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
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
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.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
This guidance summarises our approach to pharmacovigilance
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Advice on writing clear notices and maximising replies to your FSNs.
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Comply with good pharmacovigilance practice and prepare for an inspection.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Information for patients, healthcare professionals and developers of new medicines
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
Guidance on how to submit changes to labelling and patient information leaflets to MHRA.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
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).