PART 2Capital Fees for Pre-Application Meetings

Fee for scientific advice: application for, or variation to, EU marketing authorisation4.

Unless regulation 5 applies, the fee payable by a person with whom the licensing authority holds a meeting in order to provide scientific advice with a view to that person making an application for an EU marketing authorisation or an application for the variation of an EU marketing authorisation, is—

(a)

£2,201, if the advice provided at that meeting consists of advice in connection with—

(i)

quality development only; or

(ii)

safety development only;

(b)

£2,763, if the advice provided at that meeting consists only of advice in connection with clinical development;

(c)

£3,061, if the advice provided at that meeting consists only of advice in connection with quality and safety development;

(d)

£3,624, if the advice provided at that meeting consists of advice in connection with—

(i)

quality and clinical development; or

(ii)

safety and clinical development;

(e)

£4,487, if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development.