{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2007.json",
  "id": "uksi/2007/2539",
  "title": "The Veterinary Medicines Regulations 2007",
  "short_title": "Veterinary Medicines 2007",
  "long_title": "These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2006.",
  "citation": "S.I. 2007/2539",
  "type": "uksi",
  "year": "2007",
  "number": "2539",
  "version": "current",
  "date": "2007-08-30",
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/introduction",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
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      "heading": "Introduction",
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      "extent": null,
      "status": null,
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    },
    {
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      "heading": "Title and commencement",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/regulation-1",
      "extent": null,
      "status": null,
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      "path": "regulation/2",
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      "heading": "Definition of “veterinary medicinal product”, interpretation and scope",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/regulation-2",
      "extent": null,
      "status": null,
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    {
      "path": "regulation/3",
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      "heading": "Products to which these Regulations do not apply",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/regulation-3",
      "extent": null,
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    {
      "path": "part/2",
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      "heading": "Authorised veterinary medicinal products",
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    },
    {
      "path": "regulation/4",
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      "heading": "Placing a veterinary medicinal product on the market",
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      "extent": null,
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      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/regulation-5",
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      "path": "regulation/6",
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      "path": "regulation/8",
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      "path": "regulation/9",
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      "path": "regulation/21",
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      "heading": "Application for a product using a new combination of active substances",
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      "heading": "Application for a pharmacologically equivalent medicinal product",
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      "heading": "Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product",
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      "path": "schedule/1/paragraph/13",
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      "heading": "Parallel imports",
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      "path": "schedule/1/paragraph/14",
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      "heading": "Specific batch control scheme",
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      "path": "schedule/1/paragraph/15",
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      "heading": "Similar immunological products",
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      "path": "schedule/1/paragraph/16",
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      "heading": "Marketing in exceptional circumstances",
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    {
      "path": "schedule/1/part/3",
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      "number": "17",
      "heading": "Time limits",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-17",
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    {
      "path": "schedule/1/paragraph/18",
      "kind": "paragraph",
      "number": "18",
      "heading": "Place of establishment of applicant",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-18",
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      "path": "schedule/1/paragraph/19",
      "kind": "paragraph",
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      "heading": "Procedure",
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      "path": "schedule/1/paragraph/20",
      "kind": "paragraph",
      "number": "20",
      "heading": "Products authorised in another member State",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-20",
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      "parent": "schedule/1/part/3"
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    {
      "path": "schedule/1/paragraph/21",
      "kind": "paragraph",
      "number": "21",
      "heading": "Assessment reports",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-21",
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      "parent": "schedule/1/part/3"
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      "path": "schedule/1/paragraph/22",
      "kind": "paragraph",
      "number": "22",
      "heading": "Grant of a marketing authorisation",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-22",
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      "path": "schedule/1/paragraph/23",
      "kind": "paragraph",
      "number": "23",
      "heading": "Marketing authorisations for food-producing species",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-23",
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      "path": "schedule/1/paragraph/24",
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      "heading": "Refusal of a marketing authorisation",
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      "path": "schedule/1/paragraph/25",
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      "heading": "Publication following the grant of a marketing authorisation",
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      "path": "schedule/1/paragraph/26",
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      "heading": "Provisional marketing authorisation",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-26",
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      "path": "schedule/1/paragraph/27",
      "kind": "paragraph",
      "number": "27",
      "heading": "Provisions of samples and expertise",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-27",
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      "path": "schedule/1/paragraph/28",
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      "heading": "Supply of information",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-28",
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      "path": "schedule/1/paragraph/29",
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      "heading": "Duties on the holder of a marketing authorisation relating to an immunological product",
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      "path": "schedule/1/paragraph/30",
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      "heading": "Control tests",
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      "path": "schedule/1/paragraph/31",
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      "heading": "Placing on the market",
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      "path": "schedule/1/paragraph/32",
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      "heading": "Duration and validity of a marketing authorisation",
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      "heading": "Variations of marketing authorisations on the application of the holder",
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      "path": "schedule/1/paragraph/33",
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      "heading": "Variation of a marketing authorisation for a mutually recognised veterinary medicinal product",
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      "path": "schedule/1/paragraph/36",
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      "heading": "Changes after a marketing authorisation has been issued",
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      "heading": "Application for a marketing authorisation where one already exists in another member State",
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      "path": "schedule/1/paragraph/44",
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      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-44",
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    {
      "path": "schedule/1/part/7",
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      "heading": "Labelling and package leaflets",
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      "path": "schedule/1/paragraph/45",
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      "heading": "Approval by the Secretary of State",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-45",
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      "path": "schedule/1/paragraph/46",
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      "heading": "Reference to being authorised",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-46",
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      "number": "47",
      "heading": "Language",
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      "path": "schedule/1/paragraph/48",
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      "heading": "Labelling with all the information on the immediate packaging",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-48",
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      "path": "schedule/1/paragraph/49",
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      "heading": "Products with immediate and outer packaging",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-49",
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    {
      "path": "schedule/1/paragraph/51",
      "kind": "paragraph",
      "number": "51",
      "heading": "Ampoules",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-51",
      "extent": null,
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    },
    {
      "path": "schedule/1/paragraph/52",
      "kind": "paragraph",
      "number": "52",
      "heading": "Small containers other than ampoules",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-52",
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    },
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      "path": "schedule/1/paragraph/53",
      "kind": "paragraph",
      "number": "53",
      "heading": "Homeopathic remedies",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-53",
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      "path": "schedule/1/paragraph/54",
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      "number": "54",
      "heading": "Variations",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-54",
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    },
    {
      "path": "schedule/1/part/8",
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      "number": "8",
      "heading": "Pharmacovigilance",
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    {
      "path": "schedule/1/paragraph/55",
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      "heading": "Qualified persons responsible for pharmacovigilance",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-55",
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      "path": "schedule/1/paragraph/56",
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      "heading": "Duties relating to the qualified person",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-56",
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    },
    {
      "path": "schedule/1/paragraph/57",
      "kind": "paragraph",
      "number": "57",
      "heading": "Adverse reactions to a veterinary medicinal product administered in the United Kingdom",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-57",
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      "path": "schedule/1/paragraph/58",
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      "heading": "Adverse reactions to a veterinary medicinal product administered in a third country",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-58",
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      "path": "schedule/1/paragraph/59",
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      "heading": "Periodic safety update reports",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-59",
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    {
      "path": "schedule/1/paragraph/60",
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      "heading": "Release of information by the marketing authorisation holder",
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      "heading": "Action taken on account of pharmacovigilance",
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      "path": "schedule/1/part/9",
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      "path": "schedule/1/paragraph/62",
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      "heading": "Meaning of “homeopathic remedy”",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-62",
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      "heading": "Placing a homeopathic remedy on the market in accordance with a registration",
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      "path": "schedule/1/paragraph/66",
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      "heading": "Products on the market before 1994",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-66",
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      "heading": "Classification",
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      "path": "schedule/2/part/1",
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      "path": "schedule/2/paragraph/1",
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      "path": "schedule/2/paragraph/3",
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      "heading": "Granting the authorisation",
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      "path": "schedule/2/paragraph/4",
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      "heading": "The authorisation",
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      "path": "schedule/2/paragraph/6",
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      "heading": "Appeal to an appointed person",
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      "path": "schedule/2/paragraph/7",
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      "heading": "Inspection of premises",
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      "heading": "Report following inspection",
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      "heading": "Duties on the holder of a manufacturing authorisation",
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      "heading": "Qualified persons for manufacture",
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      "heading": "Register",
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      "heading": "Types of authorisation",
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      "heading": "Labelling",
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      "heading": "Records",
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      "heading": "Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-5/paragraph-6",
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      "path": "schedule/5/paragraph/7",
      "kind": "paragraph",
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      "heading": "Incorporation of a veterinary medicinal product into a premixture",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-5/paragraph-7",
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      "path": "schedule/5/paragraph/8",
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      "heading": "Incorporation of a veterinary medicinal product into feedingstuffs",
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      "path": "schedule/5/paragraph/9",
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      "heading": "Additional record keeping requirements relating to veterinary medicinal products",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-5/paragraph-9",
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      "parent": "schedule/5"
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      "path": "schedule/5/paragraph/10",
      "kind": "paragraph",
      "number": "10",
      "heading": "Labelling a premixture containing a veterinary medicinal product",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-5/paragraph-10",
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      "parent": "schedule/5"
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      "path": "schedule/5/paragraph/11",
      "kind": "paragraph",
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      "heading": "Labelling of feedingstuffs containing a specified feed additive",
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      "path": "schedule/5/paragraph/12",
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      "path": "schedule/5/paragraph/13",
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      "heading": "Supply of specified feed additives",
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      "path": "schedule/5/paragraph/14",
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      "path": "schedule/5/paragraph/15",
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      "path": "schedule/5/paragraph/16",
      "kind": "paragraph",
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      "heading": "Prescriptions for feedingstuffs containing a veterinary medicinal product",
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      "path": "schedule/5/paragraph/17",
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      "heading": "Writing the prescription",
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      "path": "schedule/5/paragraph/18",
      "kind": "paragraph",
      "number": "18",
      "heading": "Possession",
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      "path": "schedule/5/paragraph/19",
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      "heading": "Sampling and analysis",
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      "path": "schedule/5/paragraph/20",
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      "heading": "Storage",
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      "path": "schedule/5/paragraph/21",
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      "heading": "Packages and other containers",
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      "path": "schedule/5/paragraph/22",
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      "heading": "Transport",
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      "path": "schedule/5/paragraph/23",
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      "path": "schedule/5/paragraph/24",
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      "path": "schedule/5/paragraph/25",
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      "heading": "Trade between member States",
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      "path": "schedule/6",
      "kind": "schedule",
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      "heading": "Exemptions for small pet animals",
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      "path": "schedule/6/paragraph/1",
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      "heading": "Animals to which this Schedule applies",
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      "path": "schedule/6/paragraph/2",
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      "path": "schedule/6/paragraph/3",
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      "path": "schedule/6/paragraph/4",
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      "path": "schedule/6/paragraph/5",
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      "heading": "The product",
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      "path": "schedule/6/paragraph/6",
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      "path": "schedule/6/paragraph/8",
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      "heading": "Pack size",
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      "path": "schedule/6/paragraph/9",
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      "path": "schedule/7",
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      "path": "schedule/7/paragraph/1",
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      "heading": "Interpretation of Schedule 7",
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      "path": "schedule/7/paragraph/2",
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      "path": "schedule/7/paragraph/6",
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      "heading": "Translation",
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      "path": "schedule/7/part/2",
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      "path": "schedule/7/paragraph/8",
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      "path": "schedule/7/paragraph/9",
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      "heading": "Application for a marketing authorisation for an immunological product",
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      "path": "schedule/7/paragraph/10",
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      "path": "schedule/7/paragraph/11",
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      "heading": "Application for a marketing authorisation using identical data",
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      "path": "schedule/7/paragraph/12",
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      "path": "schedule/7/paragraph/13",
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      "path": "schedule/7/paragraph/17",
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      "path": "schedule/7/paragraph/20",
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      "heading": "Provision of information relating to the recognition of a United Kingdom marketing authorisation",
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      "path": "schedule/7/paragraph/21",
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      "heading": "Application for the renewal of a national marketing authorisation",
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      "path": "schedule/7/paragraph/22",
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      "heading": "Application for the renewal of a marketing authorisation granted in more than one member State",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-22",
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      "path": "schedule/7/paragraph/23",
      "kind": "paragraph",
      "number": "23",
      "heading": "Registration of a homeopathic remedy",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-23",
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      "path": "schedule/7/paragraph/24",
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      "path": "schedule/7/paragraph/25",
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      "heading": "Auditor’s certificate",
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      "heading": "Late payment of annual fees",
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      "path": "schedule/7/part/3",
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      "path": "schedule/7/paragraph/27",
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      "heading": "Application for a manufacturing authorisation",
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      "path": "schedule/7/paragraph/28",
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      "heading": "Application for a variation of a manufacturing authorisation",
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    {
      "path": "schedule/7/paragraph/29",
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      "heading": "Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-29",
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      "path": "schedule/7/paragraph/31",
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      "heading": "Site inspections—type of site",
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    {
      "path": "schedule/7/paragraph/32",
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      "heading": "Inspection of a site where immunological veterinary medicinal products are manufactured",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-32",
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    {
      "path": "schedule/7/paragraph/33",
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      "heading": "Inspection of a site where sterile veterinary medicinal products are manufactured",
      "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-33",
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    {
      "path": "schedule/7/paragraph/34",
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