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Caution is required if prescribing febuxostat in patients with pre-existing major cardiovascular disease, particularly, in those with evidence of high urate crystal and tophi burden or those initiating urate-lowering therapy…
A personal trainer was sentenced today to 31 months in jail for selling and supplying unlicensed and prescription medicines, together with Anabolic steroids, to the public.
Advise patients taking hydrochlorothiazide-containing products of the cumulative, dose-dependent risk of non-melanoma skin cancer, particularly in long-term use, and the need to regularly check for (and report) any suspiciou…
How to make a payment to MHRA by credit or debit card or a bank transfer.
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
We inform healthcare professionals that the Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. This new guidanc…
The most important risk factors for uterine perforation are insertion during lactation and insertion in the 36 weeks after giving birth. Before inserting an IUS or IUD, inform women of the risk and the symptoms of perforatio…
The MHRA has today set out its strategic approach to artificial intelligence (AI)
MHRA conferences and events
People who take stimulant laxatives for constipation are being advised that these will now be sold in smaller packs, with on-pack warnings.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
Healthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of psychiatric reactions, including depression and ps…
To apply for a manufacturer licence, complete the appropriate form. Applications for a manufacturer licence will be payable on invoice.
Healthcare professionals prescribing dupilumab should be alert to the risks of ocular reactions. New onset or worsening ocular symptoms require prompt review. Referral for ophthalmological examination should be made as appro…
In autoimmune conditions and some cancer therapies, methotrexate should be taken once a week; however, we continue to receive reports of inadvertent overdose due to more frequent dosing (including daily administration). New …
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
Systematic reviews and meta-analyses of randomised controlled trials have highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors…
Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices
Parallel import (PLPI) licences granted since January 2014.
List of Field Safety Notices from 6 to 10 May 2024.
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