# The Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989, Paragraph 2


(1) Subject to sub-paragraph (2) below, where an application for a product licence or a clinical trial certificate is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulation 3(a) or 4 of these Regulations in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 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 Medicines Act 1968, 25%.
(2) If an application for a product licence or clinical trial certificate is withdrawn either after medical, scientific and pharmaceutical assessment has been completed or following consideration of that application by a committee established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 of the Medicines Act 1968 or by the Medicines Commission, no refund or waiver of the fee payable under regulation 3(a) or 4 of these Regulations in connection with that application shall be made under this paragraph.

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Source: https://www.legislation.gov.uk/uksi/1989/418/schedule/3/paragraph/2 (the official version)
Page: https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-human-use-regulations-1989/schedule-3/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

