EMA – Revised Implementation Guide for EU Module 1, eCTD/NeeS validation Criteria

EMA publishes revised Implementation Guide for EU Module 1 Specification (v2.0), EU eCTD Validation Criteria (v5.0) and EU NeeS Validation Criteria (v4.0)

You find further information and a link to the Implementation Guide on EMA’s esubmission webpage at

http://esubmission.emea.europa.eu/

For more information on the EU Module 1 v2.0 follow the link below

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