Title IV: Veterinary medicinal products

The Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may suspend the testing, manufacture, preparation, import, use, export, wholesale distribution, packaging and placing on the market, whether free of charge or in return for payment, the holding with a view to sale or distribution free of charge, advertising, prescription, dispensing, use or administration of a veterinary medicinal product or a category of veterinary medicinal products not…

Without prejudice to any criminal proceedings that may be brought, where a veterinary medicinal product is placed on the market or used without having obtained the prior authorisation or registration required by the provisions of Regulation (EU) 2019/6 of 11 December 2018 or this Title, or is placed on the market or used in disregard of those provisions, the Agency may suspend, the testing, manufacture, preparation, import, use, export, wholesale…

In the event of failure to comply with the rules laid down in application of 9° of article L. 5141-16 relating to advertising, the Agency may: 1° Order the suspension or prohibition of advertising ; 2° Order the inclusion in the advertisement of warnings and precautions for use necessary to inform the user or the distribution of a correction; 3° Withdraw authorisation to advertise medicinal products presented as favouring the…

In the cases provided for in articles L. 5145-2-1 and L. 5145-2-2 as well as in the case of suspension or withdrawal of a marketing authorisation or registration of a veterinary medicinal product, the Agency may order the person responsible for placing the product on the market to withdraw the medicinal product from any place where it is found, or to destroy it when the medicinal product presents a danger…

The Director General of the Agence nationale de la sécurité sanitaire de l’alimentation, de l’environnement et du travail may impose financial penalties on natural or legal persons producing or marketing veterinary medicinal products mentioned in article L. 5141-2 or providing services associated with these veterinary medicinal products, financial penalties and, where appropriate, daily fines in the event of failure to comply with the following obligations: 1° The obligation, for the…

When, during an inspection, the agents of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail observe a breach of the provisions applicable to the activities and veterinary medicinal products mentioned in article L. 5141-2, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may order the person concerned to rectify the situation within a period of time…

Decrees in the Conseil d’Etat shall specify, where necessary: 1° The rules of procedure applicable in the event of the penalty provided for in articles L. 5145-3 to L. 5145-5, as well as the methods for calculating the periodic penalty payment ; 2° The procedures for applying articles L. 5145-2-1 and L. 5145-2-2.