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 to help comply with ICH E6(R3), if you are running clinical trials in the UK.
Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Guidance on the deadlines for initial and response submissions.
Detailed guidance on advertising and promoting medicines.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
Guidance on clinical trials that are categorised as ‘notifiable’.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Guidance on the process for ending a clinical trial.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Consumer advice and details of how to report problems with e-cigarettes with guidance on how to place an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
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).