Paragraph 24 Refusal of a marketing authorisation
The Secretary of State shall refuse to grant a marketing authorisation if the application does not comply with these Regulations.
In addition, she shall refuse to grant it if—
the data submitted with the application are inadequate;
the risk-benefit balance of the veterinary medicinal product is unfavourable so that the risks outweigh the benefits;
the product has insufficient therapeutic effect;
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;
the veterinary medicinal product is for a prohibited use;
the way that the product will be used will have an unnecessarily undesirable effect on the environment.
The Secretary of State may refuse a marketing authorisation—
if there is Community legislation pending that is incompatible with the requested authorisation; or
if she requests additional data and those data are not provided within such time limit as she may stipulate.