{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-3/part-III/paragraph-1",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-3/part-III/paragraph-1.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/1",
  "kind": "paragraph",
  "number": "1",
  "heading": "Product licences",
  "text": "(1) Subject to paragraphs 2 to 6 inclusive, the fee payable under regulation 14(3) in connection with the holding of a product licence relating to a medicinal product of a kind described in Column 1 of the following Table shall be the fee specified in the corresponding entry in Column 2 of that Table.\n(2) Where Column 1 of the following Table or paragraph 2 refers to a standard fee, a reduced rate fee or a maintenance fee, the fee specified in the corresponding entry in Column 2 of that Table or in that paragraph shall be payable in the circumstances specified in Part I of this Schedule.\nTABLE\nColumn 1\nColumn 2\nKind of Product\nFee Payable\n1 New Active Substance\n1 £10,000\n2 Other kinds of Medicinal Product\n(a) Any product (not being a derivative of a new active substance) in respect of which a licence has been granted in consequence of a complex application submitted on or after 1st April 1989\n2 (a) £5,000\n(b) Prescription Only Medicine\n(i) Standard Fee\n2 (b) (i) £900\n(ii) Reduced Rate Fee\n2 (b) (ii) £450\n(iii) Maintenance Fee\n2 (b) (iii) £150\n(c) Pharmacy Medicine\n(i) Standard Fee\n2 (c) (i) £450\n(ii) Reduced Rate Fee\n2 (c) (ii) £225\n(iii) Maintenance Fee\n2 (c) (iii) £100\n(d) General Sales List Medicine\n(i) Standard Fee\n2 (d) (i) £200\n(ii) Reduced Rate Fee\n2 (d) (ii) £100\n(iii) Maintenance Fee\n2 (d) (iii) £75\n(e) Herbal Product\n2 (e) £50\n(f) omoeopathic Product and Anthroposophic Product\n2 (f) £25",
  "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/1",
    "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."
}