- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
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or, an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulations 12(1)(a), 18(1) or 19(1) in connection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or an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation, is withdrawn either after medical, scientific and pharmaceutical assessment has been completed or following consideration of that application by a committee established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.
Amendments to section 44 have been made by S.I. 2005/1094 and 2006/2407.
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: