Veterinary Non eCTD Electronic Submission (VNeeS Submissions)

Regulatory Requirements and Global Compliance

VNeeS (Veterinary Non-eCTD Electronic Submissions) has emerged as a standardized and mandatory format across many regions, especially in the European Union, Companies aiming for market access across regulated and rest-of-world (ROW) markets.

What Is VNeeS?

VNeeS (Veterinary NeeS) is an electronic submission format used specifically for veterinary medicinal products. It draws inspiration from the human medicine “NeeS” format and serves as a structured electronic alternative to the more complex eCTD format.

Introduced by the Veterinary Harmonization Group and endorsed by EMA and national competent authorities (NCAs), Vet NeeS has become mandatory for most veterinary submissions in the EU including:

  • Initial Marketing Authorization Applications (MAAs)
  • Variations and Renewals
  • Post-Authorization Activities
  • Maximum Residue Limits (MRL) Applications
  • Active Substance Master Files (ASMF)
  • Vaccine Antigen Master Files (VAMF)

Regulatory Requirements for VNeeS

  1. Structure and Format
    2. The backbone of any VNeeS submission lies in its strict folder structure, modeled after the EU Regulation (EU) 2019/6. Depending on product type (pharmaceutical, biological, immunological), the dossier structure must follow predefined folder templates as outlined in Tables 1–10 of the VNeeS guideline. Each submission must contain:
    • A root folder named appropriately
    • Structured subfolders for Parts 1 to 4
    • A General Table of Contents (GTOC)
    • Hyperlinked part-specific TOCs
    • Mandatory PDF/A format documents compliant with ISO 19005 standards
    • An optional add-info folder for editable Word documents and assessor-use files
    Submissions must be validated using the publicly available VNeeS Checker Tool.
  1. Filing and Transmission
    2. Submissions in the EU must be transmitted via:
    • Common European Submission Portal (CESP) for national procedures, MRP, DCP
    • EMA eSubmission Gateway for centralised procedures
    • Some national authorities still require a paper-signed cover letter, though most accept electronic signatures or digitally signed PDFs.

Global Harmonisation: Alignment with ICH & CFR

While VNeeS is primarily an EU requirement, its principles align with broader ICH and CFR standards:
ICH Compatibility
VNeeS supports file formats and practices outlined by VICH GL53, which mirrors the ICH M2 EWG recommendations for electronic document exchange. Key features include:
  • ISO-standardized PDF/A usage
  • Clear document granularity
  • Text-searchable documents via OCR for scanned files
  • Structured metadata for easier navigation and lifecycle tracking
FDA & CFR Considerations
While the FDA’s Center for Veterinary Medicine (CVM) mandates eSubmitter and eCTD for certain veterinary drugs, many ROW markets and non-mandatory pathways may still accept VNeeS-like formats. VNeeS submissions comply with principles in 21 CFR Part 11 (Electronic Records; Electronic Signatures), ensuring:
  • Audit trail compatibility
  • Secure file handling
  • Long-term digital archiving standards
For example, Health Canada accepts veterinary submissions in non-eCTD format, but mandates the use of Regulatory Enrolment Process (REP) and CESG Gateway, requiring a structured folder format, descriptive filenames, and valid dossier identifiers.

Country-Specific VNeeS Considerations

Europe (EU/EEA):
  • Mandatory VNeeS format for all submissions since 2018
  • Valid across CP, DCP, MRP, and NP procedures
  • Alignment with Regulation (EU) 2019/6 and EMA’s eSubmission roadmap
Canada (Health Canada):
  • Accepts non-eCTD veterinary submissions
  • Mandates folder structures
  • Requires use of the REP and CESG for most submissions
Rest of World (ROW):
  • VNeeS is increasingly being recognized in harmonized submissions (e.g., Australia, GCC)
  • Countries lacking eCTD infrastructure often prefer simplified VNeeS structures

Applicants must always confirm with local authorities whether Veterinary Non eCTD Electronic Submission is acceptable and if any modifications to folder naming or document formats are needed.

Masuu Global Solutions have wide Array towards:

Masuu Global Solutions, we specialize in quality and regulatory consulting, supporting clients in navigating VNeeS submissions with full compliance to country-specific and international regulatory frameworks. our expert consultants offer end-to-end support for your veterinary product submission journey.

Whether you’re targeting the EU, North America, or ROW, we ensure your dossier meets all electronic submission requirements—compliantly and efficiently.

  • Preparation of complete VNeeS-compliant dossiers (including mixed CTD/VNeeS format)
  • Validation using official VeteeS Checker Tool
  • Conversion of source documents to text-searchable PDF/A format
  • Country-specific formatting and regulatory intelligence
  • Submission support via EMA Gateway, CESP, CESG, and other national portals
  • Lifecycle management for variations, renewals, and post-authorisation changes
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