CAAmendment object
Authorisation mandatory for
Any substantial amendments
Responsible for submission of SA
Sponsor
Standard notification form available
Yes
Standard notification form
European Standard form: Substantial Amendment Notification Form
Submissions shall be made through the Common European Submission Platform (CESP).
Timeline for approval of SA (max nr days)
35
From date of receipt of valid application
By explicit (written) notification
Guidance on submission of SA available
Yes
Guidance on submission of SA
Detailed Guidance is available on the MHRA website: "Clinical trials for medicines: manage your authorisation, report safety issues - Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report"
National legal framework in place
Yes
Applicable national legal framework/ Reference
Part 3 sections 22-24 of the Medicines for Human Use (Clinical Trial) Regulations 2004