# The Veterinary Medicines (Amendment etc.) Regulations 2024, Regulation 34: New paragraph 10A


After paragraph 10 insert—
“Hybrid veterinary medicinal products
10A. An applicant for a marketing authorisation must provide the results of relevant pre-clinical studies or clinical trials where—
(a) bioavailability studies are not capable of demonstrating bioequivalence between the veterinary medicinal product for which the authorisation is sought and a reference veterinary medicinal product for the purposes of paragraph 10; or
(b) the veterinary medicinal product for which the authorisation is sought is not pharmacologically equivalent to a reference veterinary medicinal product for the purposes of paragraph 10 as a result of a difference in relation to—
(i) the active substance or substances contained in the product;
(ii) the strength of the product;
(iii) the indications for use of the product;
(iv) the pharmaceutical form of the product;
(v) the route of administration of the product;
(vi) the withdrawal period for the product.”.

---
Source: https://www.legislation.gov.uk/ukdsi/2024/9780348258523/regulation/34 (the official version)
Page: https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-34
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.