EU clarifies when the cascade may be used for prescribing veterinary medicines

The European Commission has published recommendations clarifying the application of the veterinary medicines cascade, with the aim of helping veterinarians determine in which situations it is justified to use this exceptional mechanism.

The document, prepared by the Standing Committee on Veterinary Medicinal Products, addresses the combined application of the standard prescribing of veterinary medicines and cascade prescribing, as regulated respectively in Articles 106(1) and 112 to 114 of Regulation (EU) 2019/6.

The recommendations clarify that the existence of an authorized veterinary medicinal product for a given species and indication does not automatically preclude the use of the cascade. According to the Commission, this mechanism may be justified when the specific circumstances of a clinical case are not adequately covered by the terms of the marketing authorization for the available product. The document also provides examples of clinical situations in which this exception may apply.

The cascade allows a veterinarian, on an exceptional basis and under their professional responsibility, to use a veterinary medicinal product outside its authorized conditions of use when no authorized and available alternative exists to adequately treat the animal.

The expert group notes that a marketing authorization defines the target species, indications, and conditions of use for which the product's quality, safety, and efficacy have been demonstrated, while recognizing that such authorizations cannot cover every clinical scenario that may arise in veterinary practice.

The recommendations also state that the cascade should not be used to address widespread efficacy or safety issues arising from the use of a product in accordance with its authorized conditions, nor to justify systematic deviations from the authorized conditions when these do not respond to the specific clinical needs of the animal being treated.