New paragraph 10A
34. 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.”.