The Veterinary Medicines (Amendment etc.) Regulations 2024
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Change 1
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. .
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. .
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