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Batch Release of Veterinary Vaccines: Article 128, OCABR and OBPR
Immunological veterinary medicinal products carry a control step that most other veterinary products do not. Under Article 128 of Regulation (EU) 2019/6, a Member State[…]
Limited Markets and Exceptional Circumstances: Articles 23 and 25 for Veterinary Products
Some veterinary products will never justify a full development programme. The species is too small a market, the disease is rare or geographically confined, or[…]
Maximum Residue Limits and Withdrawal Periods: The Consumer Safety Gate for Food-Producing Species
Any veterinary medicinal product intended for food-producing animals has to clear a gate that does not exist in human medicine: the residue assessment. EU law[…]
Medicated Feed Under Regulation (EU) 2019/4: Where Pharma Meets Feed Law
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)[…]
The Veterinary Cascade: Articles 112, 113 and 114 in Practice
The cascade is the legal derogation that allows a veterinarian to treat an animal when no authorised product fits. It is set out in Articles[…]
Reserved Antimicrobials: What Regulation (EU) 2022/1255 Closes Off to Veterinary Use
Commission Implementing Regulation (EU) 2022/1255 of 19 July 2022 designates antimicrobials and groups of antimicrobials that are reserved for the treatment of certain infections in[…]
Antimicrobial Use Reporting Under Article 57: The Species Timetable Running to 2030
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[…]
Building a Veterinary Pharmacovigilance System Under Regulation (EU) 2019/6
Veterinary pharmacovigilance under Regulation (EU) 2019/6 is not a scaled-down version of the human system. It is built around continuous signal management rather than routine[…]
Veterinary Variations: Telling VNRAs and VRAs Apart, and Why It Matters
Regulation (EU) 2019/6 abandoned the familiar human-medicines variation categories and replaced them with a binary split: variations not requiring assessment, and variations requiring assessment. The[…]
Veterinary GMP Has Changed: Regulations (EU) 2025/2091 and 2025/2154 Now Apply
Since 16 July 2026, good manufacturing practice for veterinary medicinal products has been set out in directly applicable EU law rather than in guidance. Commission[…]