Regulation 162 Amendment to paragraph 1

the existing text is renumbered as sub-paragraph (1);

in sub-paragraph (1), in the definition of “pharmaceutical product”, at the end insert “or a biological veterinary medicinal product that is not immunological”;

after that sub-paragraph insert—

“(2)

For the purposes of this Schedule “manufacturing authorisation” means the following activities—

(a)

manufacture or import of an authorised veterinary medicinal product;

(b)

manufacture of a product to which paragraph 2 of Schedule 6 relates;

(c)

manufacture of a product for administration under the cascade;

(d)

manufacture of—

(i)

an autogenous vaccine;

(ii)

a stem cell product; or

(iii)

a blood product for administration to non-food animals.”.