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How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
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…
Healthcare professionals may have more responsibility to accurately prescribe an unlicensed medicine or an off-label medicine than when they prescribe a medicine within the terms of its licence.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Disabling, long-lasting or potentially irreversible adverse reactions affecting musculoskeletal and nervous systems have been reported very rarely with fluoroquinolone antibiotics. Fluoroquinolone treatment should be discont…
Decreased vitamin B12 levels, or vitamin B12 deficiency, is now considered to be a common side effect in patients on metformin treatment, especially in those receiving a higher dose or longer treatment duration and in those …
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 May 2024) launched a four-week consultation which will support improved safety for certain high risk in vitro diagnostic (IVD) devices.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'
You must get permission to export certain drugs and medicines.
A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD).
Healthcare professionals prescribing nitrofurantoin should be alert to the risks of pulmonary and hepatic adverse drug reactions and advise patients to be vigilant for the signs and symptoms in need of further investigation.
Department of Health and Social Care and MHRA register of licensed wholesale distribution sites (human and veterinary).
Marketing authorisations (MAs) granted since January 2014.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
There have been a small number of reports of serious and life-threatening anticholinergic side effects associated with hyoscine hydrobromide patches, particularly when used outside the licence. Healthcare professionals, pati…
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Advice for healthcare professionals on the reclassification of codeine linctus to a prescription-only medicine (POM), following a public consultation.
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