A Module 3 submitted in Switzerland as part of an ORBIS application does not necessarily have to be identical to the one submitted to the FDA and the other authorities involved in the ORBIS procedure. In the context of an ORBIS procedure, Module 3 must comply with the requirements applicable in Switzerland (e.g. with regard to the active substances/excipients of Ph.Eur./Ph.Helv.). In general, the other, non-country-specific modules (modules 2, 4 and 5) may also have certain differences to the FDA modules. This is due to the different guidelines / legal basis in Switzerland and the USA.
It is therefore permissible to submit an EU Module 3 as part of an ORBIS application in order to fulfil the local/regional requirements. In such a case, however, the deviations from FDA Module 3 must be explicitly listed and presented in the application
