# The Medicines (Products for Human Use) (Fees) Regulations 2012, 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 33(3) is—
(a) £9,481 where the medicinal product to which the authorization relates has a different route of administration from that of the new active substance; or
(b) £6,400 in any other case.

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Source: https://www.legislation.gov.uk/nisr/2012/134/schedule/4/paragraph/7 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-4/paragraph-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.