# The Medicines (Products for Human Use-Fees) Regulations 2008, Paragraph 7: Marketing authorization: derivatives


Unless paragraph 8 applies, where a marketing authorization is held in respect of a derivative of a new active substance, the fee payable under regulation 31(3) is—
(a) £8,692 where the medicinal product to which the authorization relates has a different route of administration from that of the new active substance;
(b) £5,868, in any other case.

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Source: https://www.legislation.gov.uk/uksi/2008/552/schedule/3/paragraph/7 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-3/paragraph-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.