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We request agency to provide Public Assessment Report for below product. Product Name: Acetylcysteine 200mg/ml Injection. MAH: Aurum Pharmaceuticals Ltd MA No: PL 12064/0026
Published: 11 June 2026
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Good day, Based on the MHRA Inspections Listing we received, we kindly request that you please provide the inspection reports for the following: DR REDDY'S LABORATORIES (UK) LIMITED, located at 410 CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, CB4 0PE, UNITED KINGDOM, Inspection End Date: January 8, 2026, INSP GDP 8553/19889136-0008. PHIL INTER PHARMA COMPANY LIMITED, located at NUMBER. 20, HUU NGHI BOULEVARD, VIETNAM-SINGAPORE INDUSTRIAL PARK (VSIP) BINH HOA WARD, HO CHI MINH CITY, CITY VN-590000, VIET NAM, Inspection End Date: November 21, 2025, INSP GMP 46387/14673770-0004. AMANAH PHARMACEUTICALS LIMITED, located at UNIT 13, FIRST QUARTER, LONGMEAD BUSINESS PARK, BLENHEIM ROAD, EPSOM, KT19 9QN, UNITED KINGDOM, Inspection End Date: October 28, 2025, INSP GDP 61385/37432789-0001. NORDIC PHARMA LIMITED, located at BUILDING 1410, ARLINGTON BUSINESS PARK, THEALE, READING, RG7 4SA, UNITED KINGDOM, Inspection End Date: October 7, 2025, INSP GDP 5827/34897770-0002. RIA GENERICS LIMITED, located at 36 INGLEBY WAY, WALLINGTON, SM6 9LR, UNITED KINGDOM, Inspection End Date: September 24, 2025, INSP GMP/GDP 36282/8148588-0012. TILLOMED LABORATORIES LIMITED, located at 220 BUTTERFIELD, GREAT MARLINGS, LUTON, LU2 8DL, UNITED KINGDOM, Inspection End Date: September 10, 2025, INSP GMP/GDP 11311/16282866-0008. NORBROOK LABORATORIES LIMITED, located at 105 ARMAGH ROAD, NEWRY, BT35 6PU, UNITED KINGDOM, Inspection End Date: July 24, 2025, INSP GLP 2000/12919-0023. Kindly let us know if any questions arise from the processing of this request. Thank you!
Published: 11 June 2026
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After the COVID injection vaccine spike proteins enters cells modifying them to manufacture more spike proteins. Which cells do they enter? Are there now, or were there ever checks for COVID vaccine particles/spike proteins in donated blood? If not, bearing in mind spike protein production in the vaccinated lasts for years, possibly indefinitely, why not? Please list the viruses, bacteria, spike proteins, nucleotides and all undesirable elements that you test for before allowing blood to be transfused into patients. How do you remove these items to make the blood safe? (Do you have standard procedures, for example filter techniques or absorption?) How about specifically from immune cells and exosomes? How many people have received a transfusion after the vaccination program? Have people who received a transfusion after the vaccination program been tested for spike protein expression? If this is not being actively researched, why not?
Published: 11 June 2026
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In switching from originator to generic dapagliflozin, please can you tell me in which country Teva’s dapagliflozin tablets are manufactured as I have concerns over what has been in the press recently in connection with Indian pharmaceutical manufacturers. I understand you cannot disclose the specific site but can you at least tell me the country of manufacture and whether the site is approved. Is the facility approved by the MHRA?
Published: 11 June 2026
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I am writing to make a request under the Freedom of Information Act 2000. Please provide copies of any assessment reports, scientific evaluation reports, or other internal decision documents prepared by the MHRA in connection with the granting of the following UK marketing authorisations: • PLGB 41042/0088 • PLGB 41042/0089 In particular, I kindly request disclosure of any documents relating to: 1. The scientific or regulatory assessment undertaken by MHRA when granting these marketing authorisations, including any available assessment reports or summaries, whether full or abbreviated. 2. The assessment and approval of any extensions or variations to these marketing authorisations relating to the extension of therapeutic indications. 3. Any consideration given by MHRA, in connection with the above authorisations or subsequent indication extensions, to the applicability of an extension of the market protection period to eleven years under the Human Medicines Regulations 2012 (as amended). If any of the requested information is held in multiple documents, please provide all documents that fall within the scope of this request. If any information cannot be disclosed, I would be grateful if you could specify the relevant exemption under the Freedom of Information Act and provide any non‑confidential portions that can be released.
Published: 11 June 2026
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I am writing to make a request under the Freedom of Information Act 2000. Please provide a list of products SKUs with a single source on the market in the UK updated to Mar -2026 or Dec-2025. The current published list is dated 2024 For each such licence, please provide the following details in an editable Excel format: * NPC Code * Molecule Substance (Active Ingredient) * NPC description (Formulation Strength Formulation Strength Unit) Pack size * Estimated quantity packs total * Estimated Packs as per PCA data * NHS price per pack * MAH -Authorisation Holder Company Name * PL Number * Legal Category (POM, P, or GSL) * Current Licence Status: Using standard MHRA terminology (e.g., Active, Cancelled/Withdrawn, Expired, Lapsed, Suspended, or Under Reinstatement, under sunset). * Sunset Clause Status: Please indicate if the licence is currently within its three-year Sunset Clause period or if a public health exemption has been granted. *
Published: 11 June 2026
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I was just wondering if you were able to give me more information about the quantities of each medicine please? The figures in the FOI response are for individual doses of the medicines, but are these all pills, vials, or something different depending on the medicine? Are you able to let me know what each one is please?
Published: 11 June 2026
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I am writing to request information under the Freedom of Information Act 2000. Please provide a statistical summary of all Yellow Card reports (including suspected adverse drug reactions and, where applicable, medical device incident reports) relating to products within the BNF category “Emollient and Barrier Preparations” for the period 1 January 2021 to the date of this request. I would prefer this information to be provided in a machine-readable format (e.g. CSV or Excel). To support understanding of patterns and trends in patient-reported outcomes, I would be grateful if the data could be provided in an aggregated format (rather than case-level data) including the following, where available: * Product or brand name * Number of reports per product, broken down by year * Reaction term (using MedDRA terminology), with counts per term * Outcome/severity categories (e.g. fatal, life-threatening, hospitalisation, medically significant, non-serious), with counts * Reporter type (e.g. patient, general practitioner, specialist), with counts In addition, I would be particularly interested in reports indicating that a product may have been ineffective or associated with worsening of the underlying condition. If available, please include: * Counts of reports coded with terms such as “condition aggravated”, “drug ineffective”, “treatment failure”, or similar MedDRA terms indicating lack of efficacy or worsening symptoms Where recorded and extractable, I would also be grateful for: * Any available information on suspected active substances and/or excipients associated with reports (for example paraffin, sodium lauryl sulfate, or isopropyl myristate) If it is not possible to extract data by excipient, I would be content to receive the data by product name only.
Published: 11 June 2026
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I am writing to request information under the Freedom of Information Act 2000. Background In response to my earlier FOI request (FOI2026/00344), the MHRA confirmed that injectable hydroxocobalamin and cyanocobalamin are classified as prescription-only medicines (POM) under Regulation 62(3) of the Human Medicines Regulations 2012, on the basis that products intended for parenteral administration are unsuitable for reclassification due to the heightened risks and complexities associated with this route of administration, making medical supervision necessary. However, a number of injectable medicines are routinely self-administered by patients at home without direct medical supervision at the point of administration, following initial training. These include but are not limited to: Insulin Subcutaneous methotrexate Injectable fertility treatments (for example gonadotrophins) Biologic medicines for conditions including rheumatoid arthritis and Crohn's disease (for example adalimumab, etanercept) Growth hormone preparations requiring reconstitution from vials Several of these products require considerably greater technical skill to prepare and administer than a simple ampoule injection, yet home self-administration is standard clinical practice for them. This appears to create an inconsistency in the application of Regulation 62(3). The regulation as cited treats parenteral administration as a uniform category requiring medical supervision. Actual regulatory and clinical practice does not treat it as uniform. Please provide: Any internal guidance, policy documents, or assessments held by the MHRA that explain how Regulation 62(3) is applied differentially across injectable medicines, including the criteria used to determine when home self-administration is considered acceptable for a POM injectable product. Any internal assessments, advice, or correspondence held by the MHRA that specifically addresses the safety profile of injectable hydroxocobalamin in the context of home self-administration, including any assessment of its therapeutic index, known toxicity ceiling, or adverse event profile compared with other injectable medicines routinely self-administered at home. Any communications held by the MHRA between its licensing, classification, or policy teams regarding whether the current POM classification of injectable hydroxocobalamin remains proportionate given its established safety profile, from January 2010 to the present date. Any risk assessments or benefit-harm analyses conducted by the MHRA comparing the risks of maintaining the current POM classification of injectable B12 (including the risk of patients sourcing unregulated alternatives) against the risks of reclassification to pharmacy or supervised pharmacy status. The criteria the MHRA applies when determining that a parenteral medicine may be suitable for patient self-administration at home, and whether injectable hydroxocobalamin has ever been assessed against those criteria.
Published: 11 June 2026
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Hi, I would like to request the following information under the Freedom of Information Act. 1. How many times has the MHRA previously reassessed approved protocols since 1st January 2021? 2. With reference to your response to question 1, how many times has the MHRA reassessed approved protocols within 6 months of initial approval? 3. With reference to questions 1 and 2, how often was this on the basis of "representations" rather than new emerging scientific evidence? 4. With reference to this letter recently published here: https://assets.publishing.service.gov.uk/media/6998b06d047739fe61889efb/Sponsor-letter110226.pdf, could you clarify what is meant by the term "representations"? 5. With reference to the same letter, could you clarify which individuals or organisations made these representations?
Published: 11 June 2026
