{
  "url": "https://openlegislation.uk/eu-decision-2012-68/annex",
  "json_url": "https://openlegislation.uk/eu-decision-2012-68/annex.json",
  "legislation": "eudn/2012/68",
  "legislation_title": "Commission Implementing Decision of 3 February 2012 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(2012) 516) (Text with EEA relevance) (2012/68/EU)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2012-68",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "Decision 2008/911/EC is amended as follows:\n(1) in Annex I, the following substance is inserted after Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum:\n‘ Vitis vinifera L., folium’\n(2) in Annex II, the following is inserted after the entry on Thymus vulgaris L., Thymus zygis Loefl. ex L.:\n‘COMMUNITY LIST ENTRY ON VITIS VINIFERA L., FOLIUM\nScientific name of the plant\nVitis vinifera L.\nBotanical family\nVitaceae\nHerbal substance\nGrapevine leaf\nCommon name of herbal substance in all EU official languages\nBG (bălgarski): лоза, лист\nCS (čeština): Červený list vinné révy\nDA (dansk): Vinblad\nDE (Deutsch): Rote Weinrebenblätter\nEL (elliniká): Φύλλο Αμπέλου\nEN (English): Grapevine leaf\nES (español): Vid, hoja de\nET (eesti keel): Viinapuu lehed\nFI (suomi): Aitoviiniköynnös, lehti\nFR (français): Feuille de vigne rouge\nHU (magyar): Bortermő szőlő levél\nIT (italiano): Vite, foglia\nLT (lietuvių kalba): Tikrųjų vynmedžių lapai\nLV (latviešu valoda): Īstā vīnkoka lapas\nMT (malti): Werqa tad-dielja\nNL (nederlands): Wijnstokblad\nPL (polski): Liść winorośli właściwej\nPT (português): Folha de videira\nRO (română): Frunze de viță-de-vie\nSK (slovenčina): List viniča\nSL (slovenščina): List vinske trte\nSV (svenska): Blad från vinranka\nIS (íslenska): Vínviðarlauf\nNO (norsk): Rød vinranke, blad\nHerbal preparation(s)\nSoft extract (2.5-4:1; extraction solvent water)\nEuropean Pharmacopoeia monograph reference\nNot applicable\nIndication(s)\nTraditional herbal medicinal product to relieve symptoms of discomfort and heaviness of legs related to minor venous circulatory disturbances.\nThe product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use.\nType of tradition\nEuropean\nSpecified strength\nPlease see “Specified posology”.\nSpecified posology\nAdults and elderly\nSoft extract (2.5-4:1; extraction solvent water) in a cream base (10 g contain 282 mg soft extract).\nApply a thin layer on the affected area 1-3 times daily.\nThe use in children and adolescents under 18 years of age is not recommended (see section “Special warnings and precautions for use”).\nRoute of administration\nCutaneous use.\nDuration of use or any restrictions on the duration of use\nAdults and elderly\nThe recommended duration of use is 4 weeks.\nIf the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.\nAny other information necessary for the safe use\nContraindications\nHypersensitivity to the active substance.\nSpecial warnings and precautions for use\nIf there is inflammation of the skin, thrombophlebitis or subcutaneous induration, severe pain, ulcers, sudden swelling of one or both legs, cardiac or renal insufficiency, a doctor should be consulted.\nThe product should not be used on broken skin, around the eyes or on mucous membranes.\nIn the absence of sufficient safety data, the use in children and adolescents below 18 years of age is not recommended.\nInteractions with other medicinal products and other forms of interaction\nNone reported.\nPregnancy and lactation\nSafety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.\nEffects on ability to drive and use machines\nNo studies on the effect on the ability to drive and use machines have been performed.\nUndesirable effects\nContact allergy and/or hypersensitivity reactions of the skin (itching and erythema, urticaria) have been reported. The frequency is not known.\nIf other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.\nOverdose\nNo case of overdose has been reported.\nPharmaceutical particulars (if necessary)\nNot applicable.\nPharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)\nNot applicable.’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "The material complies with the monograph of the Pharmacopée Française X., 1996.’"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2012/68/annex",
    "retrieved_at": "2026-11-01T15:15:32.937694+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."
}