Regulation 31 Amendment to paragraph 7

in sub-paragraph (1), for the words from “if the active” to the end substitute “if the applicant demonstrates that the active substances of the veterinary medicinal product have been in well-established veterinary use for at least 10 years, that their efficacy is documented and that they provide an acceptable level of safety”;

after sub-paragraph (1) insert—

“(1A)

Sub-paragraph (1) does not apply to applications for—

(a)

biological (including immunological) veterinary medicinal products;

(b)

novel therapies.”.