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 access to MHRA submissions portals, how to use them, where to go for help.
Guidance on the deadlines for initial and response submissions.
How to submit a proposal to the Defence and Security Accelerator
Submit new evidence if your asylum application has been refused and you have no more right to appeal - called ‘further submission’
How to submit an application, data package and responses for proposed or existing marketing authorisations.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Find out when large and small organisations affected by Extended Producer Responsibility for packaging (EPR) must collect and submit packaging data.
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).