eCTD submission

Updated EU eCTD Module 1 Specification

To accommodate several change requests submitted since version 2.0 entered in to force in September 2013, a revision of the EU eCTD Module 1 Specification has taken place and the final version is now published (EU M1 v3.0 ).

This final approved version will enter into force on 1st July 2016 and will become mandatory on 1st October 2016. After October 1st, 2016 eCTD sequences built based on EU M1 specification version 2.0 will be rejected.


More details available at:
http://esubmission.ema.europa.eu/eumodule1/index.htm
http://esubmission.ema.europa.eu/eumodule1/docs/Release%20note%20EU%20eCTD%20Module%201%20Specification%20final.pdf

Author

KnetAdmin

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