Freedom of information (FOI) releases from MHRA

This is a disclosure log of Medicines and Healthcare products Regulatory Agency's responses to freedom of information (FOI) or environmental information regulations (EIR) requests that might be of wider public interest.

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1,857 disclosures

  1. Module 4 of the CTD for zapomeran (Kostaive) mRNA COVID-19 vaccine

    Dear Medicines and Healthcare Products Regulatory Agency, please provide me with the following parts of Module 4 of the CTD for zapomeran (Kostaive) mRNA COVID-19 vaccine which you recently approved: 4.1 Table of Contents 4.2 Study Reports (the actual results from nonclinical studies, including: Pharmacology, with special regard to the proposed mechanism of action. Pharmacokinetics (ADME - Absorption, Distribution, Metabolism, Excretion). Toxicology (acute, subchronic, chronic toxicity, genotoxicity, carcinogenicity, reproductive toxicity, etc.).

    Published: 5 May 2026

  2. Cobalt/Chrome/dual taper modular hip stems

    FOI REQUEST: Cobalt / Chrome / Dual-Taper Modular Hip Stems A. Adverse Event & Safety Reporting 1. Please provide the number of Yellow Card reports received by the MHRA relating to: • cobalt or chromium ion release • corrosion, fretting, or taper junction failure • modular neck or dual-taper hip stems broken down by year from 2010 to present. 2. Of these reports, how many: • involved revision surgery • involved systemic cobalt or chromium toxicity • involved local tissue reactions (ALTR / pseudotumours) 3. Please provide any trend analysis or internal summaries held by MHRA regarding increasing or decreasing reports related to modular hip stem designs. ⸻ B. Device Types & Design Risk 4. Does the MHRA classify dual-taper or modular neck hip stems as: • higher risk than monoblock stems? • equivalent risk? Please provide any internal guidance, assessments, or policy documents addressing this. 5. Has the MHRA issued any warnings, alerts, or internal safety concerns specifically regarding: • cobalt-chrome modular necks • mixed-metal taper junctions (e.g. Ti stem + CoCr neck) 6. Please provide copies of any MHRA safety notices, field safety notices, or internal advisories relating to modular hip stems that were not publicly issued. ⸻ C. Manufacturer & Regulatory Oversight 7. Please list all manufacturers for whom the MHRA has: • received adverse event data • conducted post-market surveillance relating to modular hip stems since 2010. 8. Has the MHRA ever: • requested design changes • imposed restrictions • required enhanced surveillance on any modular hip stem system due to cobalt/chromium concerns? If yes, please provide: • dates • manufacturers involved • nature of the action taken ⸻ D. Post-Market Surveillance & Evidence Base 9. What post-market surveillance data does the MHRA rely on to assess the long-term safety of modular hip stems? 10. Has the MHRA identified any evidence gaps relating to: • long-term ion release • taper corrosion • outcomes beyond 5–10 years 11. Please provide any risk–benefit analyses, internal reviews, or expert panel discussions held by the MHRA concerning modular hip stem designs. ⸻ E. Monitoring & Patient Safety Guidance 12. Has the MHRA issued or considered issuing guidance on: • routine cobalt/chromium blood testing • imaging surveillance (MRI / MARS MRI) for patients with modular hip stems? 13. If such guidance exists but is not public, please provide it. 14. If no such guidance exists, please confirm whether the MHRA considers: • systemic metal exposure • delayed corrosion failure to be a recognised patient safety risk. ⸻ F. Comparative Risk & International Context 15. Has the MHRA reviewed or considered: • international regulatory actions • recalls or restrictions in other jurisdictions relating to modular hip stems? 16. Please provide correspondence or reports where the MHRA: • compared UK outcomes to international data • discussed divergence from other regulators’ positions. ⸻ G. Internal Communications (High-Value Question) 17. Please provide copies of internal MHRA emails, memoranda, or briefing papers since 2010 that discuss: • cobalt/chromium risk • modular neck or dual-taper hip stems • corrosion or taper failure concerns (If redaction is required, please redact personal data only.)

    Published: 5 May 2026

  3. Request for Confirmation of Current Marketing Authorisation Holder – Merbentyl Syrup 10 mg

    We understand that Merbentyl Syrup 10 mg/5 ml was initially granted marketing authorisation to Aventis Pharma Limited under PL No. PL 04425/0047. Subsequently, the ownership of the product appears to have been transferred to Winthrop Pharmaceuticals UK Limited under PL No. PL 17780/0564. As Merbentyl Syrup 10 mg/5 ml is currently not available on the UK market, we kindly request your confirmation of the current Marketing Authorisation Holder (MAH) for this product, along with the corresponding PL number.

    Published: 5 May 2026

  4. Information Request: Pharmaceutical Records - Janssen Products UK Market

    I am writing to request information under applicable freedom of information and transparency legislation regarding records held by UK Medicines and Healthcare products Regulatory Agency (MHRA). SUBJECT OF REQUEST: This request concerns records related to: - Yasmine Janssen (née Janssen), Belgian citizen, daughter of Dr. Paul Adriaan Jan Janssen (1926-2003), founder of Janssen Pharmaceutica - Ludwig Criel, Belgian businessman with positions at CMB NV, Wah Kwong Group, and Gulf Navigation Holding PJSC - QRS N.V., the Janssen family holding company based in Belgium - Related corporate entities and business activities SPECIFIC INFORMATION REQUESTED: I am seeking access to any publicly available records related to marketing authorizations, pharmacovigilance records, inspection reports, including but not limited to: 1. Registration and licensing records 2. Regulatory filings and compliance documentation 3. Public disclosure documents 4. Corporate governance records 5. Any enforcement actions or investigations (public records only) 6. Historical records from 2000 to present LEGAL BASIS: This request is made under: - Applicable freedom of information legislation in UK - Public interest in corporate governance and regulatory compliance PURPOSE: This information is requested for legitimate research purposes related to corporate governance, regulatory compliance, and historical documentation. I understand that some records may be subject to exemptions or require fees. Please advise if any fees apply or if clarification is needed regarding this request.

    Published: 5 May 2026

  5. Surveillance Data Relating to Thyroid Dysfunction Post-COVID Vaccination

    Please provide the following under the Freedom of Information Act: 1. All internally-held epidemiological analyses (published or unpublished) relating to thyroid dysfunction following any COVID-19 vaccine. 2. All Yellow Card signal assessments conducted for: * hypothyroidism * thyroiditis * autoimmune thyroid disease * vaccine-induced endocrine dysfunction 1. 2. Internal risk assessments relating to endocrine adverse events. 3. Any correspondence between MHRA and DHSC discussing thyroid-related vaccine injury signals. 4. Copies of internal deliberations where MHRA decided not to list thyroid conditions as adverse reactions in SmPC documentation. 5. Any document that evaluates the adequacy of current post-marketing surveillance for endocrine disorders.

    Published: 5 May 2026

  6. pl 58775/002 docusate sioftgel capsules

    Please share the latest risk management plan pl 58775/002 docusate sioftgel capsules

    Published: 5 May 2026

  7. ED pills

    See attached

    Published: 5 May 2026

  8. Illegal Fat-Freezing Injections

    Under the Freedom of Information Act 2000, I am requesting information regarding the seizure of illegal fat-freezing products, including unlicensed injectables such as so-called "fat-dissolving" injections like Lemon Bottle. Specifically, please provide the following information: 1. The total number of illegal fat-freezing injectable products seized by the MHRA since 1 January 2020. Please include both individual units (e.g., pens, syringes) and larger consignments (e.g., factory raids). 2. The estimated value (£) of these seized products over the same period If available, please provide this information broken down by year (2020, 2021, 2022, 2023, 2024, 2025, and 2026 to date). If any of the above information is held but exempt from disclosure, please explain which exemptions apply and provide as much detail as possible.

    Published: 5 May 2026

  9. Freedom of Information (FOI) request for Cosentyx (secukinumab) to MHRA

    I’m writing this email to submit a Freedom of Information (FOI) request for the following documents for Cosentyx (secukinumab): Cosentyx ▶ PBRER body (the latest one)

    Published: 5 May 2026

  10. Vaxrevia vaccination - embolism, thrombosis and decreased platelet count

    Dear Medicines and Healthcare Products Regulatory Agency, would you please provide me with all reports in which there was one event (MedDRA PT) from the Embolism and thrombosis HGLT (Vascular disorders SOC) and the PT of thrombocytopenia (Blood and lymphatic system disorders SOC) OR the PT of platelet count decreased (investigations SOC) OR platelet count abnormal (Investigations SOC). To be clear this request relates to event reports following exposure to Covid-19 AstraZeneca Vaccine (AZD1222/ChAdOx1-S) Vaxrevia - during the period of its licensing (2021-2024).

    Published: 5 May 2026