Regulation 47 Amendment to paragraph 26
In paragraph 26 (marketing authorisations in exceptional circumstances)—
(a)
in sub-paragraph (1)(a), after “further data” insert “, taking into account the benefit of the immediate availability on the market of the veterinary medicinal product in comparison to the risks”;
(b)
in sub-paragraph (1)(b), after “limited market” insert “, taking into account the benefit in relation to public or animal health of the availability of the product on the market in comparison to the risks.”;
(c)
after sub-paragraph (1) insert—
“(1A)An exceptional marketing authorisation may be granted subject to such further conditions, including any restrictions, as the Secretary of State considers appropriate.”.