{
  "url": "https://openlegislation.uk/eu-regulation-2019-6",
  "json_url": "https://openlegislation.uk/eu-regulation-2019-6.json",
  "id": "eur/2019/6",
  "title": "Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)",
  "short_title": "Regulation (EU) 2019/6 on veterinary medicinal products",
  "long_title": "Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)",
  "citation": "EU Regulation 2019/6",
  "type": "eur",
  "year": "2019",
  "number": "6",
  "version": "current",
  "date": "2018-12-11",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "chapter/I",
      "kind": "chapter",
      "number": "I",
      "heading": "SUBJECT MATTER, SCOPE AND DEFINITIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": "Subject matter",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Scope",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Conflict of laws",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Definitions",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "chapter/II",
      "kind": "chapter",
      "number": "II",
      "heading": "MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "chapter/II/section/1",
      "kind": "section",
      "number": "1",
      "heading": "General provisions",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Marketing authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/1"
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Submission of applications for marketing authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/1"
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Languages",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/1"
    },
    {
      "path": "chapter/II/section/2",
      "kind": "section",
      "number": "2",
      "heading": "Dossier requirements",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Data to be submitted with the application",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/2"
    },
    {
      "path": "chapter/II/section/3",
      "kind": "section",
      "number": "3",
      "heading": "Clinical trials",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Clinical trials",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/3"
    },
    {
      "path": "chapter/II/section/4",
      "kind": "section",
      "number": "4",
      "heading": "Labelling and package leaflet",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "Labelling of the immediate packaging of veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/4"
    },
    {
      "path": "article/11",
      "kind": "article",
      "number": "11",
      "heading": "Labelling of the outer packaging of veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/4"
    },
    {
      "path": "article/12",
      "kind": "article",
      "number": "12",
      "heading": "Labelling of small immediate packaging units of veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/4"
    },
    {
      "path": "article/13",
      "kind": "article",
      "number": "13",
      "heading": "Additional information on the immediate packaging or outer packaging of veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-13",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/4"
    },
    {
      "path": "article/14",
      "kind": "article",
      "number": "14",
      "heading": "Package leaflet of veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-14",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/4"
    },
    {
      "path": "article/15",
      "kind": "article",
      "number": "15",
      "heading": "General requirement regarding product information",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-15",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/4"
    },
    {
      "path": "article/16",
      "kind": "article",
      "number": "16",
      "heading": "Package leaflet of registered homeopathic veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-16",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/4"
    },
    {
      "path": "article/17",
      "kind": "article",
      "number": "17",
      "heading": "Implementing powers with respect to this Section",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-17",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/4"
    },
    {
      "path": "chapter/II/section/5",
      "kind": "section",
      "number": "5",
      "heading": "Specific requirements for generic, hybrid and combination veterinary medicinal products and for applications based on informed consent and bibliographic data",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/18",
      "kind": "article",
      "number": "18",
      "heading": "Generic veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-18",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/5"
    },
    {
      "path": "article/19",
      "kind": "article",
      "number": "19",
      "heading": "Hybrid veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-19",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/5"
    },
    {
      "path": "article/20",
      "kind": "article",
      "number": "20",
      "heading": "Combination veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-20",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/5"
    },
    {
      "path": "article/21",
      "kind": "article",
      "number": "21",
      "heading": "Application based on informed consent",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-21",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/5"
    },
    {
      "path": "article/22",
      "kind": "article",
      "number": "22",
      "heading": "Application based on bibliographic data",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-22",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/5"
    },
    {
      "path": "chapter/II/section/6",
      "kind": "section",
      "number": "6",
      "heading": "Marketing authorisations for limited market and in exceptional circumstances",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/23",
      "kind": "article",
      "number": "23",
      "heading": "Applications for limited markets",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-23",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/6"
    },
    {
      "path": "article/24",
      "kind": "article",
      "number": "24",
      "heading": "Validity of a marketing authorisation for a limited market and procedure for its re-examination",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-24",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/6"
    },
    {
      "path": "article/25",
      "kind": "article",
      "number": "25",
      "heading": "Applications in exceptional circumstances",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-25",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/6"
    },
    {
      "path": "article/26",
      "kind": "article",
      "number": "26",
      "heading": "Terms of the marketing authorisation in exceptional circumstances",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-26",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/6"
    },
    {
      "path": "article/27",
      "kind": "article",
      "number": "27",
      "heading": "Validity of a marketing authorisation in exceptional circumstances and procedure for its re-examination",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-27",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/6"
    },
    {
      "path": "chapter/II/section/7",
      "kind": "section",
      "number": "7",
      "heading": "Examination of applications and basis for granting marketing authorisations",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/28",
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      "number": "28",
      "heading": "Examination of applications",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-28",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/7"
    },
    {
      "path": "article/29",
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      "number": "29",
      "heading": "Requests to laboratories in the course of the examination of applications",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-29",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/7"
    },
    {
      "path": "article/30",
      "kind": "article",
      "number": "30",
      "heading": "Information on manufacturers in third countries",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-30",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/7"
    },
    {
      "path": "article/31",
      "kind": "article",
      "number": "31",
      "heading": "Additional information from the applicant",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-31",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/7"
    },
    {
      "path": "article/32",
      "kind": "article",
      "number": "32",
      "heading": "Withdrawal of applications",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-32",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/7"
    },
    {
      "path": "article/33",
      "kind": "article",
      "number": "33",
      "heading": "Outcome of the assessment",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-33",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/7"
    },
    {
      "path": "article/34",
      "kind": "article",
      "number": "34",
      "heading": "Classification of veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-34",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/7"
    },
    {
      "path": "article/35",
      "kind": "article",
      "number": "35",
      "heading": "Summary of the product characteristics",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-35",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/7"
    },
    {
      "path": "article/36",
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      "heading": "Decisions granting marketing authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-36",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/7"
    },
    {
      "path": "article/37",
      "kind": "article",
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      "heading": "Decisions refusing marketing authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-37",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/7"
    },
    {
      "path": "chapter/II/section/8",
      "kind": "section",
      "number": "8",
      "heading": "Protection of technical documentation",
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      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/38",
      "kind": "article",
      "number": "38",
      "heading": "Protection of technical documentation",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-38",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/8"
    },
    {
      "path": "article/39",
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      "number": "39",
      "heading": "Periods of the protection of technical documentation",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-39",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/8"
    },
    {
      "path": "article/40",
      "kind": "article",
      "number": "40",
      "heading": "Prolongation and additional periods of the protection of technical documentation",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-40",
      "extent": "E+W+S+N.I.",
      "status": null,
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    },
    {
      "path": "article/41",
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      "heading": "Patent-related rights",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-41",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/8"
    },
    {
      "path": "chapter/III",
      "kind": "chapter",
      "number": "III",
      "heading": "PROCEDURES FOR MARKETING AUTHORISATIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "chapter/III/section/1",
      "kind": "section",
      "number": "1",
      "heading": "Marketing authorisations valid throughout the Union (‘centralised marketing authorisations’)",
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      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
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      "path": "article/42",
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      "number": "42",
      "heading": "Scope of the centralised marketing authorisation procedure",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-42",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III/section/1"
    },
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      "path": "article/43",
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      "number": "43",
      "heading": "Application for centralised marketing authorisation",
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      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III/section/1"
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    {
      "path": "article/44",
      "kind": "article",
      "number": "44",
      "heading": "Procedure for centralised marketing authorisation",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-44",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III/section/1"
    },
    {
      "path": "article/45",
      "kind": "article",
      "number": "45",
      "heading": "Re-examination of the opinion of the Agency",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-45",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III/section/1"
    },
    {
      "path": "chapter/III/section/2",
      "kind": "section",
      "number": "2",
      "heading": "Marketing authorisations valid in a single Member State (‘national marketing authorisations’)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/46",
      "kind": "article",
      "number": "46",
      "heading": "Scope of national marketing authorisation",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-46",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III/section/2"
    },
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      "path": "article/47",
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      "number": "47",
      "heading": "Procedure for national marketing authorisation",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-47",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III/section/2"
    },
    {
      "path": "chapter/III/section/3",
      "kind": "section",
      "number": "3",
      "heading": "Marketing authorisations valid in several Member States (‘decentralised marketing authorisations’)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/48",
      "kind": "article",
      "number": "48",
      "heading": "Scope of decentralised marketing authorisation",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-48",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III/section/3"
    },
    {
      "path": "article/49",
      "kind": "article",
      "number": "49",
      "heading": "Procedure for decentralised marketing authorisation",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-49",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III/section/3"
    },
    {
      "path": "article/50",
      "kind": "article",
      "number": "50",
      "heading": "Request by the applicant for re-examination of the assessment report",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-50",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III/section/3"
    },
    {
      "path": "chapter/III/section/4",
      "kind": "section",
      "number": "4",
      "heading": "Mutual recognition of national marketing authorisations",
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      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/51",
      "kind": "article",
      "number": "51",
      "heading": "Scope of mutual recognition of national marketing authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-51",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III/section/4"
    },
    {
      "path": "article/52",
      "kind": "article",
      "number": "52",
      "heading": "Procedure for mutual recognition of national marketing authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-52",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III/section/4"
    },
    {
      "path": "chapter/III/section/5",
      "kind": "section",
      "number": "5",
      "heading": "Subsequent recognition in the mutual recognition and decentralised marketing authorisation procedures",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/53",
      "kind": "article",
      "number": "53",
      "heading": "Subsequent recognition of marketing authorisations by additional Member States concerned",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-53",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III/section/5"
    },
    {
      "path": "chapter/III/section/6",
      "kind": "section",
      "number": "6",
      "heading": "Review procedure",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/54",
      "kind": "article",
      "number": "54",
      "heading": "Review procedure",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-54",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III/section/6"
    },
    {
      "path": "chapter/IV",
      "kind": "chapter",
      "number": "IV",
      "heading": "POST-MARKETING AUTHORISATION MEASURES",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "chapter/IV/section/1",
      "kind": "section",
      "number": "1",
      "heading": "Union product database",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/55",
      "kind": "article",
      "number": "55",
      "heading": "Union database on veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-55",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/1"
    },
    {
      "path": "article/56",
      "kind": "article",
      "number": "56",
      "heading": "Access to the product database",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-56",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/1"
    },
    {
      "path": "chapter/IV/section/2",
      "kind": "section",
      "number": "2",
      "heading": "Collection of data by Member States and responsibilities of marketing authorisation holders",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/57",
      "kind": "article",
      "number": "57",
      "heading": "Collection of data on antimicrobial medicinal products used in animals",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-57",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/2"
    },
    {
      "path": "article/58",
      "kind": "article",
      "number": "58",
      "heading": "Responsibilities of the marketing authorisation holders",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-58",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/2"
    },
    {
      "path": "article/59",
      "kind": "article",
      "number": "59",
      "heading": "Small and medium-sized enterprises",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-59",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/2"
    },
    {
      "path": "chapter/IV/section/3",
      "kind": "section",
      "number": "3",
      "heading": "Changes to the terms of the marketing authorisations",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/60",
      "kind": "article",
      "number": "60",
      "heading": "Variations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-60",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/3"
    },
    {
      "path": "article/61",
      "kind": "article",
      "number": "61",
      "heading": "Variations that do not require assessment",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-61",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/3"
    },
    {
      "path": "article/62",
      "kind": "article",
      "number": "62",
      "heading": "Application for variations requiring assessment",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-62",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/3"
    },
    {
      "path": "article/63",
      "kind": "article",
      "number": "63",
      "heading": "Consequential changes to product information",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-63",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/3"
    },
    {
      "path": "article/64",
      "kind": "article",
      "number": "64",
      "heading": "Groups of variations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-64",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/3"
    },
    {
      "path": "article/65",
      "kind": "article",
      "number": "65",
      "heading": "Work-sharing procedure",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-65",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/3"
    },
    {
      "path": "article/66",
      "kind": "article",
      "number": "66",
      "heading": "Procedure for variations requiring assessment",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-66",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/3"
    },
    {
      "path": "article/67",
      "kind": "article",
      "number": "67",
      "heading": "Measures to close the procedure for variations requiring assessment",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-67",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/3"
    },
    {
      "path": "article/68",
      "kind": "article",
      "number": "68",
      "heading": "Implementation of variations requiring assessment",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-68",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/3"
    },
    {
      "path": "chapter/IV/section/4",
      "kind": "section",
      "number": "4",
      "heading": "Harmonisation of the summaries of product characteristics for nationally authorised products",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/69",
      "kind": "article",
      "number": "69",
      "heading": "Scope of the harmonisation of summaries of product characteristics of a veterinary medicinal product",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-69",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/4"
    },
    {
      "path": "article/70",
      "kind": "article",
      "number": "70",
      "heading": "Procedure for harmonisation of summaries of product characteristics for the reference veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-70",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/4"
    },
    {
      "path": "article/71",
      "kind": "article",
      "number": "71",
      "heading": "Procedure for harmonisation of summaries of product characteristics for generic and hybrid veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-71",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/4"
    },
    {
      "path": "article/72",
      "kind": "article",
      "number": "72",
      "heading": "Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-72",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/4"
    },
    {
      "path": "chapter/IV/section/5",
      "kind": "section",
      "number": "5",
      "heading": "Pharmacovigilance",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/73",
      "kind": "article",
      "number": "73",
      "heading": "Union pharmacovigilance system",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-73",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/5"
    },
    {
      "path": "article/74",
      "kind": "article",
      "number": "74",
      "heading": "Union pharmacovigilance database",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-74",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/5"
    },
    {
      "path": "article/75",
      "kind": "article",
      "number": "75",
      "heading": "Access to the pharmacovigilance database",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-75",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/5"
    },
    {
      "path": "article/76",
      "kind": "article",
      "number": "76",
      "heading": "Reporting and recording of suspected adverse events",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-76",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/5"
    },
    {
      "path": "article/77",
      "kind": "article",
      "number": "77",
      "heading": "Pharmacovigilance responsibilities of the marketing authorisation holder",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-77",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/5"
    },
    {
      "path": "article/78",
      "kind": "article",
      "number": "78",
      "heading": "Qualified person responsible for pharmacovigilance",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-78",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/5"
    },
    {
      "path": "article/79",
      "kind": "article",
      "number": "79",
      "heading": "Pharmacovigilance responsibilities of the competent authorities and the Agency",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-79",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/5"
    },
    {
      "path": "article/80",
      "kind": "article",
      "number": "80",
      "heading": "Delegation of tasks by competent authority",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-80",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/5"
    },
    {
      "path": "article/81",
      "kind": "article",
      "number": "81",
      "heading": "Signal management process",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-81",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/5"
    },
    {
      "path": "chapter/IV/section/6",
      "kind": "section",
      "number": "6",
      "heading": "Union interest referral",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/82",
      "kind": "article",
      "number": "82",
      "heading": "Scope of the Union interest referral",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-82",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/6"
    },
    {
      "path": "article/83",
      "kind": "article",
      "number": "83",
      "heading": "Union interest referral procedure",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-83",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/6"
    },
    {
      "path": "article/84",
      "kind": "article",
      "number": "84",
      "heading": "Decision following the Union interest referral",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-84",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV/section/6"
    },
    {
      "path": "chapter/V",
      "kind": "chapter",
      "number": "V",
      "heading": "HOMEOPATHIC VETERINARY MEDICINAL PRODUCTS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/85",
      "kind": "article",
      "number": "85",
      "heading": "Homeopathic veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-85",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/86",
      "kind": "article",
      "number": "86",
      "heading": "Registration of homeopathic veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-86",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/87",
      "kind": "article",
      "number": "87",
      "heading": "Application and procedure for registration of homeopathic veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-87",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "chapter/VI",
      "kind": "chapter",
      "number": "VI",
      "heading": "MANUFACTURING, IMPORT AND EXPORT",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/88",
      "kind": "article",
      "number": "88",
      "heading": "Manufacturing authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-88",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/89",
      "kind": "article",
      "number": "89",
      "heading": "Application for manufacturing authorisation",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-89",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/90",
      "kind": "article",
      "number": "90",
      "heading": "Procedure for granting of manufacturing authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-90",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/91",
      "kind": "article",
      "number": "91",
      "heading": "Database on manufacturing and wholesale distribution",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-91",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/92",
      "kind": "article",
      "number": "92",
      "heading": "Changes to manufacturing authorisations on request",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-92",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/93",
      "kind": "article",
      "number": "93",
      "heading": "Obligations of the holder of a manufacturing authorisation",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-93",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/94",
      "kind": "article",
      "number": "94",
      "heading": "Certificates of good manufacturing practice",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-94",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/95",
      "kind": "article",
      "number": "95",
      "heading": "Importers, manufacturers and distributors of active substances established in the Union",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-95",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/96",
      "kind": "article",
      "number": "96",
      "heading": "Record keeping",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-96",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/97",
      "kind": "article",
      "number": "97",
      "heading": "Qualified person responsible for manufacturing and batch release",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-97",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/98",
      "kind": "article",
      "number": "98",
      "heading": "Certificates of veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-98",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "chapter/VII",
      "kind": "chapter",
      "number": "VII",
      "heading": "SUPPLY AND USE",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "chapter/VII/section/1",
      "kind": "section",
      "number": "1",
      "heading": "Wholesale distribution",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII"
    },
    {
      "path": "article/99",
      "kind": "article",
      "number": "99",
      "heading": "Wholesale distribution authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-99",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/1"
    },
    {
      "path": "article/100",
      "kind": "article",
      "number": "100",
      "heading": "Application and procedures for wholesale distribution authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-100",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/1"
    },
    {
      "path": "article/101",
      "kind": "article",
      "number": "101",
      "heading": "Obligations of wholesale distributors",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-101",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/1"
    },
    {
      "path": "article/102",
      "kind": "article",
      "number": "102",
      "heading": "Parallel trade in veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-102",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/1"
    },
    {
      "path": "chapter/VII/section/2",
      "kind": "section",
      "number": "2",
      "heading": "Retail",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII"
    },
    {
      "path": "article/103",
      "kind": "article",
      "number": "103",
      "heading": "Retail of veterinary medicinal products and record keeping",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-103",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/2"
    },
    {
      "path": "article/104",
      "kind": "article",
      "number": "104",
      "heading": "Retail of veterinary medicinal products at a distance",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-104",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/2"
    },
    {
      "path": "article/105",
      "kind": "article",
      "number": "105",
      "heading": "Veterinary prescriptions",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-105",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/2"
    },
    {
      "path": "chapter/VII/section/3",
      "kind": "section",
      "number": "3",
      "heading": "Use",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII"
    },
    {
      "path": "article/106",
      "kind": "article",
      "number": "106",
      "heading": "Use of medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-106",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/3"
    },
    {
      "path": "article/107",
      "kind": "article",
      "number": "107",
      "heading": "Use of antimicrobial medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-107",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/3"
    },
    {
      "path": "article/108",
      "kind": "article",
      "number": "108",
      "heading": "Record-keeping by owners and keepers of food-producing animals",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-108",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/3"
    },
    {
      "path": "article/109",
      "kind": "article",
      "number": "109",
      "heading": "Record-keeping obligations for equine animals",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-109",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/3"
    },
    {
      "path": "article/110",
      "kind": "article",
      "number": "110",
      "heading": "Use of immunological veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-110",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/3"
    },
    {
      "path": "article/111",
      "kind": "article",
      "number": "111",
      "heading": "Use of veterinary medicinal products by veterinarians providing services in other Member States",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-111",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/3"
    },
    {
      "path": "article/112",
      "kind": "article",
      "number": "112",
      "heading": "Use of medicinal products outside the terms of the marketing authorisation in non-food-producing animal species",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-112",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/3"
    },
    {
      "path": "article/113",
      "kind": "article",
      "number": "113",
      "heading": "Use of medicinal products outside the terms of the marketing authorisation in food-producing terrestrial animal species",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-113",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/3"
    },
    {
      "path": "article/114",
      "kind": "article",
      "number": "114",
      "heading": "Use of medicinal products for food-producing aquatic species",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-114",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/3"
    },
    {
      "path": "article/115",
      "kind": "article",
      "number": "115",
      "heading": "Withdrawal period for medicinal products used outside the terms of the marketing authorisation in food-producing animal species",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-115",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/3"
    },
    {
      "path": "article/116",
      "kind": "article",
      "number": "116",
      "heading": "Health situation",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-116",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/3"
    },
    {
      "path": "article/117",
      "kind": "article",
      "number": "117",
      "heading": "Collection and disposal of waste of veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-117",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/3"
    },
    {
      "path": "article/118",
      "kind": "article",
      "number": "118",
      "heading": "Animals or products of animal origin imported into the Union",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-118",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/3"
    },
    {
      "path": "chapter/VII/section/4",
      "kind": "section",
      "number": "4",
      "heading": "Advertising",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII"
    },
    {
      "path": "article/119",
      "kind": "article",
      "number": "119",
      "heading": "Advertising of veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-119",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/4"
    },
    {
      "path": "article/120",
      "kind": "article",
      "number": "120",
      "heading": "Advertising of veterinary medicinal products subject to veterinary prescription",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-120",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/4"
    },
    {
      "path": "article/121",
      "kind": "article",
      "number": "121",
      "heading": "Promotion of medicinal products used in animals",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-121",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/4"
    },
    {
      "path": "article/122",
      "kind": "article",
      "number": "122",
      "heading": "Implementation of advertising provisions",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-122",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII/section/4"
    },
    {
      "path": "chapter/VIII",
      "kind": "chapter",
      "number": "VIII",
      "heading": "INSPECTIONS AND CONTROLS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/123",
      "kind": "article",
      "number": "123",
      "heading": "Controls",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-123",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/124",
      "kind": "article",
      "number": "124",
      "heading": "Audits by the Commission",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-124",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/125",
      "kind": "article",
      "number": "125",
      "heading": "Certificate of suitability",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-125",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/126",
      "kind": "article",
      "number": "126",
      "heading": "Specific rules on pharmacovigilance inspections",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-126",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/127",
      "kind": "article",
      "number": "127",
      "heading": "Proof of the product quality for veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-127",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/128",
      "kind": "article",
      "number": "128",
      "heading": "Proof of the product quality specific for immunological veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-128",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "chapter/IX",
      "kind": "chapter",
      "number": "IX",
      "heading": "RESTRICTIONS AND PENALTIES",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/129",
      "kind": "article",
      "number": "129",
      "heading": "Temporary safety restrictions",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-129",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/130",
      "kind": "article",
      "number": "130",
      "heading": "Suspending, revoking, or varying the terms, of marketing authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-130",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/131",
      "kind": "article",
      "number": "131",
      "heading": "Suspending or revoking a wholesale distribution authorisation",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-131",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/132",
      "kind": "article",
      "number": "132",
      "heading": "Removal of importers, manufacturers and distributors of active substance from the manufacturing and wholesale distribution database",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-132",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/133",
      "kind": "article",
      "number": "133",
      "heading": "Suspending or revoking manufacturing authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-133",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/134",
      "kind": "article",
      "number": "134",
      "heading": "Prohibiting the supply of veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-134",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/135",
      "kind": "article",
      "number": "135",
      "heading": "Penalties imposed by Member States",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-135",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/136",
      "kind": "article",
      "number": "136",
      "heading": "Financial penalties imposed by the Commission on holders of marketing authorisation for centrally authorised veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-136",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "chapter/X",
      "kind": "chapter",
      "number": "X",
      "heading": "REGULATORY NETWORK",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/137",
      "kind": "article",
      "number": "137",
      "heading": "Competent authorities",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-137",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/138",
      "kind": "article",
      "number": "138",
      "heading": "Scientific opinion for international organisations for animal health",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-138",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/139",
      "kind": "article",
      "number": "139",
      "heading": "Committee for Veterinary Medicinal Products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-139",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/140",
      "kind": "article",
      "number": "140",
      "heading": "Members of the Committee",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-140",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/141",
      "kind": "article",
      "number": "141",
      "heading": "Tasks of the Committee",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-141",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/142",
      "kind": "article",
      "number": "142",
      "heading": "Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-142",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/143",
      "kind": "article",
      "number": "143",
      "heading": "Members of the coordination group",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-143",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/144",
      "kind": "article",
      "number": "144",
      "heading": "Tasks of the coordination group",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-144",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "chapter/XI",
      "kind": "chapter",
      "number": "XI",
      "heading": "COMMON AND PROCEDURAL PROVISIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/145",
      "kind": "article",
      "number": "145",
      "heading": "Standing Committee on Veterinary Medicinal Products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-145",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XI"
    },
    {
      "path": "article/146",
      "kind": "article",
      "number": "146",
      "heading": "Amendments to Annex II",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-146",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XI"
    },
    {
      "path": "article/147",
      "kind": "article",
      "number": "147",
      "heading": "Exercise of the delegation",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-147",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XI"
    },
    {
      "path": "article/148",
      "kind": "article",
      "number": "148",
      "heading": "Data protection",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-148",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XI"
    },
    {
      "path": "chapter/XII",
      "kind": "chapter",
      "number": "XII",
      "heading": "TRANSITIONAL AND FINAL PROVISIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/149",
      "kind": "article",
      "number": "149",
      "heading": "Repeal",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-149",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XII"
    },
    {
      "path": "article/150",
      "kind": "article",
      "number": "150",
      "heading": "Relation with other Union acts",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-150",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XII"
    },
    {
      "path": "article/151",
      "kind": "article",
      "number": "151",
      "heading": "Prior applications",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-151",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XII"
    },
    {
      "path": "article/152",
      "kind": "article",
      "number": "152",
      "heading": "Existing veterinary medicinal products, marketing authorisations and registrations",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-152",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XII"
    },
    {
      "path": "article/153",
      "kind": "article",
      "number": "153",
      "heading": "Transitional provisions regarding delegated and implementing acts",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-153",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XII"
    },
    {
      "path": "article/154",
      "kind": "article",
      "number": "154",
      "heading": "Establishment of the pharmacovigilance database and of the manufacturing and wholesale distribution database",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-154",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XII"
    },
    {
      "path": "article/155",
      "kind": "article",
      "number": "155",
      "heading": "Initial input to the product database by competent authorities",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-155",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XII"
    },
    {
      "path": "article/156",
      "kind": "article",
      "number": "156",
      "heading": "Review of rules for environmental risk assessment",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-156",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XII"
    },
    {
      "path": "article/157",
      "kind": "article",
      "number": "157",
      "heading": "Commission report on traditional herbal products used to treat animals",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-157",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XII"
    },
    {
      "path": "article/158",
      "kind": "article",
      "number": "158",
      "heading": "Review of measures regarding animals of the equine species",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-158",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XII"
    },
    {
      "path": "article/159",
      "kind": "article",
      "number": "159",
      "heading": "Transitional provisions regarding certain certificates of good manufacturing practice",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-159",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XII"
    },
    {
      "path": "article/160",
      "kind": "article",
      "number": "160",
      "heading": "Entry into force and application",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/article-160",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XII"
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I",
      "kind": "annex",
      "number": "I",
      "heading": "INFORMATION REFERRED TO IN POINT (A) OF ARTICLE 8(1)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-I/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-I/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/2.1",
      "kind": "division",
      "number": "2.1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-I/division-2.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/2.2",
      "kind": "division",
      "number": "2.2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-I/division-2.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/2.3",
      "kind": "division",
      "number": "2.3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-I/division-2.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-I/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/3.1",
      "kind": "division",
      "number": "3.1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-I/division-3.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/3.2",
      "kind": "division",
      "number": "3.2",
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      "path": "annex/II/division/1/division/10",
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      "number": "10",
      "heading": "In cases of applications for marketing authorisations for veterinary medicinal products indicated for animal species and indications representing smaller market sectors, a more flexible approach may be applicable. In such cases, relevant scientific guidelines and/or scientific advice should be taken into account.",
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      "heading": "Requirements for veterinary medicinal products other than immunological veterinary medicinal products",
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      "path": "annex/II/title/I/part/2",
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      "heading": "Pharmaceutical (physico-chemical, biological or microbiological information (quality))",
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      "path": "annex/II/title/I/part/2/division/1",
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      "path": "annex/II/title/I/part/2/division/A/division/1",
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      "heading": "Usual terminology",
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      "path": "annex/II/title/I/part/2/division/A/division/3",
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      "path": "annex/II/title/I/part/2/division/A/division/3/division/3.1",
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      "heading": "In order to give ‘quantitative particulars’ of all the active substances of the veterinary medicinal products, it is necessary, depending on the pharmaceutical form concerned, to specify the mass, or the number of units of biological activity, either per dosage-unit or per unit of mass or volume, of each active substance.",
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      "path": "annex/II/title/I/part/2/division/A/division/3/division/3.2",
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      "path": "annex/II/title/I/part/2/division/C/division/1/division/1.1/division/1.1.1",
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      "heading": "Active substances listed in pharmacopoeias",
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      "path": "annex/II/title/I/part/2/division/C/division/1/division/1.4",
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    },
    {
      "path": "annex/II/title/II/part/3/division/B/division/5",
      "kind": "division",
      "number": "5",
      "heading": "Examination of immunological functions",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-3/division-B/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/3/division/B"
    },
    {
      "path": "annex/II/title/II/part/3/division/B/division/6",
      "kind": "division",
      "number": "6",
      "heading": "Special requirements for live vaccines",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/3/division/B"
    },
    {
      "path": "annex/II/title/II/part/3/division/B/division/6/division/6.1",
      "kind": "division",
      "number": "6.1",
      "heading": "Spread of the vaccine strain",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-3/division-B/division-6/division-6.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/3/division/B/division/6"
    },
    {
      "path": "annex/II/title/II/part/3/division/B/division/6/division/6.2",
      "kind": "division",
      "number": "6.2",
      "heading": "Dissemination in the vaccinated animal",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-3/division-B/division-6/division-6.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/3/division/B/division/6"
    },
    {
      "path": "annex/II/title/II/part/3/division/B/division/6/division/6.3",
      "kind": "division",
      "number": "6.3",
      "heading": "Reversion to virulence of attenuated vaccines",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-3/division-B/division-6/division-6.3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/3/division/B/division/6"
    },
    {
      "path": "annex/II/title/II/part/3/division/B/division/6/division/6.4",
      "kind": "division",
      "number": "6.4",
      "heading": "Biological properties of the vaccine strain",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-3/division-B/division-6/division-6.4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/3/division/B/division/6"
    },
    {
      "path": "annex/II/title/II/part/3/division/B/division/6/division/6.5",
      "kind": "division",
      "number": "6.5",
      "heading": "Recombination or genomic reassortment of strains",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-3/division-B/division-6/division-6.5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/3/division/B/division/6"
    },
    {
      "path": "annex/II/title/II/part/3/division/B/division/7",
      "kind": "division",
      "number": "7",
      "heading": "User safety",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-3/division-B/division-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/3/division/B"
    },
    {
      "path": "annex/II/title/II/part/3/division/B/division/8",
      "kind": "division",
      "number": "8",
      "heading": "Study of residues",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-3/division-B/division-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/3/division/B"
    },
    {
      "path": "annex/II/title/II/part/3/division/B/division/9",
      "kind": "division",
      "number": "9",
      "heading": "Interactions",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-3/division-B/division-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/3/division/B"
    },
    {
      "path": "annex/II/title/II/part/3/division/C",
      "kind": "division",
      "number": "C",
      "heading": "FIELD STUDIES",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-3/division-C",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/3"
    },
    {
      "path": "annex/II/title/II/part/3/division/D",
      "kind": "division",
      "number": "D",
      "heading": "ENVIRONMENTAL RISK ASSESSMENT",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-3/division-D",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/3"
    },
    {
      "path": "annex/II/title/II/part/3/division/E",
      "kind": "division",
      "number": "E",
      "heading": "ASSESSMENT REQUIRED FOR VETERINARY MEDICINAL PRODUCTS CONTAINING OR CONSISTING OF GENETICALLY MODIFIED ORGANISMS",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-3/division-E",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/3"
    },
    {
      "path": "annex/II/title/II/part/4",
      "kind": "part",
      "number": "4",
      "heading": "Efficacy tests",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II"
    },
    {
      "path": "annex/II/title/II/chapter/I",
      "kind": "chapter",
      "number": "I",
      "heading": null,
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/4"
    },
    {
      "path": "annex/II/title/II/chapter/I/division/1",
      "kind": "division",
      "number": "1",
      "heading": "General principles",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-I/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/chapter/I"
    },
    {
      "path": "annex/II/title/II/chapter/I/division/2",
      "kind": "division",
      "number": "2",
      "heading": "Performance of trials",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-I/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/chapter/I"
    },
    {
      "path": "annex/II/title/II/chapter/II",
      "kind": "chapter",
      "number": "II",
      "heading": null,
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/part/4"
    },
    {
      "path": "annex/II/title/II/chapter/II/division/A",
      "kind": "division",
      "number": "A",
      "heading": "GENERAL REQUIREMENTS",
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      "extent": "E+W+S+N.I.",
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      "parent": "annex/II/title/II/chapter/II"
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    {
      "path": "annex/II/title/II/chapter/II/division/A/division/1",
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      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-A/division-1",
      "extent": "E+W+S+N.I.",
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      "parent": "annex/II/title/II/chapter/II/division/A"
    },
    {
      "path": "annex/II/title/II/chapter/II/division/A/division/2",
      "kind": "division",
      "number": "2",
      "heading": "Efficacy trials carried out in the laboratory shall be controlled trials, including untreated control animals unless this is not justified for animal welfare reasons and efficacy can be otherwise demonstrated.",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-A/division-2",
      "extent": "E+W+S+N.I.",
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      "parent": "annex/II/title/II/chapter/II/division/A"
    },
    {
      "path": "annex/II/title/II/chapter/II/division/A/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-A/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/chapter/II/division/A"
    },
    {
      "path": "annex/II/title/II/chapter/II/division/A/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-A/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/chapter/II/division/A"
    },
    {
      "path": "annex/II/title/II/chapter/II/division/A/division/5",
      "kind": "division",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-A/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/chapter/II/division/A"
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    {
      "path": "annex/II/title/II/chapter/II/division/A/division/6",
      "kind": "division",
      "number": "6",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-A/division-6",
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      "parent": "annex/II/title/II/chapter/II/division/A"
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    {
      "path": "annex/II/title/II/chapter/II/division/A/division/7",
      "kind": "division",
      "number": "7",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-A/division-7",
      "extent": "E+W+S+N.I.",
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    },
    {
      "path": "annex/II/title/II/chapter/II/division/A/division/8",
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      "number": "8",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-A/division-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II/chapter/II/division/A"
    },
    {
      "path": "annex/II/title/II/chapter/II/division/A/division/9",
      "kind": "division",
      "number": "9",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-A/division-9",
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      "status": null,
      "parent": "annex/II/title/II/chapter/II/division/A"
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    {
      "path": "annex/II/title/II/chapter/II/division/B",
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      "number": "B",
      "heading": "LABORATORY TRIALS",
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    {
      "path": "annex/II/title/II/chapter/II/division/B/division/1",
      "kind": "division",
      "number": "1",
      "heading": "In principle, demonstration of efficacy shall be undertaken under well-controlled laboratory conditions by challenge after administration of the immunological veterinary medicinal product to the target animal under the recommended conditions of use. Insofar as possible, the conditions under which the challenge is carried out shall mimic the natural conditions for infection. Details of the challenge strain and its relevance shall be provided.",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-B/division-1",
      "extent": "E+W+S+N.I.",
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    {
      "path": "annex/II/title/II/chapter/II/division/B/division/2",
      "kind": "division",
      "number": "2",
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      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-B/division-2",
      "extent": "E+W+S+N.I.",
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      "path": "annex/II/title/II/chapter/II/division/C",
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      "heading": "FIELD TRIALS",
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      "extent": "E+W+S+N.I.",
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      "parent": "annex/II/title/II/chapter/II"
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      "path": "annex/II/title/II/chapter/II/division/C/division/1",
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      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-C/division-1",
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    {
      "path": "annex/II/title/II/chapter/II/division/C/division/2",
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      "number": "2",
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      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-C/division-2",
      "extent": "E+W+S+N.I.",
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    {
      "path": "annex/II/title/II/part/5",
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      "number": "5",
      "heading": "Particulars and documents",
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      "path": "annex/II/title/II/part/5/division/A",
      "kind": "division",
      "number": "A",
      "heading": "INTRODUCTION",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-5/division-A",
      "extent": "E+W+S+N.I.",
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      "heading": "LABORATORY STUDIES",
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      "extent": "E+W+S+N.I.",
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    {
      "path": "annex/II/title/II/part/5/division/C",
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      "heading": "FIELD STUDIES",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-5/division-C",
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      "path": "annex/II/title/II/part/6",
      "kind": "part",
      "number": "6",
      "heading": "Bibliographical references",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/II"
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    {
      "path": "annex/II/title/III",
      "kind": "title",
      "number": "III",
      "heading": "Requirements for specific marketing authorisation applications",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
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    {
      "path": "annex/II/title/III/division/1",
      "kind": "division",
      "number": "1",
      "heading": "Generic veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-III/division-1",
      "extent": "E+W+S+N.I.",
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    },
    {
      "path": "annex/II/title/III/division/2",
      "kind": "division",
      "number": "2",
      "heading": "Similar biological veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-III/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
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      "path": "annex/II/title/III/division/3",
      "kind": "division",
      "number": "3",
      "heading": "Well-established veterinary use",
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      "path": "annex/II/title/III/division/4",
      "kind": "division",
      "number": "4",
      "heading": "Combination veterinary medicinal products",
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      "extent": "E+W+S+N.I.",
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      "path": "annex/II/title/III/division/5",
      "kind": "division",
      "number": "5",
      "heading": "Informed consent applications",
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      "extent": "E+W+S+N.I.",
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    },
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      "path": "annex/II/title/III/division/6",
      "kind": "division",
      "number": "6",
      "heading": "Documentation for applications in exceptional circumstances",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-III/division-6",
      "extent": "E+W+S+N.I.",
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      "path": "annex/II/title/III/division/7",
      "kind": "division",
      "number": "7",
      "heading": "Mixed marketing authorisation applications",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-III/division-7",
      "extent": "E+W+S+N.I.",
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      "path": "annex/II/title/IV",
      "kind": "title",
      "number": "IV",
      "heading": "Requirements for marketing authorisation applications for particular veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-IV",
      "extent": "E+W+S+N.I.",
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    {
      "path": "annex/II/title/IV/division/1",
      "kind": "division",
      "number": "1",
      "heading": "Immunological veterinary medicinal products",
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    },
    {
      "path": "annex/II/title/IV/division/1/division/A",
      "kind": "division",
      "number": "A",
      "heading": "VACCINE ANTIGEN MASTER FILE",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-IV/division-1/division-A",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/title/IV/division/1"
    },
    {
      "path": "annex/II/title/IV/division/1/division/B",
      "kind": "division",
      "number": "B",
      "heading": "MULTI-STRAIN DOSSIER",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-IV/division-1/division-B",
      "extent": "E+W+S+N.I.",
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      "parent": "annex/II/title/IV/division/1"
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    {
      "path": "annex/II/title/IV/division/2",
      "kind": "division",
      "number": "2",
      "heading": "Homeopathic veterinary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-IV/division-2",
      "extent": "E+W+S+N.I.",
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      "path": "annex/II/title/IV/division/2/part/2",
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      "number": "PART 2",
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      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-IV/division-2/part-2",
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      "path": "annex/II/title/IV/division/2/part/2/division/a",
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      "number": "(a)",
      "heading": "Terminology",
      "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-IV/division-2/part-2/division-a",
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    {
      "path": "annex/II/title/IV/division/2/part/2/division/b",
      "kind": "division",
      "number": "(b)",
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