Update of eCTD Module 1 Specification to version 3.0.4

Update of eCTD Module 1 Specification to version 3.0.4

Update of eCTD Module 1 Specification to version 3.0.4
April 28, 2021

The EU eCTD Module 1 Specification has been updated to version 3.0.4 in April 2021 to reflect clarifications.

In the updated version, which is available for immediate use, there are no changes to the DTD (version 3.0.1 is still valid) or to the validation criteria. It contains editorial changes due to Brexit, and it includes information about the use of UUID (which should be unique for each eCTD lifecycle), format related guidance (e.g., documents that include digital signatures should be accepted) and some other clarifications.

The most remarkable updates are listed in the following table:

UKThis country code should be used for UK Northern Ireland UK(NI) until a new major version of the EU eCTD M1 specification is released that will include the correct term.
UK-MHRAThe agency code UK-MHRA refers to the United Kingdom of Northern Ireland when included in an EU eCTD submission.
STTThe (sequence) tracking table should be included in all eCTD submissions, including national and centralized procedures (NP and CP)

The validation criteria have not been updated to include the requirement for a tracking table within NP and CP (so it will not be a cause for rejection), but the requirement will be included in a future version.

 

 

For further information you can contact us at: info@asphalion.com

Or schedule a 30 minutes free consultation meeting with us by clicking at the eSubmissions calendar:

https://outlook.office365.com/owa/calendar/AsphalionSL@asphalion.onmicrosoft.com/bookings/

 

Source:

http://esubmission.ema.europa.eu/eumodule1/index.htm

Search News & Events

  • Filter by category

Share

Related news and events

RBDCOV | 14-months follow-up meeting

The second face-to-face RBDCOV meeting is taking place today at Palau Macaya in Barcelona! Our expert, Chris Mann, is attending the meeting in person. After

2nd eAF (DADI) Newsletter has been published on the EMA website!

2nd eAF (DADI) Newsletter has been published on the EMA website: The web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) – often referred to by its former project name, DADI – has been available for use as of 4 November 2022 on the new Product Lifecycle Management (PLM) Portal.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting