Swissmedic has revised the Project Orbis guidance document. In particular, the process for applications for the Project Orbis procedure is described in greater detail. The structure of the guidance document has also been modified as part of updating, and editorial changes have been made in various sections to improve clarity. The modifications that have been made do not constitute changes to the requirements for applications for the Project Orbis procedure.
The revised Project Orbis guidance document will take effect on 1 June 2026.