# The Medicines (Products for Human Use) (Fees) Regulations 2016, Paragraph 7: Marketing authorisation: derivatives


Unless paragraph 8 applies, where a marketing authorisation is held in respect of a derivative of a new active substance, the fee payable under regulation 38(1) is—
(a) £11,627 where the medicinal product to which the authorisation relates has a different route of administration from that of the new active substance; or
(b) £7,847 in any other case.

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Source: https://www.legislation.gov.uk/uksi/2016/190/schedule/4/paragraph/7 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.