The Veterinary Medicines Regulations 2007

Refusal of a marketing authorisation

24.—(1) The Secretary of State must refuse to grant a marketing authorisation if the application does not comply with these Regulations.

(2) In addition, he must 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;

(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 to grant a marketing authorisation—

(a) if there is Community legislation pending that is incompatible with the requested authorisation; or

(b) if he requests additional data and those data are not provided within such time limit as he may stipulate.

(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, he must notify the applicant accordingly, and the applicant may, within 28 days of the notification, appeal to the Veterinary Products Committee.