ANSES-ANMV is responsible for controlling the advertising of veterinary medicinal products. For this reason, all advertising documents must be submitted to the Agency, and some even require authorisation, before being distributed.
The article has been added to your library
Updated on 22/04/2020
Advertising of veterinary medicinal products
The work of ANSES-ANMV involves initially verifying that advertising includes the statements defined by the regulations. The Agency then examines the consistency between the advertising message and the summary of product characteristics (SPC, annex to the MA decision that describes the authorised conditions of use for a given medicinal product). ANSES-ANMV also studies the literature references documenting the claims.
Presentation of the regulations on advertising of veterinary drugs:
The decree introduces the definition of the concept of advertising and, conversely, specifies the cases that do not fall within its scope.
Advertising covers all forms of information (including canvassing), prospecting or inducement aimed at promoting the prescription, dispensing, sale or consumption of these veterinary medicinal products.
Advertising in any form whatsoever is only possible for medicinal products that have obtained an administrative authorisation, i.e. a national or European marketing authorisation, a parallel import authorisation or a registration.
In the event that the authorisation is suspended, advertising is prohibited.
Advertising for autogenous vaccines is maintained under its current regime, i.e. prohibited except for institutional information.
One of the main changes concerns the extension of the prior authorisation scheme. Previously, this scheme only concerned the advertising of medicines designed to combat Category 1 and 2 health hazards.
ANSES also issued advertising approval for television and radio commercials intended for the public.
From now on, advertisements subject to authorisation concern veterinary medicinal products containing antibiotics, veterinary medicinal products subject to a risk management plan, those intended to combat Category 1 health hazards and those containing hormones.
Similarly, all advertising to the public is now subject to prior authorisation, regardless of the type of veterinary medicinal product.
These authorisations are valid for two years.
Other advertisements remain subject to prior submission.
Applications for authorisation and advertising submissions must be made two months prior to publication.
Two categories of legal persons may be the targets of the advertisements:
- beneficiaries (pharmacists, veterinarians) for all medicinal products;
- the general public for non-prescription drugs.
Advertising to animal breeders is therefore only possible for non-prescription veterinary medicinal products.
The legal notices that must appear in advertisements are minimal and depend on the recipients of the advertisement. A special statement must appear for antibiotics: any advertisement for veterinary antibiotics must include a message stating that any antibiotic prescription has an impact on bacterial resistance and must be justified.
The offering of samples is defined more restrictively: it is only permitted in the first two years following the actual marketing in France or after a major amendment to the MA (new dosage, new pharmaceutical form, extension of indications).
The decree also defines advertising in favour of a veterinary pharmaceutical company or establishment: this concerns any information document of a scientific, technical or financial nature that does not aim to promote a veterinary medicinal product.
Guide to good advertising practices (in French) : this brings together in a single document all the regulations and recommendations concerning the advertising of veterinary medicinal products.
Contact at ANSES-ANMV: Gwénaëlle Nouail – email@example.com