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Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS.
Healthcare professionals reminded that tacrolimus may be associated with possible risk of malignancy.
This document provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
A list of herbal ingredients which are banned or restricted for unlicensed medicines.
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…
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
New safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnanc…
How the MHRA processes variations to Marketing Authorisations (MAs)
Medicines and Healthcare product Regulatory Agency official Parental Leave policy and procedures.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages. The article also includ…
If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and start treatment urgently (including antibiotics and surgical debridement). Fournier’s gangrene is a rare but potentially life-threatening infection that requi…
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