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

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

_
PSUR Repository

Industry access

NCA access
_

Projects:

eCTD v4.0

CESSP

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

03-09-2018

Guideline on eSubmissions for Veterinary products – version 2.6 now in force.

Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council came into force on 27 January 2017.

With VNeeS version 2.6 now in force, the structure of the electronic dossier has been brought in line with structure described in the Commission Implementing Regulation.

17-08-2018

Reminder concerning the Common Repository: applicants are reminded that for procedures involving only Centrally Authorised products, submission should be done only once, via the EMA eSubmission Gateway. No additional submission should be done via CESP, CD or DVD, as National Competent Authorities have now access to the Common repository. For further details, please consult the Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for Medicinal Products for Veterinary use (CVMP) (EMA/466102/2007).

29-06-2018

The document “Exceptions to the VNeeS format” has been updated. Please see the link in the section “Current Guidance” below.

04-06-2018

Mandatory use of the Common Repository for veterinary submissions

The use of the Common Repository by National Competent Authorities (NCAs) to retrieve veterinary submissions is now mandatory since the 1st of June 2018. Please see further details in the Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for Medicinal Products for Veterinary use (CVMP) (EMA/466102/2007)

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 (02.2018) Updated
  • Change Control Process Download (07. 2016)
  • 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
  • Terms of Reference (06. 2012) - Download

 

 

EMA
© 1995-2018 European Medicines Agency | Disclaimer | For technical support, please visit the EMA Service Desk 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