Applications and company responses should be submitted to the Veterinary Medicines Directorate.
This applies to applications for marketing authorisations, homeopathic registrations, animal test certificates, specific batch control, autogenous vaccines, non-food animal blood banks, and equine stem cell centres.
Applications and responses must be submitted electronically:
as an eSubmission in accordance with the TIGesVet guidelines available on the European Medicines Agency (EMA) website.
by email using Eudralink (normal email should not be used) to email@example.com. The maximum capacity of the email is 200 MB. The subject line should identify if it is a submission of an application or a response to the VMD.
using the Common European Submission Platform (CESP)
on CD sent to: Information Services, VMD, Woodham Lane, New Haw, Addlestone, Surrey KT15 3LS.
The TIGesVet guidelines state that each page within a file should be numbered. It does not specifically state whether the numbering should be sequential throughout the whole dossier so the VMD does not ask for this.
A root folder is part of the TIGesVet structure and should be the first folder you create when preparing your e-submission.
Following receipt of an application, the e-submission will be subject to technical validation. This is a check to make sure the technical requirements of the e-submission meet the TIGesVet guidelines. If the application fails technical validation, you will be informed and told what to do to bring your application up to standard.
The validation team will contact you if they need further information from you to bring your application up to standard. When submitting the information, please submit a replacement pdf file rather than just part of a pdf file as this helps maintain the integrity of the application dossier.
You should follow the naming conventions for the folder and files set out in the TIGesVet guidelines. For some software programmes using anything other than lower case letters, or numbers 0 to 9, can cause problems and you run the risk of your submission failing technical validation.
Although the application structure for national-only schemes do not completely fit within the TIGesVet guidelines, you may still submit your application electronically using as many of the principles laid out in the guidelines as possible, eg file size, naming conventions, and indexing. This applies to the following:
- marketing authorisations for parallel import (MAPI)
- exceptional marketing authorisations
- specific batch control
- animal test certificates (ATC)
- autogenous vaccine authorisations (AVA)
- non-food animal blood banks (NFABBA)
- equine stem cell centres (ESCCA)
Active substance master files (ASMF)
ASMFs may be submitted electronically and in Common Technical Document (CTD) or Notice to Applicants (NTA) format. However CTD format is preferred.
For information or queries email firstname.lastname@example.org