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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 3.0.2 is now available. An editorial change has been made to the specification without a change in the version number.  The version v3.0.2 enters into force immediately and recommend it to be used as soon possible. There are no changes to the DTD in this version and the validation criterion has not changed and should continue to be used with the latest version of the specification.

  EU M1 v1.4.1 EU M1 v2.0 EU M1 v3.0

EU M1 v3.0.1

EU M1 v3.0.2
Status For reference only For reference only For reference only For reference only Approved & recommended to be used from April 2017
Release Notes

View Specification Release Notes

View Annex Release Notes

View View View - 12.7.2016 View 06.04.2017
Specification View
View View View - 17.05.2016 View 06.04.2017
Annex View View View View View
DTD Download     v.3.0.1 v.3.0.1
Examples Download        
Package Download Download Download Download - 06.06.2016 Download - 06.06.2016
Implementation Guide   Download Download Download - 12.7.2016 Download - 12.7.2016
Checksum of          
eu-regional.dtd  (new version number) 91654e96e3bafc5e89df7f892477b246 9dc9debb051a9e5762fc19a1f55132da 667C7387EE1D4C61D5EA840299BD2A70 290503BF171E7E2E80EF90F0BDE5D91E 290503BF171E7E2E80EF90F0BDE5D91E
eu-envelope.mod (new version number) 664a76e3f31a9553d3375d3b21815904 0ebe02fcdff7e40eff94a88074ca21 BB838F3FF8446CDA93BAA62A1F55BA25 D0727AE0FB68B19EDAE49AB9E2E22A4A D0727AE0FB68B19EDAE49AB9E2E22A4A
eu-leaf.mod 2e976bc60658a964affa5026369a371e 23b854174e61c68044b9f53c0009af95 23B854174E61C68044B9F53C0009AF95 23B854174E61C68044B9F53C0009AF95 23B854174E61C68044B9F53C0009AF95
eu-regional.xsl (modified) 54f9889822e1d08cc23b902fc6a66aaa bf40b657579356c7b4d6c866625d8171 3ABF1FE58FB6C8118DEF52EBAB947E0B 0107179C3739EBBD6B00CE492FE6E1E7 0107179C3739EBBD6B00CE492FE6E1E7

 

 



 

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