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Common Repository

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eSubmission Gateway & eSubmission Web Client

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Delivery file UI

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eSubmission Gateway

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PSUR Repository
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Industry access

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eCTD

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eCTD v4.0

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eSignatures

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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

05-09-2017

An upgrade to the VNeeS checker version 2.5.b has been published on the websites of the French competent authority (ANSES-ANMV) and of the Belgian competent authority (FAGG-AFMPS) - see links under section “Current Guidance” below.

The update is related to the use of PDF/A as a best practice criterion. It is a purely technical improvement which does not change submission requirements for applicants. This version 2.5.b will enter into force in January 2018, but it can already be used instead of the previous version 2.4, as the technical validation criteria are identical. The version 2.4 is still valid until January 2018.  

23-08-2017

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

General FAQ relating to PDF/A has been published.

15 June 2017

A statement of intent on the stepwise implementation of VICH GL53 on Electronic exchange of documents: electronic file format has been published. and is available here.

1 April 2017

The use of XML delivery file is now mandatory for all veterinary electronic submissions via eSubmission Gateway/WebClient. All veterinary electronic submissions coming to the European Medicines Agency (EMA) should contain a relevant XML delivery file which should be included in the submission package. This eliminates the need to follow specific filenaming conventions when naming submission ZIP packages sent to the EMA.

A dedicated User guide to XML delivery file creation as well as multimedia training is provided below (see section ‘EMA eSubmission Gateway/ Web Client for Veterinary Procedures’).

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.

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.

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 (06.2017) 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
  • eSubmission guideline Version 2.4 (12. 2015) Download
  • Terms of Reference (06. 2012) - Download
  • Change Control Process (12.2011) Download

 

 

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