# The Veterinary Medicines (Amendment etc.) Regulations 2024, Regulation 31: Amendment to paragraph 7


In paragraph 7 (bibliographic application)—
(a) in sub-paragraph (1), for the words from “if the active” to the end substitute “if the applicant demonstrates that the active substances of the veterinary medicinal product have been in well-established veterinary use for at least 10 years, that their efficacy is documented and that they provide an acceptable level of safety”;
(b) after sub-paragraph (1) insert—
“(1A) Sub-paragraph (1) does not apply to applications for—
(a) biological (including immunological) veterinary medicinal products;
(b) novel therapies.”.

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Source: https://www.legislation.gov.uk/ukdsi/2024/9780348258523/regulation/31 (the official version)
Page: https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-31
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.