Part five: Health products

Any exclusive right to sell veterinary medicinal products to one or more categories of retailer is prohibited.

I.-The holders of marketing authorisations for veterinary medicinal products referred to in article L. 5141-1 and the companies involved in the manufacture and distribution of medicated feed declare to the competent administrative authority the veterinary medicinal products containing one or more antimicrobial substances which they sell or which are sold on their behalf on national territory. Manufacturers and distributors of medicated feed shall also mention the prescribing veterinarian and the…

On the occasion of the sale of veterinary medicinal products containing one or more antibiotic substances, discounts, rebates, the differentiation of general and special conditions of sale within the meaning ofarticle L. 441-1 of the French Commercial Code or the provision of free units and all equivalent practices are prohibited. Any commercial practice aimed at circumventing, directly or indirectly, this prohibition by granting discounts, rebates or discounts on another range…

The use in veterinary medicine of medicinal products or medicated feedingstuffs containing one or more antibiotic substances is carried out in compliance with recommendations for good use designed to prevent the development of risks to human and animal health associated with antibiotic resistance, established, on a proposal from the Agence nationale chargée de la sécurité sanitaire de l’alimentation, de l’environnement et du travail and after obtaining the opinion of the…

I.-Any breach of the prohibitions set out in the first paragraph of article L. 5141-14-2 is punishable by an administrative fine of up to €15,000 for a natural person and up to €75,000 for a legal entity. II – The amount of the fine mentioned in I of this article is doubled if the breach is repeated within two years of the date on which the first penalty decision became…

The dispensing of certain medicinal products by pharmacists or veterinary surgeons, where their pharmaceutical form so permits, may be by the unit, provided that the integrity of the immediate packaging and the conditions laid down in the marketing authorisation are respected.

Veterinarians established in another Member State of the European Union performing professional acts on an occasional basis, after having declared themselves as service providers, are subject to the provisions of Article 111 of Regulation (EU) 2019/6 of 11 December 2018 and to the regulatory provisions adopted pursuant to this Article. These veterinarians are subject to the rules on prescribing and dispensing set out in Article L. 5143-5.

Health professionals, establishments, persons or organisations appearing on a list established by decree in the Conseil d’Etat are required to declare any effects likely to be attributed to the use of a veterinary medicinal product. This decree also determines the obligations of these professionals with regard to the declaration of the effects of a medicinal product for human use administered to an animal, including under the conditions provided for in…

The following shall be determined, as necessary, by decree in the Conseil d’Etat: 1° The conditions under which the additional information provided for in Article 13 of Regulation 2019/6 of 11 December 2018 may be displayed on the immediate packaging or outer packaging of veterinary medicinal products ; 2° The procedures applicable to applications for a marketing authorisation for a veterinary medicinal product and to variations thereto, as well as…