2012/68/EU: 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

Decision 2008/911/EC · Decision · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

Annexes I and II to Decision 2008/911/EC are amended in accordance with the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Supplementary provisions

ANNEXSupplementary provisions

ANNEX Decision 2008/911/EC is amended as follows: (1) in Annex I, the following substance is inserted after Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum: ‘ Vitis vinifera L., folium’ (2) in Annex II, the following is inserted after the entry on Thymus vulgaris L., Thymus zygis Loefl. ex L.: ‘COMMUNITY LIST ENTRY ON VITIS VINIFERA L., FOLIUM Scientific name of the plant Vitis vinifera L. Botanical family Vitaceae Herbal substance Grapevine leaf ( 1 ) Common name of herbal substance in all EU official languages BG (bălgarski): лоза, лист CS (čeština): Červený list vinné révy DA (dansk): Vinblad DE (Deutsch): Rote Weinrebenblätter EL (elliniká): Φύλλο Αμπέλου EN (English): Grapevine leaf ES (español): Vid, hoja de ET (eesti keel): Viinapuu lehed FI (suomi): Aitoviiniköynnös, lehti FR (français): Feuille de vigne rouge HU (magyar): Bortermő szőlő levél IT (italiano): Vite, foglia LT (lietuvių kalba): Tikrųjų vynmedžių lapai LV (latviešu valoda): Īstā vīnkoka lapas MT (malti): Werqa tad-dielja NL (nederlands): Wijnstokblad PL (polski): Liść winorośli właściwej PT (português): Folha de videira RO (română): Frunze de viță-de-vie SK (slovenčina): List viniča SL (slovenščina): List vinske trte SV (svenska): Blad från vinranka IS (íslenska): Vínviðarlauf NO (norsk): Rød vinranke, blad Herbal preparation(s) Soft extract (2.5-4:1; extraction solvent water) European Pharmacopoeia monograph reference Not applicable Indication(s) Traditional herbal medicinal product to relieve symptoms of discomfort and heaviness of legs related to minor venous circulatory disturbances. The product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use. Type of tradition European Specified strength Please see “Specified posology”. Specified posology Adults and elderly Soft extract (2.5-4:1; extraction solvent water) in a cream base (10 g contain 282 mg soft extract). Apply a thin layer on the affected area 1-3 times daily. The use in children and adolescents under 18 years of age is not recommended (see section “Special warnings and precautions for use”). Route of administration Cutaneous use. Duration of use or any restrictions on the duration of use Adults and elderly The recommended duration of use is 4 weeks. If 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. Any other information necessary for the safe use Contraindications Hypersensitivity to the active substance. Special warnings and precautions for use If 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. The product should not be used on broken skin, around the eyes or on mucous membranes. In the absence of sufficient safety data, the use in children and adolescents below 18 years of age is not recommended. Interactions with other medicinal products and other forms of interaction None reported. Pregnancy and lactation Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. Effects on ability to drive and use machines No studies on the effect on the ability to drive and use machines have been performed. Undesirable effects Contact allergy and/or hypersensitivity reactions of the skin (itching and erythema, urticaria) have been reported. The frequency is not known. If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted. Overdose No case of overdose has been reported. Pharmaceutical particulars (if necessary) Not applicable. Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product) Not applicable. ( 1 ) The material complies with the monograph of the Pharmacopée Française X., 1996.’ " ( 1 ) The material complies with the monograph of the Pharmacopée Française X., 1996.’ ’

Other acts of the same type

Decision (EU) 2023/2532 of the European Central Bank of 9 November 2023 amending Decision (EU) 2022/911 concerning the terms and conditions of TARGET-ECB (ECB/2022/22) (ECB/2023/27)Council Decision (EU) 2023/2538 of 9 November 2023 on the position to be taken on behalf of the European Union within the Association Council established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Georgia, of the other part, as regards the amendment of Annex XXII to that Agreement Council Decision (EU) 2023/2577 οf 9 November 2023 on the signing, on behalf of the Union, of the Agreement in the form of an Exchange of Letters between the European Union and the Kingdom of Norway amending the Agreement of the European Union and the Kingdom of Norway pursuant to Article XXVIII of the General Agreement on Tariffs and Trade (GATT) 1994 relating to the modification of concessions on all the tariff-rate quotas included in the EU Schedule CLXXV as a consequence of the United Kingdom’s withdrawal from the European Union Council Decision (EU) 2023/2600 of 9 November 2023 on the position to be taken on behalf of the European Union within the Joint Committee established by the Agreement between the European Union, of the one part, and the Government of the Faroe Islands, of the other part, on the participation of the Faroe Islands in Union programmes, as regards the adoption of the Joint Committee’s Rules of Procedure Council Decision (EU) 2023/2608 of 9 November 2023 on the position to be taken on behalf of the European Union within the Association Committee in Trade configuration and within the Association Council established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part as regards the positive assessment of the implementation of phases 1 and 2 as set out in Annex XXI-A to the Association Agreement, and the market access linked thereto Council Decision (EU) 2023/2692 of 9 November 2023 on the position to be taken on behalf of the European Union in the Specialised Committee on Road Transport established by the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, on the adaptation of technical specifications of the smart tachograph 2 Council Decision (EU) 2023/2848 of 9 November 2023 authorising the opening of negotiations for agreements, in the form of an Exchange of Letters, amending and supplementing the agreements for scientific and technological cooperation between the European Union and the People’s Democratic Republic of Algeria, the Arab Republic of Egypt, the Hashemite Kingdom of Jordan, the Republic of Lebanon and the Kingdom of Morocco, respectively, setting out the terms and conditions for their participation with regard to Horizon Europe in the Partnership for Research and Innovation in the Mediterranean Area (PRIMA) jointly undertaken by several Member States Commission Implementing Decision (EU) 2023/2520 of 8 November 2023 on the request for registration, pursuant to Regulation (EU) 2019/788 of the European Parliament and of the Council, of the European citizens’ initiative entitled Trust and Freedom Commission Implementing Decision (EU) 2023/2521 of 8 November 2023 on the request for registration, pursuant to Regulation (EU) 2019/788 of the European Parliament and of the Council, of the European citizens’ initiative entitled I’m Going European: An ECI to Connect your National and European Citizenship (notified under document C(2023) 7583)Commission Implementing Decision (EU) 2023/2522 of 8 November 2023 on the request for registration, pursuant to Regulation (EU) 2019/788 of the European Parliament and of the Council, of the European citizens’ initiative entitled Creation of a European Environment Authority Commission Implementing Decision (EU) 2023/2523 of 8 November 2023 on the request for registration, pursuant to Regulation (EU) 2019/788 of the European Parliament and of the Council, of the European citizens’ initiative entitled EU Live Bus Stop Info (notified under document C(2023) 7436)Council Decision (EU) 2023/2582 of 8 November 2023 on the position to be taken on behalf of the European Union at the 5th session of the OTIF ad hoc Committee on Legal Affairs and International Cooperation

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

What to look at next

Browse all EU Legal ActsEvery instrument by type and year, full text free to read section by sectionEuropean Union legislation EU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and year European Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview