Information requests (IRs) concerning Modules 1–5 will in future always be issued directly by Swissmedic to the applicant in Switzerland. The IRs will be sent in English with a response deadline of 10 calendar days as a rule. This change in procedure applies to all Orbis applications with a submission date on or after 1 January 2022. For all pending Orbis applications, Swissmedic will continue to send IRs concerning Modules 2–5 via the FDA and IRs concerning Module 1 to the applicant in Switzerland
Due to this change in procedure, Swissmedic has revised the guidance document Project Orbis HMV4. The guidance document is valid with effect from 1 January 2022.