{
  "url": "https://openlegislation.uk/eu-regulation-2008-1234",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-1234.json",
  "id": "eur/2008/1234",
  "title": "Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance) (revoked)",
  "short_title": "Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing…",
  "long_title": "Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance)",
  "citation": "EU Regulation No 1234/2008",
  "type": "eur",
  "year": "2008",
  "number": "1234",
  "version": "current",
  "date": "2008-11-24",
  "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-2008-1234/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "chapter/I",
      "kind": "chapter",
      "number": "I",
      "heading": "GENERAL PROVISIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": "Subject matter and scope",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-1",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/I"
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Definitions",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-2",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/I"
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Classification of variations",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-3",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/I"
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Guidelines",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-4",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/I"
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Recommendation on unforeseen variations",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-5",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/I"
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Variations leading to the revision of product information",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-6",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/I"
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Grouping of variations",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-7",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/I"
    },
    {
      "path": "chapter/II",
      "kind": "chapter",
      "number": "II",
      "heading": "VARIATIONS TO MARKETING AUTHORISATIONS GRANTED IN ACCORDANCE WITH DIRECTIVE 87/22/EEC, CHAPTER 4 OF DIRECTIVE 2001/82/EC OR CHAPTER 4 OF DIRECTIVE 2001/83/EC",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Notification procedure for minor variations of type IA",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-8",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/II"
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Notification procedure for minor variations of type IB",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-9",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/II"
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "‘Prior Approval’ procedure for major variations of type II",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-10",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/II"
    },
    {
      "path": "article/11",
      "kind": "article",
      "number": "11",
      "heading": "Measures to close the procedures of Articles 8 to 10",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-11",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/II"
    },
    {
      "path": "article/12",
      "kind": "article",
      "number": "12",
      "heading": "Human influenza vaccines",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-12",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/II"
    },
    {
      "path": "article/13",
      "kind": "article",
      "number": "13",
      "heading": "Coordination group and arbitration",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-13",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/II"
    },
    {
      "path": "chapter/IIa",
      "kind": "chapter",
      "number": "IIa",
      "heading": "VARIATIONS TO PURELY NATIONAL MARKETING AUTHORISATIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/13a",
      "kind": "article",
      "number": "13a",
      "heading": "Notification procedure for minor variations of type IA",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-13a",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IIa"
    },
    {
      "path": "article/13b",
      "kind": "article",
      "number": "13b",
      "heading": "Notification procedure for minor variations of type IB",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-13b",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IIa"
    },
    {
      "path": "article/13c",
      "kind": "article",
      "number": "13c",
      "heading": "‘Prior Approval’ procedure for major variations of type II",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-13c",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IIa"
    },
    {
      "path": "article/13d",
      "kind": "article",
      "number": "13d",
      "heading": "Grouping of variations to purely national marketing authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-13d",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IIa"
    },
    {
      "path": "article/13e",
      "kind": "article",
      "number": "13e",
      "heading": "Measures to close the procedures of Articles 13a to 13c",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-13e",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IIa"
    },
    {
      "path": "article/13f",
      "kind": "article",
      "number": "13f",
      "heading": "Human influenza vaccines",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-13f",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IIa"
    },
    {
      "path": "chapter/III",
      "kind": "chapter",
      "number": "III",
      "heading": "VARIATIONS TO CENTRALISED MARKETING AUTHORISATIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/14",
      "kind": "article",
      "number": "14",
      "heading": "Notification procedure for minor variations of type IA",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-14",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/III"
    },
    {
      "path": "article/15",
      "kind": "article",
      "number": "15",
      "heading": "Notification procedure for minor variations of type IB",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-15",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/III"
    },
    {
      "path": "article/16",
      "kind": "article",
      "number": "16",
      "heading": "‘Prior Approval’ procedure for major variations of type II",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-16",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/III"
    },
    {
      "path": "article/17",
      "kind": "article",
      "number": "17",
      "heading": "Measures to close the procedures of Articles 14 to 16",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-17",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/III"
    },
    {
      "path": "article/18",
      "kind": "article",
      "number": "18",
      "heading": "Human influenza vaccines",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-18",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/III"
    },
    {
      "path": "chapter/IV",
      "kind": "chapter",
      "number": "IV",
      "heading": null,
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "chapter/IV/section/1",
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      "number": "1",
      "heading": "Special procedures",
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      "parent": "chapter/IV"
    },
    {
      "path": "article/19",
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      "number": "19",
      "heading": "Extensions of marketing authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-19",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IV/section/1"
    },
    {
      "path": "article/20",
      "kind": "article",
      "number": "20",
      "heading": "Worksharing procedure",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-20",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IV/section/1"
    },
    {
      "path": "article/21",
      "kind": "article",
      "number": "21",
      "heading": "Pandemic situation with respect to human influenza",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-21",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IV/section/1"
    },
    {
      "path": "article/22",
      "kind": "article",
      "number": "22",
      "heading": "Urgent safety restrictions",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-22",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IV/section/1"
    },
    {
      "path": "chapter/IV/section/2",
      "kind": "section",
      "number": "2",
      "heading": "Amendments to the decision granting the marketing authorisation and implementation",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IV"
    },
    {
      "path": "article/23",
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      "number": "23",
      "heading": "Amendments to the decision granting the marketing authorisation",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-23",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IV/section/2"
    },
    {
      "path": "article/23a",
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      "number": "23a",
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      "status": "repealed",
      "parent": "chapter/IV/section/2"
    },
    {
      "path": "article/24",
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      "number": "24",
      "heading": "Implementation of variations",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-24",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IV/section/2"
    },
    {
      "path": "article/24a",
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      "number": "24a",
      "heading": "Application of national provisions on variations to purely national marketing authorisations",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-24a",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/IV/section/2"
    },
    {
      "path": "chapter/V",
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      "number": "V",
      "heading": "FINAL PROVISIONS",
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      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/25",
      "kind": "article",
      "number": "25",
      "heading": "Continuous monitoring",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-25",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "chapter/V"
    },
    {
      "path": "article/26",
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      "number": "26",
      "heading": "Review",
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      "status": "repealed",
      "parent": "chapter/V"
    },
    {
      "path": "article/27",
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      "number": "27",
      "heading": "Repeal and transitional provision",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/article-27",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
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    },
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      "path": "article/28",
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      "heading": "Entry into force",
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      "status": "repealed",
      "parent": "chapter/V"
    },
    {
      "path": "signature",
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      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I",
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      "number": "I",
      "heading": "Extensions of marketing authorisations",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "annex/I/division/1",
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      "number": "1",
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      "url": "https://openlegislation.uk/eu-regulation-2008-1234/annex-I/division-1",
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    },
    {
      "path": "annex/I/division/2",
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      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2008-1234/annex-I/division-2",
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    {
      "path": "annex/I/division/3",
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      "path": "annex/II",
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      "path": "annex/II/division/1",
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      "path": "annex/II/division/2",
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    {
      "path": "annex/III/division/13",
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