Since June 1, 2018, the National Competent Authorities no longer accept veterinary submissions for Centralized Procedures via CD, DVD or Eudralink. This means that the EMA eSubmission Gateway / Web Client is now the only route for VNeeS submissions.
On September 1, 2018 a further regulation came into effect, mandating that all processes coordinated by the EMA must be included in the Common Repository. These are automatically maintained by the EMA (eSubmission Gateway / Web Client).
The Common Repository had already been required since last year for all Human Centralized Procedure submissions. Now the mandate is being extended to bring the same benefits to veterinary submissions.
The Common Repository has shortened the retrieval and validation time for inbound applications. It also provides continuous and immediate access to up-to-date dossiers. Another effect of the change has been to reduce the number of submissions sent by the applicants / MAHs, which in turn reduces the time and resources needed to handle them.
European NCAs no longer have to retrieve submission data directly; they now have access to the Common Repository for searching, browsing, and downloading. For this reason, electronic or physical data should no longer be transmitted directly to the NCAs. In fact, doing this may actually cause a delay in the processing of your application.
LORENZ would like to help you to comply with all of these regulations, and to make your transition as smooth as possible. For example, with the VNeeS version of our workstation solution docuBridge ONE, you can easily manage the conversion and import the necessary data into our solution. In addition, our software ensures that your current and future submissions all comply with the latest regulations from the Health Agency.
If you are interested in LORENZ docuBridge ONE VNeeS, please click here for more information about our docuBridge ONE solution or click here to go directly to our online store. After your purchase, you can install the software right away – and start submitting in no time!