Regulation 45 Amendment to paragraph 24

in paragraph (b) for “risk-benefit balance” substitute “benefit-risk balance”;

for paragraph (c) substitute—

“(c)

the applicant has not provided sufficient evidence of the efficacy of the product in relation to the target species;”;

after paragraph (f) insert—

“(g)

the veterinary medicinal product is a veterinary medicinal product which contains an antimicrobial which is presented for use in order to promote the growth of treated animals or to increase yields from treated animals;

(h)

the risk for public health in case of development of antimicrobial resistance or antiparasitic resistance outweighs the benefits of the veterinary medicinal product to animal health;

(i)

the risks to public or animal health or to the environment are not sufficiently addressed;

(j)

the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the application;

(k)

the active substance within the veterinary medicinal product meets the criteria for being considered persistent, bio-accumulative and toxic and the veterinary medicinal product is intended to be used in food-producing animals (except where it is demonstrated that the active substance is essential to prevent or control a serious risk to animal health).”.