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This guidance summarises our approach to pharmacovigilance
1. General Approach to the operation of pharmacovigilance The MHRA retains…
How to help patients and their families reduce the risks of harm from opioid medicines.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Supporting information to accompany the National Patient Safety Alert on patient hoists and slings NatPSA/2026/005/MHRA.
Patient factsheet providing information on pneumococcal disease and pneumococcal vaccination.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
An overview of the systems and processes DHSC and NHS England use for responding to medicine shortages.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Comply with good pharmacovigilance practice and prepare for an inspection.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages, making them more flammable.
How to write clear and effective field safety notices (FSNs) for medical devices.
Patient factsheet providing information on respiratory syncytial virus (RSV) and RSV vaccination.
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
Do not include personal or financial information like your National Insurance number or credit card details.
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