CELEX: 32012D0068
Language: en
Date: 2012-02-03 00:00:00
Title: 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

7.2.2012   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 34/8
            
         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 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.
   
      Done at Brussels, 3 February 2012.
      
         
            For the Commission
         
         John DALLI
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 311, 28.11.2001, p. 67.
   
      (2)  OJ L 328, 6.12.2008, p. 42.
   
      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.’