Amendment to paragraph 48
61. For paragraph 48 (labelling with all information on immediate packaging) substitute—
“Labelling of immediate packaging of veterinary medicinal products
48.—(1) Subject to paragraph 50, the following information must be provided on the immediate packaging of a veterinary medicinal product—
(a)the name of the 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 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)the route of administration;
(i)if applicable, the withdrawal period, even if such period is zero.
(2) Where there is no outer packaging for the product, the information set out in paragraph 49 must be included on the immediate packaging of the veterinary medicinal product.
(3) The information referred to in paragraph (1) must appear in easily legible and clearly comprehensible characters, or in abbreviations or pictograms.”.