{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012.json",
  "id": "uksi/2012/1916",
  "title": "The Human Medicines Regulations 2012",
  "short_title": "Human Medicines 2012",
  "long_title": "These Regulations consolidate the law of the United Kingdom concerning medicinal products for human use (“products”) in respect of the topics described below.",
  "citation": "S.I. 2012/1916",
  "type": "uksi",
  "year": "2012",
  "number": "1916",
  "version": "current",
  "date": "2012-07-19",
  "revised": true,
  "valid_from": "2026-03-31",
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 399,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "part/1",
      "kind": "part",
      "number": "1",
      "heading": "General",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/1",
      "kind": "regulation",
      "number": "1",
      "heading": "Citation and commencement",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-1",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/2",
      "kind": "regulation",
      "number": "2",
      "heading": "Medicinal products",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/2A",
      "kind": "regulation",
      "number": "2A",
      "heading": "Definition of advanced therapy medicinal product etc.",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-2A",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/3",
      "kind": "regulation",
      "number": "3",
      "heading": "Scope of these Regulations: special provisions",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/3A",
      "kind": "regulation",
      "number": "3A",
      "heading": "Preparation and assembly of medicinal products used for vaccination against an infectious disease or in the reformulation of such products",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-3A",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/4",
      "kind": "regulation",
      "number": "4",
      "heading": "Special provisions for pharmacies etc",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/5",
      "kind": "regulation",
      "number": "5",
      "heading": "Classification of medicinal products",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-5",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/6",
      "kind": "regulation",
      "number": "6",
      "heading": "The licensing authority and the Ministers",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-6",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/7",
      "kind": "regulation",
      "number": "7",
      "heading": "Advertisements relating to medicinal products",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-7",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/8",
      "kind": "regulation",
      "number": "8",
      "heading": "General interpretation",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "part/2",
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      "number": "2",
      "heading": "Administration",
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      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/9",
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      "heading": "Commission on Human Medicines",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-9",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/10",
      "kind": "regulation",
      "number": "10",
      "heading": "Functions of the Commission",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-10",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/11",
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      "number": "11",
      "heading": "British Pharmacopoeia Commission",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-11",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/12",
      "kind": "regulation",
      "number": "12",
      "heading": "Reporting to Ministers",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-12",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/13",
      "kind": "regulation",
      "number": "13",
      "heading": "Co-option of additional members of advisory bodies",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-13",
      "extent": null,
      "status": null,
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    },
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      "path": "regulation/14",
      "kind": "regulation",
      "number": "14",
      "heading": "Appointment of expert advisory groups",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-14",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/15",
      "kind": "regulation",
      "number": "15",
      "heading": "Delegation of functions to expert advisory groups",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-15",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/16",
      "kind": "regulation",
      "number": "16",
      "heading": "Further provision about advisory bodies and expert advisory groups etc",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-16",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "part/3",
      "kind": "part",
      "number": "3",
      "heading": "Manufacture and distribution of medicinal products and active substances",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "part/3/chapter/1",
      "kind": "chapter",
      "number": "1",
      "heading": "Interpretation",
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      "extent": null,
      "status": null,
      "parent": "part/3"
    },
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      "path": "regulation/A17",
      "kind": "regulation",
      "number": "A17",
      "heading": "Interpretation",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-A17",
      "extent": null,
      "status": null,
      "parent": "part/3/chapter/1"
    },
    {
      "path": "part/3/chapter/1A",
      "kind": "chapter",
      "number": "1A",
      "heading": "Good manufacturing practice and good distribution practice",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/B17",
      "kind": "regulation",
      "number": "B17",
      "heading": "Regulations on good manufacturing practice",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-B17",
      "extent": null,
      "status": null,
      "parent": "part/3/chapter/1A"
    },
    {
      "path": "regulation/C17",
      "kind": "regulation",
      "number": "C17",
      "heading": "Guidelines on good manufacturing practice and good distribution practice",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-C17",
      "extent": null,
      "status": null,
      "parent": "part/3/chapter/1A"
    },
    {
      "path": "part/3/chapter/2",
      "kind": "chapter",
      "number": "2",
      "heading": "Manufacturing and wholesale dealing",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "part/3/crossheading/grant-etc-of-licences",
      "kind": "crossheading",
      "number": null,
      "heading": "Grant etc of licences",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "part/3/chapter/2"
    },
    {
      "path": "regulation/17",
      "kind": "regulation",
      "number": "17",
      "heading": "Manufacturing of medicinal products",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-17",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/17A",
      "kind": "regulation",
      "number": "17A",
      "heading": "Manufacturing of MM medicinal products",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-17A",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/17B",
      "kind": "regulation",
      "number": "17B",
      "heading": "Manufacturing of POC medicinal products",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-17B",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/18",
      "kind": "regulation",
      "number": "18",
      "heading": "Wholesale dealing in medicinal products",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-18",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/18A",
      "kind": "regulation",
      "number": "18A",
      "heading": "Approved country for import",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-18A",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/19",
      "kind": "regulation",
      "number": "19",
      "heading": "Exemptions from requirement for wholesale dealer's licence",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-19",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/20",
      "kind": "regulation",
      "number": "20",
      "heading": "Mixing of medicines",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-20",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/21",
      "kind": "regulation",
      "number": "21",
      "heading": "Application for manufacturer's or wholesale dealer's licence",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-21",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/22",
      "kind": "regulation",
      "number": "22",
      "heading": "Factors relevant to determination of application for manufacturer's or wholesale dealer's licence",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-22",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/23",
      "kind": "regulation",
      "number": "23",
      "heading": "Grant or refusal of licence",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-23",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/24",
      "kind": "regulation",
      "number": "24",
      "heading": "Standard provisions of licences",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-24",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/25",
      "kind": "regulation",
      "number": "25",
      "heading": "Duration of licence",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-25",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/26",
      "kind": "regulation",
      "number": "26",
      "heading": "General power to suspend, revoke or vary licences",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-26",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/27",
      "kind": "regulation",
      "number": "27",
      "heading": "Procedure where licensing authority proposes to suspend, revoke or vary licence",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-27",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/27A",
      "kind": "regulation",
      "number": "27A",
      "heading": "Effect of suspension or variation relating to modular unit or POC site",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-27A",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/28",
      "kind": "regulation",
      "number": "28",
      "heading": "Suspension of licence in cases of urgency",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-28",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/29",
      "kind": "regulation",
      "number": "29",
      "heading": "Variation of licence on the application of the holder",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-29",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/29A",
      "kind": "regulation",
      "number": "29A",
      "heading": "Variation of MM master file",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-29A",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/29B",
      "kind": "regulation",
      "number": "29B",
      "heading": "Variation of POC master file",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-29B",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "regulation/30",
      "kind": "regulation",
      "number": "30",
      "heading": "Provision of information",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-30",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/grant-etc-of-licences"
    },
    {
      "path": "part/3/crossheading/miscellaneous-and-offences",
      "kind": "crossheading",
      "number": null,
      "heading": "Miscellaneous and offences",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "part/3/chapter/2"
    },
    {
      "path": "regulation/31",
      "kind": "regulation",
      "number": "31",
      "heading": "Certification of manufacturer's licence",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-31",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/miscellaneous-and-offences"
    },
    {
      "path": "regulation/32",
      "kind": "regulation",
      "number": "32",
      "heading": "Sale and supply of starting materials",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-32",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "part/3/crossheading/miscellaneous-and-offences"
    },
    {
      "path": "regulation/33",
      "kind": "regulation",
      "number": "33",
      "heading": "Offence concerning data for advanced therapy medicinal products",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-33",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/miscellaneous-and-offences"
    },
    {
      "path": "regulation/34",
      "kind": "regulation",
      "number": "34",
      "heading": "Offences: breach of regulations and false information and defence concerning starting materials",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-34",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3/crossheading/miscellaneous-and-offences"
    },
    {
      "path": "regulation/35",
      "kind": "regulation",
      "number": "35",
      "heading": "Penalties",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-35",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/miscellaneous-and-offences"
    },
    {
      "path": "part/3/crossheading/conditions-for-holding-a-manufacturers-licence",
      "kind": "crossheading",
      "number": null,
      "heading": "Conditions for holding a manufacturer's licence",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3/chapter/2"
    },
    {
      "path": "regulation/36",
      "kind": "regulation",
      "number": "36",
      "heading": "Conditions for manufacturer's licence",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-36",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3/crossheading/conditions-for-holding-a-manufacturers-licence"
    },
    {
      "path": "regulation/37",
      "kind": "regulation",
      "number": "37",
      "heading": "Manufacturing and assembly",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-37",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/conditions-for-holding-a-manufacturers-licence"
    },
    {
      "path": "regulation/37A",
      "kind": "regulation",
      "number": "37A",
      "heading": "Manufacturing and assembly of MM medicinal products: additional requirements",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-37A",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/conditions-for-holding-a-manufacturers-licence"
    },
    {
      "path": "regulation/37B",
      "kind": "regulation",
      "number": "37B",
      "heading": "Manufacturing and assembly of POC medicinal products: additional requirements",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-37B",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/conditions-for-holding-a-manufacturers-licence"
    },
    {
      "path": "regulation/38",
      "kind": "regulation",
      "number": "38",
      "heading": "Imports from states other than EEA States / countries other than approved countries for import",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-38",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3/crossheading/conditions-for-holding-a-manufacturers-licence"
    },
    {
      "path": "regulation/39",
      "kind": "regulation",
      "number": "39",
      "heading": "Further requirements for manufacturer's licence",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-39",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3/crossheading/conditions-for-holding-a-manufacturers-licence"
    },
    {
      "path": "regulation/40",
      "kind": "regulation",
      "number": "40",
      "heading": "Obligation to provide information relating to control methods",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-40",
      "extent": null,
      "status": null,
      "parent": "part/3/crossheading/conditions-for-holding-a-manufacturers-licence"
    },
    {
      "path": "regulation/41",
      "kind": "regulation",
      "number": "41",
      "heading": "Requirements as to qualified persons",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-41",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3/crossheading/conditions-for-holding-a-manufacturers-licence"
    },
    {
      "path": "part/3/crossheading/conditions-for-holding-a-wholesale-dealers-licence",
      "kind": "crossheading",
      "number": null,
      "heading": "Conditions for holding a wholesale dealer's licence",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3/chapter/2"
    },
    {
      "path": "regulation/42",
      "kind": "regulation",
      "number": "42",
      "heading": "Conditions for wholesale dealer's licence",
      "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-42",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3/crossheading/conditions-for-holding-a-wholesale-dealers-licence"
    },
    {
      "path": "regulation/43",
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      "number": "43",
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      "path": "part/13",
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      "path": "part/14",
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      "affecting_title": "The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025",
      "affecting_provisions": "art. 12(2)"
    },
    {
      "type": "words inserted",
      "affected_provisions": "reg. 167(2)(b)",
      "affecting": "uksi/2025/1249",
      "affecting_title": "The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025",
      "affecting_provisions": "art. 12(6)"
    },
    {
      "type": "words inserted",
      "affected_provisions": "reg. 222A(4)",
      "affecting": "uksi/2025/1249",
      "affecting_title": "The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025",
      "affecting_provisions": "art. 12(11)"
    },
    {
      "type": "words inserted",
      "affected_provisions": "reg. 274(2)(a)",
      "affecting": "uksi/2025/1249",
      "affecting_title": "The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025",
      "affecting_provisions": "art. 12(15)"
    },
    {
      "type": "inserted",
      "affected_provisions": "reg. 346(2)(c)(xxviiieza)",
      "affecting": "uksi/2025/1249",
      "affecting_title": "The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025",
      "affecting_provisions": "art. 12(16)(a)"
    },
    {
      "type": "words inserted",
      "affected_provisions": "Sch. 25 para. 6A",
      "affecting": "uksi/2025/1249",
      "affecting_title": "The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025",
      "affecting_provisions": "art. 12(17)"
    },
    {
      "type": "words inserted",
      "affected_provisions": "Sch. 26 para. 10A",
      "affecting": "uksi/2025/1249",
      "affecting_title": "The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025",
      "affecting_provisions": "art. 12(18)"
    }
  ],
  "made_under": [],
  "changes_made_to": 1076,
  "changes_made_to_url": "https://openlegislation.uk/human-medicines-regulations-2012/changes.json",
  "changes_made_by": 462,
  "changes_made_by_url": "https://openlegislation.uk/human-medicines-regulations-2012/changes/by-it.json",
  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/human-medicines-regulations-2012/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}