Module 12 Presentations

eSubmission guidance

ICH M2 EWG - Electronic Common Technical Document Specification Version 3.2.2 (Jul 2008).

EU Module 1 Specification v3.0.4 Version 2.0 (Apr 2021) BPG eCTD MRP/DCP Revision 7 (Apr 2020) eCTD and ASMF Version 2.3 (July 2020) eCTD validation criteria Version 7.1 (Sep 2018)

http://esubmission.ema.europa.eu/

The Organisationfor Professionals in Regulatory Affairs