The Medicines (Products for Human Use — Fees) Regulations 1995

3.—(1) Subject to sub-paragraphs (2) and (3), where an application for the grant of, or for a variation to, a marketing authorization or a clinical trial certificate, or for the renewal of a clinical trial certificate is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulations 4(a), 7(1) or 10 in connection with that application shall be refunded or, if it has not yet been paid, shall be waived—

(a)if the application has been received but no medical, scientific or pharmaceutical assessment thereof has begun, 90%;

(b)except in a case to which sub-paragraph (c) applies. if medical, scientific or pharmaceutical assessment has begun but not been completed, 50%;

(c)if a request for further information in connection with the application has been made by the licensing authority under section 44(1) (provision of information to licensing authority) of the Act, 25%.

(2) In a case to which sub-paragraph (1)(a) applies, that provision shall not have effect so as to render an applicant liable to pay more than £1,500 in respect of the fee in connection with that application.

(3) If an application for the grant of, or for a variation to, a marketing authorization or clinical trial certificate, or for the renewal of a clinical trial certificate, is withdrawn either after medical, scientific and pharmaceutical assessment has been completed or following consideration of that application by a committee established under section 4 (establishment of committees) of the Act or by the Medicines Commission, no refund or waiver of the fee payable under regulation 4(a), 7(1) or 10 in connection with that application shall be made under this paragraph.