ORBIS Typ C Procedure

Explanation of ORBIS type C procedure

The procedural steps and milestones of ORBIS Type C procedures (for details see "Swissmedic website") correspond to the selected Swissmedic procedure (standard procedure, fast-track procedure, procedure with prior notification, etc.). For ORBIS type A and type B applications with information requests, the milestone LoQ is skipped, and a preliminary decision is issued directly. In the case of type C ORBIS applications, Swissmedic has, so far, always sent a separate LoQ, although theoretically (as with all other authorisation procedures) it is possible to issue a preliminary decision directly. As with the other types, in the case of an ORBIS type C procedure (FDA approval already available), the request for implementation must be submitted to the FDA. The FDA then informs Swissmedic accordingly. However, it is always possible to submit a sponsor authorisation letter (SAL) with the application outside ORBIS, which entitles Swissmedic to request the unredacted assessment reports directly from the FDA for a preparation or indication already authorised in the USA.

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