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Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
General advice on vigilance - electronic cigarettes devices and refill containers.
Information for manufacturers of Software as a Medical Device, detailing events that may cause indirect harm and are therefore reportable.
Falsified, potentially harmful Ozempic▼ and Saxenda products have been found in the UK.
Healthcare professionals should be vigilant for suspected adverse reactions and safety concerns associated with e-cigarettes and e-liquids, commonly known as vapes. Please report adverse reactions to the Yellow Card scheme and promote vigilance among patients.
Comply with good pharmacovigilance practice and prepare for an inspection.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Ministry of Defence Police (MDP) expand use of Project Servator and train more people to spot and report suspicious activity.
The third report from the country’s largest study on coronavirus rates of infection has been published today showing that cases are increasing steadily across the country.
The MHRA has developed, and now has in place, a four-stranded approach to vigilance, which is summarised in this report.
The medicines used to treat vitamin B12 deficiency (hydroxocobalamin, cyanocobalamin) contain cobalt. There are case reports in the literature describing cobalt sensitivity-type reactions in patients being treated for vitamin B12 deficiency.
Submissions related to human medicines need to be submitted directly to the MHRA.
Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products
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