# The Medicines (Products for Human Use-Fees) Regulations 2008, 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.

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Source: https://www.legislation.gov.uk/uksi/2008/552/regulation/4 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

