{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991.json",
  "id": "uksi/1991/1474",
  "title": "The Medicines (Products for Human Use — Fees) Regulations 1991",
  "short_title": "Medicines (Products for Human Use — Fees) 1991",
  "long_title": "These Regulations make provision for the fees which are to be payable under the Medicines Act 1971 in respect of licences and certificates relating to medicinal products for human use granted under the Medicines Act 1968.",
  "citation": "S.I. 1991/1474",
  "type": "uksi",
  "year": "1991",
  "number": "1474",
  "version": "current",
  "date": "1991-06-27",
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 67,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/introduction",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "part/I",
      "kind": "part",
      "number": "I",
      "heading": "GENERAL",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/1",
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      "number": "1",
      "heading": "Citation, commencement and scope",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/regulation-1",
      "extent": null,
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/2",
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      "heading": "Interpretation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/regulation-2",
      "extent": null,
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/3",
      "kind": "regulation",
      "number": "3",
      "heading": "Fees payable in connection with applications and inspections",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/regulation-3",
      "extent": null,
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "part/II",
      "kind": "part",
      "number": "II",
      "heading": "CAPITAL FEES FOR APPLICATIONS FOR LICENCES OR CERTIFICATES AND FOR ASSOCIATED INSPECTIONS",
      "url": null,
      "extent": null,
      "status": null,
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    },
    {
      "path": "regulation/4",
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      "heading": "Applications for licences and certificates",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/regulation-4",
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      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/regulation-5",
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    {
      "path": "regulation/6",
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      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/regulation-6",
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    {
      "path": "part/III",
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      "heading": "CAPITAL FEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES OR CERTIFICATES AND FOR ASSOCIATED INSPECTIONS",
      "url": null,
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    },
    {
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      "heading": "Variations of licences and certificates",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/regulation-7",
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    {
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    {
      "path": "regulation/9",
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    {
      "path": "part/IV",
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      "number": "IV",
      "heading": "CAPITAL FEES FOR APPLICATIONS FOR RENEWALS OF CLINICAL TRIAL CERTIFICATES AND FOR CERTAIN MANUFACTURERS' LICENCES AND FOR ASSOCIATED INSPECTIONS",
      "url": null,
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      "path": "regulation/10",
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      "path": "regulation/11",
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      "heading": "Renewals of certain manufacturers' licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/regulation-11",
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      "path": "regulation/12",
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      "path": "part/V",
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      "heading": "FEES FOR INSPECTIONS MADE DURING THE CURRENCY OF A LICENCE",
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    },
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      "path": "regulation/13",
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    {
      "path": "part/VI",
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      "path": "regulation/14",
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      "extent": null,
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    {
      "path": "part/VII",
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      "number": "VII",
      "heading": "ADMINISTRATION",
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      "path": "regulation/15",
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      "heading": "Payment of fees to Ministers",
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    {
      "path": "regulation/16",
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      "heading": "Time for payment of capital fees in connection with applications or inspections",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/regulation-16",
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    {
      "path": "regulation/17",
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      "heading": "Time for payment of capital fees — applications made by small companies",
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      "path": "regulation/18",
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      "heading": "Time for payment of periodic fees",
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    },
    {
      "path": "regulation/19",
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      "heading": "Adjustment, waiver, reduction or refund of fees",
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    },
    {
      "path": "regulation/20",
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      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/regulation-20",
      "extent": null,
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    },
    {
      "path": "regulation/21",
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      "number": "21",
      "heading": "Civil proceedings to recover unpaid fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/regulation-21",
      "extent": null,
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    },
    {
      "path": "part/VIII",
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      "number": "VIII",
      "heading": "REVOCATION, SAVINGS AND TRANSITIONAL PROVISIONS",
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      "parent": null
    },
    {
      "path": "regulation/22",
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      "heading": "Revocation and Savings",
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      "path": "regulation/23",
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    },
    {
      "path": "signature",
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    {
      "path": "schedule/1",
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      "heading": "CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, LICENCES AND CERTIFICATES",
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      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
      "affecting_provisions": "reg.10(a)"
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      "affecting_provisions": "reg.3(a)"
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      "affecting_provisions": "reg.3(b)"
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      "affecting_provisions": "reg.5"
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      "type": "revoked",
      "affected_provisions": "reg.9A",
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      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
      "affecting_provisions": "reg.11(a)"
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      "affecting_provisions": "reg.6"
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      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
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    {
      "type": "amended",
      "affected_provisions": "Sch.1, Pt I, para 1 (defn of complex application)",
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      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
      "affecting_provisions": "reg.7(2)(b)(i)"
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    {
      "type": "added",
      "affected_provisions": "Sch.1, Pt I, para 1 (defn of complex application) paras (o)-(q)",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
      "affecting_provisions": "reg.7(2)(b)(iii)"
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    {
      "type": "added",
      "affected_provisions": "Sch.1, Pt I, para 1 (defn of simple application) sub- para (b)",
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      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
      "affecting_provisions": "reg.7(2)(c)"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.1, Pt II, para 1, Table, entry l(a)(b), 2-6",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
      "affecting_provisions": "reg.2, Sch"
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      "affected_provisions": "Sch.1, Pt II, para 2",
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      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
      "affecting_provisions": "reg.2, Sch"
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    {
      "type": "amended",
      "affected_provisions": "Sch.1, Pt II, para 4(1) (defn of primary applicant)",
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      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
      "affecting_provisions": "reg.7(3)(b)(i)"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.1, Pt II, para 4(2)",
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      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
      "affecting_provisions": "reg.7(3)(b)(ii)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.1, Pt II, para 4(3)",
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      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
      "affecting_provisions": "reg.7(3)(b)(iii)"
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      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
      "affecting_provisions": "reg.2, Sch"
    },
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      "type": "substituted",
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      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
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    {
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      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
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      "affecting_provisions": "reg.7(4)(a)"
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      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
      "affecting_provisions": "reg.2, Sch"
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    {
      "type": "added",
      "affected_provisions": "Sch.1, Pt III, para 2A",
      "affecting": "uksi/1994/696",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1994",
      "affecting_provisions": "reg.7(4)(c)"
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    {
      "type": "revoked",
      "affected_provisions": "Instrument",
      "affecting": "uksi/1995/1116",
      "affecting_title": "The Medicines (Products for Human Use — Fees) Regulations 1995",
      "affecting_provisions": "reg.22"
    }
  ],
  "made_under": [
    {
      "id": "ukpga/1971/69",
      "title": "Medicines Act 1971",
      "url": "https://openlegislation.uk/medicines-act-1971",
      "provisions": [
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      ]
    }
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  "changes_made_to": 67,
  "changes_made_to_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/changes.json",
  "changes_made_by": 0,
  "changes_made_by_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/changes/by-it.json",
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  "instruments_made_under_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1991/1474",
    "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."
}