Decision: Human medicines: register of electronic export certificates
Department of Health and Social Care and MHRA register of electronic export certificates (human).
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Aurum pre-filled syringes phased introduction of new 10ml CONNECT syringe barrel: Importance of selecting compatible needle-free connectors to minimise the risk of syringe blockage (DSI/2025/02)
Due to a phased introduction of the new 10ml CONNECT barrel design for the Aurum pre-filled syringes, the range of compatible needle free connectors (NFCs) differs between the established syringe barrel and the new syringe barrel. It is vital that healthcare professionals use compatible NFCs with Aurum pre-filled syringes to prevent delays to delivery of emergency medication.
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Class 4 Medicines Defect Notification: Erythromycin Stearate BP 250mg Tablets, Amdipharm UK Ltd, EL(25)A/32
Amdipharm UK Ltd has informed MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in this notification includes a superseded PIL.
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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.
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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.
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Class 3 Medicines Recall: Omeprazole 20 mg/15 ml Oral Solution, Glenmark Pharmaceuticals Europe Ltd, EL(25)A/30
Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration of the product in the bottles.
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AI Airlock, CERSIs and a new global AI network for health regulators
Med Tech Regs blog, June 2025: A focus on Software and AI.
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Research: Review of risk minimisation for disabling and potentially long-lasting/irreversible side effects associated with fluoroquinolone antibiotics
Public Assessment Report on the review of risk minimisation for fluoroquinolone antibiotics.
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If you take a GLP-1 medicine and have been hospitalised by acute pancreatitis, the Yellow Card Biobank wants to hear from you
GLP-1 medicines are licensed for Type 2 diabetes and weight management, and include the branded products Ozempic, Mounjaro and Wegovy
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MHRA seizes 7.7 million doses of illegal medicines and removes hundreds of illegal online listings as part of Operation Pangea
Operation Pangea brings together health regulators, customs authorities, law enforcement agencies, and private sector partners to tackle the threat posed by global criminal networks
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Class 2 Medicines Recall: Depo-Medrone 80 mg in 2 mL, Maxearn Limited EL(25)A/29
A batch of Depo-Medrone has been released to the market with an error. The vial over label incorrectly states that the total vial content is 40 mg in 1 mL, when the correct total vial content is 80mg in 2 mL (with a concentration of 40mg/ml of methylprednisolone acetate).
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Form: Medicines: variation forms for a manufacturer’s licence
Forms to make a variation to a manufacturer’s licence.