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How the MHRA makes decisions on what is a medicinal product (borderline products).
Healthcare professionals prescribing aripiprazole are reminded to be alert to the risk of addictive gambling and other impulse control disorders. Healthcare professionals should advise patients, their families and friends to…
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 vitami…
Implementing the Artificial Intelligence (AI) White Paper principles.
Check what side effects people have reported when they've taken a medicine.
Detailed recommendations for dose restrictions when used with some other drugs as interactions may increase the risk of adverse effects, or reduce the effectiveness of statin treatment.
How to change the ownership from one marketing authorisation (MA) holder to another.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
The Medicines and Healthcare Products Regulatory Agency (MHRA) website is now on GOV.UK.
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
Warnings about the risk of severe and fatal burns are being extended to all paraffin-based emollients regardless of paraffin concentration. Data suggest there is also a risk for paraffin-free emollients. Advise patients who …
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 May 2024) launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD).
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
No one should stop taking valproate without advice from their healthcare professional
Information and guidance on a range of medical devices for users and patients.
We inform healthcare professionals of the recent campaign to promote awareness of the risk and new resources available to support safe use following previous advice to health and care professionals.
A report covering adverse reactions to approved COVID-19 vaccines
Information about the EU Regulations and their implementation in Northern Ireland
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
This guidance summarises our approach to pharmacovigilance
Don’t include personal or financial information like your National Insurance number or credit card details.
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