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Department of Health and Social Care and MHRA register of electronic export certificates (human).
List of Field Safety Notices from 22 to 26 April 2024.
The MHRA has today set out its strategic approach to artificial intelligence (AI)
Implementing the Artificial Intelligence (AI) White Paper principles.
Further measures to be introduced to ensure patients who are prescribed montelukast for the treatment of asthma are informed of the risk of neuropsychiatric reactions
The MHRA will introduce a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines
A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after trea…
Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hall…
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Public Assessment Report of review of Finasteride safety data and expert advice on management of risks.
How to contact MHRA for specific services or enquiries.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
List of Field Safety Notices from15 to 19 April 2024.
Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure.
The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
Information about suspected side effects of e-cigarettes and how to report side effects.
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