{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-3/part-III/paragraph-3",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-3/part-III/paragraph-3.json",
  "legislation": "uksi/1991/1474",
  "legislation_title": "The Medicines (Products for Human Use — Fees) Regulations 1991",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991",
  "path": "schedule/3/part/III/paragraph/3",
  "kind": "paragraph",
  "number": "3",
  "heading": "Product licences",
  "text": "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—\n(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;\n(b) where it is of a different dosage form to the new active substance, £5,000;",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "substituted",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994"
    },
    {
      "type": "amended",
      "affecting": "uksi/1992/756",
      "affecting_title": "The Medicines (Products for Human Use– Fees) Amendment Regulations 1992"
    },
    {
      "type": "amended",
      "affecting": "uksi/1992/756",
      "affecting_title": "The Medicines (Products for Human Use– Fees) Amendment Regulations 1992"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1991/1474/schedule/3/part/III/paragraph/3",
    "retrieved_at": "2026-10-29T14:42:17.847283+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."
}