These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
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Field Safety Notices: 15 to 19 September 2025
List of Field Safety Notices from 15 to 19 September 2025.
MHRA Safety Roundup: October 2025
Summary of the latest safety advice for medicines and medical device users
First major overhaul of medical device regulation comes into force across Great Britain
New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market.
Increased risks identified with Profemur cobalt chrome modular neck hip replacements
Patients implanted with affected devices should expect to be contacted directly for a follow-up assessment, if required.
Class 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, EL(25)A/52
Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.
Class 3 Medicines Recall: Kimmtrak 200 micrograms/mL concentrate for solution for infusion, Immunocore Limited, EL(25)A/28
Immunocore Limited is recalling the batches listed below as a precautionary measure. The recall is due to a decrease in potency identified during stability testing. All other stability test results remain within specification.