Section 5: Labelling.

Without prejudice to the information required by the legislative and regulatory provisions relating to poisonous substances, the labelling of the immediate packaging and the outer packaging of a veterinary medicinal product which is the subject of a marketing authorisation must include the following information, in accordance with the marketing authorisation, which is legible, comprehensible and indelible: 1° The name of the medicinal product, the strength, the pharmaceutical form and the…

Ampoules and other small primary packagings on which it is impossible to include all the particulars provided for in Article R. 5141-73 may include only the following information: 1° The name of the medicinal product ; 2° The quantitative composition in active substances; 3° The route of administration; 4° The batch number; 5° The expiry date; 6° The words “for veterinary use”. In this case, the outer packaging must include…

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.