CAAmendment object

Notification mandatory for

Any substantial amendments

Authorisation mandatory for

All clinical trials resp. investigations

Responsible for submission of SA


Timeline for approval of SA (max nr days)

30 (silent approval)

Guidance on submission of SA

Modality: in writing, providing a rationale and a draft of the revised relevant part of the dossier.

Applicable national legal framework/ Reference

Section 56(1)&(2) Act on Pharmaceuticals
Section 6 Decree on GCP