EU Telematics PIM _
 

VET eSubmission

_

Home

_

Human eSubmission

_
Veterinary esubmission
_

eSubmission CMB

_
CMB Documents
_

Documentation

_

Projects:

_

Common Repository

_
CESP
_

eAF

_

CESSP

_
eASMF
_
ePMF
_

eSubmission Gateway & eSubmission Web Client

_

Delivery file UI

_

eSubmission Gateway

_
PSUR Repository
_

Industry access

_
NCA access
_

eCTD

_

eCTD v4.0

_

EU Module 1

_

eSignatures

_
_

 

The Veterinary Harmonisation Group, an evolution of the former TIGes‑Veterinary Sub Group, is a subgroup of the eSubmission CMB and is made up of representatives from National Competent Authorities, the EMA and Industry. Its objective is to develop and implement standards for the submission of electronic information in the context of European veterinary medicines approval procedures.

News

13-12-2016

VNeeS guideline v 2.5 and validation checklist v2.5 have been published and will enter into force in June 2017. With this new version 2.5, rules for technical validation remain unchanged, therefore the current VNeeS Checker v.2.4b (validation tool) will remain valid from June 2017.

05-12-2016

A new version of eSubmission XML Delivery File UI is now available, extending the use of XML delivery files to Maximum Residue Limits (MRL) and veterinary Periodic Safety Update Report (PSUR) submissions. Guidance on the new functionalities is included in the updated User guide to XML delivery file creation.
In anticipation of mandatory use of eSubmission Gateway/Web Client for veterinary procedural submissions to EMA, a follow-up Q&A Session for Industry – Mandatory Use of eSubmission Gateway will be held on 12 January 2017, from 13:00 to 15:00 UK time. Applicants are invited to raise any questions they may still have transitioning to the mandatory use.

To register or send a query, please contact eAFwebinar-registration@ema.europa.eu. Please use REGISTRATION or QUERY in your message title as applicable.

A statement of intent on an extension of Common Repository to all veterinary submissions in the centralised procedure has been published.

The use of XML delivery files for all Veterinary submissions will become mandatory on 1 April 2017 - statement of intent.

30-11-2016

The VNeeS format is becoming mandatory for ALL submissions in European procedures (CP, DCP and MRP) as of 1 January 2017, as detailed in the Annex to the eSubmission roadmap.

30-06-2016

An upgrade to the VNeeS checker version 2.4.b has been published on the websites of the French competent authority (ANSES-ANMV) and will soon be published on the website of the Belgian competent authority (FAGG-AFMPS) - see links under Current Guidance. The updates are related to the technical implementation, i.e. (i) include a change in dealing with uppercases in the filenames to avoid issues with case insensitive file systems, (ii) leading dots in the paths of the hyperlinks are accepted and (iii) technical details of checking of the hyperlinks in the bookmarks pane is strengthened. These are purely technical improvements which do not change submission requirements for applicants.   

Current Guidance

Until 30 June 2016, only the VNeeS Guideline version 2.3, validation checklist version 2.3 and checker version 2.3b should be used but applicants are advised to use internally in parallel the version 2.4 of the VNeeS Guideline, validation checklist and checker to familiarise themselves with this new version until it enters into force on 1 July 2016. Any feedback should be sent to esubmission@ema.europa.eu

EMA eSubmission Gateway/ Web Client for Veterinary Procedures

Useful Links/Documents

EU Change Control Process

  • Change Request Tracking table Download (12.2016) New
  • Change Control Process Download (07. 2016)
  • Veterinary eSubmission Change Request Q&A Form Download (07. 2016)

Historical Documents

  • Terms of Reference (2006)- Download
  • E-submission Roadmap (2009)- Download
  • eSubmission guideline Version 1.0 (10. 2009) Download
  • eSubmission guideline Version 2.0 (02. 2011) Download
  • eSubmission guideline Version 2.2 (01. 2013) Download
  • Terms of Reference (06. 2012) - Download
  • Change Control Process (12.2011) Download

 

 

EMA
© 1995-2016 European Medicines Agency | Disclaimer | For technical support, visit the EMA Service Desk portal: https://servicedesk.ema.europa.eu