The Veterinary Medicines Regulations 2013

Labelling [F1an intermediate feedingstuff] containing a [F2medicinal premix]E+W+S

12.—(1) [F3An intermediate feedingstuff] containing a [F4medicinal premix] must be clearly and legibly labelled with the following—

(a)the words “[F5INTERMEDIATE FEEDINGSTUFF]” (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 [F6medicinal premix] and the authorisation number;

(c)the name and amount of the active substance (mg/kg) in the [F7intermediate feedingstuff];

(d)the range of acceptable inclusion rates of the [F8intermediate feedingstuff] into the final feedingstuffs, the range of acceptable levels of the active ingredients in the final feedingstuffs and the words “refer to the [F9medicated feedingstuffs prescription] for the exact inclusion rate” or equivalent wording;

(e)warnings and contra-indications;

[F10(ea)a statement that the product must be used in accordance with its summary of product characteristics;

(eb)the contact details (including a free helpline number) for the supplier of the product;

(ec)the words “inappropriate disposal of this product poses a serious threat to the environment”;

(ed)in the case of a product containing an antibiotic, the words “inappropriate disposal of this product may contribute to antimicrobial resistance”;]

(f)the withdrawal period, and a statement that, if the [F11medicated feedingstuffs prescription] requires a longer withdrawal period, that is the one that applies;

(g)the expiry date;

(h)any special storage instructions [F12required by the marketing authorisation];

(i)where a [F13medicated feedingstuffs prescription] is required, a statement to this effect.

(2) If there is more than one [F14medicinal premix] used, the longest withdrawal period must be shown on the label.

(3) If the [F15intermediate feedingstuff] 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 [F16an intermediate feedingstuff] unless it is labelled in accordance with this paragraph.

Labelling a premixture containing a veterinary medicinal productN.I.

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.