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VET eSubmission

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Human eSubmission
eCTD v3.2
eCTD EU M1 specification

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Veterinary eSubmission
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eSubmission expert group
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eSubmission expert group documents

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External Links

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Systems:

Common Repository

eAF

eASMF
ePMF
CESP Delivery

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

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PSUR Repository

Industry access

NCA access
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Projects:

eCTD v4.0

DADI (eAF)

Paediatric submissions

SPOR

eSignatures

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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

16-07-2021

Updated draft version of the VNeeS specification v3.0 now available

An updated version (v3.0) of the draft guideline on the specifications for provision of an electronic submission (eSubmission) for veterinary medicinal products (Draft VNeeS guideline) is now available.

The updates appearing in track-changes have been implemented mostly to align with the VMP-Regulation (EU) 2019/6. Please note that more updates will be envisaged towards October 2021 when relevant guidelines will be published.

The basic folder structures as defined in Tables 1 to 4 in this draft guidance are not subject to further change and we would therefore encourage Service providers in charge of updating VNeeS validation tools to use this draft guideline as a basis for updating their systems.

11-03-2021

A new version of the eSubmission Gateway XML delivery file is now available

An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced changes to the delivery file (addition of ‘nitrosamine related’ radio button for initial variation submissions (human domain only) and renaming the ‘Customer Reference’ field to ‘purchase order number’ for all relevant submission types and submission units (H&V).

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

08-03-2021

A new version of the eSubmission Gateway XML delivery file for veterinary changes is now available

An updated version of the eSubmission Gateway XML delivery file user interface for veterinary MRL and referral submissions is now available. This update has introduced changes to the delivery file (changes in the available submission units and mandatory use of customer number and Purchase Order number). .

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

28-01-2021

The Guideline on eSubmissions for Veterinary products has been updated to version 2.7.1, applicable immediately. This minor change is Brexit related change in the list of country codes in table 4.
This change has no impact on the validation rules and the current VNeeS Checker tool (v2.6) remains unchanged.
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01-12-2020

The VNeeS Q&A relating to eSubmission for Veterinary Applications has been updated.

05-10-2020

The Guideline on eSubmission for Veterinary products - version 2.7 entered into force on 01 October 2020.

31-03-2020

The updated VNeeS guideline version 2.7 is now available and will enter into force on 1st October 2020.

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 (July 2021) Updated
  • Change Control Process Download (07. 2020) Updated
  • Veterinary eSubmission Change Request Q&A Form Download (07. 2016)

Historical Documents

  • Terms of Reference (2006)- 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
  • eSubmission guideline Version 2.4 (12. 2015) Download
  • eSubmission guideline Version 2.5 (06.2017) Download
  • eSubmission guideline Version 2.6 (09-2018) Download
  • Terms of Reference (06. 2012) - Download

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
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