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12.—(1) A premixture containing a veterinary medicinal product must be clearly and legibly labelled with the following—
(a)the words “MEDICATED PREMIXTURE” (or, if it is to be labelled as “complementary feedingstuffs” under legislation implementing Council Directive 79/373/EEC on the marketing of compound feedingstuffs(1), “MEDICATED COMPLEMENTARY FEEDINGSTUFFS” ) in upper case letters;
(b)the proprietary name of the veterinary medicinal product and the authorisation number;
(c)the name and amount of the active substance (mg/kg) in the premixture;
(d)the range of acceptable inclusion rates of the premixture into the final feedingstuffs, the range of acceptable levels of the active ingredients in the final feedingstuffs and the words “refer to the prescription for the exact inclusion rate” or equivalent wording;
(e)warnings and contra-indications;
(f)the withdrawal period, and a statement that, if the prescription requires a longer withdrawal period, that is the one that applies;
(g)the expiry date;
(h)any special storage instructions;
(i)where a prescription is required, a statement to this effect.
(2) If there is more than one veterinary medicinal product used, the longest withdrawal period must be shown on the label.
(3) If the premixture also contains a specified feed additive to which this Schedule applies it must also contain the information required under Article 16 of Regulation (EC) No 1831/2003(2).
(4) No person may supply such a premixture unless it is labelled in accordance with this paragraph.
OJ No L86, 6.4.1979, p. 30.
OJ No L268, 18.10.2003, p. 29. Regulation (EC) no 1831/2003 was last amended by Article 29 of Regulation (EC) No 767/2009 (OJ No L229, 1.9.2009, p. 1.)
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