EU Telematics PIM � _
 

VET eSubmission

_

Home

_

Human eSubmission
eCTD v3.2
eCTD EU M1 specification

_
Veterinary eSubmission
_
eSubmission expert group
_

eSubmission expert group documents

_

External Links

_

Systems:

Common Repository

eAF

eASMF
ePMF
CESP Portal
CESP Delivery

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

PLM Portal eAF (DADI)

PLM Portal

_
PSUR Repository

Industry access

NCA access
_

Projects:

eCTD v4.0

Paediatric submissions

SPOR

eSignatures

_
_

 

The Veterinary Harmonisation Group (VHG) is a subgroup of the eSubmission expert group 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. The documents are approved by the eSubmission expert group before publication.

News

18-01-2023

A new version of the eSubmission Gateway XML delivery file for veterinary Variations Requiring Assessment (VRA) now available

An updated version of the eSubmission Gateway XML delivery file user interface for veterinary VRA submissions is available starting with 17 January 2024, 18:00 CET.
This update introduced a split of the submission type VRA to 4 different submission types according to the Timetable as per defined in the Variation Classification document.

The users should note that they should always select the standard timetable (E/S/R) for each scope, regardless of a different TT having been agreed.

For grouped VRA, in the delivery file, the applicant should select the longest timetable applicable to any of the included variations in the application.

Updated release notes and user guidance are published in the relevant section.

Users should note that the delivery files created prior to the new release will not work after the go live.

15-01-2023

A new version of the eSubmission Gateway XML delivery file for veterinary Variations Requiring Assessment (VRA) is planned for release in the evening of 17 January 2024

An updated version of the eSubmission Gateway XML delivery file user interface for veterinary VRA submissions is planned for release in the evening of 17th January 2024. This update will introduce a split of the submission type VRA to 4 different submission types according to the Timetable as per defined in the Variation Classification document.

The users should note that they should always select the standard timetable (E/S/R) for each scope, regardless of a different TT having been agreed.

For grouped VRA, in the delivery file, the applicant should select the longest timetable applicable to any of the included variations in the application.

Users should note that the delivery files created prior to the new release will not work after the go live.

23-10-2023

Updated VNeeS checker for v3.1 now available

An updated version of the VNeeS checker provided by Anses - ANMV is now available.

06-10-2023

Updated version of the VNeeS specification v3.1 now available

The guideline on eSubmissions for Veterinary products version 3.1 has now been published. It will enter into force on 1 November 2023 (see links under section “Current Guidance” below).

The update is related to a best practice criterion in the technical validation checklist for the additional information folder (“add-info”). In case you will be using a checker tool not yet aligned with this new best practice requirement, for relevant submissions like SRPs, in case of doubt, we recommend to verify the path length in the add-info folder with the publicly available VNeeS checker tool to avoid potential technical blocks during dossier upload and thus circumvent the need for last minute changes of your submission. .

31-07-2023

Updated version of the eAF v1.26.0.0 (veterinary variation)

An updated version 1.26.0.0 of the veterinary variation eAFs is available starting with 24 July 2023.
A single change has been implemented to address a non-blocking bug (related to the formatting of the page).

It is recommended to use this latest form for new submissions (document properties date 24.07.2023). Please note that there is no version number change and that the release notes are not published for this minor change at this time.

18-07-2023

Use of PDF/A (For Industry representatives)

This communication is a reminder that, whilst awaiting mandatory use of PDF/A, its use is still strongly recommended to create any new documents. Only this approach ensures that electronic archives both on industry and agency side will contain exactly the same files as submitted because no further conversion to an archive format is needed. Note that postponing implementation until PDF/A is mandated brings further disadvantages as a growing number of legacy files may need to be converted for future submissions. As communicated earlier, the intent is to mandate the use of PDF/A once the new web-based electronic application forms (eAFs), which are currently established in the human domain and which contrary to the current eAFs can be compliant to PDF/A, are also rolled out in the veterinary domain.

For further information on the use of PDF/A, please see the following documents published on this page:

General FAQ relating to PDF/A (December 2021)

Statement of intent on the stepwise implementation of VICH GL53 on Electronic exchange of documents: electronic file format

Previous news is available here.

Current Guidance

EMA eSubmission Gateway/ Web Client for Veterinary Procedures

Announcements

Guidance

Common Repository for Veterinary Procedures

More information about Common Repository can be found here.

Useful Links/Documents

EU Change Control Process

  • Change Request Tracking table Download (October 2023) Updated
  • Change Control Process Download (07. 2020)
  • Veterinary eSubmission Change Request Q&A Form Download (December 2021)

Historical Documents

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

 

EMA
European Medicines Agency ©1995-2024 | Disclaimer | For technical support, please visit the EMA Service Desk (ServiceNow) portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here