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eCTD EU Module 1 Specification

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28-11-2023

eCTD EU Module 1 Specification proposed changes now open for public consultation (Deadline: 12 January 2024)

The Human Harmonisation Group has analysed the change requests received upon opening the eCTD EU Module 1 Specification for review and is now publishing the draft documents for public consultation: The eCTD EU Module 1 Specification contains a summary of the proposed changes in the Document control table, and all the amendments are highlighted throughout the text with the track changes feature.
The eCTD EU Validation Criteria contains a summary of the proposed changes in the Document control tab.

Please submit your questions and comments via email to EUM1Spec@ema.europa.eu by the end of the day 12 January 2024.

After consolidating the public comments, the final versions of the documents and all the relevant files (including the Release notes, Package, Checksums) will be published on the eSubmission website. The date of entering into force will be announced at the time of the publication and will allow 9 months for the implementation of the changes.

26-10-2022

eCTD EU Module 1 Specification now open for review and all stakeholders are invited to submit change requests on the specification - deadline extended until 1st November 2022
The Human Harmonisation Group has decided to open the eCTD EU Module 1 Specification for review and all stakeholders are invited to review the list of submitted change requests and, to submit new change requests on the specification.
Please find a list of submitted change requests and the template to submit any new change requests to the current version of the eCTD EU M1 specification. Please submit your change requests via email to EUM1Spec@ema.europa.eu by the end of the day 1st of November 2022.

26-09-2022

eCTD EU Module 1 Specification now open for review and all stakeholders are invited to submit change requests on the specification
The Human Harmonisation Group has decided to open the eCTD EU Module 1 Specification for review and all stakeholders are invited to review the list of submitted change requests and, to submit new change requests on the specification.
Please find a list of submitted change requests and the template to submit any new change requests to the current version of the eCTD EU M1 specification. Please submit your change requests via email to EUM1Spec@ema.europa.eu by the end of the day 25th of October 2022.

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          
eu-regional.dtd 91654e96e3bafc5e89df7f892477b246 9dc9debb051a9e5762fc19a1f55132da 290503BF171E7E2E80EF90F0BDE5D91E 290503BF171E7E2E80EF90F0BDE5D91E 290503BF171E7E2E80EF90F0BDE5D91E
eu-envelope.mod  664a76e3f31a9553d3375d3b21815904 0ebe02fcdff7e40eff94a88074ca21 D0727AE0FB68B19EDAE49AB9E2E22A4A D0727AE0FB68B19EDAE49AB9E2E22A4A D0727AE0FB68B19EDAE49AB9E2E22A4A
eu-leaf.mod 2e976bc60658a964affa5026369a371e 23b854174e61c68044b9f53c0009af95 23B854174E61C68044B9F53C0009AF95 23B854174E61C68044B9F53C0009AF95 23B854174E61C68044B9F53C0009AF95
eu-regional.xsl 54f9889822e1d08cc23b902fc6a66aaa bf40b657579356c7b4d6c866625d8171 0107179C3739EBBD6B00CE492FE6E1E7 0107179C3739EBBD6B00CE492FE6E1E7 0107179C3739EBBD6B00CE492FE6E1E7

 

 


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