The EU M1 1.3 Specification has been released. Here's the link to the information.
From the transition guidance document:
The Specifications and DTD of the eCTD EU Module 1 v1.3 include several changes to v1.2.1 (see Release Notes for EU M1 v1.3), but the principal change is alignment to the 2008 updated version of the CTD guidance, specifically to include section 1.10 for the information relating to paediatrics. The CTD M1 guidance and eCTD EU M1 specification are published simultaneously.
Applicants are given 6 months from the date of publication to implement EU M1 v1.3 for all European procedures, and eCTD applications submitted after 31st December 2008 using any previous version of the EU M1 specification (i.e. v1.0, v1.1 or v1.2.1) will not be accepted.
The 6 month deadline applies not only to new applications, but also to all lifecycle
sequences/submissions for applications ongoing at the time. Please note that, for existing applications, it is not expected that all existing submissions will be updated to EU M1 v1.3 and re-submitted; it is, however, expected that authoring and review tools will allow for a change in DTD mid-lifecycle.
Posts
|