We have a question related to the specific guideline for provision of an electronic submission (e-submission) for a veterinary medicinal product.
This guideline assists the applicants and regulators with submissions of initial dossiers as well all the documents submitted during the registration process (such as the List Of Questions or the List of Outstanding issues for new veterinary vaccines). It specifies the basic parameters required for an acceptable electronic submission known as Veterinary Nees (VNees) with the specific structure of each part of the dossier (See figure below).
Our question is whether this VNeeS format will also be required during the registration procedure (i.e. submission of LOQ or LoOI to EMA)? and how will be handled in IRIS. Usually, there are a lot of files in these submissions and different folders are created according to the structure created with the VNeeS. After that, only one file was submitted via Synplicity with all the documents inside.
Will this continue to be the case in IRIS? Or there will be changes with the implementation of IRIS related to the submission format of the initial dossiers?
