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
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
A guide to the legislation enabling drug services and others to supply take home naloxone without a prescription to save a life in an emergency.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Information on telecare monitoring systems and personal alarms that can help you stay safe and independent at home.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
How to contact the MHRA for specific services or enquiries.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
How to get access to MHRA submissions portals, how to use them, where to go for help.
Fees payable to the MHRA from 2025.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
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).