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The basic folder structures as defined in Tables 1 to 4 in this draft guidance are not subject to further change and we would therefore encourage Service providers in charge of updating VNeeS validation tools to use this draft guideline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

10-09-2019

Please be informed that the VHG reached a decision regarding mandatory use of the PDF/A format in VNeeS, starting after the transition period when the CESP dataset module becomes mandatory for all submission types. The current planning in the new version of the eSubmission Roadmap that was recently adopted by HMA currently says that the CESP dataset module will be live for all procedures before the end of 2021 and then becomes mandatory 6 months after.

Relevant documents, i.e. VNeeS guideline and VNeeS checker tool will be updated and published 6 months before mandatory use of PDF/A.

02-07-2019

The updated Q&A on PDF/A format is now available.

18-12-2018

Reminder of mandatory use of VNeeS for all submissions in National Procedures by 01 January 2019.

According to the Annex 3 to the HMA eSubmission Roadmap on the implementation of mandatory VNeeS format for Veterinary regulatory submissions, the use of VNeeS only for all submissions in National Procedures will be mandatory from Q1 2019.

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)

 

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’).

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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