52.—(1) Where an application for a marketing authorisation is withdrawn before determination, or refused on the grounds that data requested by the Secretary of State have not been supplied within the time limit specified in the request, the applicant may request a refund of a proportion of the fee (or, if the fee has not yet been paid, a reduction of the fee) in accordance with this paragraph.
(2) The request for a reduced fee must be made in writing within two months of the withdrawal of the application, or of the date of notification of a refusal.
(3) No reduction is payable if the application is withdrawn after all the data have been fully assessed, or if the application has been referred to the Veterinary Products Committee.
| Stage at which application is withdrawn | Percentage reduction or refund |
|---|---|
| The assessment (veterinary, scientific or pharmaceutical) has not yet begun: | 90% |
| The assessment has begun but the Secretary of State has not yet requested further data: | 50% |
| The Secretary of State has requested further information but it has not yet been provided: | 25% |
| The Secretary of State has been supplied with further information requested but has not yet fully assessed it, or the application has not been referred to the Veterinary Products Committee: | 10% |
Commencement Information
I1Sch. 7 para. 52 in force at 1.10.2006, see reg. 1