The Veterinary Medicines Regulations 2005

Reduction of fees when an application is withdrawn

This section has no associated Explanatory Memorandum

53.—(1) Where an application for a marketing authorisation is withdrawn before determination, the Secretary of State shall refund a proportion of the fee in accordance with this paragraph.

(2) Where no payment has been made, the applicant may apply reductions of the fee otherwise payable in connection with that application in accordance with this paragraph.

(3) The request for a reduced fee must be made in writing within two months of the withdrawal of the application, or a refusal of the application on the grounds that data that she has requested have not been supplied within the specified time limit.

(4) If no assessment (veterinary, scientific or pharmaceutical) has begun, the refund or reduction is 90%.

(5) If assessment has begun but the Secretary of State has not yet requested further data, the refund or reduction is 50%.

(6) If the Secretary of State has requested further information but it has not yet been provided, the refund or reduction is 25%.

(7) If the further information requested has been supplied but has not yet been fully assessed or the application has not been referred to the Veterinary Products Committee, the refund or reduction is 10%.

(8) Once the further information has been fully assessed, or the application has been referred to the Veterinary Products Committee, no reduction is made.