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.”.