# The Medicines (Products for Human Use—Fees) Amendment Regulations 1996, Regulation 6: Amendment of Schedule 3 to the principal Regulations


(1) In paragraph 1 (interpretation) of Part I of Schedule 3 (periodic fees) to the principal Regulations, in the definition of “maintenance fee”, in sub-paragraph (b) for “the relevant calendar year” substitute “that period”.
(2) For paragraph 3 (derivatives of new active substances) of Part III (periodic fees for marketing authorizations and licences) of Schedule 3 to the principal Regulations substitute—
“3 Subject to paragraph 4, where a marketing authorization is held in respect of a derivative of a new active substance, the fee payable under regulation 14(3) shall be—
(a) where it has a different route of administration from that of the new active substance, £4,800;
(b) in any other case, £3,400.”.
(3) In paragraph 4 (transitional arrangements for periodic fees) of Part III of Schedule 3 to the principal Regulations omit sub-paragraphs (1) and (2).
(4) In Part IV (marketing authorizations for which a single periodic fee is payable) of Schedule 3 to the principal Regulations omit paragraph 2 (homoeopathic or anthroposophic products).

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Source: https://www.legislation.gov.uk/uksi/1996/683/regulation/6 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-usefees-amendment-regulations-1996/regulation-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.