# The Veterinary Medicines Regulations 2013, Paragraph 24: Refusal of a marketing authorisation

Extent: E+W+S

(1) The Secretary of State must refuse to grant a marketing authorisation if the application does not comply with these Regulations.
(2) In addition, the Secretary of State must refuse to grant it if—
(a) the data submitted with the application are inadequate;
(b) the benefit-risk balance of the veterinary medicinal product is unfavourable;
(c) the applicant has not provided sufficient evidence of the efficacy of the product in relation to the target species;
(d) the withdrawal period proposed by the applicant is not long enough to ensure food safety, or is insufficiently substantiated;
(e) the veterinary medicinal product is for a prohibited use;
(f) the way that the product will be used will have an unnecessarily undesirable effect on the environment.
(g) the veterinary medicinal product is a veterinary medicinal product which contains an antimicrobial which is presented for use in order to promote the growth of treated animals or to increase yields from treated animals;
(h) the risk for public health in case of development of antimicrobial resistance or antiparasitic resistance outweighs the benefits of the veterinary medicinal product to animal health;
(i) the risks to public or animal health or to the environment are not sufficiently addressed;
(j) the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the application;
(k) the active substance within the veterinary medicinal product meets the criteria for being considered persistent, bio-accumulative and toxic and the veterinary medicinal product is intended to be used in food-producing animals (except where it is demonstrated that the active substance is essential to prevent or control a serious risk to animal health).
(3) The Secretary of State may refuse to grant a marketing authorisation—
(a) if there is ... legislation pending that is incompatible with the requested authorisation; or
(b) if additional data have been requested and those data are not provided within such time limit as may be stipulated.
(4) If the Secretary of State, on the grounds of safety, quality or efficacy, intends to refuse an application, or proposes to grant a marketing authorisation that is different from the one applied for, the Secretary of State must notify the applicant accordingly, and the applicant may appeal to the Veterinary Products Committee.

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Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/24 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-24
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.