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
Submission dates and how the submissions using the EC decision reliance procedure work.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
5 quick tips on submitiing your paper for review
Submissions related to human medicines need to be submitted directly to the MHRA.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Use this form to submit an article to feature in a future edition of the serious and organised crime (SOC) local partnerships bulletin.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
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 an application, data package and responses for proposed or existing marketing authorisations.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Submission of notifications for northern Ireland under article 20 of directive 2014/40/EU.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products
How to apply for marketing authorisation via this new procedure.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
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).