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eCTD EU Module 1 Specification

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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
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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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