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
- Structure and Format 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
- Filing and Transmission 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
- Audit trail compatibility
- Secure file handling
- Long-term digital archiving standards
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
- Accepts non-eCTD veterinary submissions
- Mandates folder structures
- Requires use of the REP and CESG for most submissions
- 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
Frequently Asked Questions
VNeeS, also known as Veterinary NeeS, is a structured electronic submission format designed specifically for veterinary medicinal products. It provides a standardized alternative to eCTD and is widely used for veterinary regulatory submissions, particularly across the EU.
VNeeS can be used for various regulatory activities, including initial Marketing Authorisation Applications, variations, renewals, post-authorisation submissions, Maximum Residue Limit (MRL) applications, Active Substance Master Files (ASMFs), and Vaccine Antigen Master Files (VAMFs), depending on the applicable authority requirements.
A VNeeS dossier follows a defined electronic structure with an appropriately named root folder, Parts 1–4, General Table of Contents (GTOC), and hyperlinked part-specific tables of contents. Documents are generally provided in searchable PDF/A format, with an optional folder for editable or assessor-use files.
A VNeeS dossier should be checked carefully to ensure that its folder structure, documents, hyperlinks, filenames, and other technical requirements are correct. Validation using the applicable VNeeS Checker Tool helps identify technical issues before the dossier is transmitted to the regulatory authority.
The transmission method depends on the procedure and country. In Europe, submissions may be sent through the Common European Submission Portal (CESP) for applicable national, MRP, and DCP procedures, while centralized procedures use the EMA eSubmission Gateway. Other countries may use their own electronic submission portals.
Although VNeeS is strongly associated with the EU veterinary regulatory environment, similar structured non-eCTD approaches may be accepted in other markets. Health Canada, for example, accepts non-eCTD veterinary submissions through its applicable electronic processes, while some ROW markets may accept or prefer simplified electronic dossier structures. Local requirements should always be confirmed before submission.
VNeeS follows principles that support consistent electronic document exchange, including PDF/A standards, searchable documents, appropriate document granularity, structured metadata, and long-term electronic archiving. These practices are also consistent with broader electronic submission principles reflected in VICH and other regulatory frameworks.
Requirements can differ between markets even when a VNeeS-style structure is accepted. The EU, Canada, Australia, GCC, and other ROW markets may have different portal, folder naming, document format, signature, or identifier requirements, so the dossier should be adapted to the specific authority and submission procedure.
Yes. Masuu Global provides end-to-end VNeeS support, including dossier preparation, mixed CTD/VNeeS formatting, document conversion to searchable PDF/A, technical validation, country-specific formatting, and submission support through applicable portals such as EMA Gateway, CESP, and CESG.
Yes. Our support can continue throughout the product lifecycle, including variations, renewals, post-authorisation changes, technical updates, and subsequent regulatory submissions. We help maintain the dossier in the required electronic format while adapting it to changing country-specific regulatory requirements.