Regulation 48 Amendment to paragraph 27

in sub-paragraph (1) at the end insert “and to provide the results of any control tests carried out in relation to such materials or the finished product in accordance with the methods to be used under the terms of the marketing authorisation”;

after sub-paragraph (2) insert—

“(3)

The Secretary of State may require an applicant for a marketing authorisation to provide samples of a veterinary medicinal product for testing.

(4)

The samples mentioned in sub-paragraph (3) may be used—

(a)

to test the veterinary medicinal product and its constituents at any stage of development of the product in order to ensure that the control methods used by the manufacturer are satisfactory; and

(b)

to verify that, where a veterinary medicinal product is intended for administration to a food-producing animal, the means used for residue detection in relation to pharmacologically active substances are satisfactory.”.