{
  "url": "https://openlegislation.uk/eu-decision-2008-911/annex-II/division-3/division-13/division-2",
  "json_url": "https://openlegislation.uk/eu-decision-2008-911/annex-II/division-3/division-13/division-2.json",
  "legislation": "eudn/2008/911",
  "legislation_title": "Commission Decision of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document number C(2008) 6933) (Text with EEA relevance) (2008/911/EC)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2008-911",
  "path": "annex/II/division/3/division/13/division/2",
  "kind": "division",
  "number": null,
  "heading": "Special warnings and precautions for use",
  "text": "The use in children under 12 years of age is not recommended due to lack of adequate data.\nIf the symptoms worsen during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted. For tinctures and extracts containing ethanol the appropriate labelling for ethanol, taken from the Guideline on excipients in the label and package leaflet of medicinal products for human use, must be included.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Inserted by Commission Decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 9703) (Text with EEA relevance) (2010/30/EU)."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Substituted by Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Inserted by Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2008/911/annex/II/division/3/division/13/division/2",
    "retrieved_at": "2026-11-01T15:16:38.490330+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."
}