{
  "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977",
  "json_url": "https://openlegislation.uk/medicines-leaflets-regulations-1977.json",
  "id": "uksi/1977/1055",
  "title": "The Medicines (Leaflets) Regulations 1977",
  "short_title": "Medicines (Leaflets) 1977",
  "long_title": "These Regulations made under the Medicines Act 1968 implement certain Community obligations under Council Directive 75/319/EEC which relates to proprietary medicinal products. The regulations prescribe particulars to be contained in leaflets supplied with proprietary medicinal products.",
  "citation": "S.I. 1977/1055",
  "type": "uksi",
  "year": "1977",
  "number": "1055",
  "version": "current",
  "date": "1977-06-21",
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 29,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/introduction",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/1",
      "kind": "regulation",
      "number": "1",
      "heading": "Citation and commencement",
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/regulation-1",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/2",
      "kind": "regulation",
      "number": "2",
      "heading": "Interpretation",
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/regulation-2",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/3",
      "kind": "regulation",
      "number": "3",
      "heading": "Standard requirements relating to leaflets",
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/regulation-3",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/4",
      "kind": "regulation",
      "number": "4",
      "heading": "General provisions",
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/regulation-4",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/5",
      "kind": "regulation",
      "number": "5",
      "heading": "Approval of contents of leaflets",
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/regulation-5",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/6",
      "kind": "regulation",
      "number": "6",
      "heading": "Temporary and transitional provisions",
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/regulation-6",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/signature",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule",
      "kind": "schedule",
      "number": null,
      "heading": "PARTICULARS REQUIRED TO BE INCLUDED IN LEAFLETS",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/paragraph/1",
      "kind": "paragraph",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/schedule/paragraph-1",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/schedule/paragraph-2",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/3",
      "kind": "paragraph",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/schedule/paragraph-3",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/4",
      "kind": "paragraph",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/schedule/paragraph-4",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/5",
      "kind": "paragraph",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/schedule/paragraph-5",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/6",
      "kind": "paragraph",
      "number": "6",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/schedule/paragraph-6",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/7",
      "kind": "paragraph",
      "number": "7",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/schedule/paragraph-7",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/8",
      "kind": "paragraph",
      "number": "8",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/schedule/paragraph-8",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/9",
      "kind": "paragraph",
      "number": "9",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/schedule/paragraph-9",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "note",
      "kind": "note",
      "number": null,
      "heading": "Explanatory note",
      "url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/note",
      "extent": null,
      "status": null,
      "parent": null
    }
  ],
  "outstanding_effects": [
    {
      "type": "added",
      "affected_provisions": "reg.2(1) (defns of generator, kit, precursor and product to which Chs II to V of the 1965 Directive applies)",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.2(2)"
    },
    {
      "type": "substituted",
      "affected_provisions": "reg.2(1) (defn of proprietary medicinal product)",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.2(3)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.2(01) (defns of radiopharmaceutical , radiopharmaceutical -associated product, relevant medicinal product and summary of product characteristics)",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.2(4)"
    },
    {
      "type": "substituted",
      "affected_provisions": "reg.3",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.3"
    },
    {
      "type": "added",
      "affected_provisions": "reg.3A",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.4"
    },
    {
      "type": "amended",
      "affected_provisions": "reg.4(1)",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(2)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.4(1A)",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(3)"
    },
    {
      "type": "amended",
      "affected_provisions": "reg.4(2) rev in pt and",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(4)"
    },
    {
      "type": "amended",
      "affected_provisions": "reg.4(3)",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(5)"
    },
    {
      "type": "revoked",
      "affected_provisions": "reg.4(5)",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(6)"
    },
    {
      "type": "amended",
      "affected_provisions": "reg.4(6)",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(7)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.4(7)-(9)",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.5(8)"
    },
    {
      "type": "amended",
      "affected_provisions": "reg.5(1)",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.6(1)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.5(2A)",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.6(2)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch.2",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.8"
    },
    {
      "type": "substituted",
      "affected_provisions": "Sch, head",
      "affecting": "uksi/1992/3274",
      "affecting_title": "The Medicines (Leaflets) Amendment Regulations 1992",
      "affecting_provisions": "reg.7"
    },
    {
      "type": "added",
      "affected_provisions": "reg.2(1) (defns of certificate of registration, homoeopathic medicinal product and homoeopathic product, which Council directive 92/73/EEC appl)",
      "affecting": "uksi/1994/104",
      "affecting_title": "The Medicines (Labelling and Leaflets) Amendment Regulations 1994",
      "affecting_provisions": "reg.5(2)(3)"
    },
    {
      "type": "amended",
      "affected_provisions": "reg.2(1) (defns of product, which Chapters II to V of the 1965 Directive apply and proprietary medicinal product)",
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      "affecting_title": "The Medicines (Labelling and Leaflets) Amendment Regulations 1994",
      "affecting_provisions": "reg.5(4)(5)"
    },
    {
      "type": "amended",
      "affected_provisions": "reg.3(1)",
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      "affecting_title": "The Medicines (Labelling and Leaflets) Amendment Regulations 1994",
      "affecting_provisions": "reg.6"
    },
    {
      "type": "added",
      "affected_provisions": "reg.3B",
      "affecting": "uksi/1994/104",
      "affecting_title": "The Medicines (Labelling and Leaflets) Amendment Regulations 1994",
      "affecting_provisions": "reg.7"
    },
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      "type": "amended",
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      "affecting": "uksi/1994/104",
      "affecting_title": "The Medicines (Labelling and Leaflets) Amendment Regulations 1994",
      "affecting_provisions": "reg.8"
    },
    {
      "type": "amended",
      "affected_provisions": "reg.5(1)(2)",
      "affecting": "uksi/1994/104",
      "affecting_title": "The Medicines (Labelling and Leaflets) Amendment Regulations 1994",
      "affecting_provisions": "reg.9"
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    {
      "type": "added",
      "affected_provisions": "Sch.3",
      "affecting": "uksi/1994/104",
      "affecting_title": "The Medicines (Labelling and Leaflets) Amendment Regulations 1994",
      "affecting_provisions": "reg.10"
    },
    {
      "type": "substituted",
      "affected_provisions": "reg. 1 heading",
      "affecting": "uksi/1994/3144",
      "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994",
      "affecting_provisions": "Sch. 7 para. 5(a)"
    },
    {
      "type": "reg. 1 renumbered as reg. 1(1)",
      "affected_provisions": "reg. 1",
      "affecting": "uksi/1994/3144",
      "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994",
      "affecting_provisions": "Sch. 7 para. 5(b)"
    },
    {
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      "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994",
      "affecting_provisions": "Sch. 7 para. 5(c)"
    },
    {
      "type": "am",
      "affected_provisions": "reg 1",
      "affecting": "uksi/2005/2753",
      "affecting_title": "Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005",
      "affecting_provisions": "reg 21, Schedule, para 3"
    },
    {
      "type": "continued",
      "affected_provisions": "Regulations",
      "affecting": "uksi/2012/1916",
      "affecting_title": "The Human Medicines Regulations 2012",
      "affecting_provisions": "Sch. 32 para. 2(4)"
    },
    {
      "type": "continued",
      "affected_provisions": "Regulations",
      "affecting": "uksi/2012/1916",
      "affecting_title": "The Human Medicines Regulations 2012",
      "affecting_provisions": "Sch. 32 para. 3(7)(d)"
    }
  ],
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  "changes_made_to_url": "https://openlegislation.uk/medicines-leaflets-regulations-1977/changes.json",
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  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1977/1055",
    "retrieved_at": "2026-10-29T19:56:58.709390+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."
}