HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 34/8
EN
Official Journal of the European Union
7.2.2012
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,
(3) Decision
2008/911/EC
should
therefore
be
amended
accordingly.
Having regard to the Treaty on European Union and the Treaty
on the Functioning of the European Union,
(4) The
measures
provided
for
in
this
Decision
are
in
accordance with the opinion of the Standing
Having regard to Directive 2001/83/EC of the European
Committee on Medicinal Products for Human Use,
Parliament and of the Council of 6 November 2001 on the
Community code relating to medicinal products for human
HAS ADOPTED THIS DECISION:
use ( 1 ), and in particular Article 16f thereof,
Article 1
Having regard to the opinion of the European Medicines
Agency, formulated on 15 July 2010 by the Committee for
Annexes I and II to Decision 2008/911/EC are amended in
Herbal Medicinal Products,
accordance with the Annex to this Decision.
Whereas:
Article 2
This Decision is addressed to the Member States.
(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.
Done at Brussels, 3 February 2012.
(2) It
is
therefore
appropriate
to
include Vitis vinifera L. in the
For the Commission
list of herbal substances, preparations and combinations
thereof for use in traditional herbal medicinal products
John DALLI
established by Commission Decision 2008/911/EC ( 2 ).
Member of the Commission
( 1 ) OJ L 311, 28.11.2001, p. 67.
( 2 ) OJ L 328, 6.12.2008, p. 42.

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EN
7.2.2012 Official
Journal
of
the
European
Union L
34/9
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 (blgarski): лоза, лист
LT (lietuvi kalba): Tikrj vynmedi lapai
CS (etina): erven list vinné révy
LV (latvieu valoda): stā vīnkoka lapas
DA (dansk): Vinblad
MT (malti): Werqa tad-dielja
DE (Deutsch): Rote Weinrebenbltter
NL (nederlands): Wijnstokblad
EL (elliniká): Φλλο Αμπλου
PL (polski): Li winoroli waciwej
EN (English): Grapevine leaf
PT (português): Folha de videira
ES (espaol): Vid, hoja de
RO (romn): Frunze de vi-de-vie
ET (eesti keel): Viinapuu lehed
SK (slovenina): List vinia
FI (suomi): Aitoviinikynns, lehti
SL (slovenina): List vinske trte
FR (franais): Feuille de vigne rouge
SV (svenska): Blad frn vinranka
HU (magyar): Borterm szl levél
IS (íslenska): Vínviarlauf
IT (italiano): Vite, foglia
NO (norsk): Rd 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

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L 34/10
EN
Official Journal of the European Union
7.2.2012
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 recom
mended.
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.

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EN
7.2.2012 Official
Journal
of
the
European
Union L
34/11
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 Franaise X., 1996.’

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Document Outline

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