# The Medicines (Products for Human Use) (Fees) Regulations 2012, 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.

---
Source: https://www.legislation.gov.uk/nisr/2012/134/regulation/4 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.