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EU readme

This is the EU Module 1 Template. It is a draft. It follows the EU Module 1 Specification, as required in Appendix 5 (Regional specific information: Module 1) of the ICH eCTD Specification V 2.0 February 12, 2002.

It also contains the Application Form (old Part 1 A) DTD and example according to Electronic Application Form Specification.

The EU regional DTDs are in the directory util/dtd. The EU DTDs have the prefix eu-. They are modularized; i.e., the DTDs are in several files as opposed to one file. The DTDs have the extension dtd and the modules (fragments) the extension mod. For example, eu-envelope.mod is included in eu-index.dtd and eu-application.dtd, a place holder file for Application Form. Comments on the EU Module 1 Template should be forwarded to M.T. Carrasco Benitez.