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
Information on telecare monitoring systems and personal alarms that can help you stay safe and independent at home.
How to contact the MHRA for specific services or enquiries.
Approach to MHRA’s assessment of applications for medicines that use alternative methods to replace animals in science
How to help patients and their families reduce the risks of harm from opioid medicines.
Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
Guidance on using non-investigational medicinal products in a clinical trial.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
An overview of the process to get a marketing authorisation (MA), including submitting, fast-tracking an application, naming your medicine and paying fees.
How to get access to MHRA submissions portals, how to use them, where to go for help.
Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
Guidance on good manufacturing practice and the use of radiopharmaceutical investigational medicinal products in clinical trials.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
How to conform with the legal requirements for placing medical devices on the market.
The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
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).