{
  "url": "https://openlegislation.uk/eu-directive-1965-65",
  "json_url": "https://openlegislation.uk/eu-directive-1965-65.json",
  "id": "eudr/1965/65",
  "title": "Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products",
  "short_title": "Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products",
  "long_title": null,
  "citation": "EU Directive 1965/65",
  "type": "eudr",
  "year": "1965",
  "number": "65",
  "version": "current",
  "date": "1965-01-26",
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 39,
  "provisions": [],
  "outstanding_effects": [
    {
      "type": "amendment",
      "affected_provisions": "Art. 22",
      "affecting": "eudr/1966/454",
      "affecting_title": "Council Directive 66/454/EEC of 28 July 1966 amending Article 22 of the Council Directive of 26 January 1965 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. 4(2)",
      "affecting": "eudr/1975/319",
      "affecting_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",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 11(2)",
      "affecting": "eudr/1975/319",
      "affecting_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",
      "affecting_provisions": "Directive"
    },
    {
      "type": "replacement",
      "affected_provisions": "Art. 24",
      "affecting": "eudr/1975/319",
      "affecting_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",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 4 TER",
      "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. 4(2) VERS.EN",
      "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": "addition",
      "affected_provisions": "Art. 4 BI",
      "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. 13(1)",
      "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": "completion",
      "affected_provisions": "Art. 4(2)",
      "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": "addition",
      "affected_provisions": "Art. 9 BI",
      "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(2)",
      "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": "repeal",
      "affected_provisions": "Art. 16",
      "affecting": "eudr/1987/21",
      "affecting_title": "Council Directive 87/21/EEC of 22 December 1986 amending Directive 65/65/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. 4(2)",
      "affecting": "eudr/1987/21",
      "affecting_title": "Council Directive 87/21/EEC of 22 December 1986 amending Directive 65/65/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. 1(5)",
      "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. 1(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": "addition",
      "affected_provisions": "Art. 13(9)",
      "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. 4 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": "Text",
      "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": "Title",
      "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. 14(5)",
      "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. 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. 20",
      "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. 19",
      "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. 18",
      "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. 15",
      "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. 17",
      "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. 13",
      "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. 14",
      "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. 16",
      "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": "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": "replacement",
      "affected_provisions": "Art. 7",
      "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. 3",
      "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": "completion",
      "affected_provisions": "Art. 4",
      "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 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": "amendment",
      "affected_provisions": "Art. 4(2)",
      "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. 6",
      "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. 7 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": "replacement",
      "affected_provisions": "Art. 4 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"
    }
  ],
  "made_under": [],
  "changes_made_to": 39,
  "changes_made_to_url": "https://openlegislation.uk/eu-directive-1965-65/changes.json",
  "changes_made_by": 0,
  "changes_made_by_url": "https://openlegislation.uk/eu-directive-1965-65/changes/by-it.json",
  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/eu-directive-1965-65/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1965/65",
    "retrieved_at": "2026-11-01T15:23:55.594724+00:00"
  },
  "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."
}