01.01.2016 - Since May 2014, Swissmedic has been scanning all documents relating to entirely paper-based submissions so that they are available in digital form for internal processing. This approach helps Swissmedic to process applications efficiently. Applications submitted as an eCTD or eDok are not scanned since they already exist in digital form.
In the past, companies submitting entirely paper-based applications had to submit an original on paper and an additional hard copy. This was to ensure that enough copies were available if necessary during the introductory phase of digital file processing. Swissmedic has found, however, that the internal need for hard copies is diminishing constantly. Therefore, for entirely paper-based authorisation applications, Swissmedic will no longer require an additional hard copy as of 1 January 2016. For applications submitted in this form, Swissmedic now requires only a paper original accompanied, as in the past, by the necessary cover sheets (for requirements see
The requirements for applications submitted in eDok format (paper original without cover sheets plus an electronic copy) and in eCTD format (Module 1 as a paper original plus eCTD) will remain unchanged for the time being.
Swissmedic would like to take this opportunity of emphasising once again that eCTD is the preferred format for submitting authorisation applications. Whenever possible, companies should use submit applications in eCTD format rather than as hard copy or in eDok format.
Swissmedic would like to take this opportunity of emphasising once again that eCTD is the preferred format for submitting authorisation applications. Whenever possible, companies should use submit applications in eCTD format rather than as hard copy or in eDok format.