Amendment to paragraph 22
43. In paragraph 22 (grant of marketing authorisation)—
(a)the existing text is renumbered as sub-paragraph (2);
(b)above that text insert—
“22.—(1) The Secretary of State must, before granting a marketing authorisation—
(a)verify that the data submitted complies with the requirements set out in these Regulations;
(b)assess the application and data submitted in respect of the veterinary medicinal product; and
(c)reach a conclusion in relation to the benefit-risk balance of granting a marketing authorisation in respect of the veterinary medicinal product.”.
(c)below the existing text (renumbered as sub-paragraph (2)) insert—
“(3) The Secretary of State must set out any terms and conditions in connection with placing the product on the market when granting a marketing authorisation.
(4) Where the marketing authorisation relates to a veterinary medicinal product that contains an antimicrobial the Secretary of State may require the holder of the marketing authorisation to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive in relation to the development of antimicrobial resistance.”.