Part five: Health products

When permitted under article R. 5141-84, advertising of veterinary medicinal products to the public: 1° Is designed in such a way that the advertising nature of the message is obvious and the product is clearly identified as a veterinary medicinal product; 2° Contains at least : a) The name of the veterinary medicinal product ; b) Information essential for the proper use of the veterinary medicinal product; c) An express…

For the advertising mentioned in articles R. 5141-83 and R. 5141-84, the advertising texts and documents must be filed with the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, by any means giving a date certain, two months before they are distributed.

Advertising for … is subject to prior authorisation from the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail: 1° Antibiotics ; 2° Veterinary medicinal products subject to a risk management plan ; 3° Medicinal products presented as favouring the diagnosis, prevention or treatment of diseases classified as first category health hazards in the nomenclature provided for inarticle L. 201-1 of the Rural…

As long as the information concerning each medicinal product reproduces in full the summary of product characteristics mentioned in article R. 5141-15, publications intended to reference veterinary medicinal products are exempt from the authorisation provided for in article R. 5141-86. This exemption does not apply to publications by marketing authorisation holders and companies exploiting veterinary medicinal products.

Advertising of self-vaccines for veterinary use is prohibited. However, holders of the authorisation referred to in article L. 5141-12 may distribute information about their activities to veterinarians only. This information must comply with the terms of the authorisation provided for in article R. 5141-132.

The companies referred to in article R. 5142-1 are prohibited from directly or indirectly providing users and persons authorised to prescribe or dispense medicinal products with premiums, objects or products of any kind or from granting direct or indirect material advantages other than the price conditions in force. However, donations intended to encourage research and teaching for the benefit of public establishments or foundations recognised as being in the public…

I.-The amount of the tax provided for in 5° of 1 of I of article L. 5141-8 is set at : a) €2,000 per request for prior authorisation for advertising relating to a medicinal product and comprising up to five advertising supports and €400 for any additional support; b) €2,000 per request for prior authorisation for advertising relating to an advertising support for several veterinary medicinal products and €400 for…

I.-The marketing authorisation holders and the companies mentioned in article R. 5142-1 may only issue free samples of veterinary medicinal products to veterinarians who make a prior written request. II – Free samples may be issued for two years following the first effective marketing in France for : 1° A proprietary medicinal product benefiting from a first registration or a first marketing authorisation, or ; 2° A medicinal product which…