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 get information including patient information leaflets (PILs), details on how the medicine can be used (SPCs) and scientific reports (PARs).
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
A letter to community pharmacy contractors to set out the detail of the agreed funding arrangements for community pharmacy.
Dear community pharmacy contractors, We are writing to update you on the…
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Guidance on the various types of modifications that can be made to a clinical trial approval.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Guidance on labelling for medicinal products used in clinical trials.
Information on telecare monitoring systems and personal alarms that can help you stay safe and independent at home.
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.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to help patients and their families reduce the risks of harm from opioid medicines.
How to contact the MHRA for specific services or enquiries.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
How to apply for a clinical trial (prior to 28 April 2026) including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to get access to MHRA submissions portals, how to use them, where to go for help.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Do not 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).