CAAmendment object
Authorisation mandatory for
All clinical trials requiring authorisation by CA
Responsible for submission of SA
Sponsor
Legal representative domiciled in the respective country
Timeline for approval of SA (max nr days)
30
Additional Information
The Agency informs the responsible EC and other competent cantonal authorities of its decision.
Other amendments must be declared to the CA, but do not require explicit approval by the CA.
Cave: Some of them require explicit approval by the EC according to Art. 29 KlinV/ClinO.