{
  "url": "https://openlegislation.uk/eu-directive-1975-318",
  "json_url": "https://openlegislation.uk/eu-directive-1975-318.json",
  "id": "eudr/1975/318",
  "title": "Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products",
  "short_title": "Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products",
  "long_title": null,
  "citation": "EU Directive 1975/318",
  "type": "eudr",
  "year": "1975",
  "number": "318",
  "version": "current",
  "date": "1975-05-20",
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 10,
  "provisions": [],
  "outstanding_effects": [
    {
      "type": "completion",
      "affected_provisions": "Annex",
      "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": "Annex",
      "affecting": "eudr/1987/19",
      "affecting_title": "Council Directive 87/19/EEC of 22 December 1986 amending Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco- toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 2 BI",
      "affecting": "eudr/1987/19",
      "affecting_title": "Council Directive 87/19/EEC of 22 December 1986 amending Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco- toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 2 QUATER",
      "affecting": "eudr/1987/19",
      "affecting_title": "Council Directive 87/19/EEC of 22 December 1986 amending Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco- toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "addition",
      "affected_provisions": "Art. 2 TER",
      "affecting": "eudr/1987/19",
      "affecting_title": "Council Directive 87/19/EEC of 22 December 1986 amending Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco- toxicological and clinical standards and protocols in respect of the testing of 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": "replacement",
      "affected_provisions": "Annex",
      "affecting": "eudr/1991/507",
      "affecting_title": "Commission Directive 91/507/EEC of 19 July 1991 modifying the Annex to Council Directive 75/318/EEC on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products",
      "affecting_provisions": "Directive"
    },
    {
      "type": "amendment",
      "affected_provisions": "Art. 2 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": "completion",
      "affected_provisions": "Annex",
      "affecting": "eudr/1999/82",
      "affecting_title": "Commission Directive 1999/82/EC of 8 September 1999 amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (Text with EEA relevance)",
      "affecting_provisions": "Directive"
    },
    {
      "type": "completion",
      "affected_provisions": "Annex",
      "affecting": "eudr/1999/83",
      "affecting_title": "Commission Directive 1999/83/EC of 8 September 1999 amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (Text with EEA relevance)",
      "affecting_provisions": "Directive"
    }
  ],
  "made_under": [],
  "changes_made_to": 10,
  "changes_made_to_url": "https://openlegislation.uk/eu-directive-1975-318/changes.json",
  "changes_made_by": 0,
  "changes_made_by_url": "https://openlegislation.uk/eu-directive-1975-318/changes/by-it.json",
  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/eu-directive-1975-318/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1975/318",
    "retrieved_at": "2026-11-01T15:23:47.793842+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."
}