This Swiss specific addendum, or other document but with equivalent purpose and content, must be submitted to the ethics committee, for applications submitted before November 1, 2024, but which can only be approved after November 1 under the new law.

If the trial protocol is prepared under the old law and submitted after November 1, 2024, the Swiss specific addendum must be submitted at the same time.

In any case, the addendum must be submitted before the first participant is included in the clinical trial.