{
  "url": "https://openlegislation.uk/eu-regulation-2019-4",
  "json_url": "https://openlegislation.uk/eu-regulation-2019-4.json",
  "id": "eur/2019/4",
  "title": "Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (Text with EEA relevance)",
  "short_title": "Regulation (EU) 2019/4 on the manufacture, placing on the market and use of medicated feed",
  "long_title": "Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (Text with EEA relevance)",
  "citation": "EU Regulation 2019/4",
  "type": "eur",
  "year": "2019",
  "number": "4",
  "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-2019-4/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-2019-4/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-2019-4/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Definitions",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "chapter/II",
      "kind": "chapter",
      "number": "II",
      "heading": "MANUFACTURE, STORAGE, TRANSPORT AND PLACING ON THE MARKET",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "General obligations",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Composition",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Homogeneity",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Cross-contamination",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Anticipated production",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Specific labelling requirements",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "Packaging",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/11",
      "kind": "article",
      "number": "11",
      "heading": "Advertising of medicated feed and intermediate products",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/12",
      "kind": "article",
      "number": "12",
      "heading": "Intra-Union trade and import",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "chapter/III",
      "kind": "chapter",
      "number": "III",
      "heading": "APPROVAL OF ESTABLISHMENTS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/13",
      "kind": "article",
      "number": "13",
      "heading": "Approval obligations",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-13",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/14",
      "kind": "article",
      "number": "14",
      "heading": "Lists of approved establishments",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-14",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/15",
      "kind": "article",
      "number": "15",
      "heading": "Transitional measures concerning the implementation of the requirements for approval and registration",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-15",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "chapter/IV",
      "kind": "chapter",
      "number": "IV",
      "heading": "PRESCRIPTION AND USE",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/16",
      "kind": "article",
      "number": "16",
      "heading": "Prescription",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-16",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/17",
      "kind": "article",
      "number": "17",
      "heading": "Use of medicated feed",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-17",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/18",
      "kind": "article",
      "number": "18",
      "heading": "Collection or discard systems of unused or expired products",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-18",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "chapter/V",
      "kind": "chapter",
      "number": "V",
      "heading": "PROCEDURAL AND FINAL PROVISIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/19",
      "kind": "article",
      "number": "19",
      "heading": "Amendment of Annexes",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-19",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/20",
      "kind": "article",
      "number": "20",
      "heading": "Exercise of the delegation",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-20",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/21",
      "kind": "article",
      "number": "21",
      "heading": "Committee procedure",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-21",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/22",
      "kind": "article",
      "number": "22",
      "heading": "Penalties",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-22",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/23",
      "kind": "article",
      "number": "23",
      "heading": "Amendment to Regulation (EC) No 183/2005",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-23",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/24",
      "kind": "article",
      "number": "24",
      "heading": "Transitional measures",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-24",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/25",
      "kind": "article",
      "number": "25",
      "heading": "Repeal",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-25",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/26",
      "kind": "article",
      "number": "26",
      "heading": "Entry into force and application",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/article-26",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I",
      "kind": "annex",
      "number": "I",
      "heading": "SPECIFIC REQUIREMENTS FOR FEED BUSINESS OPERATORS IN ACCORDANCE WITH ARTICLE 4",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I/section/1",
      "kind": "section",
      "number": "1",
      "heading": "Facilities and equipment",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/section/1/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-1/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/1"
    },
    {
      "path": "annex/I/section/1/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-1/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/1"
    },
    {
      "path": "annex/I/section/2",
      "kind": "section",
      "number": "2",
      "heading": "Personnel",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/section/2/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-2/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/2"
    },
    {
      "path": "annex/I/section/2/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-2/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/2"
    },
    {
      "path": "annex/I/section/3",
      "kind": "section",
      "number": "3",
      "heading": "Manufacture",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/section/3/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-3/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/3"
    },
    {
      "path": "annex/I/section/3/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-3/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/3"
    },
    {
      "path": "annex/I/section/3/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-3/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/3"
    },
    {
      "path": "annex/I/section/3/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-3/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/3"
    },
    {
      "path": "annex/I/section/4",
      "kind": "section",
      "number": "4",
      "heading": "Quality control",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/section/4/division/1",
      "kind": "division",
      "number": "1",
      "heading": "A quality control plan shall be drawn up in writing and implemented. It shall include, in particular, checks on the critical points in the manufacturing process, sampling procedures and frequencies, methods of analysis and their frequency, compliance with the specifications for the medicated feed and intermediate products and the measures to be taken in the event of non-compliance.",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-4/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/4"
    },
    {
      "path": "annex/I/section/4/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-4/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/4"
    },
    {
      "path": "annex/I/section/5",
      "kind": "section",
      "number": "5",
      "heading": "Storage and transport",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/section/5/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-5/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/5"
    },
    {
      "path": "annex/I/section/5/division/2",
      "kind": "division",
      "number": "2",
      "heading": "Veterinary medicinal products shall be stored in separate, safe and secure areas. Those areas shall be of sufficient capacity and properly identified to allow orderly storage of the various veterinary medicinal products.",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-5/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/5"
    },
    {
      "path": "annex/I/section/5/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-5/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/5"
    },
    {
      "path": "annex/I/section/5/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-5/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/5"
    },
    {
      "path": "annex/I/section/6",
      "kind": "section",
      "number": "6",
      "heading": "Record-keeping",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/section/6/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-6/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/6"
    },
    {
      "path": "annex/I/section/6/division/2",
      "kind": "division",
      "number": "2",
      "heading": "The record referred to in paragraph 1 of this Section shall contain:",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-6/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/6"
    },
    {
      "path": "annex/I/section/7",
      "kind": "section",
      "number": "7",
      "heading": "Complaints and product recall",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/section/7/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-7/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/7"
    },
    {
      "path": "annex/I/section/7/division/2",
      "kind": "division",
      "number": "2",
      "heading": "Feed business operators shall put in place a system for the prompt withdrawal from the market of medicated feed or intermediate products and, if necessary, for the recall of medicated feed or intermediate products from the distribution network in case they fail to comply with the requirements of this Regulation.",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-7/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/7"
    },
    {
      "path": "annex/I/section/8",
      "kind": "section",
      "number": "8",
      "heading": "Additional requirements for mobile mixers",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/section/8/division/1",
      "kind": "division",
      "number": "1",
      "heading": "Mobile mixers shall have a copy of the following documents available in the vehicle, in the official language of the Member State where the manufacture of medicated feed takes place:",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-8/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/8"
    },
    {
      "path": "annex/I/section/8/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-8/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/8"
    },
    {
      "path": "annex/I/section/8/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-I/section-8/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/section/8"
    },
    {
      "path": "annex/II",
      "kind": "annex",
      "number": "II",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-II",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/III",
      "kind": "annex",
      "number": "III",
      "heading": "SPECIFIC LABELLING REQUIREMENTS REFERRED TO IN ARTICLE 9(1)",
      "url": "https://openlegislation.uk/eu-regulation-2019-4/annex-III",
      "extent": "E+W+S+N.I.",
      "status": null,
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