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SWISSMEDIC GUIDANCES

As of January 2010, Swissmedic accepts eSubmissions in the eCTD format.  Swissmedic does not accept NeeS.

The following table summarizes the eCTD-related guidance documents issued by Swissmedic. For more information on DTDs, style sheets and examples, see the SwissMedic eCTD documentation page.

Swissmedic eCTD Guidance Documents

Document Issue Date URL
CH Module 1 Specification 1.1, May 2010 Click here for link
Guidance for Industry on Providing Regulatory Information in eCTD Format 1.2, Nov 2010 Click here for link
Questions and Answers of Swissmedic eCTD Implementation 1.4, Aug 2012 Click here for link