eCTD submission

Switzerland (Swiss Medic) Module 1 Specification for eCTD Version 1.3

As per Swissmedic the new M1 eCTD Specification (v1.3) and validation criteria (v1.3) have been edited, expanded and updated. The M1 folder structure and file naming have been modified. With a view to future eGov portal developments, a number of validation criteria have been adjusted or added in v1.3.

The new versions (v1.3) are accepted from 1st October 2015 however the transition period applies until 31st March 2016. During this transition period v1.2 and v1.3 are accepted and valid.

For More information:

https://www.swissmedic.ch/zulassungen/01520/02265/02927/index.html?lang=enhttps://www.swissmedic.ch/zulassungen/01520/01662/index.html?lang=en

https://www.swissmedic.ch/zulassungen/01520/01662/index.html?lang=en

Author

KnetAdmin

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