Amendments to clinical trials

12 January 2009, Updated 26 February 2018

The Danish Medicines Agency receives many enquiries about amendments to clinical trials.

Therefore, we have made an overview listing the significant amendments for which it is necessary to apply for an authorisation.

The overview also includes which amendments must be submitted for information, and which amendments must not be submitted.

Amendments to clinical trial application (CTA) (pdf - 0.55 MB)

Form

Notification of Amendment (Substantial Amendment Notification Form, Word - 94 KB)

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