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 apply for marketing authorisation via this new procedure.
Submission dates and how the submissions using the EC decision reliance procedure work.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
This is a consultation on a statutory instrument to amend the Human Medicines Regulations 2012 to remove the provision which provides the legal basis to the European Commission Decision Reliance Procedure (ECDRP).
This research maps the global state of protracted displacement, examining patterns and trends in numbers, geographic spread and funding
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Guidance on the acceptance stage for Nationally Significant Infrastructure Projects.
Check how the advice and information we give applies to you, what you can expect from us and what to do if you think you have incorrect information.
This brief outlines a pilot tool to begin understanding the opportunities for self-reliance and livelihood assistance afforded by displacement
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
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. We’ll send you a link to a feedback form. It will take only 2 minutes to fill in. Don’t worry we won’t send you spam or share your email address with anyone.