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I am writing to request information under the Freedom of Information Act regarding melatonin immediate‑release tablets that are licensed in the UK Specifically, I would like to request: A list of all melatonin immediate‑release tablet products that currently hold a valid UK Marketing Authorisation (MA) Please include, where available: * Product name * Strength * Pharmaceutical form * Packsize * MA number * Marketing Authorisation Holder (MAH) * Manufacturer * Indication * License status : Active & Commercialised OR Active & not Commercialised OR Withdrawn OR SUNSET DATE - Active & Non Commercialised [X]
Published: 11 May 2026
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Please provide all recorded information held by the MHRA relating to the development, consideration, or adoption of guidelines similar to the US FDA's January 2026 draft guidance titled "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products" (issued by CDER/CBER). This includes, but is not limited to: Any internal plans, reports, correspondence, meeting minutes, or assessments concerning the use of Bayesian statistical methods (e.g., informative priors, posterior probabilities of efficacy, adaptive designs, borrowing of historical/real-world data) in UK clinical trials for drugs and biological products. How such methods are being evaluated in the context of the 2026 updates to the UK Clinical Trials Regulations, MHRA guidance on adaptive designs/in-silico modelling, or the government's "Replacing animals in science" strategy (November 2025), including MHRA's planned involvement in the International Medicines Regulator's Working Group on 3Rs. Any timelines, milestones, or progress updates on developing MHRA-specific guidance or aligning with FDA/EMA approaches. Any correspondence with DSIT, Home Office, EMA, FDA, or other bodies on this topic since 1 January 2026 (or earlier if linked to clinical trial modernisation or alternative methods).
Published: 11 May 2026
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Could the following information be provided? Copies of the last two MHRA WDA(H) inspections of Cantourage UK Limited relating to the two sites below which are listed on WDA(H) 54893? This should include all the observations and all communications up to and including responses and the ultimate closure of each inspection. If there was any further communication following the closure—such as updates or amendments to the CAPAs —copies of these documents should also be included. • Unit 6, 13 Ramsgate Street, London, E8 2FD, United Kingdom • First Floor, Rear Building of 238-240 Bethnal Green Road, London, E2 0AA, United Kingdom Additionally, please also provide a copy of the full current WDA(H) certificate for Cantourage UK Limited.
Published: 11 May 2026
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We are writing to request copies of Module 2.4 (Nonclinical Overview), Module 2.5 (Clinical Overview), and Module 5 (Clinical Study Reports) for Sertraline 50 mg and 100 mg film-coated tablets (PL 20416/0214-0215), which are currently held by Crescent Pharma Limited. The licence was transferred following a change of ownership from Rx Pharma (previous Licence No. PL 18869/0022). Upon review of our records, we note that we do not hold these documents as approved by the MHRA. To ensure our records remain complete and compliant with the approved dossier, we kindly request copies of the authorised Module 2.4, Module 2.5, and Module 5 (Clinical Study Reports) for this product.
Published: 11 May 2026
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This is an indirect FOI request, done on behalf of the Swedish Medical Products Agency, MPA. I am in no way impersonating an official at the Agency, and this private initiative should only be construed as an effort to help the MPA to finally get the missing information in this important matter. In the year 2011 Sweden, as Co-rapporteur regarding the approval av Prozac/Fontex for children, should have received the Non-Clinical Assessment Report of Prozac from the MHRA, so that the MPA could give its comments to it before finalization. The MPA never got this AR, from September 2011, and did not then get the opportunity to comment on it. The MPA has informed me that now, 15 years later, they got the attached redacted version of the report. And we come to this: I now request that the MHRA releases the unredacted AR to the MPA (the report that should have arrived 15 years ago). Even if the MPA doesn't have a chance to now give its comments and fulfil its obligations as Co-rapporteur, the Agency finally will gain access to the original unredacted report. I would appreciate a confirmation that the report has been sent to the MPA.
Published: 11 May 2026
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I am writing to request information under the Freedom of Information Act 2000. Please provide: Details of any applications received by the MHRA to reclassify hydroxocobalamin or cyanocobalamin injection ampoules from prescription-only medicine (POM) to pharmacy (P) status, including the date received, the applicant, and the outcome. If no such applications have been received, please confirm this in writing. Any horizon-scanning reviews, internal papers, or correspondence in which the MHRA has considered whether the current POM classification of injectable B12 remains appropriate, from January 2010 to the present date.
Published: 11 May 2026
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I am writing to request information under the Freedom of Information Act 2000. Cyanocobalamin and hydroxocobalamin injection ampoules are available for purchase without a prescription in several EU member states, including France and Germany. In the United Kingdom, these products are classified as prescription-only medicines (POM). Please provide: The date on which hydroxocobalamin and/or cyanocobalamin injection ampoules were classified as prescription-only medicines in the UK, and the regulatory instrument or process by which this classification was established. Any internal assessments, advice, or correspondence held by the MHRA that informed or supported the decision to classify these products as prescription-only rather than pharmacy (P) or general sale medicines. Any communications between the MHRA and the Department of Health and Social Care, NHS England, or NICE regarding the prescription-only classification of injectable B12 products, from January 2000 to the present date.
Published: 11 May 2026
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Last year the agency was kind enough to share a list of all UK marketing authorisations with the following meta data; [cid:c08837b2-a88d-4175-b666-87a7fb9f5a75] Is it possible to receive a similar updated list please?
Published: 11 May 2026
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I’m writing this email to submit a Freedom of Information (FOI) request for “Ocrevus of PBRER body (the latest one)” Requesting document is listed below and please let me know if you need additional information Ocrevus ▶ PBRER body (the latest one)
Published: 11 May 2026
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I am writing to request information under the Freedom of Information Act 2000. Injectable hydroxocobalamin and cyanocobalamin products formulated for veterinary use are available in the United Kingdom without a prescription, including via online veterinary pharmacies and agricultural suppliers. Injectable hydroxocobalamin formulated for human use is classified as a prescription-only medicine (POM). Please provide: Any internal assessments, advice, or correspondence held by the MHRA that addresses the differential regulatory treatment of injectable B12 products for human versus veterinary use, including any consideration of whether this differential creates a patient safety risk through off-label sourcing of veterinary products by human patients. Any evidence that the MHRA is aware of patients sourcing veterinary injectable B12 products for self-administration, and any action taken or considered in response. Any communications between the MHRA and the Veterinary Medicines Directorate (VMD) regarding the classification of injectable B12 products and the implications of the difference in human and veterinary regulatory status.
Published: 11 May 2026
