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eCTD EU Module 1 Specification

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Updated EU M1 eCTD Specification

The EU eCTD Module 1 Specification has been updated to reflect clarifications and the updated version 3.0.3 is now available. The version 3.0.3 entered into force in November 2017 for immediate use. There are no changes to the DTD in this version (version 3.0.1 is still valid) and the validation criterion was not changed as a result of this update.  However, please note that new validation criteria (version 7.1) came into force 1 September 2018.

  EU M1 v1.4.1 EU M1 v2.0

EU M1 v3.0.1

EU M1 v3.0.3
Status For reference only For reference only

Version 3.0 is replaced by version 3.0.1 (minor correction of the DTD)

Version 3.0.2 is replaced by version 3.0.3 (editorial update)

Approved -  to be used from April 2017
Release Notes

View Specification Release Notes

View Annex Release Notes

View View - 12.7.2016 View 16.11.2017
Specification View
View View - 17.05.2016 View
Annex View View View  
DTD Download   v.3.0.1 v.3.0.1
Examples Download      
Package Download Download Download - 06.06.2016 Download - 06.06.2016
Implementation Guide   Download Download - 12.7.2016 Download - 06.06.2016
Checksum of        
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