Amendment to paragraph 12
134. In paragraph 12 (labelling a premixture containing veterinary medicinal product)—
(a)in sub-paragraph (1)—
(i)in the words before paragraph (a)—
(aa)for “A premixture” substitute “An intermediate feedingstuff”;
(bb)for “veterinary medicinal product” substitute “medicinal premix”;
(ii)in paragraph (a) for “MEDICATED PREMIXTURE” substitute “INTERMEDIATE FEEDINGSTUFF”;
(iii)in paragraph (b) for “veterinary medicinal product” substitute “medicinal premix”;
(iv)in paragraph (c) for “premixture” substitute “intermediate feedingstuff”;
(v)in paragraph (d)—
(aa)for “premixture” substitute “intermediate feedingstuff”;
(bb)for “prescription” substitute “medicated feedingstuffs prescription”;
(vi)after paragraph (e) insert—
“(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”;”;
(vii)in paragraph (f) for “prescription” substitute “medicated feedingstuffs prescription”;
(viii)in paragraph (h) at the end insert “required by the marketing authorisation”;
(ix)in paragraph (i) for “prescription” substitute “medicated feedingstuffs prescription”;
(b)in sub-paragraph (2) for “veterinary medicinal product” substitute “medicinal premix”;
(c)in sub-paragraph (3) for “premixture” substitute “intermediate feedingstuff”;
(d)in sub-paragraph (4) for “a premixture” substitute “an intermediate feedingstuff”;
(e)in the heading—
(i)for “a premixture” substitute “an intermediate feedingstuff”;
(ii)for “veterinary medicinal product” substitute “medicinal premix”.