The Veterinary Medicines (Amendment etc.) Regulations 2024
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Change 1
43 Amendment to paragraph 22
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. .
43 Amendment to paragraph 22
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. .
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