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.