Paragraph 4 Withdrawal of application in relation to marketing authorisation, traditional herbal registration or clinical trial authorisation
Subject to sub-paragraph (2), where an application for the grant of, or for a variation to, a marketing authorisation or traditional herbal registration, or, an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulations 12(1)(a), 19(1) or 20(1) in connection with that application or notice shall be refunded or, if it has not yet been paid, shall be waived—
if the application or notice has been received but no medical, scientific or pharmaceutical assessment thereof has begun, 90%;
except in a case to which sub-paragraph (c) 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 regulation 30 (provision of information) of the Human Medicines Regulations or in pursuance of a European Union provision which applies to applications for marketing authorisations or traditional herbal registrations, 25%.
If an application for the grant of, or for a variation to, a marketing authorisation or traditional herbal registration, or an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation, is withdrawn either after medical, scientific and pharmaceutical assessment has been completed or following consideration of that application by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products, no refund or waiver of the fee payable under regulation 12(1)(a), 19(1) or 20(1) in connection with that application or notice shall be made under this paragraph.