very useful (also the FDA does it). Specifically, I would need information from labels on where medicines are produced. For example, a table with BNF Presentation Name, year and manufacturing country.
Published: 4 December 2025
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Please note that we are in development phase for Nizatidine 150mg & 300mg Capsule and wish to file a National application in UK (UK wide). Our kind request to agency to provide clinical overview Nizatidine Capsule.
Published: 4 December 2025
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This is a request under the Freedom of Information Act 2000. Context (for search only): Patient adverse incident relating to Löwenstein prisma SMART max CPAP WM090TD supplied in GB; MHRA handling references CEC 233182 and Yellow Card 2025/005/018/501/003. Scope and timeframe * Timeframe: 1 January 2024 – present. * Device: Löwenstein prisma SMART max WM090TD (all GB configurations; include any UDI/Basic-UDI identifiers recorded by MHRA). * Records held by MHRA in any form (emails, letters, file notes, database entries, attachments, meeting minutes, slide decks, spreadsheets). Information requested (editable/redacted copies welcome) 1. Foam material / design-change communications * Correspondence with the manufacturer/sponsor/UK representative about sound-abatement foam used in WM090TD, including material family (polyester-PU / polyether-PU), placement in the breathing gas pathway, and any design-change notification. * A one-page extract/screenshot showing the effective date and/or production identifiers (lot/serial/UDI-PI) MHRA recorded or was notified of for the foam configuration change. 1. ISO 18562 / biocompatibility evidence reviewed by MHRA * Any test reports, summaries, or review notes MHRA received/reviewed regarding ISO 18562-2/-3 particulates/VOCs for WM090TD (or the representative device the manufacturer relied on), and any MHRA internal assessment notes of those reports. * If full reports were requested but not received, please supply the request(s), follow-ups, and responses indicating non-receipt. 1. Intake evidence and investigation artefacts provided to MHRA * Any time-stamped intake photographs, chain-of-custody logs, sample handling logs, analytical method files (e.g., FTIR/SEM-EDX/GC-MS summaries) or test-lab accreditation details supplied to MHRA by the manufacturer/sponsor for this case. * If MHRA does not hold these artefacts, please provide the MHRA request(s) for them (if made) and any responses declining. 1. Risk management & PMS/vigilance * Any risk assessments or risk-benefit evaluations MHRA received/reviewed from the manufacturer relating to foam degradation/particle emission in WM090TD (ISO 14971 context). * Post-market surveillance records held by MHRA for WM090TD: signal detection notes, case aggregation, assessment memos, and any decision records for “reportable vs non-reportable” classification of this incident. 1. UDI/Basic-UDI and device master data * The UDI-DI and Basic UDI-DI entries MHRA holds for WM090TD in GB and the effective-date metadata for the configuration that reflects the foam change. A database screenshot/export is sufficient. 1. IFU/label review * Any MHRA notes, emails, or assessments regarding IFU/label content for WM090TD as it relates to disclosure of gas-path foam materials/risks and any outcomes (e.g., requests to the sponsor, compliance checks). 1. Regulator liaison * Any communications with other regulators (e.g., TGA, FDA) about WM090TD foam composition/design change and/or vigilance signals, including any MHRA internal notes summarising those exchanges. 1. Case outcome records * The closing note/minute (one page) for MHRA’s internal entry on this case indicating the rationale for accepting the manufacturer’s conclusion and any conditions/follow-up (e.g., request for full reports outstanding). If information is not held / held elsewhere * If any category above is not held by MHRA, please provide a one-line confirmation of “not held” and, under s16 FOIA, indicate the public authority/body (e.g., Approved Body/Notified Body) most likely to hold it, if known. Format & narrowing * Electronic copies are preferred (PDF/CSV/screenshots). * I consent to redaction of personal data and commercial specifics that are not necessary to show what was provided/recorded and when. * If any elements engage s43(2) or other exemptions, please provide partial disclosure of non-sensitive fields (e.g., dates, identifiers, document titles, decision summaries) and a schedule of documents describing what is withheld and why. Public interest This request concerns patient safety and post-market surveillance for a life-supporting respiratory device. Narrow extracts showing what MHRA requested/received, what was recorded about foam configuration/effective dates, and what assessment took place serve the public interest and enable coherent cross-jurisdictional safety management.
Published: 4 December 2025
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The applicant would like to request for Public Assessment Report for PL17736/0084-Mebeverine 50mg/5ml Sugar Free Oral Suspension.
Published: 4 December 2025
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I am in the process of reviewing a GISP for IVC filters in our MRI department. I was wondering if there were any reported incidents related to IVC filters in the MHRA database? Any information you have would be greatly appreciated.
Published: 4 December 2025
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Please confirm whether anyone from Royal Preston Hospital made any referrals or reports to you in May or June 2024, regarding the following medical items: Stryker Anchor C Cage, self-drilling screws or an ACDF set. The information does not need to be in a specific format
Published: 4 December 2025
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Hello, Please can you inform me of the number of direct Yellow Card reports received, from 16th September 2022 to date, by the four groups of reporters below, but excluding suspected side-effects following COVID-19 vaccination. 1. Patients. 2. Doctors. 3. Nurses. 4. Pharmacists. I look forward to hearing from you and thank you for your help. I know that you have a 20 working day turnaround time from the date of receipt, but I would be most grateful for a reply by the first week of November 2025 (or earlier), please, thank you.
Published: 4 December 2025
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I am seeking information on the products Chloramphenicol 5 & 10 % w/v Ear Drops from Martindale Pharma (PL 00156/0050 & PL 00156/0051). Could you please confirm if these products have been approved with a full dossier application, so that they can be used as a reference medicinal product? In addition, is there any PAR that could be provided from MHRA's side for these products? If these are not the reference medicinal products, could please let us know which are considered as the reference products for Chloramphenicol Ear Drops in UK? Thank you very much in advance and best regards
Published: 4 December 2025
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Kindly clarify whether the product was withdrawn from the market by MHRA, or if it was voluntarily discontinued for marketing purposes. As per available information, ‘the marketing authorisation was withdrawn on 06 November 2019’.
Published: 4 December 2025
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We are writing to submit a Freedom of Information (FOI) request under the Freedom of Information Act 2000. We kindly request the following information: We attach the Smpc for the product Dulcoease 100mg capsules for reference. We would like to confirm the accuracy of the statement under Section 6.5 - Nature and Contents of container : Quote PVC/PVdC blister packs with aluminium foil containing 10, 20, 30, 40, 50 or 60 capsules. Polyethylene / polypropylene containers, e.g.: securitainers / tampertainers containing 30, 100 and 250 capsules. Not all pack sizes may be marketed. Unquote
Published: 4 December 2025
