With the pressure mounting to implement the New Veterinary Regulations (NVR) which came into force 28th January 2022, releases of the Union Product Database (UPD) to be implemented under the NVR are getting more frequent. In true software development fashion, is the EMA using the Agile approach to get solutions out more frequently and much quicker?

First things first: What is the Union Product Database?

The New Veterinary Regulations EU 2019/6 came into force 28th January 2022. Under the NVR, the European Medicines Agency (EMA) shall establish and maintain a Union Product Database as we highlighted in previous blogs here. But the UPD is still under development with the EMA releasing new versions of the software in a true Agile fashion. The latest iterative version v1.5.3-4 has just been released with a number of improvements and corrections.

What is Agile?

Agile is the ability to create and respond to change. It is a way of dealing with, and ultimately succeeding in, an uncertain and turbulent environment. Key Agile concepts include:

  • Incremental development: Agile teams usually favour an incremental development strategy where each release is usable and an expansion upon the previous version.
  • Iterative development: Agile projects are mostly iterative, allowing to repeat software development such as when prototyping.

Now to the changes in UPD v1.5.3-4, what is new?

With the latest release of the UPD there are new features implemented for MAHs that can be summarised as follows:

  • Search/view/export product (data and documents)
  • Notifications for Create and Update of products
  • Download, Submit and View Volume of Sales information
  • Submit VNRA (Variations Not Requiring Assessment) and View VNRA submissions
  • Submit updates for Marketing authorisation stat

There is also new functionality supporting the API:

  • Create MRP (data and documents)
  • Update Common Data for products under DCP/MRP (data and documents)
  • Update National Data for products under MRP (data and documents)

The (known) issues

Good progress has been made in getting the next version of the UPD ready for MAHs, NCAs, and every other member of the veterinary medicinal product community. There are however a fair number of issues still outstanding, with UPD 7992 and 7994 as mentioned in our previous blog being only two of them. Both were around the submission of sales data to be delivered by the MAH.

In summary

Again, good progress has been made with the UPD development in only a couple of weeks and new functionality has been made available to search and update data. Delivering the UPD via an Agile development process has certainly worked well, especially considering the tight deadlines. Nevertheless, there are still outstanding issues that need to be addressed and with the NVR now in force, urgent attention to these issues is required.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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