Nařízení Komise (EU) 2017/612 ze dne 30. března 2017, kterým se s účinkem ode dne 1. dubna 2017 mění nařízení Rady (ES) č. 297/95, pokud jde o úpravu poplatků, které se platí Evropské agentuře pro léčivé přípravky, na základě míry inflace (Text s významem pro EHP. )

Tento náhled textu slouží k rychlé orientaci. Formátovaný text a další informace k předpisu nařízení 612/2017/EU najdete na stránkách systému Eurlex, který je provozovaný Evropskou unií.
   
            
            
               CS
            
            
               Úřední věstník Evropské unie
            
            
               L 86/7
            
         
      
   
   
   NAŘÍZENÍ KOMISE (EU) 2017/612
   ze dne 30. března 2017,
   kterým se s účinkem ode dne 1. dubna 2017 mění nařízení Rady (ES) č. 297/95, pokud jde o úpravu poplatků, které se platí Evropské agentuře pro léčivé přípravky, na základě míry inflace
   (Text s významem pro EHP)
   EVROPSKÁ KOMISE,
   s ohledem na Smlouvu o fungování Evropské unie,
   s ohledem na nařízení Rady (ES) č. 297/95 ze dne 10. února 1995 o poplatcích, které se platí Evropské agentuře pro hodnocení léčivých přípravků (1), a zejména na čl. 12 pátý pododstavec uvedeného nařízení,
   vzhledem k těmto důvodům:
   
      
      
      
         
            
               (1)
            
            
               Podle čl. 67 odst. 3 nařízení Evropského parlamentu a Rady (ES) č. 726/2004 (2) sestávají příjmy Evropské agentury pro léčivé přípravky z příspěvků Unie a z poplatků, které agentuře platí podniky. Nařízení (ES) č. 297/95 stanoví kategorie a výši těchto poplatků.
            
         
      
   
   
      
      
      
         
            
               (2)
            
            
               Uvedené poplatky by měly být aktualizovány s přihlédnutím k míře inflace za rok 2016. Podle údajů zveřejněných Statistickým úřadem Evropské unie dosáhla v roce 2016 míra inflace v Unii 1,2 %.
            
         
      
   
   
      
      
      
         
            
               (3)
            
            
               Pro zjednodušení by upravené výše poplatků měly být zaokrouhleny na nejbližších 100 EUR.
            
         
      
   
   
      
      
      
         
            
               (4)
            
            
               Nařízení (ES) č. 297/95 by proto mělo být odpovídajícím způsobem změněno.
            
         
      
   
   
      
      
      
         
            
               (5)
            
            
               Z důvodu právní jistoty by se toto nařízení nemělo vztahovat na platné žádosti, které nejsou vyřízeny ke dni 1. dubna 2017.
            
         
      
   
   
      
      
      
         
            
               (6)
            
            
               V souladu s článkem 12 nařízení (ES) č. 297/95 má být aktualizace provedena s účinností ode dne 1. dubna 2017. Je tudíž vhodné, aby toto nařízení vstoupilo v platnost neprodleně a použilo se od uvedeného dne,
            
         
      
   
   PŘIJALA TOTO NAŘÍZENÍ:
   Článek 1
   Nařízení (ES) č. 297/95 se mění takto:
   
      
      
      
         
            
               1)
            
            
               článek 3 se mění takto:
               
                  
                  
                  
                     
                        
                           a)
                        
                        
                           odstavec 1 se mění takto:
                           
                              
                              
                              
                                 
                                    
                                       i)
                                    
                                    
                                       písmeno a) se mění takto:
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   v prvním pododstavci se částka „278 800 EUR“ nahrazuje částkou „282 100 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve druhém pododstavci se částka „28 000 EUR“ nahrazuje částkou „28 300 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve třetím pododstavci se částka „7 000 EUR“ nahrazuje částkou „7 100 EUR“,
                                                
                                             
                                          
                                       
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       ii)
                                    
                                    
                                       písmeno b) se mění takto:
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   v prvním pododstavci se částka „108 200 EUR“ nahrazuje částkou „109 500 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve druhém pododstavci se částka „180 200 EUR“ nahrazuje částkou „182 400 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve třetím pododstavci se částka „10 800 EUR“ nahrazuje částkou „10 900 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve čtvrtém pododstavci se částka „7 000 EUR“ nahrazuje částkou „7 100 EUR“,
                                                
                                             
                                          
                                       
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       iii)
                                    
                                    
                                       písmeno c) se mění takto:
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   v prvním pododstavci se částka „83 700 EUR“ nahrazuje částkou „84 700 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve druhém pododstavci se rozmezí „od 20 900 EUR do 62 700 EUR“ nahrazuje rozmezím „od 21 200 EUR do 63 500 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve třetím pododstavci se částka „7 000 EUR“ nahrazuje částkou „7 100 EUR“;
                                                
                                             
                                          
                                       
                                    
                                 
                              
                           
                        
                     
                  
               
               
                  
                  
                  
                     
                        
                           b)
                        
                        
                           odstavec 2 se mění takto:
                           
                              
                              
                              
                                 
                                    
                                       i)
                                    
                                    
                                       v písm. a) prvním pododstavci se částka „7 000 EUR“ nahrazuje částkou „7 100 EUR“,
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       ii)
                                    
                                    
                                       písmeno b) se mění takto:
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   v prvním pododstavci se částka „83 700 EUR“ nahrazuje částkou „84 700 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve druhém pododstavci se rozmezí „od 20 900 EUR do 62 700 EUR“ nahrazuje rozmezím „od 21 200 EUR do 63 500 EUR“;
                                                
                                             
                                          
                                       
                                    
                                 
                              
                           
                        
                     
                  
               
               
                  
                  
                  
                     
                        
                           c)
                        
                        
                           v odstavci 3 se částka „13 800 EUR“ nahrazuje částkou „14 000 EUR“;
                        
                     
                  
               
               
                  
                  
                  
                     
                        
                           d)
                        
                        
                           v odstavci 4 se částka „20 900 EUR“ nahrazuje částkou „21 200 EUR“;
                        
                     
                  
               
               
                  
                  
                  
                     
                        
                           e)
                        
                        
                           v odstavci 5 se částka „7 000 EUR“ nahrazuje částkou „7 100 EUR“;
                        
                     
                  
               
               
                  
                  
                  
                     
                        
                           f)
                        
                        
                           odstavec 6 se mění takto:
                           
                              
                              
                              
                                 
                                    
                                       i)
                                    
                                    
                                       v prvním pododstavci se částka „100 000 EUR“ nahrazuje částkou „101 200 EUR“,
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       ii)
                                    
                                    
                                       ve druhém pododstavci se rozmezí „od 24 900 EUR do 74 900 EUR“ nahrazuje rozmezím „od 25 200 EUR do 75 800 EUR“;
                                    
                                 
                              
                           
                        
                     
                  
               
            
         
      
   
   
      
      
      
         
            
               2)
            
            
               v čl. 4 prvním pododstavci se částka „69 400 EUR“ nahrazuje částkou „70 200 EUR“;
            
         
      
   
   
      
      
      
         
            
               3)
            
            
               článek 5 se mění takto:
               
                  
                  
                  
                     
                        
                           a)
                        
                        
                           odstavec 1 se mění takto:
                           
                              
                              
                              
                                 
                                    
                                       i)
                                    
                                    
                                       písmeno a) se mění takto:
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   v prvním pododstavci se částka „139 600 EUR“ nahrazuje částkou „141 300 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve druhém pododstavci se částka „13 800 EUR“ nahrazuje částkou „14 000 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve třetím pododstavci se částka „7 000 EUR“ nahrazuje částkou „7 100 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   čtvrtý pododstavec se mění takto:
                                                   
                                                      
                                                      
                                                      
                                                         
                                                            
                                                               —
                                                            
                                                            
                                                               částka „69 400 EUR“ se nahrazuje částkou „70 200 EUR“,
                                                            
                                                         
                                                      
                                                   
                                                   
                                                      
                                                      
                                                      
                                                         
                                                            
                                                               —
                                                            
                                                            
                                                               částka „7 000 EUR“ se nahrazuje částkou „7 100 EUR“,
                                                            
                                                         
                                                      
                                                   
                                                
                                             
                                          
                                       
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       ii)
                                    
                                    
                                       písmeno b) se mění takto:
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   v prvním pododstavci se částka „69 400 EUR“ nahrazuje částkou „70 200 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve druhém pododstavci se částka „117 800 EUR“ nahrazuje částkou „119 200 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve třetím pododstavci se částka „13 800 EUR“ nahrazuje částkou „14 000 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve čtvrtém pododstavci se částka „7 000 EUR“ nahrazuje částkou „7 100 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   pátý pododstavec se mění takto:
                                                   
                                                      
                                                      
                                                      
                                                         
                                                            
                                                               —
                                                            
                                                            
                                                               částka „34 900 EUR“ se nahrazuje částkou „35 300 EUR“,
                                                            
                                                         
                                                      
                                                   
                                                   
                                                      
                                                      
                                                      
                                                         
                                                            
                                                               —
                                                            
                                                            
                                                               částka „7 000 EUR“ se nahrazuje částkou „7 100 EUR“,
                                                            
                                                         
                                                      
                                                   
                                                
                                             
                                          
                                       
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       iii)
                                    
                                    
                                       písmeno c) se mění takto:
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   v prvním pododstavci se částka „34 900 EUR“ nahrazuje částkou „35 300 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve druhém pododstavci se rozmezí „od 8 700 EUR do 26 200 EUR“ nahrazuje rozmezím „od 8 800 EUR do 26 500 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve třetím pododstavci se částka „7 000 EUR“ nahrazuje částkou „7 100 EUR“;
                                                
                                             
                                          
                                       
                                    
                                 
                              
                           
                        
                     
                  
               
               
                  
                  
                  
                     
                        
                           b)
                        
                        
                           odstavec 2 se mění takto:
                           
                              
                              
                              
                                 
                                    
                                       i)
                                    
                                    
                                       v písm. a) prvním pododstavci se částka „7 000 EUR“ nahrazuje částkou „7 100 EUR“,
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       ii)
                                    
                                    
                                       písmeno b) se mění takto:
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   v prvním pododstavci se částka „41 800 EUR“ nahrazuje částkou „42 300 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve druhém pododstavci se rozmezí „od 10 500 EUR do 31 500 EUR“ nahrazuje rozmezím „od 10 600 EUR do 31 900 EUR“,
                                                
                                             
                                          
                                       
                                       
                                          
                                          
                                          
                                             
                                                
                                                   —
                                                
                                                
                                                   ve třetím pododstavci se částka „7 000 EUR“ nahrazuje částkou „7 100 EUR“;
                                                
                                             
                                          
                                       
                                    
                                 
                              
                           
                        
                     
                  
               
               
                  
                  
                  
                     
                        
                           c)
                        
                        
                           v odstavci 3 se částka „7 000 EUR“ nahrazuje částkou „7 100 EUR“;
                        
                     
                  
               
               
                  
                  
                  
                     
                        
                           d)
                        
                        
                           v odstavci 4 se částka „20 900 EUR“ nahrazuje částkou „21 200 EUR“;
                        
                     
                  
               
               
                  
                  
                  
                     
                        
                           e)
                        
                        
                           v odstavci 5 se částka „7 000 EUR“ nahrazuje částkou „7 100 EUR“;
                        
                     
                  
               
               
                  
                  
                  
                     
                        
                           f)
                        
                        
                           odstavec 6 se mění takto:
                           
                              
                              
                              
                                 
                                    
                                       i)
                                    
                                    
                                       v prvním pododstavci se částka „33 400 EUR“ nahrazuje částkou „33 800 EUR“,
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       ii)
                                    
                                    
                                       ve druhém pododstavci se rozmezí „od 8 300 EUR do 24 900 EUR“ nahrazuje rozmezím „od 8 400 EUR do 25 200 EUR“;
                                    
                                 
                              
                           
                        
                     
                  
               
            
         
      
   
   
      
      
      
         
            
               4)
            
            
               v čl. 6 prvním pododstavci se částka „41 800 EUR“ nahrazuje částkou „42 300 EUR“;
            
         
      
   
   
      
      
      
         
            
               5)
            
            
               článek 7 se mění takto:
               
                  
                  
                  
                     
                        
                           a)
                        
                        
                           v prvním pododstavci se částka „69 400 EUR“ nahrazuje částkou „70 200 EUR“;
                        
                     
                  
               
               
                  
                  
                  
                     
                        
                           b)
                        
                        
                           ve druhém pododstavci se částka „20 900 EUR“ nahrazuje částkou „21 200 EUR“;
                        
                     
                  
               
            
         
      
   
   
      
      
      
         
            
               6)
            
            
               článek 8 se mění takto:
               
                  
                  
                  
                     
                        
                           a)
                        
                        
                           odstavec 1 se mění takto:
                           
                              
                              
                              
                                 
                                    
                                       i)
                                    
                                    
                                       ve druhém pododstavci se částka „83 700 EUR“ nahrazuje částkou „84 700 EUR“,
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       ii)
                                    
                                    
                                       ve třetím pododstavci se částka „41 800 EUR“ nahrazuje částkou „42 300 EUR“,
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       iii)
                                    
                                    
                                       ve čtvrtém pododstavci se rozmezí „od 20 900 EUR do 62 700 EUR“ nahrazuje rozmezím „od 21 200 EUR do 63 500 EUR“,
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       iv)
                                    
                                    
                                       v pátém pododstavci se rozmezí „od 10 500 EUR do 31 500 EUR“ nahrazuje rozmezím „od 10 600 EUR do 31 900 EUR“;
                                    
                                 
                              
                           
                        
                     
                  
               
               
                  
                  
                  
                     
                        
                           b)
                        
                        
                           odstavec 2 se mění takto:
                           
                              
                              
                              
                                 
                                    
                                       i)
                                    
                                    
                                       ve druhém pododstavci se částka „278 800 EUR“ nahrazuje částkou „282 100 EUR“,
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       ii)
                                    
                                    
                                       ve třetím pododstavci se částka „139 600 EUR“ nahrazuje částkou „141 300 EUR“,
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       iii)
                                    
                                    
                                       v pátém pododstavci se rozmezí „od 3 000 EUR do 240 300 EUR“ nahrazuje rozmezím „od 3 000 EUR do 243 200 EUR“,
                                    
                                 
                              
                           
                           
                              
                              
                              
                                 
                                    
                                       iv)
                                    
                                    
                                       v šestém pododstavci se rozmezí „od 3 000 EUR do 120 300 EUR“ nahrazuje rozmezím „od 3 000 EUR do 121 700 EUR“;
                                    
                                 
                              
                           
                        
                     
                  
               
               
                  
                  
                  
                     
                        
                           c)
                        
                        
                           v odst. 3 prvním pododstavci se částka „7 000 EUR“ nahrazuje částkou „7 100 EUR“.
                        
                     
                  
               
            
         
      
   
   Článek 2
   Toto nařízení se nepoužije na platné žádosti, které nejsou vyřízeny ke dni 1. dubna 2017.
   Článek 3
   Toto nařízení vstupuje v platnost prvním dnem po vyhlášení v Úředním věstníku Evropské unie.
   Použije se ode dne 1. dubna 2017.
   
      Toto nařízení je závazné v celém rozsahu a přímo použitelné ve všech členských státech.
      V Bruselu dne 30. března 2017.
      
         
            Za Komisi
         
         
            předseda
         
         Jean-Claude JUNCKER
      
   
   
   
      (1)  Úř. věst. L 35, 15.2.1995, s. 1.
   
      (2)  Nařízení Evropského parlamentu a Rady (ES) č. 726/2004 ze dne 31. března 2004, kterým se stanoví postupy Společenství pro registraci humánních a veterinárních léčivých přípravků a dozor nad nimi a kterým se zřizuje Evropská agentura pro léčivé přípravky (Úř. věst. L 136, 30.4.2004, s. 1).
   


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