Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

Article 11 Labelling of the outer packaging of veterinary medicinal products

1. The outer packaging of a veterinary medicinal product shall contain the following information and shall contain no information other than:

(a) the information referred to in Article 10(1);

(b) the contents by weight, volume or number of immediate packaging units of the veterinary medicinal product;

(c) a warning that the veterinary medicinal product must be kept out of the sight and reach of children;

(d) a warning that the veterinary medicinal product is ‘for animal treatment only’;

(e) without prejudice to Article 14(4), a recommendation to read the package leaflet;

(f) in the case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’;

(g) in the case of veterinary medicinal products not subject to a veterinary prescription, the indication or indications;

(h) the marketing authorisation number.

2. A Member State may decide that, on the outer packaging of a veterinary medicinal product made available in its territory, an identification code shall be added to the information required under paragraph 1. Such a code may be used to replace the marketing authorisation number referred to in point (h) of paragraph 1.

3. The information referred to in paragraph 1 of this Article shall appear in easily legible and clearly comprehensible characters, or in abbreviations or pictograms common throughout the Union, as listed in accordance with Article 17(2).

4. Where there is no outer packaging, all the information referred to in paragraphs 1 and 2 shall appear on the immediate packaging.