# The Veterinary Medicines Regulations 2013, Paragraph 10A: Hybrid veterinary medicinal products

Extent: E+W+S

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.

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Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/10A (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-10A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.