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14/02/2022

Legal classification of "borderline" products

The National Veterinary Medicines Agency (Anses-ANMV) is regularly requested in order to classify the legal status of products under French and Community regulations and to determine whether or not these products, their marketing, production and distribution are covered by the rules on veterinary medicinal products.

To this end, Anses-ANMV relies on the definition of veterinary medicinal product, in accordance with European Directive 2001/82/EC, as amended, transposed in Articles L. 5111-1 and L. 5141-1 of the Combined Public Health Code. 

ANSES has drawn up a note setting out its position on the classification of ‘frontier’ products, namely whether they are covered by the regulation of veterinary medicinal products or other regulations. This note can be found here (PDF).

The Market Surveillance and Pharmacovigilance Unit registers, evaluates and replies to product qualification requests from various stakeholders (industry, state services, veterinarians, etc.) in order to determine whether or not they are dependent on the regulation of veterinary medicinal products.  

In the case of alerts on products which do not comply with the rules, the products in question must be brought into conformity.

To access the thematic file

For any request or question concerning the legal classification of a product, you can contact the Agency at the following address : usm@anses.fr ou Qualif_ANMV@anses.fr