Regulation 4 Fee for scientific advice: application for, or variation to, EU marketing authorization

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 authorization or an application for the variation of an EU marketing authorization, is—

(a)

£2,378, if the advice provided at that meeting consists of advice in connection with—

(i)

quality development only; or

(ii)

safety development only;

(b)

£2,986, if the advice provided at that meeting consists only of advice in connection with clinical development;

(c)

£3,309, if the advice provided at that meeting consists only of advice in connection with quality and safety development;

(d)

£3,917, 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)

£4,849, if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development.