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)
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:
Article 1U.K.
Annexes I and II to Decision 2008/911/EC are amended in accordance with the Annex to this Decision.
Article 2U.K.
This Decision is addressed to the Member States.
Done at Brussels, 3 February 2012.
For the Commission
John Dalli
Member of the Commission
ANNEXU.K.
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.:
‘COMMUNITY LIST ENTRY ON VITIS VINIFERA L., FOLIUM
Scientific name of the plant
Vitis vinifera L.
Botanical family
Vitaceae
Herbal substance
Grapevine leaf(3)
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.’
The material complies with the monograph of the Pharmacopée Française X., 1996.’