{
  "url": "https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.2/division-II.6.2.1",
  "json_url": "https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.2/division-II.6.2.1.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.6.2/division/II.6.2.1",
  "kind": "division",
  "number": "II.6.2.1",
  "heading": null,
  "text": "Pharmacokinetic investigations shall provide information on the absorption of the substance, its distribution and persistence in the tissues, its metabolism and excretion. The oral route shall be the main route of administration in the pharmacokinetic studies as this is the route by which consumers are exposed.",
  "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.6.2/division/II.6.2.1",
    "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."
}