EU Telematics PIM � _
 

VET eSubmission

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Home

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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

21-04-2022

Updated General FAQ relating to eSubmission for Veterinary Applications is now available

The General FAQ relating to eSubmission for Veterinary Applications has been updated and is now available below.

22-12-2021

Updated final version of the VNeeS specification 3.0 now available

A final, clean 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 have been implemented to align with the VMP-Regulation (EU) 2019/6.

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

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.

 

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