CAAmendment object
Notification mandatory for
Any substantial amendments
Authorisation mandatory for
All clinical trials resp. investigations
Responsible for submission of SA
Sponsor
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