Veterinary medicinal product

A veterinary medicinal product is any substance or combination of substances presented as having properties for treating or preventing disease in animals, or which may be used in or administered to animals with a view to restoring, correcting or modifying physiological functions, making a medical diagnosis or carrying out euthanasia. Its regime is laid down by Regulation (EU) 2019/6, applicable since 28 January 2022, which replaced Directive 2001/82/EC and applies directly in the Member States. In France, the competent authority is the National Agency for Veterinary Medicinal Products, which is part of Anses.

Marketing authorisation

The Regulation retains the centralised, decentralised, mutual recognition and national procedures, the centralised procedure being mandatory for certain categories, in particular medicinal products derived from biotechnological processes. Assessment at Union level is entrusted to the Committee for Medicinal Products for Veterinary Use of the European Medicines Agency. The Regulation abolished the five-yearly renewal, the authorisation now being in principle granted for an unlimited period, and it thoroughly overhauled pharmacovigilance, which is now based on signal management.

Protection of technical documentation

The Regulation grants the applicant a period of protection of technical documentation during which a generic may not refer to it. The basic period is ten years for the main species, such as cattle, sheep raised for meat, pigs, chickens, dogs and cats, and it is longer for antimicrobials, for bees and for other species, with possible extensions where the authorisation is extended to new species. This regime, more fragmented than the data exclusivity applicable to medicinal products for human use, weighs heavily on development strategy.

Use, antimicrobial resistance and patents

Veterinary prescription is regulated, and the veterinarian may, by way of derogation and under his or her own responsibility, use a medicinal product outside the terms of its authorisation under the cascade principle. The Regulation strengthens the fight against antimicrobial resistance by allowing certain antimicrobials to be reserved for human use and by strictly limiting their preventive use. Veterinary medicinal products are patentable under the ordinary conditions and may benefit from a supplementary protection certificate, since Regulation (EC) No 469/2009 covers medicinal products for both human and veterinary use. The exclusion of methods of treatment also applies to the animal body.

Key points

Since 2022, veterinary medicinal products have been governed by a directly applicable EU regulation, separate from the texts on medicinal products for human use. The authorisation is in principle unlimited in time, and documentation protection varies according to the target species. Before any extension strategy, the effect of a new target species on the duration of regulatory protection should be checked and aligned with the timetable of patents and supplementary protection certificates.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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