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The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.
Fake, potentially harmful Ozempic and Saxenda pens have been found in the UK: you should only access these medicines via a medical prescription.
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines
Information about new applications, post-licensing, advertising, product information and fees.
List of Field Safety Notices from 12 to 16 February 2024
Following a review, the MHRA has updated previous guidance (DSI/2022/003) on the use of paclitaxel coated devices (PCD) in the treatment of peripheral arterial disease (PAD).
The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with pseudoephedrine.
Collection of information and guidance for patients and for healthcare professionals on the reproductive risks of valproate and new safety measures introduced to reduce these risks.
For the first time in the UK, obese patients and people who are overweight with weight-related health problems could now have access to Mounjaro, currently used for Type 2 diabetes, to help manage their weight and support we…
The MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate). This follows a comprehensive review of safety data, advic…
Exeltis UK Limited has informed the MHRA regarding an inconsistency in the Patient Information Leaflet (PIL) packaged in cartons of the specified batches of Gepretix 100mg capsules.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
Information about the risks of taking valproate medicines during pregnancy.
Report a problem ('adverse incident') with a medical device or medicine to MHRA using the Yellow Card Scheme
Marketing authorisations (MAs) granted since January 2014.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Healthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of disabling and potentially long-lasting or irrevers…
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