EMEA Posts Veterinary eSubmission Guidelines

The EMEA recently posted their guidance on Veterinary eSubmissions, v1.1, called the "VNeeS". In general this guidance suggests that you use a folder structure similar to the methods used in existing NeeS submissions, but corresponding to 4 parts instead of the 5 modules of an eCTD.

Additionally, one global PDF-based TOC (GTOC) should be created to allow navigation of the entire dossier, and 4 TOCs for each of the 4 parts. One subtle difference is that it appears that the global TOC should refer to all sub-documents, not just the individual part-TOCs (a subtle difference from the NeeS Guidance).

All in all, this should be relatively easily met by most modern publishing systems capable of delivering a NeeS.

This also sets an interesting precedent as in Europe its a candidate for one of the first non-eCTD eSubmission formats and helps build a future case for the ubiquity of RPS.