Regulation (EU) 2019/4, adopted on 11 December 2018, governs the manufacture, placing on the market and use of medicated feed. It sits alongside Regulation (EU) 2019/6 as the second half of the EU’s veterinary medicines reform, and it applies to feed business operators rather than to pharmaceutical manufacturers. For companies whose veterinary products are incorporated into feed, that split creates a compliance interface that is easy to under-manage.
What the regulation sets out to do
The regulation establishes rules for producing, selling and using medicated feed more responsibly, with the containment of antimicrobial resistance as an explicit driver. It repealed Council Directive 90/167/EEC and amended Regulation (EC) No 183/2005 on feed hygiene, bringing medicated feed into a single directly applicable framework.
The core requirements
- Authorised products only. Medicated feed may be manufactured only with veterinary medicinal products authorised for the purpose of manufacturing medicated feed, and the compatibility of all compounds used must be ensured for safety and efficacy.
- Prescription. Supply to the animal keeper depends on a veterinary prescription under Article 16, although manufacture and placing on the market may precede it.
- Cross-contamination control. Feed business operators manufacturing, storing, transporting or placing medicated feed or intermediate products on the market must apply measures to avoid cross-contamination.
- Facilities, personnel and quality control. The regulation sets expectations across the chain, including hygiene and access control, staff training, separation of manufacturing and quality control functions, homogeneous dispersal of the veterinary medicinal product in the feed, and controlled storage and transport.
The interface problem
The veterinary medicinal product is authorised under one regime and incorporated under another, by a different operator, often in a different company. The marketing authorisation holder controls the product information, the compatibility data and the authorisation for use in medicated feed. The feed business operator controls the manufacturing conditions and the cross-contamination controls. Neither can discharge the other’s duties, but a failure at the interface lands on the product.
In practice this means the summary of product characteristics needs to give the feed manufacturer what it actually needs, technical queries need a route into the marketing authorisation holder that does not depend on a commercial contact, and contractual arrangements should make the respective responsibilities explicit rather than assumed.
The antimicrobial overlay
Substances reserved for human medicine under Commission Implementing Regulation (EU) 2022/1255 may not be used in medicated feed. Antimicrobial products incorporated into feed also sit within the wider stewardship expectations of Regulation (EU) 2019/6, including the data collection framework under Article 57.
How PQRA helps
PQRA supports animal health companies at the medicated feed interface: confirming that product authorisations cover the intended route, reviewing product information for adequacy from the feed manufacturer’s perspective, structuring technical and quality agreements with feed business operators, and assessing antimicrobial stewardship exposure across feed-incorporated portfolios.
For support with medicated feed compliance, contact PQRA.
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