{
  "url": "https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.1/division-II.6.1.4",
  "json_url": "https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.1/division-II.6.1.4.json",
  "legislation": "eur/2018/782",
  "legislation_title": "Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2018-782",
  "path": "annex/I/division/II/division/II.6/division/II.6.1/division/II.6.1.4",
  "kind": "division",
  "number": "II.6.1.4",
  "heading": null,
  "text": "Data on the pharmacodynamic effects of a substance shall:\n(a)enable to identify/characterise the mode/mechanism of action of the substance;\n(b)enable characterisation of the dose-response relationship for relevant pharmacological endpoints;\n(c)provide insight into the potential toxic effects of the substance based on knowledge of known effects of other substances with similar pharmacodynamic properties;\n(d)aid the understanding of the mechanisms underlying adverse effects seen in toxicology studies;\n(e)provide, in certain cases, information on the relevance of effects seen in laboratory animals for humans.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2018/782/annex/I/division/II/division/II.6/division/II.6.1/division/II.6.1.4",
    "retrieved_at": "2026-11-01T14:44:06.594245+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."
}