The Medicines (Products for Human Use) (Fees) Regulations 2016

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

This section has no associated Explanatory Memorandum

4.  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.