Regulation 43 Amendment to paragraph 22

the existing text is renumbered as sub-paragraph (2);

above that text insert—

“22.

(1)

The Secretary of State must, before granting a marketing authorisation—

(a)

verify that the data submitted complies with the requirements set out in these Regulations;

(b)

assess the application and data submitted in respect of the veterinary medicinal product; and

(c)

reach a conclusion in relation to the benefit-risk balance of granting a marketing authorisation in respect of the veterinary medicinal product.”.

below the existing text (renumbered as sub-paragraph (2)) insert—

“(3)

The Secretary of State must set out any terms and conditions in connection with placing the product on the market when granting a marketing authorisation.

(4)

Where the marketing authorisation relates to a veterinary medicinal product that contains an antimicrobial the Secretary of State may require the holder of the marketing authorisation to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive in relation to the development of antimicrobial resistance.”.