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Disclaimer

This package contains the eCTD Template as mentioned in the Appendix 2 of the ICH eCTD Specification V 2.0 February 12, 2002. This version is a draft; i.e., it has not been yet approved by the ICH M2 Expert Working Group (M2 EWG). Check for the latest version.

The name of the files/directories are as defined in the Appendix 4. The style sheet (and related files) will probably change.

This eCTD Template also includes the EU Module 1 Template and an unapproved USA Module 1 Template. The official USA and Japan Module 1 templates will be included once they become available. Comments on the eCTD Template should be forwareded to M.T. Carrasco Benitez.