The mission of ANMV aims, first of all, at checking that the advertisements contain the information defined by the legislation. The Agency then examines the consistency between the advertising message and the summary of product characteristics (annex to the MA decision which describes the conditions of use authorised for a given medicinal product). ANMV also studies bibliographical references that the document claims.
As a reminder, advertising for veterinary medicinal products may be carried out only by the holder of the marketing authorisation for the medicinal products concerned by the advertising or by the person declared by the MA holder under the conditions laid down in Article L. 5142-1-5 of the Public Health Code.
Definition
Advertising of veterinary medicinal products means any representation, in any form, related to veterinary medicinal products, with a view to promoting the supply, distribution, sale, prescription or use of veterinary medicinal products, including the provision of samples and sponsorship.
Only veterinary medicinal products that are authorised or registered in France may be advertised.
The suspension of a marketing authorisation shall exclude any advertising of the veterinary medicinal product, during the period of such suspension, in the Member State where the authorisation is suspended.
Prior authorisation
Advertisements subject to authorisation shall relate to:
- veterinary medicinal products containing antimicrobials;
- veterinary medicinal products subject to a risk management plan;
- veterinary medicinal products promoted as enabling the diagnosis, prevention or treatment of diseases referred to in Article L221-1 of the Rural and Maritime Fisheries Code;
- veterinary medicinal products containing substances with anabolic, anticatabolising and beta-agonist activity;
- immunological veterinary medicinal products intended for animal keepers in a professional environment.
These authorizations are valid for two years. However, they shall end before the expiry of that period if the marketing authorisation or registration has been varied.
Other advertisements are subject to prior declaration.
All advertising filings must be made two months before their dissemination.
Addressees
Advertisements for veterinary medicinal products may be addressed to several categories of natural or legal persons:
- the persons authorised to issue them by Articles L. 5143-2 and L. 5143-6, for those whom they are authorised to prescribe or issue (veterinarians, pharmacists, persons responsible for the derogating circuit);
- keepers of animals in a professional context;
- the public.
Free sample
Marketing authorisation holders and authorised establishments referred to in Article L. 5142-2 may issue free samples of veterinary medicinal products only to natural or legal persons authorised to prescribe or issue them in accordance with Articles L. 5143-2 and L. 5143-6 who make a prior written request.
Such samples shall not contain antimicrobials or substances classified as psychotropic or narcotic, or to which the regulation of narcotic drugs is applied in whole or in part.
Other information
The Decree also defines advertising in favour of a veterinary pharmaceutical company or establishment: This applies to any scientific, technical or financial information document not intended to promote a veterinary medicinal product.
To access the thematic file
The guide to good advertising practices brings together in a single document all the rules and recommendations relating to the advertising of veterinary medicinal products.
If you have any questions about advertising, you can contact the Agency at the following address : publicite-anmv@anses.fr