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Systems:

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News

13-04-2018

The VNeeS Checker version 2.6 (entering into force September 2018) has now been published. See the section Future Guidance below.

09-04-2018

Stepwise implementation towards mandatory use of the Common Repository for veterinary submissions

The use of the Common Repository by National Competent Authorities (NCAs) to retrieve veterinary submissions will be mandatory from 1st June 2018. Until this time, a transition period is ongoing, whereby the use of the Common Repository is being implemented in a stepwise approach, as indicated 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)

08-03-2018

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce improvements and new fields to the user interface. This change is a further step towards integration of the XML delivery file and the Formatted Table Template; however this release does not affect yet the use of the Formatted Table Template.

Please note that the delivery files created prior to the new release should work following the deployment of the new versions.
One of the new fixtures will be introduction of Brexit Related procedure indicator.

Users can indicate if the change is a Brexit related procedure. This is applicable to initial submissions for the following submission types:

  • Variations Type IA (H & V)
  • Variations Type IAIN (H & V)
  • Variations Type IB (H & V)
  • Variations Type II (H & V)
  • Transfer MA (H & V)
  • Notification 61-3 (H only)

01-03-2018

The guideline on eSubmissions for Veterinary products – version 2.6 has now been published. It will enter into force on 1 September 2018 - see links under section “Future Guidance” below.

The update is related to alignment with the eSubmission roadmap and forthcoming CESP dataset module, clarification on upper-case file extension, update of CMDv reference guidance, addition of a pass/fail criterion related to hidden files, update of the MRL dossier structure. As those updates will change submission requirements for applicants, i.e. technical validation criteria will not be identical, the version 2.6 will be valid only when entering into force from 1st September 2018. 
 

19-02-2018

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

 

01-03-2018

The guideline on eSubmissions for Veterinary products – version 2.6 has now been published. It will enter into force on 1 September 2018 - see links under section “Future Guidance” below.

The update is related to alignment with the eSubmission roadmap and forthcoming CESP dataset module, clarification on upper-case file extension, update of CMDv reference guidance, addition of a pass/fail criterion related to hidden files, update of the MRL dossier structure. As those updates will change submission requirements for applicants, i.e. technical validation criteria will not be identical, the version 2.6 will be valid only when entering into force from 1st September 2018. 
 

19-02-2018

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

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’).

 

 

 

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