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