# The Veterinary Medicines (Amendment etc.) Regulations 2024, Regulation 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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Source: https://www.legislation.gov.uk/ukdsi/2024/9780348258523/regulation/43 (the official version)
Page: https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-43
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.