We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.
We also use cookies set by other sites to help us deliver content from their services.
You have accepted additional cookies. You can change your cookie settings at any time.
You have rejected additional cookies. You can change your cookie settings at any time.
Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
The new set of regulations The Medical Devices (Post-market Surveillance…
Requirements of the manufacturers PMS system (Regulations 44ZE, 44ZF,…
Reporting under the GB Medical Devices Vigilance System (Regulations 44ZC,…
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 opioid medicines to help patients and their families reduce the risks of harm.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How to write clear and effective field safety notices (FSNs) for medical devices.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
Comply with good pharmacovigilance practice and prepare for an inspection.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
This guidance summarises our approach to pharmacovigilance
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
Guidance on how to report suspected adverse incidents and safety concerns with diabetes management equipment to the Yellow Card scheme.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
Information for patients, healthcare professionals and developers of new medicines
A flyer to circulate to customers alongside a field safety notice covering what it is and why it's important to take action.
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve GOV.UK, we’d like to know more about your visit today. Please fill in this survey (opens in a new tab and requires JavaScript).