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16/07/09 - Swiss eCTD Module 1 specifications and validation criteria Swiss Medic has published drafts of the "Swiss eCTD Validation Criteria" (describes the criteria for technical validation of eCTD submissions in Swissmedic) and "Swiss Module 1 Specifications for eCTD" (describes the requirements a valid Swiss Module 1 in eCTD format has to comply with) on their website. The specifications represent drafts that may undergo some changes until they are published as versions 1.0 in October 2009. (source) |
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