Paragraph 2
Subject to sub-paragraph (2) below, where an application for a product licence or a clinical trial certificate is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulation 3(a) or 4 of these Regulations in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:—
if the application has been received but no medical, scientific or pharmaceutical assessment thereof has begun, 90%;
except in a case to which paragraph (c) below applies, if medical, scientific or pharmaceutical assessment has begun but not been completed, 50%;
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%.
If an application for a product licence or clinical trial certificate is withdrawn either after medical, scientific and pharmaceutical assessment has been completed or following consideration of that application by a committee established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.