{
  "url": "https://openlegislation.uk/eu-directive-1975-319",
  "json_url": "https://openlegislation.uk/eu-directive-1975-319.json",
  "id": "eudr/1975/319",
  "title": "Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products",
  "short_title": "Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products",
  "long_title": null,
  "citation": "EU Directive 1975/319",
  "type": "eudr",
  "year": "1975",
  "number": "319",
  "version": "current",
  "date": "1975-05-20",
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 57,
  "provisions": [],
  "outstanding_effects": [
    {
      "type": "replacement",
      "affected_provisions": "Art. 9",
      "affecting": "eudr/1978/420",
      "affecting_title": "Council Directive 78/420/EEC of 2 May 1978 amending Second Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "amendment",
      "affected_provisions": "Art. 10(1)",
      "affecting": "eudr/1978/420",
      "affecting_title": "Council Directive 78/420/EEC of 2 May 1978 amending Second Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 15",
      "affecting": "eudr/1983/570",
      "affecting_title": "Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 10",
      "affecting": "eudr/1983/570",
      "affecting_title": "Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 9",
      "affecting": "eudr/1983/570",
      "affecting_title": "Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "CH 3",
      "affecting": "eudr/1983/570",
      "affecting_title": "Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 8",
      "affecting": "eudr/1983/570",
      "affecting_title": "Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 11",
      "affecting": "eudr/1983/570",
      "affecting_title": "Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 13",
      "affecting": "eudr/1983/570",
      "affecting_title": "Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 14",
      "affecting": "eudr/1983/570",
      "affecting_title": "Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 12",
      "affecting": "eudr/1983/570",
      "affecting_title": "Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "amendment",
      "affected_provisions": "Art. 34",
      "affecting": "eudr/1989/341",
      "affecting_title": "Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 19 BI",
      "affecting": "eudr/1989/341",
      "affecting_title": "Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "amendment",
      "affected_provisions": "Art. 6",
      "affecting": "eudr/1989/341",
      "affecting_title": "Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "amendment",
      "affected_provisions": "Art. 26",
      "affecting": "eudr/1989/341",
      "affecting_title": "Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 33(4)",
      "affecting": "eudr/1989/341",
      "affecting_title": "Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "completion",
      "affected_provisions": "Art. 30",
      "affecting": "eudr/1989/341",
      "affecting_title": "Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 28 BI",
      "affecting": "eudr/1989/341",
      "affecting_title": "Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "completion",
      "affected_provisions": "Art. 19",
      "affecting": "eudr/1989/341",
      "affecting_title": "Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 16(1)",
      "affecting": "eudr/1989/341",
      "affecting_title": "Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 33(3)",
      "affecting": "eudr/1989/341",
      "affecting_title": "Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 4(B)",
      "affecting": "eudr/1989/341",
      "affecting_title": "Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 33(2)",
      "affecting": "eudr/1989/341",
      "affecting_title": "Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "repeal",
      "affected_provisions": "Art. 7",
      "affecting": "eudr/1992/27",
      "affecting_title": "Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets",
      "affecting_provisions": "Directive"
    },
    {
      "type": "repeal",
      "affected_provisions": "Art. 6",
      "affecting": "eudr/1992/27",
      "affecting_title": "Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 29 OCTIES",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 15 BI",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 29 DECIES",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 29 BI",
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      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 10",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 29 QUATER",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 29 NONIES",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 9",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "amendment",
      "affected_provisions": "Art. 19 BI",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 29 QUINQUIES",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 13",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 29 SEXIES",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 15",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 29 TER",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 37 TER",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 37 BI",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 15 TER",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 12",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 29 SEPTIES",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 14",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 11",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "amendment",
      "affected_provisions": "Art. 22(1)",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 15 QUATER",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 8",
      "affecting": "eudr/1993/39",
      "affecting_title": "Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 29 BI 3",
      "affecting": "eudr/2000/38",
      "affecting_title": "Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (Text with EEA relevance)",
      "affecting_provisions": "Directive"
    },
    {
      "type": "completion",
      "affected_provisions": "Art. 29 QUATER",
      "affecting": "eudr/2000/38",
      "affecting_title": "Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (Text with EEA relevance)",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 29 TER",
      "affecting": "eudr/2000/38",
      "affecting_title": "Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (Text with EEA relevance)",
      "affecting_provisions": "Directive"
    },
    {
      "type": "amendment",
      "affected_provisions": "Art. 29 SEXIES",
      "affecting": "eudr/2000/38",
      "affecting_title": "Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (Text with EEA relevance)",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 29 NONIES",
      "affecting": "eudr/2000/38",
      "affecting_title": "Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (Text with EEA relevance)",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 29 QUINQUIES",
      "affecting": "eudr/2000/38",
      "affecting_title": "Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (Text with EEA relevance)",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 29 OCTIES",
      "affecting": "eudr/2000/38",
      "affecting_title": "Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (Text with EEA relevance)",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 29 SEPTIES",
      "affecting": "eudr/2000/38",
      "affecting_title": "Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (Text with EEA relevance)",
      "affecting_provisions": "Directive"
    }
  ],
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    "source_url": "https://www.legislation.gov.uk/eudr/1975/319",
    "retrieved_at": "2026-11-01T15:23:47.774732+00:00"
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  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}