{
  "url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-5/division-5.2/division-5.2.4",
  "json_url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-5/division-5.2/division-5.2.4.json",
  "legislation": "eudr/2001/83",
  "legislation_title": "Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use",
  "legislation_url": "https://openlegislation.uk/eu-directive-2001-83",
  "path": "annex/I/part/I/division/5/division/5.2/division/5.2.4",
  "kind": "division",
  "number": "5.2.4",
  "heading": "Reports of human pharmaco-dynamic studies",
  "text": "a)) The pharmaco-dynamic action correlated to the efficacy shall be demonstrated including:\nthe dose-response relationship and its time course,\njustification for the dosage and conditions of administration,\nthe mode of action, if possible.\nThe pharmaco-dynamic action not related to efficacy shall be described.\nThe demonstration of pharmaco-dynamic effects in human beings shall not in itself be sufficient to justify conclusions regarding any particular potential therapeutic effect.\nb)) If the medicinal product is normally to be administered concomitantly with other medicinal products, particulars shall be given of joint administration tests performed to demonstrate possible modification of the pharmacological action.\nPharmaco-dynamic interactions between the active substance and other medicinal products or substances shall be investigated.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/I/division/5/division/5.2/division/5.2.4",
    "retrieved_at": "2026-11-01T15:22:59.083752+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."
}