For Type C ORBIS applications (Written Report Only Orbis), timelines apply according to the selected Swissmedic procedure type (standard procedure, Fast Track procedure (FTP) or Temporary Authorisation procedure, procedure with prior notification (PPN)). For Type A and possibly also Type B ORBIS applications, Information Requests (IRs) rather than LoQs are issued by Swissmedic. Usually, a preliminary decision is issued directly. However, this is not the rule for Type C applications where the milestones, according to the selected Swissmedic procedure type, apply (i.e., LoQ, preliminary decision, final decision).
For a Type C ORBIS application (as for any other ORBIS procedure), the initial request to participate must be first submitted to the FDA. The FDA then submits a corresponding request to Swissmedic.It is always possible to submit a sponsor authorization letter (SAL) with an application outside of ORBIS, which entitles Swissmedic to request the unredacted assessment reports directly from the FDA for a medicinal product or indication already approved in the USA.
