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

Unless regulation 5 or 44 apply, 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 EC marketing authorization or an application for the variation of a marketing authorization, is—

(a)

£2,227, if the advice provided at that meeting consists of advice in connection with—

(i)

quality development only, or

(ii)

safety development only;

(b)

£2,797, if the advice provided at that meeting consists only of advice in connection with clinical development;

(c)

£3,099, if the advice provided at that meeting consists only of advice in connection with quality and safety development;

(d)

£3,669, 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)

£4,542, if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development.