Since 28 January 2022, veterinary medicines across the European Union have been governed by Regulation (EU) 2019/6, a directly applicable regulation that repealed Directive 2001/82/EC and rewrote almost every process a marketing authorisation holder depends on. Four years on, the compliance gaps we see are rarely about the headline principles. They are about operational detail: who submits what, into which database, and by when.
A regulation, not a directive
The shift from a directive to a regulation is more than a legal formality. Directive 2001/82/EC had to be transposed into national law, which produced twenty-seven variations on a theme. Regulation (EU) 2019/6 applies directly in every Member State, without transposition. For companies operating across several markets, that removes a layer of national divergence in the core rules, although national competent authorities still administer national authorisations, inspections and enforcement.
What the regulation reorganised
- Marketing authorisation routes. Centralised, decentralised, mutual recognition and national procedures all remain, with revised scope and timetables.
- Lifecycle management. Variations were reclassified into those requiring assessment and those not requiring assessment, with the latter handled through a notification model.
- Product data. The Union Product Database, managed by the European Medicines Agency and launched alongside the regulation in January 2022, became the single reference point for authorised products in the Union.
- Antimicrobial stewardship. Obligations on the collection and reporting of antimicrobial sales and use data, restrictions on antimicrobials reserved for human medicine, and conditions on use outside the terms of the authorisation.
- Pharmacovigilance. A move away from routine periodic reports towards continuous signal management supported by a pharmacovigilance system master file.
The dossier itself
Technical requirements for the marketing authorisation dossier sit in Annex II, as replaced by Commission Delegated Regulation (EU) 2021/805. The dossier is structured in parts covering the summary and administrative information, quality documentation, safety, and efficacy, with distinct expectations depending on whether the product is a non-biological, a biological, or an immunological veterinary medicinal product. Companies moving a human-medicines dossier team onto a veterinary file are often surprised by how different the residue, environmental and target-animal safety expectations are.
Where companies are still catching up
In our experience the recurring pressure points are data rather than science. Product records in the Union Product Database drift out of step with the approved summary of product characteristics. Notification-type variations are implemented but not submitted within the expected window. Antimicrobial data obligations are treated as a veterinarian’s problem rather than a shared one. None of these are difficult to fix, but all of them are visible to a competent authority.
How PQRA helps
PQRA supports pharmaceutical companies and animal health businesses across the full veterinary lifecycle: selecting the right authorisation route, building and maintaining the dossier under Annex II, managing variations and database records, and establishing pharmacovigilance and quality systems that hold up to inspection. We work with companies entering the Greek market for the first time and with established marketing authorisation holders tidying up legacy portfolios.
If you are reviewing your veterinary portfolio against Regulation (EU) 2019/6, get in touch with PQRA to discuss where the gaps are and what it takes to close them.
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