{
  "url": "https://openlegislation.uk/eu-decision-2018-133/introduction",
  "json_url": "https://openlegislation.uk/eu-decision-2018-133/introduction.json",
  "legislation": "eudn/2018/133",
  "legislation_title": "Commission Implementing Decision (EU) 2018/133 of 24 January 2018 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(2018) 213) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2018-133",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Implementing Decision (EU) 2018/133\nof 24 January 2018\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(2018) 213)\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 2 February 2016 by the Committee for Herbal Medicinal Products,\nWhereas:\n(1)\nValeriana officinalis L. can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and it complies with the requirements set out in that Directive.\n(2)\nIt is therefore appropriate to include Valeriana officinalis L. 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(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": "X",
      "label": "X1",
      "text": "Substituted by Corrigendum to Commission Implementing Decision (EU) 2018/133 of 24 January 2018 amending Decision 2008/911/EC shing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (Official Journal of the European Union L 22 of 26 January 2018)."
    },
    {
      "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/2018/133/introduction",
    "retrieved_at": "2026-11-01T15:13:12.726016+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."
}