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List of Field Safety Notices from 22 to 26 April 2024.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
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.
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months af…
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.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
A list of authorised orphan medicinal products registered by the UK Licensing Authority.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure.
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