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Under the Freedom of Information Act 2000, I request the following information relating to Powered ECHELON PVS staplers at Blackpool Teaching Hospitals NHS Foundation Trust. 1. Please provide details of all incidents recorded by the Trust involving Powered ECHELON PVS staplers during the last five years. 2. Please provide details of all incidents recorded by the Trust involving Powered ECHELON PVS staplers between 15 December 2023 and 31 January 2024. 3. Please provide any anonymised supporting information held in relation to these incidents, where this can be disclosed under the Freedom of Information Act 2000.
Published: 9 September 2026
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Published: 9 September 2026
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OPD Laboratories Limited has decided to maintain the following Product Licence of Parallel Import (PLPI) as an active licence, despite the corresponding UK reference marketing authorisation having been cancelled: * PLPI 15814/2087 - SEVIKAR(r) 20 mg/5 mg film-coated tablets OPD Laboratories Limited will continue to fulfil all pharmacovigilance obligations for this PLPI in accordance with the current UK pharmacovigilance requirements and intends to continue marketing the product in the UK. We would be grateful if you could provide a copy of the Risk Management Plan (RMP) and/or details of any additional risk minimisation measures that were applicable to the cancelled UK reference marketing authorisation PL 08265/0026, for our reference and to support our ongoing pharmacovigilance activities.
Published: 9 September 2026
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Many thanks for your response, dated 1 July, to my FOI request. I note that you have identified some information falling within my request, but are not able to comply with the request because to do so would exceed the appropriate limit of costs set out in the FOI Act. I make the following additional points and requests in response to your letter. Any documents provided to, generated by or held by MHRA in relation to the assessment of Aumseqa that refer to AstraZeneca and/or Tagrisso (osimertinib) You have said that “Initial searches (including words such as “AstraZeneca” and “Osimertinib, Aumseqa”) have revealed that over 10,000 documents are likely to respond to initial searches”. I appreciate that this is a large number of documents that refer to AstraZeneca during the assessment of Aumseqa. Having reviewed the details in your letter, I set out the following parameters for the request: • Time period: date of application (3 June 2022) to date of authorisation (3 June 2025) of Aumseqa • Search terms: I propose the following search terms, to be combined - “osimertinib” AND (“aumolertinib” OR "almonertinib" OR "HS*10296" OR “EQ143” OR “Aumseqa”) (i.e. documents that include both osimertinib and one of the other terms within the same document) • Example documents: Given these parameters, I would expect at least the following documents to be included in the results, and suggest these documents are first considered by the MHRA: o Lists of Questions or List of Outstanding Issues from the MHRA to the applicant during the assessment of aumolertinib and the Responses to Questions from the applicant o Documents explaining the assessment by MHRA that aumolertinib is a new active substance, as noted in section IV.1 of the PAR. o Any request for scientific advice by the applicant in relation to the development and authorisation of Aumseqa, and the MHRA’s response to any such requests, such as the advice sought on 1 September 2022. Any requests, decisions or correspondence in relation to the timing of, or delay to, the publication of the Aumseqa public assessment report I appreciate the information you have set out about the preparation of the PAR. Having reviewed the details in your letter, I request the following documents: • Initial / first draft PAR provided to MAH as sent on 1 July 2025 • Correspondence with MAH that the assessment reports were particularly lengthy, and the review cycle is expected to be quite involved, provide shortly after 1 July 2025 • Further guidance provided to MAH on 15 July 2025 • MAH’s proposals received 22 July 2025 • Updated PAR draft received from MAH on 22 August 2025 • Updated PAR draft provided to MAH 19 Nov 2025 • Further comments on PAR received 12 December 2025 • Any documents showing input from statistics in Jan 2026 If, despite these restrictions and parameters, this request is still over the appropriate limit, we are happy to pay reasonable costs associated with this search.
Published: 9 September 2026
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Following the recent MHRA communication regarding PLPI licences, we understand that a Risk Management Plan (RMP) is available for Levocarnitine Paediatric 30% Oral Solution (PL 48053/0005), as referenced in the attached document, "List of Cancelled UK MAs Cross-Referenced to a PLPI Licence & RMP - July 2026 v2." As the holder of the corresponding PLPI licence, OPD Laboratories Limited would be grateful if you could provide a copy of the RMP for PL 48053/0005 - Levocarnitine Paediatric 30% Oral Solution for our reference and to support our ongoing pharmacovigilance activities.
Published: 9 September 2026
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Based on the information provided in FOI2025/0103 and FOI2026/00662, we understand that Rosemont product PL00427/0222 was approved through a Marketing Authorisation (MA) transfer from Broflex Syrup, held by Bioglan Laboratories Limited (PL 00041/0029). We also understand that Broflex Syrup held by Bioglan Laboratories Limited (PL 00041/0029) was approved as a "piggyback" abridged simple application, using Broflex Syrup held by Bio-Medical Services Limited, York (PL 04532/0001) as the reference product. We would appreciate clarification on the regulatory status of Broflex Syrup held by Bio-Medical Services Limited, York (PL 04532/0001). Specifically: 1. Was this product authorised as the original (innovator) product supported by a full dossier, including complete quality, non-clinical, and clinical data? 2. If not, was it itself authorised by reference to another medicinal product? 3. If it was authorised by reference to another product, please provide details of the original authorised product for Trihexyphenidyl Syrup 5 mg/5 mL (First approved product for Trihexyphenidyl Syrup). 4. Please also provide the regulatory authorisation history between the original authorised Trihexyphenidyl Syrup 5 mg/5 mL product and Broflex Syrup held by Bio-Medical Services Limited, York (PL 04532/0001), including any relevant changes in ownership, licensing, or marketing authorisation transfers.
Published: 9 September 2026
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I have two requests that relate to each other that I am hoping you will be able to assist with. The information I am requesting is the following from the Architecture Repository 1. The Agency Value Chain at the top level. 1. The Agency Process Groups for the Compliance and Enforcement Activity group(s) 1. The Two Agency diagrams showing the process landscape, one showing the core processes and one showing the supporting processes. 1. The Agency Target Process for the Consolidated Inspections Process used as to show the Agency's direction with process modelling to the ISO 9001 auditor. This consists of a set of BPMN diagrams that show the processes made up of sub-processes and tasks. I need all the diagrams so that I can show a slice of the architecture through to task level. 1. The analysis of the user stories required to support each task in the consolidated inspection process. This is to show the value of end to end target processes in estimating effort. I am happy that any elements / objects referring to the confidential enforcement activities are redacted. I am writing a paper on the use of Value Chain's in the Public Sector and their relationship to Business Architecture. My understanding from internet search indicates that in 2017 the NAO stated that Value Chains were difficult to implement in the Public Sector. Having implemented a Value Chain and process architecture under it at the MHRA it would be good to have a worked case study example that I can use as a reference as to how they can be implemented and used. I am only planning to use a vertical slice from the value chain through to inspections process tasks at level 5 as worked top to bottom examples. I trust that as the Ministry of Defences Strategy Map was published in Kaplan and Norton's book strategy maps, p422, that it would be possible to publish an agreed slice through the architecture as described above under an Open Government Licence with appropriate Crown Copyright accreditation given. Kaplan & Norton's Balanced Scorecard Collaborative were my former employers so I am familiar with the MoD case study as published. Please advise if we can work to an agreed position and slice of the diagrams for publication.
Published: 9 September 2026
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Thank you for acknowledging my request under reference FOI2026/00804. I am writing promptly because the scope reproduced in your acknowledgement differs materially from the request I submitted. To avoid unnecessary searches and any risk of exceeding the cost limit, please treat the following as a clarification of the original request, not as a new or expanded request. The relevant date range is: 25 December 2020 to 10 January 2021 inclusive. I request only recorded information documenting the nature, scope, or form of the "MHRA agreement" referred to in the UK COVID-19 Technical Report, Chapter 9, in connection with the JCVI recommendation that the interval between doses of BNT162b2 could extend to 12 weeks. Specifically, I request: 1. Any formal agreement, memorandum, written confirmation, decision record, or meeting record provided by or recording the position of MHRA concerning the acceptability of a programme interval of up to 12 weeks for BNT162b2. 2. Any record explaining whether the wording "at least 21 days" in MHRA's updated advice and applicable product information was understood by MHRA as permitting a programme interval of up to 12 weeks, or whether it stated only a minimum interval without affirmatively endorsing that particular upper interval. For the avoidance of doubt: - I am not requesting general correspondence with Pfizer/BioNTech. - I am not requesting all communications concerning dose spacing. - I am not requesting a general search for legal opinions. - I am not asking about a Conditional Marketing Authorization unless a record within the narrow scope above specifically relies on one. - Duplicate records, routine administrative correspondence, and press-monitoring material remain excluded. Please confirm that the request will be processed using this clarified scope. If any further refinement would assist disclosure under section 16 of the Freedom of Information Act 2000, I would be happy to discuss it.
Published: 9 September 2026
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Further to FOI2026/00663, please treat this email as a new, narrowed FOI request. We request disclosure of the Final Clinical Study Report for CTA 18024-0212-001 relating to THCV, limited to: • final safety conclusions, • aggregate adverse event tables, • anonymised non-clinical or clinical safety summaries, • and any other severable non-confidential content. We are content for redactions to be applied where necessary and do not seek sponsor-identifying, confidential, or commercially sensitive material. If the full report cannot be disclosed, please provide any releasable portions of it.
Published: 9 September 2026
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Could you please advise, generic approvals received example Nifedipine 5mg capsules by Relonchem Ltd, I would like to request for FOI on this approval and information submitted in sections 2.4, 2.5, 2.6 and 2.7. I am happy to receive redacted information as per MHRA’s standard procedure.
Published: 9 September 2026
