In the case of small immediate packaging other than ampoules containing only one dose of use and on which it is impossible to include all the information provided for in Article R. 5141-74, the information provided for in Article R. 5141-73 appears only on the outer packaging.
The inclusion of an information leaflet for the user in the packaging of a medicinal product is compulsory, unless the information mentioned in article R. 5141-77 appears directly on the outer packaging or the immediate packaging. When an information leaflet is attached to the packaging of a veterinary medicinal product, it relates solely to that medicinal product and its various strengths and presentations, unless a derogation is granted by the…
The leaflet is drawn up in accordance with the summary of product characteristics. It includes : 1° The name or corporate name and address of the marketing authorisation holder and, where appropriate, those of the company exploiting the medicinal product, as well as, if they are distinct, those of the manufacturer or manufacturers; 2° The name of the veterinary medicinal product followed by the strength and pharmaceutical form as well…
Packages or containers of medicated feedingstuffs, including those prepared extemporaneously under the conditions provided for in articles L. 5143-2 and L. 5143-3, bear the words “medicated feedingstuffs” printed on both sides in clearly visible letters at least four centimetres high. The labelling of medicated feedingstuffs is blue in colour and includes the information required by the regulations applicable to the labelling of foodstuffs as well as the following information: 1°…
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.
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…
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…
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,…
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.
Advertising in favour of veterinary medicinal products is only authorised in relation to those which they are authorised to prescribe or supply by natural or legal persons authorised to supply them by articles L. 5143-2 and L. 5143-6.
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75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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