20 June 2013

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


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


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