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How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Pharmacovigilance system requirements
List of Field Safety Notices from 22 to 26 April 2024.
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 treatment has stopped. Healthcare professionals are...
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
How to apply for marketing authorisation via this new procedure.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
We are producing guidance and information for industry, healthcare professionals and patients covering the coronavirus (COVID-19) outbreak.
Advice on writing clear notices and maximising replies to your FSNs.
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
The review of the safety of isotretinoin has concluded.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
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