EU Telematics PIM � _

eCTD EU Module 1 Specification




Human eSubmission
eCTD v3.2
eCTD EU M1 specification

Veterinary eSubmission
eSubmission expert group

eSubmission expert group documents


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eCTD v4.0


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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 3.0.4 is available for immediate use. Release notes with practical information on changes are provided below. 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. The current validation criteria (version 7.1) that came into force 1 September 2018 remains as the current version.

  EU M1 v1.4.1 EU M1 v2.0 EU M1 v3.0.1 EU M1 v3.0.3 EU M1 v3.0.4
Status For reference only For reference only For reference only For reference only Approved and should be used from April 2021
Release Notes

View Specification Release Notes

View Annex Release Notes

View View - 12.7.2016 View 16.11.2017 View Specification Release Notes including practical information
Specification View
View View - 17.05.2016 View View April 2021
Annex View View View View View
DTD Download   v.3.0.1 v.3.0.1 v.3.0.1
Examples Download        
Package Download Download Download - 06.06.2016 Download - 06.06.2016 Download - 06.06.2016
Implementation Guide   Download Download - 12.7.2016 Download - 06.06.2016 For immediate implementation
Checksum of          
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For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.


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