The Union Product Database sits at the centre of Regulation (EU) 2019/6. Launched in January 2022 and managed by the European Medicines Agency, it is the single Union-wide register of authorised veterinary medicinal products. For a marketing authorisation holder it is not a passive record: it is a live compliance obligation, and the quality of what sits in it is visible to every competent authority in the Union.
What the database holds
The database brings together product information for veterinary medicinal products authorised in the Union, whatever the route of authorisation. That includes the identifying data for the product, the authorisation details, and the product literature. Because it is Union-wide, it replaces the patchwork of national registers that companies previously had to reconcile by hand.
Why it is an obligation, not a convenience
Two duties in particular turn the database from a reference tool into a workload:
- Variations not requiring assessment. Under Regulation (EU) 2019/6, minor changes listed in Commission Implementing Regulation (EU) 2021/17 are implemented first and recorded afterwards. Active use of the database for these submissions is obligatory for the marketing authorisation holder, and the notification window is short.
- Availability and volume data. The regulation places reporting duties on holders in relation to their products on the Union market. Where these are handled as an afterthought, they tend to be late.
Where records drift
The common failure is quiet rather than dramatic. A variation is approved nationally and the summary of product characteristics is updated, but the database entry is not. A product is withdrawn from one market and the record still shows it as marketed. A pack size is discontinued and nobody closes the loop. Individually these look trivial. Collectively they make a portfolio look unmanaged, and they are the first thing an inspector or assessor can check without asking you for anything.
Practical controls that work
- Assign named ownership of database records per product, not per project.
- Make the database update a mandatory step in the variation workflow, with the submission reference captured before the change is signed off as complete.
- Reconcile the database against your own product master data on a fixed cycle rather than when something goes wrong.
- Check that the entry and the approved product literature say the same thing, in the same language versions.
- Keep an audit trail of who changed what, so that a query years later does not become an archaeology project.
How PQRA helps
PQRA manages Union Product Database records on behalf of marketing authorisation holders, including notification-type variation submissions, reconciliation of entries against approved product information, and clean-up of legacy portfolios where records have fallen out of step. We also build the internal procedures that keep records current once the backlog is cleared, so that the database becomes a by-product of good process rather than a separate project.
If your veterinary product records need review, contact PQRA for a portfolio assessment.
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