# The Medicines (Products for Human Use — Fees) Regulations 1991, Paragraph 3: Product licences


Subject to paragraph 4 below, where a licence is held in respect of a derivative of a new active substance, the fee payable under regulation 14(3) shall be—
(a) where it is of the same dosage form as, but of a different strength of active ingredient or different combination of active ingredients than, that relating to the new active substance, £3,000;
(b) where it is of a different dosage form to the new active substance, £5,000;

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Source: https://www.legislation.gov.uk/uksi/1991/1474/schedule/3/part/III/paragraph/3 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-3/part-III/paragraph-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.