CELEX: 32018D0134
Language: en
Date: 2018-01-24 00:00:00
Title: Commission Implementing Decision (EU) 2018/134 of 24 January 2018 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(2018) 218) (Text with EEA relevance. )

26.1.2018   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 22/41
            
         COMMISSION IMPLEMENTING DECISION (EU) 2018/134
   of 24 January 2018
   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(2018) 218)
      
   
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to 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 2 February 2016 by the Committee for Herbal Medicinal Products
   Whereas:
   
               (1)
            
            
               
                  Sideritis scardica Griseb., herba 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 Sideritis scardica Griseb., herba 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, 24 January 2018.
      
         
            For the Commission
         
         Vytenis ANDRIUKAITIS
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 311, 28.11.2001, p. 67.
   
      (2)  Commission Decision 2008/911/EC of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (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 Pimpinella anisum L:
                  ‘Sideritis scardica Griseb., herba.’;
               
            
                  (2)
               
               
                  In Annex II, the following is inserted after the COMMUNITY LIST ENTRY on Pimpinella anisum L:
                  ‘UNION LIST ENTRY ON SIDERITIS SCARDIA GRISEB., HERBA
                  
                              
                                 Scientific name of the plant
                              
                           
                        
                              
                                 Sideritis scardica Griseb.
                           
                        
                              
                                 Botanical family
                              
                           
                        
                              Lamiaceae (Labiatae)
                           
                        
                              
                                 Herbal substance
                              
                           
                        
                              Ironwort (Sideritis herba)
                           
                        
                              
                                 Common name in all EU official languages of herbal preparation
                              
                           
                        
                              BG (bălgarski): Мурсалски чай, стрък
                              CS (čeština): nať hojníku
                              DA (dansk): Kortkroneurt
                              DE (Deutsch): Balkan-Gliedkraut
                              EL (elliniká): Πόα σιδηρίτου
                              EN (English): Ironwort
                              ES (español): Siderita, partes aéreas de
                              ET (eesti keel): haavarohuürt
                              FI (suomi): raudakki, verso
                              FR (français): Crapaudine (parties aériennes de)
                              HR (hrvatska): očistova zelen
                              HU (magyar): sármányvirág virágos hajtása
                              IT (italiano): Stregonia parti aeree fiorite
                           
                           
                              LT (lietuvių kalba): Timsrų žolė
                              LV (latviešu valoda): Siderītu laksts
                              MT (Malti): ħaxixa tas-Sideritis
                              NL (Nederlands): (Griekse) bergthee, kruid
                              PL (polski): Ziele gojnika
                              PT (português): Siderite, partes aéreas
                              RO (română): iarba de ceaiul muntelui cretan
                              SK (slovenčina): Vňať ránhoja
                              SL (slovenščina): zel sklepnjaka
                              SV (svenska): Sårmynta, ört
                              IS (íslenska):
                              NO (norsk): Gresk fjellte
                           
                        
                              
                                 Herbal preparations
                              
                           
                        
                              Comminuted herbal substance
                           
                        
                              
                                 European Pharmacopoeia monograph reference
                              
                           
                        
                              Not applicable
                           
                        
                              
                                 Indications
                              
                           
                        
                              Indication (1)
                              Traditional herbal medicinal product used for the relief of cough associated with cold.
                              Indication (2)
                              Traditional herbal medicinal product used for the relief of mild gastrointestinal discomfort.
                              The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
                           
                        
                              
                                 Type of tradition
                              
                           
                        
                              European
                           
                        
                              
                                 Specified strength
                              
                           
                        
                              Please see “Specified posology”.
                           
                        
                              
                                 Specified posology
                              
                           
                        
                              
                                 Adults and elderly
                              
                              Indication (1) and (2)
                              Single dose: Herbal tea: 2-4 g of the comminuted herbal substance in 150-200 ml of water as a herbal infusion 2-3 times daily
                              Daily dose: up to 12 g
                              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
                              
                           
                        
                              Oral use
                           
                        
                              
                                 Duration of use or any restrictions on the duration of use
                              
                           
                        
                              Indication (1)
                              If symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
                              Indication (2)
                              If 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 and to other plants of the Lamiaceae (Labiatae) family.
                              
                                 Special warnings and precautions for use
                              
                              The use in children and adolescents under 18 years of age has not been established due to lack of adequate data.
                              If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
                              
                                 Interactions with other medicinal products and other forms of interaction
                              
                              None reported
                              
                                 Fertility, pregnancy and lactation
                              
                              Safety during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended.
                              No fertility data available.
                              
                                 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
                              
                              None known
                              If adverse reactions occur, a doctor or 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.’