Article 57 of Regulation (EU) 2019/6 requires Member States to collect data on the volume of sales and on the use of antimicrobial medicinal products in animals and to send collated data to the European Medicines Agency, which analyses it and publishes annual reports. The obligation is being phased in by animal species, and the next phase affects a much wider range of species than the first.
The phased timetable
- Phase one. Data on antimicrobial use in cattle, pigs, chickens and turkeys, covering all categories and production stages, has been collected and reported yearly to the Agency since 30 September 2024.
- Phase two. Data on other food-producing species is collected from 1 January 2026, with yearly reporting to the Agency beginning 30 June 2027. This phase brings in sheep, goats, horses, geese, ducks, rabbits raised for food production, and farmed fish including Atlantic salmon, rainbow trout, gilthead seabream, sea bass and carp.
- Phase three. Data on non-food-producing species, namely dogs, cats and fur animals, is collected and reported yearly to the Agency starting from 30 June 2030.
The format of the data to be collected and reported is established in Commission Implementing Regulation (EU) 2022/209.
Why this reaches marketing authorisation holders
The legal reporting duty sits with Member States, which is why some companies treat Article 57 as somebody else’s problem. That is a mistake for three reasons. National collection systems draw on sales and distribution data that originates with marketing authorisation holders and wholesalers. Species and production-stage attribution depends on product information that only the holder controls. And once national and Union-level use data is published, it becomes the evidence base for stewardship policy, prescribing restrictions and, eventually, commercial pressure on specific product classes.
What to get right now
- Confirm which of your products fall within the antimicrobial scope and which species they are authorised for.
- Check that product records, including those in the Union Product Database, carry accurate species and pharmaceutical form data, because attribution depends on it.
- Understand how the Greek national collection system draws data from your distribution chain, and who in your organisation is the contact point.
- For phase two species, recognise that collection is already under way, even though the first reporting deadline to the Agency is in 2027.
- Read your own use data before a regulator interprets it for you.
The strategic reading
Antimicrobial use data is becoming a visible, comparable, published metric across the Union. For companies with antimicrobial products in their veterinary portfolio, the sensible posture is to understand where those products sit in the emerging picture and to plan accordingly, rather than to be surprised by an annual surveillance report.
How PQRA helps
PQRA advises animal health companies on antimicrobial stewardship obligations under Regulation (EU) 2019/6, including product classification, data quality in product records, engagement with the Greek national collection system, and interpretation of published Union surveillance data for portfolio planning.
To discuss your antimicrobial portfolio and its reporting exposure, contact PQRA.
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