CAAmendment object
Authorisation mandatory for
All clinical trials requiring authorisation by CA
Responsible for submission of SA
Sponsor
Standard notification form available
Yes
Standard notification form
A standard notification form and cover letter sample are posted on the Ministry’s website.
Timeline for approval of SA (max nr days)
30
From submission of the EC decision
Guidance on submission of SA available
Yes
Guidance on submission of SA
A comprehensive guideline providing detailed guidance on format, content and required appendixes of application as well as on the trial conduct (notification on amendments, trial termination etc.) is available (Guidance on The Format of Applications for the Clinical Trials of Medicinal and Biological Products [to The Ministry] 2014).
Additional Information
Amendments requiring a decision and approval are determined according to the Guideline for Good Clinical Practice (2014).