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

Article 10 Labelling of the immediate packaging of veterinary medicinal products

1. The immediate packaging of a veterinary medicinal product shall contain the following information and shall, subject to Article 11(4), contain no information other than:

(a) the name of the veterinary medicinal product, followed by its strength and pharmaceutical form;

(b) a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;

(c) the batch number, preceded by the word ‘Lot’;

(d) the name or company name or logo name of the marketing authorisation holder;

(e) the target species;

(f) the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’;

(g) special storage precautions, if any;

(h) route of administration; and

(i) if applicable, the withdrawal period, even if such period is zero.

2. 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).

3. Notwithstanding paragraph 1, a Member State may decide that, on the immediate packaging of a veterinary medicinal product made available in its territory, an identification code shall be added to the information required under paragraph 1.