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

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