Module 12 2019

Module 1 Specifications

EU Module 1 Specification, version 3.0.3 http://esubmission.ema.europa.eu/eumodule1/

For other ICH regions (US and JP) or other countries using eCTD (CA, CH) other regional M1 specification FDA: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSu bmissionRequirements/ElectronicSubmissions/UCM163552.pdf

The Organisation for Professionals in Regulatory Affairs

Slide 38