David Holguin

We have a question related to the specific guideline for provision of an electronic submission (e-submission) for a veterinary medicinal product.

This guideline assists the applicants and regulators with submissions of initial dossiers as well all the documents submitted during the registration process (such as the List Of Questions or the List of Outstanding issues for new veterinary vaccines). It specifies the basic parameters required for an acceptable electronic submission known as Veterinary Nees (VNees) with the specific structure of each part of the dossier (See figure below).

Our question is whether this VNeeS format will also be required during the registration procedure (i.e. submission of LOQ or LoOI to EMA)? and how will be handled in IRIS. Usually, there are a lot of files in these submissions and different folders are created according to the structure created with the VNeeS. After that, only one file was submitted via Synplicity with all the documents inside. 

Will this continue to be the case in IRIS? Or there will be changes with the implementation of IRIS related to the submission format of the initial dossiers? 

 

With the arrival of 2025 and the application of IRIS with immediate effect for the regulatory processes for veterinary health and after attending the training on the new IRIS platform, we have had a couple of questions that we would like to ask and see if anybody can help us with them.

1- First of them, an automatic deletion of draft submissions will be performed if more than 7 months have been spent without any modification of the draft. In the case of new regulatory procedures via centralised procedure or new variations finalised, will all the data submitted be deleted after 7 months? Or will always be available in the IRIS platform?

2- And the second question is related to the specific guideline for provision of an electronic submission (e-submission) for a veterinary medicinal product. This guideline assists the applicants and regulators with submissions of initial dossiers as well all the documents submitted during the registration process (such as the List Of Questions or the List of Outstanding issues for new veterinary vaccines). It specifies the basic parameters required for an acceptable electronic submission known as Veterinary Nees (VNees) with the specific structure of each part of the dossier (See figure below). Our question is whether this VNeeS format will also be required during the registration procedure (i.e. submission of LOQ or LoOI to EMA) and how will be handled in IRIS. Usually, there are a lot of files in these submissions and different folders are created according to the structure created with the VNeeS. After that, only one file was submitted via Synplicity with all the documents inside.
 

Good morning,
How we can see which mailboxes are set as product contacts?
Thank you.

Hello all, 

could you please clarify how could MAHs check if each of the products that are going to be migrated to IRIS do have appointed contact person and personal e-mail adress?

We were reading guidance regarding registration of all contacts in EMA Account Management System (IAM) which is mandatory by 31 October 2024 (or as soon as possible if products are already transitioned to IRIS) but did not find info how to double-check appointed persons and their e-mails. 

Many thanks in advance
Kind regards, 
David