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Article R5141-79 of the French Public Health Code

To ensure that veterinary medicinal products comply with the declared formula, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may have samples taken by the agents mentioned in Article L. 5146-1 under the conditions set out in Article R. 5146-2. Samples may be taken from medicinal products and, if necessary, from raw materials, intermediate products or other constituents.

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Article R5141-80 of the French Public Health Code

Each sample consists of two samples. One sample is sent to the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (French National Agency for Food, Environmental and Occupational Health and Safety), while the other is kept by the establishment holding the stock for possible analysis by both parties. Samples are taken so that they are as identical as possible. Each sample contains the minimum quantity, in…

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Article R5141-81 of the French Public Health Code

For reasons of public health, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may require a company exploiting an immunological veterinary medicinal product to submit samples of each batch of the finished product and, if necessary, of the bulk product for inspection before it is placed on the market. At the request of the Director General of the Agence nationale de…

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Article R5141-82 of the French Public Health Code

Advertising for veterinary medicinal products means any form of information, including canvassing, canvassing or inducement, intended to promote the prescription, supply, sale or consumption of these veterinary medicinal products. The following are not included in the scope of this definition 1° Correspondence, accompanied, where appropriate, by any non-promotional document required to answer a specific question about a particular veterinary medicinal product; 2° Specific information and reference documents relating, for example,…

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Article R5141-82-1 of the French Public Health Code

Only veterinary medicinal products for which the authorisation referred to in article L. 5141-5 or the registration referred to in article L. 5141-9 has been obtained or which benefit from a parallel import authorisation pursuant to article L. 5142-7 may be advertised, in any form whatsoever. Advertising for veterinary medicinal products whose authorisation or registration has been suspended is prohibited.

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Article R5141-84-1 of the French Public Health Code

In all cases, advertising must not be misleading or undermine the protection of human or animal health. It must present the medicinal product objectively and encourage its proper use. It must never make veterinary consultation appear superfluous, nor be accompanied by promises or advantages of any kind, nor use attestations or expert opinions.

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Article R5141-85 of the French Public Health Code

Advertising of veterinary medicinal products to the natural or legal persons mentioned in article R. 5141-83 must include at least the following information: 1° The name of the medicinal product ; 2° The intended species ; 3° The qualitative and quantitative composition of the active ingredients; 4° The rules governing the prescription and supply of the medicinal product; 5° The therapeutic indications, contra-indications and side-effects included in or annexed to…

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Article R5141-85-1 of the French Public Health Code

The information contained in the advertisement mentioned in article R. 5141-85 for a veterinary medicinal product is consistent with the information contained in the summary of product characteristics mentioned in article R. 5141-15. This information is accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form a personal opinion of the therapeutic value of the medicinal product. All written information must be perfectly legible by the recipient of…

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