Information about how we handle potential corporate conflicts of interest (COI) between different parts of the Agency.
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Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture (DSI/2025/005)
An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem components.
Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34
Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contamination of the medicinal product.
Class 4 Medicines Defect Notification: Lexon UK Ltd, Moclobemide 150mg tablets, EL(25)A/50
Lexon UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification is missing important updated safety information.
Class 3 Medicines Recall: Tamoxifen 20mg Film-Coated Tablets, Wockhardt UK Ltd, EL(25)A/31
Wockhardt UK Limited is recalling a batch as a precautionary measure following the identification of a dissolution failure during stability testing.
Types of application for marketing authorisations (legal basis of applications)
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Chris Kessler: How access to innovative rare therapies can transform the lives of children like Charlie
A story of hope, medical innovation, and the impact of effective regulation on access to treatment.