Veterinary medicine - ANMV

Veterinary medicinal products which are intended for an exhaustive list of species kept only as pets : aquarium or pond animals, ornamental fish, apartment birds, travelling pigeons, terrarium animals, small rodents, ferrets and rabbits benefit from a simplified marketing procedure.

Regulation (EU) 2019/6 establishes an EU-wide pharmacovigilance system led by the European Medicines Agency (EMA) in collaboration with Member States for all veterinary medicinal products authorised in at least one EU country. The entry into force of this Regulation on 28 January 2022 brought a change of approach to pharmacovigilance which is now based on a signal detection process. This system allows active and continuous monitoring of pharmacovigilance data in order to detect potential safety problems early. For more information

Antiparasitics containing fipronil account for nearly one-third of adverse drug reactions reported in pet rabbits. These products, intended for use in dogs and cats, should not be administered to rabbits.

On 30 May 2023, the European Union (EU) and the United States made significant progress towards mutual recognition of inspections of manufacturers of chemical veterinary medicinal products.

The provisions relating to the advertising of veterinary medicinal products are regulated by the European Regulation 2019/6 and supplemented, in France, by other obligations added in the Public Health Code (PHC). The main French provisions are as follows: Advertising for veterinary medicinal products may only be carried out by the marketing authorisation holder (MAH) of the medicinal products concerned by the advertisement or by the representative declared by the MAH in accordance with the provisions of Article L.5142-1.5 - I of the PHC. Only authorised veterinary medicinal products (marketing authorisation or parallel trade) or registered in France may be advertised in any form. Advertising in favour of veterinary medicinal products shall be authorised to physical person or legal entity authorised to issue them by Articles L. 5143-2 and L. 5143-6 of the PHC only for those whom they are authorised to prescribe or to issue. Public advertising is only possible for veterinary medicinal products not subject to veterinary prescription. Where medicinal products are being promoted to persons qualified to prescribe or supply them in accordance with the Regulation, no gifts, pecuniary advantages or benefit in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of prescription or supply of medicinal products. All advertising materials must be submitted to Anses-ANMV for declaration or authorisation, at least 2 months prior to their dissemination (transmission of the projects to publicite-anmv@anses.fr ).

Joint interview with Jean-Pierre Orand, Director of the French Agency for Veterinary Medicinal Products (ANMV) within ANSES, and Caroline Semaille, Deputy Director General in charge of Operations at the French Health Products Safety Agency (ANSM).