The Medicines (Products for Human Use-Fees) Regulations 2008

Withdrawal of application in relation to marketing authorization, traditional herbal registration or clinical trial authorisation

4.—(1) Subject to sub-paragraph (2) , where an application for the grant of, or for a variation to, a marketing authorization 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or, an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulations 12(1)(a), 18(1) or 19(1) in connection with that application or notice shall be refunded or, if it has not yet been paid, shall be waived—

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

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

(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(1) or in pursuance of a Community provision which applies to applications for marketing authorizations or traditional herbal registrations, 25 per cent.

(2) If an application for the grant of, or for a variation to, a marketing authorization 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or an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation, is withdrawn either after medical, scientific and pharmaceutical assessment has been completed or following consideration of that application by a committee established under section 4 (establishment of committees) of the Act or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act, no refund or waiver of the fee payable under regulation 12(1)(a), 18(1) or 19(1) in connection with that application or notice shall be made under this paragraph.

(1)

Amendments to section 44 have been made by S.I. 2005/1094 and 2006/2407.