List of Field Safety Notices from 24 to 28 November 2025.
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MHRA Safety Roundup: November 2025
Summary of the latest safety advice for medicines and medical device users
Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion, EL(25)A/43
Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.
Fake Mounjaro (tirzepatide) KwikPen 15mg pre-filled pens
Fake medicines are illegally produced products that may contain incorrect ingredients, no active ingredients, or harmful substances.
Clinical trials for medicines: apply for authorisation in the UK
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Form: Blood bank compliance report template
Template for a blood bank compliance report and guidance on completing it.
MHRA publishes final Business Plan for 2023-2026 Corporate Plan
The new Business Plan sets out priorities for 2025–26: Protecting public safety and maintaining public trust; delivering efficient, predictable services through regulatory excellence; being an agile organisation that drives innovation; being a great place to work and providing excellent customer service.