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 common name where the medicinal product contains only one active substance and bears an invented name;

2° The qualitative and quantitative composition in active substances per dosage unit or, depending on the form of administration, for a given volume or weight, using the common names;

3° The manufacturing batch number;

4° The marketing authorisation number;

5° The name or corporate name and address of the marketing authorisation holder and, where applicable, those of the company exploiting the medicinal product;

6° The intended animals, the method of administration, the route of administration; a space is provided to indicate the prescribed dosage;

7° The withdrawal period, for all the species concerned and for the various foodstuffs concerned, even if this is zero;

8° The expiry date in clear text;

9° Storage precautions, if applicable;

10° Special precautions for disposing of unused medicinal products or waste derived from veterinary medicinal products, together with a reference to any appropriate collection system in place;

11° Any other information required by the marketing authorisation decision;

12° The words "for veterinary use".

13° Where applicable, the words "to be dispensed only on prescription", together with a reference to the minimum shelf life of the prescription set by the decree provided for in the last paragraph of II of Article L. 234-1 of the Rural and Maritime Fishing Code and any reference resulting from the provisions adopted in application of the fourth paragraph of Article R. 5141-26; these words may appear only on the outer packaging;

14° The pharmaceutical form and the content by weight, volume or units of administration; this information may only appear on the outer packaging.

If there is no outer packaging, all the information which, by virtue of this article, should appear on the outer packaging, must appear on the immediate packaging.

The information provided for above shall be written in French. They may also be written in other languages, provided that the same particulars appear in all the languages used.

For medicinal products which have been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may authorise or require the outer packaging to bear additional information concerning distribution, possession, sale or any precautionary measures, provided that this information is not contrary to Community legislation or to the terms of the marketing authorisation.

This additional information must appear in a box with a blue border so as to be clearly separated from the information mentioned in 1° to 14° above.