CAAmendment object
Authorisation mandatory for
Any changes to the conditions of the clinical investigation/ clinical investigation plan
Responsible for submission of SA
Sponsor
Timeline for approval of SA (max nr days)
30
In case that the CA does not provide its decision within the specified timeline, the changes shall be considered approved thereby.
Additional Information
The proposed changes in the clinical investigation dossier and a written approval of the proposed changes by the ethics committee shall be submitted to the CA.