{
  "url": "https://openlegislation.uk/medicines-labelling-regulations-1976",
  "json_url": "https://openlegislation.uk/medicines-labelling-regulations-1976.json",
  "id": "uksi/1976/1726",
  "title": "The Medicines (Labelling) Regulations 1976",
  "short_title": "Medicines (Labelling) 1976",
  "long_title": null,
  "citation": "S.I. 1976/1726",
  "type": "uksi",
  "year": "1976",
  "number": "1726",
  "version": "current",
  "date": null,
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 90,
  "provisions": [],
  "has_text": false,
  "pdfs": [
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      "title": "Printed copy",
      "main": true,
      "language": null,
      "date": "2012-07-11",
      "size": 8200706,
      "url": "https://openlegislation.uk/medicines-labelling-regulations-1976/pdf/uksi_19761726_en.pdf",
      "source_url": "https://www.legislation.gov.uk/uksi/1976/1726/pdfs/uksi_19761726_en.pdf"
    }
  ],
  "outstanding_effects": [
    {
      "type": "amended",
      "affected_provisions": "reg. 14D",
      "affecting": "uksi/1977/2168",
      "affecting_title": "The Medicines (Labelling) Amendment (No. 2) Regulations 1977",
      "affecting_provisions": null
    },
    {
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      "affecting_title": "The Medicines (Labelling) Amendment (No. 2) Regulations 1977",
      "affecting_provisions": null
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    {
      "type": "amended",
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      "affecting_provisions": null
    },
    {
      "type": "amended",
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      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1977",
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      "type": "amended",
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      "affecting_provisions": null
    },
    {
      "type": "amended",
      "affected_provisions": "sch. 1 para. 9",
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      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1977",
      "affecting_provisions": null
    },
    {
      "type": "inserted",
      "affected_provisions": "sch. 5",
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      "affecting_provisions": null
    },
    {
      "type": "inserted",
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      "affecting_provisions": null
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    {
      "type": "inserted",
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      "affecting_provisions": null
    },
    {
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      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1977",
      "affecting_provisions": null
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    {
      "type": "inserted",
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    {
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    {
      "type": "amended",
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    },
    {
      "type": "amended",
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    },
    {
      "type": "amended",
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      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1977",
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    },
    {
      "type": "amended",
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      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1977",
      "affecting_provisions": null
    },
    {
      "type": "amended",
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      "affecting": "uksi/1978/1140",
      "affecting_title": "The Medicines (Licensing of Intra-Uterine Contraceptive Devices) (Miscellaneous Amendments) Regulations 1978",
      "affecting_provisions": null
    },
    {
      "type": "amended",
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      "affecting_title": "The Medicines (Labelling and Advertising to the Public) Regulations 1978",
      "affecting_provisions": null
    },
    {
      "type": "inserted",
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      "affecting": "uksi/1981/1791",
      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1981",
      "affecting_provisions": null
    },
    {
      "type": "amended",
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      "affecting": "uksi/1983/1729",
      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1983",
      "affecting_provisions": null
    },
    {
      "type": "inserted",
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      "affecting": "uksi/1983/1729",
      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1983",
      "affecting_provisions": null
    },
    {
      "type": "amended",
      "affected_provisions": "reg. 3",
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      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1983",
      "affecting_provisions": null
    },
    {
      "type": "inserted",
      "affected_provisions": "sch. 1 para. 11A",
      "affecting": "uksi/1983/1729",
      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1983",
      "affecting_provisions": null
    },
    {
      "type": "amended",
      "affected_provisions": "sch. 1 para. 7",
      "affecting": "uksi/1985/1558",
      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1985",
      "affecting_provisions": null
    },
    {
      "type": "inserted",
      "affected_provisions": "sch. 1 para. 7A",
      "affecting": "uksi/1985/1558",
      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1985",
      "affecting_provisions": null
    },
    {
      "type": "replaced",
      "affected_provisions": "sch. 1 para. 5",
      "affecting": "uksi/1985/2008",
      "affecting_title": "The Medicines (Labelling) and (Leaflets for Veterinary Drugs) (Amendment) Regulations 1985",
      "affecting_provisions": null
    },
    {
      "type": "inserted",
      "affected_provisions": "sch. 1 para. 5A",
      "affecting": "uksi/1985/2008",
      "affecting_title": "The Medicines (Labelling) and (Leaflets for Veterinary Drugs) (Amendment) Regulations 1985",
      "affecting_provisions": null
    },
    {
      "type": "amended",
      "affected_provisions": "reg. 18",
      "affecting": "uksi/1988/1009",
      "affecting_title": "The Medicines (Labelling of Medicinal Products for Incorporation in Animal Feeding Stuffs and of Medicated Animal Feeding Stuffs) Regulations 1988",
      "affecting_provisions": null
    },
    {
      "type": "revoked",
      "affected_provisions": "sch. 3 para. 4",
      "affecting": "uksi/1988/1009",
      "affecting_title": "The Medicines (Labelling of Medicinal Products for Incorporation in Animal Feeding Stuffs and of Medicated Animal Feeding Stuffs) Regulations 1988",
      "affecting_provisions": null
    },
    {
      "type": "amended",
      "affected_provisions": "reg. 3",
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      "affecting_title": "The Medicines (Labelling of Medicinal Products for Incorporation in Animal Feeding Stuffs and of Medicated Animal Feeding Stuffs) Regulations 1988",
      "affecting_provisions": null
    },
    {
      "type": "revoked",
      "affected_provisions": "reg. 14",
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      "affecting_title": "The Medicines (Labelling of Medicinal Products for Incorporation in Animal Feeding Stuffs and of Medicated Animal Feeding Stuffs) Regulations 1988",
      "affecting_provisions": null
    },
    {
      "type": "revoked",
      "affected_provisions": "sch. 3 para. 5",
      "affecting": "uksi/1988/1009",
      "affecting_title": "The Medicines (Labelling of Medicinal Products for Incorporation in Animal Feeding Stuffs and of Medicated Animal Feeding Stuffs) Regulations 1988",
      "affecting_provisions": null
    },
    {
      "type": "amended",
      "affected_provisions": "sch. 1 para. 8",
      "affecting": "uksi/1989/1183",
      "affecting_title": "The Medicines (Data Sheet and Labelling) Amendment Regulations 1989",
      "affecting_provisions": null
    },
    {
      "type": "amended",
      "affected_provisions": "sch. 1 para. 12",
      "affecting": "uksi/1989/1183",
      "affecting_title": "The Medicines (Data Sheet and Labelling) Amendment Regulations 1989",
      "affecting_provisions": null
    },
    {
      "type": "amended",
      "affected_provisions": "sch. 1 para. 9",
      "affecting": "uksi/1989/1183",
      "affecting_title": "The Medicines (Data Sheet and Labelling) Amendment Regulations 1989",
      "affecting_provisions": null
    },
    {
      "type": "added",
      "affected_provisions": "reg.3(1) (defn of product to whichCII to Vofthe 1985 Directive applies)",
      "affecting": "uksi/1992/3273",
      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1992",
      "affecting_provisions": "reg.2(4)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.3(1) (deln of cominon name)",
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      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1992",
      "affecting_provisions": "reg.2(2)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.3(1) (defn of name)",
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      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1992",
      "affecting_provisions": "reg.2(3)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.3(1) (defn of relevant medicinal product)",
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      "affecting_provisions": "reg.2(5)"
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    {
      "type": "added",
      "affected_provisions": "reg.3(1) (defn of strength)",
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      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1992",
      "affecting_provisions": "reg.2(6)"
    },
    {
      "type": "added",
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      "affecting": "uksi/1992/3273",
      "affecting_title": "The Medicines (Labelling) Amendment Regulations 1992",
      "affecting_provisions": "reg.3"
    },
    {
      "type": "added",
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    {
      "type": "added",
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      "affecting": "uksi/1994/104",
      "affecting_title": "The Medicines (Labelling and Leaflets) Amendment Regulations 1994",
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    },
    {
      "type": "amended",
      "affected_provisions": "reg.3(1) (defn of product, which Chapters II to V of the 1965 Directive apply)",
      "affecting": "uksi/1994/104",
      "affecting_title": "The Medicines (Labelling and Leaflets) Amendment Regulations 1994",
      "affecting_provisions": "reg.2(b)"
    },
    {
      "type": "added",
      "affected_provisions": "reg.3(1) (defn of homoeopathic product . . . Council Directive 92/73/EEC applies)",
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    {
      "type": "added",
      "affected_provisions": "Sch.9",
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      "affecting_provisions": "reg.4"
    },
    {
      "type": "inserted",
      "affected_provisions": "reg. 3A",
      "affecting": "uksi/1994/3142",
      "affecting_title": "The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994",
      "affecting_provisions": "Sch. 5 para. 4"
    },
    {
      "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. 3(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",
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    },
    {
      "type": "inserted",
      "affected_provisions": "reg. 1(2)",
      "affecting": "uksi/1994/3144",
      "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994",
      "affecting_provisions": "Sch. 7 para. 3(c)"
    },
    {
      "type": "revoked in part",
      "affected_provisions": "Regulations",
      "affecting": "uksi/1996/2194",
      "affecting_title": "The Animal Test Certificates Regulations 1996",
      "affecting_provisions": "reg. 6 Sch. 3"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 4F(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 5(d)"
    },
    {
      "type": "words inserted",
      "affected_provisions": "reg. 3(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 5(a)(i)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 3(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 5(a)(ii)"
    },
    {
      "type": "words deleted",
      "affected_provisions": "reg. 3(1)",
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      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 5(a)(iii)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 3(1)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 5(a)(iv)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 4A(5)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 5(b)(i)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 4A(5)(b)",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 5(b)(ii)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 4B",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002",
      "affecting_provisions": "reg. 5(c)"
    },
    {
      "type": "words omitted",
      "affected_provisions": "reg. 10",
      "affecting": "uksi/2004/1031",
      "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
      "affecting_provisions": "Sch. 10 Pt. 2 para. 6(5)"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 16(1)",
      "affecting": "uksi/2004/1031",
      "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
      "affecting_provisions": "Sch. 10 Pt. 2 para. 6(6)(a)"
    },
    {
      "type": "words omitted",
      "affected_provisions": "reg. 16(2)",
      "affecting": "uksi/2004/1031",
      "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
      "affecting_provisions": "Sch. 10 Pt. 2 para. 6(6)(b)"
    },
    {
      "type": "omitted",
      "affected_provisions": "Sch. 2",
      "affecting": "uksi/2004/1031",
      "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
      "affecting_provisions": "Sch. 10 Pt. 2 para. 6(7)"
    },
    {
      "type": "words inserted",
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      "affecting": "uksi/2004/1031",
      "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
      "affecting_provisions": "Sch. 10 Pt. 2 para. 6(2)"
    },
    {
      "type": "words omitted",
      "affected_provisions": "reg. 2(b)(i)",
      "affecting": "uksi/2004/1031",
      "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
      "affecting_provisions": "Sch. 10 Pt. 2 para. 6(3)"
    },
    {
      "type": "omitted",
      "affected_provisions": "reg. 6",
      "affecting": "uksi/2004/1031",
      "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
      "affecting_provisions": "Sch. 10 Pt. 2 para. 6(4)"
    },
    {
      "type": "revoked",
      "affected_provisions": "reg. 9(1)(b)",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(4)"
    },
    {
      "type": "words revoked",
      "affected_provisions": "reg. 16(1)",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(7)(a)(i)"
    },
    {
      "type": "words revoked",
      "affected_provisions": "reg. 16(1)",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(7)(a)(ii)"
    },
    {
      "type": "words revoked",
      "affected_provisions": "reg. 16(1)",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(7)(a)(iii)"
    },
    {
      "type": "words revoked",
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      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(7)(b)"
    },
    {
      "type": "revoked",
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      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(8)"
    },
    {
      "type": "words revoked",
      "affected_provisions": "Sch. 1 para. 3",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt 3 para 10(9)(a)"
    },
    {
      "type": "revoked",
      "affected_provisions": "Sch. 1 para. 5",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(9)(b)"
    },
    {
      "type": "revoked",
      "affected_provisions": "Sch. 1 para. 5A",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(9)(c)"
    },
    {
      "type": "revoked",
      "affected_provisions": "Sch. 1 para. 11A",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(9)(d)"
    },
    {
      "type": "revoked",
      "affected_provisions": "Sch. 1 para. 13",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(9)(e)"
    },
    {
      "type": "revoked",
      "affected_provisions": "Sch. 3",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(10)"
    },
    {
      "type": "revoked",
      "affected_provisions": "Sch. 5 para. 6–8",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(11)"
    },
    {
      "type": "revoked",
      "affected_provisions": "Sch. 6 para. 6–7",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(12)"
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    {
      "type": "revoked",
      "affected_provisions": "reg. 14D",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(6)"
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    {
      "type": "substituted",
      "affected_provisions": "reg. 3A",
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      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(2)"
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      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(3)"
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      "affected_provisions": "reg. 12(1)(a)",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 10(5)"
    },
    {
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      "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 2"
    },
    {
      "type": "words substituted",
      "affected_provisions": "reg. 17(6)",
      "affecting": "uksi/2005/2754",
      "affecting_title": "The Medicines (Advisory Bodies) (No. 2) Regulations 2005",
      "affecting_provisions": "Sch. 4 para. 2"
    },
    {
      "type": "continued",
      "affected_provisions": "Regulations",
      "affecting": "uksi/2012/1916",
      "affecting_title": "The Human Medicines Regulations 2012",
      "affecting_provisions": "Sch. 32 para. 3(7)(c)"
    },
    {
      "type": "continued",
      "affected_provisions": "Regulations",
      "affecting": "uksi/2012/1916",
      "affecting_title": "The Human Medicines Regulations 2012",
      "affecting_provisions": "Sch. 32 para. 2(4)"
    }
  ],
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  "changes_made_to": 90,
  "changes_made_to_url": "https://openlegislation.uk/medicines-labelling-regulations-1976/changes.json",
  "changes_made_by": 0,
  "changes_made_by_url": "https://openlegislation.uk/medicines-labelling-regulations-1976/changes/by-it.json",
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  "instruments_made_under_url": "https://openlegislation.uk/medicines-labelling-regulations-1976/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1976/1726",
    "retrieved_at": "2026-10-29T20:17:59.341919+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."
}