PART 3Amendments to Schedule 1 to the 2013 Regulations
Amendment to paragraph 2243
In paragraph 22 (grant of marketing authorisation)—
a
the existing text is renumbered as sub-paragraph (2);
b
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.
c
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.