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Supports effective delivery of planning application process.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Watch our caseworkers' top tips to make sure your applications are complete and correct. Avoid more than 20 common requisition points.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Around 40% of series applications don’t meet the requirements. We recommend you read this guide if you are considering making a series application.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Guide to called-in planning applications
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
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