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
Submissions related to human medicines need to be submitted directly to the MHRA.
How to submit an application, data package and responses for proposed or existing marketing authorisations.
Guidance to aid producers of e-cigarettes and refill containers to prepare notifications for their products.
Instructions on how members of the public can submit their submissions to support the work of the team of experts leading the review.
How to submit a proposal to the Defence and Security Accelerator
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Login or register to the DASA online submission service
Submit new evidence if your asylum application has been refused and you have no more right to appeal - called ‘further submission’
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products
Guide to the submission process.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
How to use the HM Land Registry Pre-submission Enquiry Service and Application Management Service.
The process for the simultaneous review of veterinary drug submissions by Health Canada’s Veterinary Drugs Directorate and the UK's Veterinary Medicines Directorate.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
The process to raise matters in relation to the implementation of environment and labour chapters of a Free Trade Agreement.
Interested parties can review records of applications and statements submitted to OPRED as required by environmental regulations.
The process for the simultaneous review of veterinary medicine submissions by Switzerland’s Swissmedic and the UK's Veterinary Medicines Directorate.
A party seeking an opinion or determination from the SSRO may find it helpful to complete this submission template and return it to referrals@ssro.gov.uk.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
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).