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
Help improve GOV.UK Sign up to take part in user research (opens in a new tab)
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Who can supply or administer medicines to patients without a doctor under a PGD, which medicines they can supply, and legal requirements for PGDs.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How the MHRA makes decisions on what is a medicinal product (borderline products).
This document provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Detailed guidance on advertising and promoting medicines.
Guidance and advice for community pharmacies in England providing services to people who use drugs and alcohol.
Fees payable to the MHRA from 2025.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages, making them more flammable.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
How the MHRA processes variations to medicines' marketing authorisations for the UK and Northern Ireland.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
How to use the procedure for medicines licensing applications.
Information on comparator products used in studies supporting abridged marketing authorisation application.
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
Guidance on the deadlines for initial and response submissions.
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).