# The Medicines (Products for Human Use — Fees) Regulations 1991, Paragraph 2


(1) Subject to sub-paragraph (2), where an application for the grant of, or for a variation to, a product licence or a clinical trial certificate, or for the renewal of a clinical trial certificate is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulations 4(a), 7(a) or 10 in connection with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) below 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) of the Act, 25%.
(2) If an application for the grant of, or for a variation to, a product licence or clinical trial certificate, or for the renewal of a clinical trial certificate, is withdrawn either after medical, scientific or pharmaceutical assessment has been completed or following consideration of that application by a committee established under section 4 of the Act or by the Medicines Commission, no refund or waiver of the fee payable under regulations 4(a), 7(a) or 10 in connection with that application shall be made under this paragraph.

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Source: https://www.legislation.gov.uk/uksi/1991/1474/schedule/5/paragraph/2 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-5/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.