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Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)

article  10

CELEX:  02019R0006-20220128

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).
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)

article  10

CELEX:  02019R0006-20220128

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.