Section 6: Notice.

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°…