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Guidance for Industry on Providing Regulatory Information in eCTD Format
The paper "Guidance for Industry on Providing Regulatory Information in eCTD Format" version 0.92 provides guidance for practical aspects related to eCTD submissions to Swissmedic. Version 1.0 of the guidance is applicable for electronic only submissions to Swissmedic as of January 1, 2010.
Guidance for Industry on Providing Regulatory Information in eCTD Format
(30.10.2009 | 266 kb | pdf)
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