{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-5",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-5.json",
  "legislation": "uksi/2016/190",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2016",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016",
  "path": "schedule/4/paragraph/5",
  "kind": "paragraph",
  "number": "5",
  "heading": "Marketing authorisations",
  "text": "Unless paragraphs 6 to 10 apply, the fee payable under regulation 38(1) in connection with the holding of a marketing authorisation relating to a medicinal product of a kind described in column 1 of the following table is the applicable fee specified in the corresponding entry in column 2 of that table.\nPeriodic fees for holding a marketing authorisation\nColumn 1Type of Medicinal Product\nColumn 2Fee payable\n1. New Active Substance\n£11,627\n2. Parallel Import\n£368\n3. Others\n(a)\nAny product (not being a derivative of a new active substance) in respect of which a marketing authorisation has been granted in consequence of a complex application submitted on or after 1st April 1989\n£11,627\n(b)\nPrescription Only Medicine\n(i)\nStandard Fee\n£2,908\n(ii)\nReduced Rate Fee\n£1,450\n(iii)\nLower Fee\n£368\n(c)\nPharmacy\n£368\n(d)\nGeneral Sale List\n£368\n(e)\nHerbal remedy\n£92\n(f)\nTraditional herbal registrations\n£92\n(g)\nNational homoeopathic product\n£92\n(h)\nHomoeopathic or anthroposophic product which is the subject of a licence of right\n£92",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sum in Sch. 4 para. 5 Table Entry 1 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sum in Sch. 4 para. 5 Table Entry 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sum in Sch. 4 para. 5 Table Entry 3(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(c)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Sum in Sch. 4 para. 5 Table Entry 3(b)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(d)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Sum in Sch. 4 para. 5 Table Entry 3(b)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(e)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Sum in Sch. 4 para. 5 Table Entry 3(b)(iii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(f)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Sum in Sch. 4 para. 5 Table Entry 3(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(f)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Sum in Sch. 4 para. 5 Table Entry 3(d) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(f)"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Sum in Sch. 4 para. 5 Table Entry 3(e)-(h) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(g)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/schedule/4/paragraph/5",
    "retrieved_at": "2026-10-28T23:27:13.215121+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."
}