# The Veterinary Medicines Regulations 2005, Paragraph 24: Refusal of a marketing authorisation


(1) The Secretary of State shall refuse to grant a marketing authorisation if the application does not comply with these Regulations.
(2) In addition, she shall refuse to grant it if—
(a) the data submitted with the application are inadequate;
(b) the risk-benefit balance of the veterinary medicinal product is unfavourable so that the risks outweigh the benefits;
(c) the product has insufficient therapeutic effect;
(d) the withdrawal period proposed by the applicant is not long enough to ensure that Council Regulation (EEC) No. 2377/90 is complied with, 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.
(3) The Secretary of State may refuse a marketing authorisation—
(a) if there is Community legislation pending that is incompatible with the requested authorisation; or
(b) if she requests additional data and those data are not provided within such time limit as she may stipulate.

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Source: https://www.legislation.gov.uk/uksi/2005/2745/schedule/1/paragraph/24 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2005/schedule-1/paragraph-24
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.