{
  "url": "https://openlegislation.uk/medicines-products-for-human-usefees-amendment-regulations-1996/regulation-6",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-usefees-amendment-regulations-1996/regulation-6.json",
  "legislation": "uksi/1996/683",
  "legislation_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1996",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-usefees-amendment-regulations-1996",
  "path": "regulation/6",
  "kind": "regulation",
  "number": "6",
  "heading": "Amendment of Schedule 3 to the principal Regulations",
  "text": "(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”.\n(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—\n“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—\n(a) where it has a different route of administration from that of the new active substance, £4,800;\n(b) in any other case, £3,400.”.\n(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).\n(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).",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1996/683/regulation/6",
    "retrieved_at": "2026-10-29T12:48:48.755279+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}