Swissmedic: Changes to the Project Orbis guidance document

1 June 2026

Swissmedic: Changes to the Project Orbis guidance document

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.

For more information, see here and here.

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