{
  "url": "https://openlegislation.uk/eu-decision-2016-1658/introduction",
  "json_url": "https://openlegislation.uk/eu-decision-2016-1658/introduction.json",
  "legislation": "eudn/2016/1658",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2016-1658",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Implementing Decision (EU) 2016/1658\nof 13 September 2016\namending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products\n(notified under document C(2016) 5747)\n(Text with EEA relevance)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to 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, and in particular Article 16f thereof,\nHaving regard to the opinion of the European Medicines Agency, formulated on 25 March 2014 by the Committee for Herbal Medicinal Products,\nWhereas:\n(1)\nIn 2008 an opinion of the European Medicines Agency established that Eleutherococcus senticosus (Rupr. et Maxim) Maxim complied with the requirements set out in Directive 2001/83/EC as a herbal substance, a herbal preparation or a combination thereof within the meaning of that Directive and it was therefore included in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC.\n(2)\nAs part of its review of monographs and list entries to keep them relevant, the Committee for Herbal Medicinal Products has reviewed the list entry Eleutherococcus senticosus (Rupr. et Maxim) Maxim and adopted an opinion to change the list entry with regard to the name of the herbal substance in certain EU official languages, the phrasing of the herbal preparations, update of the reference to the European Pharmacopoeia and update of some information necessary for the safe use, e.g. revision of the contraindications. Some of those changes are the result of an update of the template for list entries.\n(3)\nDecision 2008/911/EC should therefore be amended accordingly.\n(4)\nThe measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,\nHAS ADOPTED THIS DECISION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 311, 28.11.2001, p. 67."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Commission Decision 2008/911/EC of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (OJ L 328, 6.12.2008, p. 42)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2016/1658/introduction",
    "retrieved_at": "2026-11-01T15:13:50.708292+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."
}