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 112 to 114 of Regulation (EU) 2019/6, and it is narrower than many people assume. Understanding where the cascade ends matters as much to marketing authorisation holders as it does to prescribing veterinarians, because it defines the edge of your product’s lawful use.
Three articles, three situations
- Article 112 covers non-food-producing animal species.
- Article 113 covers food-producing terrestrial species.
- Article 114 covers food-producing aquatic species.
The hierarchy
Where no authorised veterinary medicinal product is available for the condition, the veterinarian works down an order of preference: first a veterinary medicinal product authorised in that Member State or another Member State, for the same or another species; then, if none exists, an authorised human medicinal product; and finally, if neither is available, a veterinary medicinal product prepared extemporaneously. The order is not a menu. It is a sequence, and each step is only reached when the one above it is genuinely exhausted.
Cascade use is not the same as off-label use
This distinction is the one most often blurred. Off-label use means use of a veterinary medicinal product that is not in accordance with the summary of product characteristics. Cascade use is the narrower set of circumstances covered by the legal derogations. Use that falls outside those derogations is not a grey area; it is unlawful. For companies, that matters when commercial or medical teams are asked about uses beyond the authorised indication.
Antimicrobials under the cascade
The cascade does not give free rein on antimicrobials. Commission Implementing Regulation (EU) 2024/1973, published in July 2024, establishes a list of antimicrobials that shall not be used under Articles 112 and 113, or that may only be used under those articles subject to certain conditions. Separately, substances reserved for human medicine under Implementing Regulation (EU) 2022/1255 are prohibited in animals outright, so the cascade offers no route to them.
Residues and withdrawal periods
When the cascade is used in food-producing animals, withdrawal periods must be set to protect the consumer. The regulation prescribes how to derive them where the product carries no withdrawal period for the species concerned. For eggs, for example, the longest withdrawal period in the summary of product characteristics for any species is multiplied by a factor of 1.5, or a default of ten days applies where the product is not authorised for animals producing eggs for human consumption.
How PQRA helps
PQRA advises marketing authorisation holders on the boundary between authorised use, cascade use and unlawful off-label use, including how that boundary should shape product information, medical information responses and commercial training. We also support companies assessing whether a recognised cascade practice justifies pursuing a formal authorisation for an additional species or indication.
For advice on veterinary product use and indication strategy, contact PQRA.
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