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CHAPTER II U.K. MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS

Section 4 U.K. Labelling and package leaflet

Article 10U.K.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.