{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995.json",
  "id": "uksi/1995/1116",
  "title": "The Medicines (Products for Human Use — Fees) Regulations 1995",
  "short_title": "Medicines (Products for Human Use — Fees) 1995",
  "long_title": "These Regulations make provision for the fees payable under the Medicines Act 1971 in respect of marketing authorizations, licences and certificates relating to medicinal products for human use.",
  "citation": "S.I. 1995/1116",
  "type": "uksi",
  "year": "1995",
  "number": "1116",
  "version": "current",
  "date": "1995-04-20",
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 697,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/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",
      "kind": "regulation",
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      "heading": "Citation and commencement",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-1",
      "extent": null,
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "regulation/2",
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      "number": "2",
      "heading": "Interpretation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/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-1995/regulation-3",
      "extent": null,
      "status": null,
      "parent": "part/I"
    },
    {
      "path": "part/II",
      "kind": "part",
      "number": "II",
      "heading": "CAPITAL FEES F0R APPLICATIONS FOR AUTHORIZATIONS, LICENCES OR CERTIFICATES AND FOR ASSOCIATED INSPECTIONS",
      "url": null,
      "extent": null,
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    },
    {
      "path": "regulation/4",
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      "heading": "Applications for authorizations, licences or certificates",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-4",
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    {
      "path": "regulation/5",
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      "heading": "Inspections in connection with multiple applications for authorizations or licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-5",
      "extent": null,
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    {
      "path": "regulation/6",
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      "heading": "Applications for certificates by exporters of medicinal products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-6",
      "extent": null,
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    {
      "path": "part/III",
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      "number": "III",
      "heading": "CAPITAL FEES FOR APPLICATIONS FOR VARIATIONS OF AUTHORIZATIONS, LICENCES OR CERTIFICATES AND FOR ASSOCIATED INSPECTIONS",
      "url": null,
      "extent": null,
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      "parent": null
    },
    {
      "path": "regulation/7",
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      "heading": "Variations of authorizations, licences and certificates",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-7",
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      "path": "regulation/8",
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      "path": "regulation/9",
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    {
      "path": "part/IV",
      "kind": "part",
      "number": "IV",
      "heading": "CAPITAL FEES FOR APPLICATIONS FOR RENEWALS OF CLINICAL TRIAL CERTIFICATES AND FOR CERTAIN MANUFACTURER'S LICENCES AND FOR ASSOCIATED INSPECTIONS",
      "url": null,
      "extent": null,
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    },
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      "path": "regulation/10",
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      "path": "regulation/11",
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      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-11",
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    {
      "path": "regulation/12",
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      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-12",
      "extent": null,
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    {
      "path": "part/V",
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      "number": "V",
      "heading": "FEES FOR INSPECTIONS MADE DURING THE CURRENCY OF A MARKETING AUTHORIZATION OR LICENCE",
      "url": null,
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    },
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      "path": "regulation/13",
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      "extent": null,
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    },
    {
      "path": "part/VI",
      "kind": "part",
      "number": "VI",
      "heading": "PERIODIC FEES FOR MARKETING AUTHORIZATIONS AND LICENCES",
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      "parent": null
    },
    {
      "path": "regulation/14",
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      "heading": "Periodic fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-14",
      "extent": null,
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      "parent": "part/VI"
    },
    {
      "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",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-15",
      "extent": null,
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    {
      "path": "regulation/16",
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      "number": "16",
      "heading": "Time for payment of capital fees in connection with applications or inspections",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-16",
      "extent": null,
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    {
      "path": "regulation/17",
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      "heading": "Time for payment of capital fees applications made by small companies",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-17",
      "extent": null,
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    {
      "path": "regulation/18",
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      "heading": "Time for payment of periodic fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-18",
      "extent": null,
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    },
    {
      "path": "regulation/19",
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      "heading": "Adjustment, waiver, reduction or refund of fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-19",
      "extent": null,
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      "parent": "part/VII"
    },
    {
      "path": "regulation/20",
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      "number": "20",
      "heading": "Suspension of licences and certificates",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-20",
      "extent": null,
      "status": null,
      "parent": "part/VII"
    },
    {
      "path": "regulation/21",
      "kind": "regulation",
      "number": "21",
      "heading": "Civil proceedings to recover unpaid fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-21",
      "extent": null,
      "status": null,
      "parent": "part/VII"
    },
    {
      "path": "part/VIII",
      "kind": "part",
      "number": "VIII",
      "heading": "REVOCATION, SAVINGS AND TRANSITIONAL PROVISIONS",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/22",
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      "heading": "Revocation and savings",
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    },
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      "path": "regulation/23",
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      "heading": "Transitional provisions",
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      "extent": null,
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    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/signature",
      "extent": null,
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    },
    {
      "path": "schedule/1",
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      "number": "1",
      "heading": "CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES AND CERTIFICATES",
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      "heading": "Identical variations",
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      "affected_provisions": "Sch.1, Pt.III, paras.3(c), 6(b),11",
      "affecting": "uksi/1998/574",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998",
      "affecting_provisions": "reg.5, Sch."
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.3, Pt.I, para.1 (defns. of reduced rate fee and standard fee)",
      "affecting": "uksi/1998/574",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998",
      "affecting_provisions": "reg.4(1)(c)"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.1, Pt.III, para.2(a)-(c)",
      "affecting": "uksi/1998/574",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998",
      "affecting_provisions": "reg.5, Sch."
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.2, para.2(a)(ii)(iii) (iv)(b)(i)(ii)(iii)(iv)",
      "affecting": "uksi/1998/574",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998",
      "affecting_provisions": "reg.5, Sch."
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.1, Pt.II, para.6(2)(b)",
      "affecting": "uksi/1998/574",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998",
      "affecting_provisions": "reg.4(1)(a)"
    },
    {
      "type": "rev. in pt.",
      "affected_provisions": "Sch.3, Pt.III, para.1, Table",
      "affecting": "uksi/1998/574",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998",
      "affecting_provisions": "reg.4(6)"
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.1, Pt.III, para.6",
      "affecting": "uksi/1999/566",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999",
      "affecting_provisions": "reg.4(1)"
    },
    {
      "type": "amended",
      "affected_provisions": "regs.6,10,11, Sch.1, Pt.II, paras.1, Table, 5,6, Pt.III, paras.2,3. 6-12",
      "affecting": "uksi/1999/566",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999",
      "affecting_provisions": "reg.4(2), Sch."
    },
    {
      "type": "amended",
      "affected_provisions": "Sch.2, paras.2.5, Sch.3, Pt.III, paras. 1, Table, 2,3,7,8",
      "affecting": "uksi/1999/566",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999",
      "affecting_provisions": "reg.4(2), Sch."
    },
    {
      "type": "added",
      "affected_provisions": "Pt.llA",
      "affecting": "uksi/2000/3031",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 2000",
      "affecting_provisions": "reg.3"
    },
    {
      "type": "added",
      "affected_provisions": "reg.2 defn(s).",
      "affecting": "uksi/2000/3031",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 2000",
      "affecting_provisions": "reg 2"
    },
    {
      "type": "amended",
      "affected_provisions": "reg.16",
      "affecting": "uksi/2000/3031",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 2000",
      "affecting_provisions": "reg 4"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.4, para.4A",
      "affecting": "uksi/2000/3031",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 2000",
      "affecting_provisions": "reg.6"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.1, Pt.llA",
      "affecting": "uksi/2000/3031",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 2000",
      "affecting_provisions": "reg.5"
    },
    {
      "type": "sum substituted",
      "affected_provisions": "Sch. 1 Pt. 2 para. 6(4)",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "sums substituted",
      "affected_provisions": "Sch. 1 Pt. 2 para. 5(1)(a)-(c)",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "words inserted",
      "affected_provisions": "Sch. 1 Pt. 3 para. 4 5",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(3)(a)"
    },
    {
      "type": "sums substituted",
      "affected_provisions": "Sch. 1 Pt. 2 para. 1(1) Table",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "words inserted",
      "affected_provisions": "reg. 2(1)",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(1)"
    },
    {
      "type": "inserted",
      "affected_provisions": "Sch. 3 Pt. 3 para. 4(2A)",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(4)(a)"
    },
    {
      "type": "sum substituted",
      "affected_provisions": "reg. 11(1)",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "sums substituted",
      "affected_provisions": "reg. 6(1)(a)-(c)",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "sums substituted",
      "affected_provisions": "Sch. 3 Pt. 3 para. 7-8",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "words inserted",
      "affected_provisions": "Sch. 3 Pt. 1 para. 1",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(3)(b)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 1 Pt. 2 para. 1 Table",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(2)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 3 Pt. 3 para. 4(4)(a)",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(4)(b)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 3 Pt. 3 para. 4(5)",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(4)(c)"
    },
    {
      "type": "sums substituted",
      "affected_provisions": "Sch. 1 Pt. 2 para. 6(1)(2)",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "substituted",
      "affected_provisions": "Sch. 3 Pt. 3 para. 4(6)",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(4)(d)"
    },
    {
      "type": "sum substituted",
      "affected_provisions": "Sch. 1 Pt. 2 para. 7",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "sums substituted",
      "affected_provisions": "Sch. 3 Pt. 3 para. 1 Table",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "sum substituted",
      "affected_provisions": "reg. 10",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "sum substituted",
      "affected_provisions": "Sch. 2 para. 5(1)",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "sums substituted",
      "affected_provisions": "Sch. 2 para. 2(a)-(d)",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "sums substituted",
      "affected_provisions": "Sch. 1 Pt. 3 para. 6-12",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "sums substituted",
      "affected_provisions": "Sch. 3 Pt. 3 para. 2-3",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "sums substituted",
      "affected_provisions": "Sch. 1 Pt. 3 para. 2-3",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000",
      "affecting_provisions": "reg. 4(5) Sch."
    },
    {
      "type": "am",
      "affected_provisions": "Sch 5, para 6",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(13)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 4, para 4A",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(11)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 3, Pt IV, para 1",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(10)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 3, Pt III, paras 7, 8",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(14), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "reg 6",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(3), (14), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 3, Pt III, para 1, Table",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(14), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 2, para 5",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(14), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 2, para 2",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(14), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, paras 6–12",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(9), (14), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, paras 2, 3",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(14), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 1 defn(s)",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(8)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt II, paras 5–7",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(14), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt I, para 1 defn(s)",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(5)"
    },
    {
      "type": "am",
      "affected_provisions": "reg 16",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(4)"
    },
    {
      "type": "am",
      "affected_provisions": "regs 10, 11",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(14), Schedule"
    },
    {
      "type": "renumbered (as regs 6A, 6B, 6C)",
      "affected_provisions": "regs 4A, 4B, 4C",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(2)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 5, para 2A",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(12)"
    },
    {
      "type": "added",
      "affected_provisions": "reg 2 defn(s)",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(1)(c), (d)"
    },
    {
      "type": "rev in pt",
      "affected_provisions": "reg 2 defn(s)",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(1)(a)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt II, para 1, Table",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(6), (14), Schedule"
    },
    {
      "type": "rev",
      "affected_provisions": "reg 2 defn(s)",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(1)(b)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 7",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(14), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt IIA, para 2",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(7)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 3, Pt III, paras 2, 3",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001",
      "affecting_provisions": "reg 5(14), Schedule"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 1 Pt. 2 para. 1(1) Table",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(f)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 1 Pt. 3 para. 5",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(h)(ii)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 3 Pt. 4 para. 1",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(j)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 3 Pt. 1 para. 1",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(i)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 4 para. 4A(a)(i)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(k)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 4 para. 4A(b)(i)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(k)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 1 Pt. 3 para. 4",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(h)(ii)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 5 para. 6",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(l)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 1 Pt. 2A para. 2",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(g)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 1 Pt. 1 para. 1",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(e)(ii)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 1 Pt. 3 para. 1",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(h)(i)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 6A",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(b)(i)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 6A",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(b)(ii)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 2(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(a)(iv)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 6B",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(c)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 2(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(a)(iii)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 6C",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(d)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "Sch. 1 Pt. 1 para. 1",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(e)(i)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 2(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(a)(i)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 2(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 16(a)(ii)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 2, para 2",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 5, para 2B",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (8)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 3, Pt III, paras 2, 3",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 2, para 5",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 3, Pt III, para 1, Table",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 3, Pt III, paras 7, 8",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 1, Pt III, para 5A",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (6)(c)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 6",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (6)(d), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 3",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, paras 7–11",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 1 defn(s)",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (6)(a)(ii)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 2",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (6)(b), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 12",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (6)(e)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt II, para 6",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt II, para 4",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (5)(c)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt II, para 7",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 12",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 1, Pt II, para 1A",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (5)(b)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt I, para 1 defn(s)",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (4)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt II, para 1, Table",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "reg 6",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt IIA, para 2",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt II, para 1",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (5)(a)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 1, Pt III, para 15",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (6)(f)"
    },
    {
      "type": "added",
      "affected_provisions": "reg 2 defn(s)",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (2)"
    },
    {
      "type": "added",
      "affected_provisions": "regs 12A, 12B (Pt IVA)",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (3)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 1, Pt III, para 1 defn(s)",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (6)(a)(i)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt II, para 5",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 1, Pt IV",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (7)"
    },
    {
      "type": "am",
      "affected_provisions": "reg 10",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "reg 11",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002",
      "affecting_provisions": "reg 5(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 2",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 11(1), (3)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 1 defn(s)",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 11(1), (2)(c)"
    },
    {
      "type": "subst",
      "affected_provisions": "Sch 1, Pt III, para 1 defn(s)",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 11(1), (2)(b)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 1, Pt III, para 1 defn(s)",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 11(1), (2)(a)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt II, para 1, Table",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 10"
    },
    {
      "type": "am",
      "affected_provisions": "reg 3B",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 9"
    },
    {
      "type": "am",
      "affected_provisions": "reg 2",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 8(1), (3)"
    },
    {
      "type": "am",
      "affected_provisions": "reg 2 defn(s)",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 8(1), (2)(b)"
    },
    {
      "type": "am",
      "affected_provisions": "reg 2 defn(s)",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 8(1), (2)(a)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 5, para 2",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 13(1), (3)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 5, para 1A",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 13(1), (2)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 3, Pt I, para 1 defn(s)",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 12"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 14",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 11(1), (6)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, paras 4, 5",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 11(1), (5)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 3",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
      "affecting_provisions": "reg 11(1), (4)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 5, para 5A",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (8)(b)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 3, Pt III, paras 7, 8",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 5, para 2",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (8)(a)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 2, para 5A",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (7)(f)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 2, para 5",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 2, para 5",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (7)(e)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 2, para 4",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (7)(d)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 2, para 3",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (7)(c)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 2, para 2",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 2, para 2",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (7)(b)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 2, para 1 defn(s)",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (7)(a)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch 1, Pt IIIA",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (6)"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt IV, paras 1, 2",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 15",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 3, Pt III, paras 1–3",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, paras 6–12",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, para 5A",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt III, paras 2, 3",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt IIA, para 2",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt II, paras 4–7",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt II, para 1A",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "Sch 1, Pt II, para 1",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "reg 16",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (5)(b)"
    },
    {
      "type": "am",
      "affected_provisions": "reg 16",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (5)(a)"
    },
    {
      "type": "am",
      "affected_provisions": "reg 11",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "am",
      "affected_provisions": "reg 10",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "added",
      "affected_provisions": "regs 9A–9C (Pt IIIA)",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (4)"
    },
    {
      "type": "am",
      "affected_provisions": "reg 6",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (9), Schedule"
    },
    {
      "type": "added",
      "affected_provisions": "regs 3A–3C (Pt IA)",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
      "affecting_provisions": "reg 4(1), (3)"
    },
    {
      "type": "am",
      "affected_provisions": "reg 2 defn(s)",
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      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003",
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      "title": "Medicines Act 1971",
      "url": "https://openlegislation.uk/medicines-act-1971",
      "provisions": [
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    }
  ],
  "changes_made_to": 697,
  "changes_made_to_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/changes.json",
  "changes_made_by": 3,
  "changes_made_by_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/changes/by-it.json",
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  "instruments_made_under_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1995/1116",
    "retrieved_at": "2026-10-29T13:10:38.932521+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."
}