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Updated on 08/04/2020

Legal classification of "borderline" products

The French Agency for Veterinary Medicinal Products (ANSES-ANMV) is regularly called upon to qualify the legal status of products with regard to French and EU regulations and to determine whether these products, their placing on the market, their production and distribution fall within the scope of the regulations on veterinary medicinal products.

To do this, ANSES-ANMV relies on the definition of a veterinary medicinal product according to European Directive 2001/82/EC as amended, which has been transposed into Articles L. 5111-1 and L. 5141-1 of the Public Health Code.

ANSES has drawn up a note defining its position regarding the classification of so-called "borderline" products, i.e. whether they fall within the scope of the veterinary medicinal product regulations or of other regulations. This note can be consulted via this link.

The Market Surveillance Unit registers, assesses and responds to applications for product qualification from various parties (manufacturers, government departments, veterinarians, etc.) in order to determine whether the products are subject to veterinary medicinal product regulations.

Regarding reports of products that do not comply with the regulations, the products in question must be brought into compliance.

For any request or question relating to the legal qualification of a product, please contact the Agency at the following address: