11/09/09 - EU NEES validation criteria v1.0

A set of technical validation criteria to be applied to all non-eCTD electronic submissions (NeeS) has been drafted by a subgroup of representatives from the Telematics Implementation group for eSubmission (TIGes) and the the European Review System (EURS) Implementation group. It is intended that these criteria will be built into eCTD validation tools to allow automated technical validation of both eCTD and NeeS. The NeeS validation criteria v1.0 should be read together with the EU NeeS Guidance drafted by the Harmonisation Topic Group. (source)
E-mail this page   Printable version of this page
Developed by Interactive Studios