The EMA recently released a draft version 3.0 of the VNeesS specification for the provision of electronic submissions for veterinary medicinal products in the EU. Although more updates are expected, the EMA states that the basic folder structures of the draft specification are not subject to further changes. But what have Marketing Authorisation Holders (MAHs) to look out for?
Why has the VNeeS specification been updated?
The main reason for adapting the VNeeS guidance document is to align with Regulation (EU) 2019/6. One example being the change for “Variations / Extension” as shortly the marketing application will be valid for an unlimited period.
What is the impact of changes undertaken to the file/folder structure?
For a start, suppliers have to update their software to incorporate the new file/folder structure. This will lead to a new software release for MAHs in some form, with the supplier either providing a new software package or updating the database tables holding the relevant information. In any case, updates are required.
Marketing Authorisation Holders have to adapt the changes in file/folder structure too. In case of a more manual submission process, the naming conventions need to be incorporated into the current process. In case Marketing Application Holders are utilising publishing software or RIM solutions, software upgrades are required. This could be time consuming and requires additional resources.
In addition, there is another obstacle to look out for: references to section “4a3-tas” that use the section name might not be valid anymore. Further details are outlined below.
Last but not least the VNeeS checker has to be updated, providing support for the new file/folder structure and change in folder names.
What needs to change?
There are subtle changes that nevertheless need to be taken care of. Comparing for example file/folder structures for VNeeS 2.7 against VNeeS 3.0 (draft) for “Folder structure and Standard files for an electronic application for a pharmaceutical product”, we can pick up the following:
The proposed new file/folder structure is as follows:
Checking the same Table under “Folder structure and Standard files for an electronic application for a pharmaceutical product”, we can also identify a new sub section in Part 4a (Part 4a3-dose-determ). Incidentally, this moves the current sub-section Part 4a3 to become the new Part 4a4.
From the outside, the changes in the new VNeeS file/folder structure are subtle. However, considering that software suppliers have to update the VNeeS file/folder structures and their validation engines and MAHs have to update their system, whether RIM or publishing tools, work has to be undertaken on both sides. As of today, no mandatory date for the VNeeS 3.0 implementation has been published but software suppliers as well as MAHs need to prepare accordingly.