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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.
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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 |
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|
|
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| 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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| 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 |
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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