Submissions for combined trials
Swissmedic has updated the guidance for the submission of combined trials, and for submissions for already authorised trials that are newly becoming combined trials.
You can find the corresponding information in Annex A7 of the Swissmedic information sheets BW600_00_015e_MB (for combined trials of medicinal products and medical devices) and BW600_00_016e_MB (for combined trials of medicinal products and companion diagnostics / IVDs).