Regulation 134 Amendment to paragraph 12

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”.