THE EUROPEAN COMMISSION,
Having regard to the Treaty on European Union and the Treaty on the Functioning of the European Union,
Having 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(1), and in particular Article 16f thereof,
Having regard to the opinion of the European Medicines Agency, formulated on 15 July 2010 by the Committee for Herbal Medicinal Products,
Whereas:
(1) Vitis vinifera 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.
(2) It is therefore appropriate to include Vitis vinifera 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(2).
(3) Decision 2008/911/EC should therefore be amended accordingly.
(4) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,
HAS ADOPTED THIS DECISION:
Annexes I and II to Decision 2008/911/EC are amended in accordance with the Annex to this Decision.
This Decision is addressed to the Member States.
Done at Brussels, 3 February 2012.
For the Commission
John Dalli
Member of the Commission
Decision 2008/911/EC is amended as follows:
in Annex I, the following substance is inserted after Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum:
‘Vitis vinifera L., folium’
in Annex II, the following is inserted after the entry on Thymus vulgaris L., Thymus zygis Loefl. ex L.:
Vitis vinifera L.
Vitaceae
Grapevine leaf(3)
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
Soft extract (2.5-4:1; extraction solvent water)
Not applicable
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.
European
Please see “Specified posology”.
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”).
Cutaneous use.
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.
Hypersensitivity to the active substance.
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.
None reported.
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
No studies on the effect on the ability to drive and use machines have been performed.
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.
No case of overdose has been reported.
Not applicable.
Not applicable.’
The material complies with the monograph of the Pharmacopée Française X., 1996.’