Çàðåãèñòðèðîâàíî â Ìèíþñòå ÐÔ 17 ìàÿ 2011 ã. N 20768

 

ÌÈÍÈÑÒÅÐÑÒÂÎ ÇÄÐÀÂÎÎÕÐÀÍÅÍÈß È ÑÎÖÈÀËÜÍÎÃÎ ÐÀÇÂÈÒÈß

ÐÎÑÑÈÉÑÊÎÉ ÔÅÄÅÐÀÖÈÈ

 

ÔÅÄÅÐÀËÜÍÀß ÑËÓÆÁÀ ÏÎ ÍÀÄÇÎÐÓ Â ÑÔÅÐÅ ÇÄÐÀÂÎÎÕÐÀÍÅÍÈß

È ÑÎÖÈÀËÜÍÎÃÎ ÐÀÇÂÈÒÈß

 

ÏÐÈÊÀÇ

îò 6 àïðåëÿ 2011 ã. N 1785-Ïð/11

 

Î ÂÍÅÑÅÍÈÈ ÈÇÌÅÍÅÍÈÉ

 ÏÐÈÊÀÇ ÔÅÄÅÐÀËÜÍÎÉ ÑËÓÆÁÛ ÏÎ ÍÀÄÇÎÐÓ Â ÑÔÅÐÅ

ÇÄÐÀÂÎÎÕÐÀÍÅÍÈß È ÑÎÖÈÀËÜÍÎÃÎ ÐÀÇÂÈÒÈß ÎÒ 10 ÌÀß 2007 Ã.

N 836-ÏÐ/07 "ÎÁ ÓÒÂÅÐÆÄÅÍÈÈ ÔÎÐÌ ÄÎÊÓÌÅÍÒÎÂ, ÈÑÏÎËÜÇÓÅÌÛÕ

ÔÅÄÅÐÀËÜÍÎÉ ÑËÓÆÁÎÉ ÏÎ ÍÀÄÇÎÐÓ Â ÑÔÅÐÅ ÇÄÐÀÂÎÎÕÐÀÍÅÍÈß

È ÑÎÖÈÀËÜÍÎÃÎ ÐÀÇÂÈÒÈß Â ÏÐÎÖÅÑÑÅ ËÈÖÅÍÇÈÐÎÂÀÍÈß

ÔÀÐÌÀÖÅÂÒÈ×ÅÑÊÎÉ ÄÅßÒÅËÜÍÎÑÒÈ"

 

 öåëÿõ ïðèâåäåíèÿ íîðìàòèâíûõ ïðàâîâûõ àêòîâ Ôåäåðàëüíîé ñëóæáû ïî íàäçîðó â ñôåðå çäðàâîîõðàíåíèÿ è ñîöèàëüíîãî ðàçâèòèÿ â ñîîòâåòñòâèå ñ Ïîñòàíîâëåíèåì Ïðàâèòåëüñòâà Ðîññèéñêîé Ôåäåðàöèè îò 13 íîÿáðÿ 2010 ã. N 903 "Î âíåñåíèè èçìåíåíèé â Ïîëîæåíèå î ëèöåíçèðîâàíèè ôàðìàöåâòè÷åñêîé äåÿòåëüíîñòè" (Ñîáðàíèå çàêîíîäàòåëüñòâà Ðîññèéñêîé Ôåäåðàöèè, 2010, N 47, ñò. 6126), Ïðèêàçîì Ìèíèñòåðñòâà çäðàâîîõðàíåíèÿ è ñîöèàëüíîãî ðàçâèòèÿ Ðîññèéñêîé Ôåäåðàöèè îò 27 èþëÿ 2010 ã. N 553í "Îá óòâåðæäåíèè âèäîâ àïòå÷íûõ îðãàíèçàöèé" (çàðåãèñòðèðîâàí â Ìèíþñòå Ðîññèè 8 ñåíòÿáðÿ 2010 ã. N 18393) ïðèêàçûâàþ:

1. Âíåñòè â Ïðèêàç Ôåäåðàëüíîé ñëóæáû ïî íàäçîðó â ñôåðå çäðàâîîõðàíåíèÿ è ñîöèàëüíîãî ðàçâèòèÿ îò 10 ìàÿ 2007 ã. N 836-Ïð/07 "Îá óòâåðæäåíèè ôîðì äîêóìåíòîâ, èñïîëüçóåìûõ Ôåäåðàëüíîé ñëóæáîé ïî íàäçîðó â ñôåðå çäðàâîîõðàíåíèÿ è ñîöèàëüíîãî ðàçâèòèÿ â ïðîöåññå ëèöåíçèðîâàíèÿ ôàðìàöåâòè÷åñêîé äåÿòåëüíîñòè" (çàðåãèñòðèðîâàí â Ìèíþñòå Ðîññèè 20 àâãóñòà 2007 ã. N 10016), ñ èçìåíåíèÿìè, âíåñåííûìè Ïðèêàçîì Ôåäåðàëüíîé ñëóæáû ïî íàäçîðó â ñôåðå çäðàâîîõðàíåíèÿ è ñîöèàëüíîãî ðàçâèòèÿ îò 2 èþëÿ 2008 ã. N 5175-Ïð/08 (çàðåãèñòðèðîâàí â Ìèíþñòå Ðîññèè 18 èþëÿ 2008 ã. N 12010) è Ïðèêàçîì Ôåäåðàëüíîé ñëóæáû ïî íàäçîðó â ñôåðå çäðàâîîõðàíåíèÿ è ñîöèàëüíîãî ðàçâèòèÿ îò 22 íîÿáðÿ 2010 ã. N 10609-Ïð/10 (çàðåãèñòðèðîâàí â Ìèíþñòå Ðîññèè 17 äåêàáðÿ 2010 ã. N 19225), ñëåäóþùèå èçìåíåíèÿ:

 Ïðèëîæåíèè N 1:

1.1. Ïóíêò 6 Çàÿâëåíèÿ î ïðåäîñòàâëåíèè ëèöåíçèè (äëÿ þðèäè÷åñêîãî ëèöà èëè èíäèâèäóàëüíîãî ïðåäïðèíèìàòåëÿ) èçëîæèòü â ñëåäóþùåé ðåäàêöèè:

 

┌───┬───────────────────────┬───────────────┬────────────────────┐

│6. │Âèä îáîñîáëåííîãî      │Àäðåñà ìåñò    │Âèäû ðàáîò,        

   │îáúåêòà                │îñóùåñòâëåíèÿ  │îñóùåñòâëÿåìûå íà  

                          │äåÿòåëüíîñòè   │îáúåêòå            

                          │(ñ óêàçàíèåì                      

                          │ïî÷òîâîãî                         

                          │èíäåêñà)                          

├───┼───────────────────────┼───────────────┼────────────────────┤

   │1. Îðãàíèçàöèÿ îïòîâîé               │_____ <*> îïòîâàÿ  

   │òîðãîâëè ëåêàðñòâåííûìè               │òîðãîâëÿ           

   │ñðåäñòâàìè                            │ëåêàðñòâåííûìè     

                                         │ñðåäñòâàìè äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ñðåäñòâ äëÿ        

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │2. Àïòå÷íûå                                               

   │îðãàíèçàöèè:                                             

                                                            

   │2.1. Àïòåêà ãîòîâûõ                   │_____ <*> ðîçíè÷íàÿ │

   │ëåêàðñòâåííûõ ôîðì                    │òîðãîâëÿ           

                                         │ëåêàðñòâåííûìè     

                                         │ïðåïàðàòàìè äëÿ    

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │2.2. Àïòåêà                           │_____ <*> ðîçíè÷íàÿ │

   │ïðîèçâîäñòâåííàÿ                      │òîðãîâëÿ           

                                         │ëåêàðñòâåííûìè     

                                         │ïðåïàðàòàìè äëÿ    

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*>          

                                         │èçãîòîâëåíèå       

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │2.3. Àïòåêà                           │_____ <*> ðîçíè÷íàÿ │

   │ïðîèçâîäñòâåííàÿ ñ                    │òîðãîâëÿ           

   │ïðàâîì èçãîòîâëåíèÿ                   ëåêàðñòâåííûìè     

   àñåïòè÷åñêèõ                          │ïðåïàðàòàìè äëÿ    

   │ëåêàðñòâåííûõ                         │ìåäèöèíñêîãî       

   │ïðåïàðàòîâ                            │ïðèìåíåíèÿ         

                                         │_____ <*>          

                                         │èçãîòîâëåíèå       

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ, â òîì  

                                         │÷èñëå àñåïòè÷åñêèõ 

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │2.4. Àïòå÷íûé ïóíêò                   │_____ <*> ðîçíè÷íàÿ

                                         │òîðãîâëÿ           

                                         │ëåêàðñòâåííûìè     

                                         │ïðåïàðàòàìè äëÿ    

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ          

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │2.5. Àïòå÷íûé êèîñê                   │_____ <*> ðîçíè÷íàÿ

                                         │òîðãîâëÿ           

                                         │ëåêàðñòâåííûìè     

                                         │ïðåïàðàòàìè äëÿ    

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │______ <*> õðàíåíèå │

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │3. Ñòðóêòóðíûå                                            

   │ïîäðàçäåëåíèÿ                                            

   │ìåäèöèíñêèõ                                              

   │îðãàíèçàöèé:                                             

                                                             

   │3.1. Àïòåêà ãîòîâûõ                   │_____ <*> ðîçíè÷íàÿ │

   │ëåêàðñòâåííûõ ôîðì                    │òîðãîâëÿ           

                                         │ëåêàðñòâåííûìè     

                                         │ïðåïàðàòàìè äëÿ    

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │3.2. Àïòåêà                           │_____ <*> ðîçíè÷íàÿ │

   │ïðîèçâîäñòâåííàÿ                      │òîðãîâëÿ           

                                         │ëåêàðñòâåííûìè      

                                         │ïðåïàðàòàìè äëÿ    

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*>          

                                         │èçãîòîâëåíèå       

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │3.3. Àïòåêà                           │_____ <*> ðîçíè÷íàÿ │

   │ïðîèçâîäñòâåííàÿ ñ                    │òîðãîâëÿ           

   │ïðàâîì èçãîòîâëåíèÿ                   ëåêàðñòâåííûìè     

   àñåïòè÷åñêèõ                          │ïðåïàðàòàìè äëÿ    

   │ëåêàðñòâåííûõ                         │ìåäèöèíñêîãî       

   │ïðåïàðàòîâ                            │ïðèìåíåíèÿ         

                                         │_____ <*>          

                                         │èçãîòîâëåíèå       

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ, â òîì  

                                         │÷èñëå àñåïòè÷åñêèõ 

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │3.4. Àïòå÷íûé ïóíêò                   │_____ <*> ðîçíè÷íàÿ

                                         │òîðãîâëÿ           

                                         │ëåêàðñòâåííûìè     

                                         │ïðåïàðàòàìè äëÿ    

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │3.5. Àïòå÷íûé êèîñê                   │_____ <*> ðîçíè÷íàÿ

                                         │òîðãîâëÿ           

                                         │ëåêàðñòâåííûìè     

                                         │ïðåïàðàòàìè äëÿ    

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ          

                                                            

   │4. Îáîñîáëåííûå                                          

   │ïîäðàçäåëåíèÿ                                            

   │ìåäèöèíñêèõ                                               

   │îðãàíèçàöèé,                                             

   │ðàñïîëîæåííûå â                                          

   │ñåëüñêèõ ïîñåëåíèÿõ, â                                  

   │êîòîðûõ îòñóòñòâóþò                                      

   │àïòå÷íûå îðãàíèçàöèè:                                    

                                                            

   │4.1. Öåíòð (îòäåëåíèå) │               │_____ <*> ðîçíè÷íàÿ

   │îáùåé âðà÷åáíîé                       │òîðãîâëÿ           

   │(ñåìåéíîé) ïðàêòèêè                   ëåêàðñòâåííûìè     

                                         │ïðåïàðàòàìè äëÿ    

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │4.2. Àìáóëàòîðèÿ                      │_____ <*> ðîçíè÷íàÿ │

                                         │òîðãîâëÿ           

                                         │ëåêàðñòâåííûìè     

                                         │ïðåïàðàòàìè äëÿ    

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │4.3. Ôåëüäøåðñêèé ïóíêò│               │_____ <*> ðîçíè÷íàÿ

                                         │òîðãîâëÿ           

                                         │ëåêàðñòâåííûìè     

                                         │ïðåïàðàòàìè äëÿ    

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │4.4. Ôåëüäøåðñêî-                     │_____ <*> ðîçíè÷íàÿ │

   │àêóøåðñêèé ïóíêò                      │òîðãîâëÿ           

                                         │ëåêàðñòâåííûìè     

                                         │ïðåïàðàòàìè äëÿ    

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ          

                                                            

   │5. Èíäèâèäóàëüíûå                     │_____ <*> ðîçíè÷íàÿ │

   │ïðåäïðèíèìàòåëè                       │òîðãîâëÿ           

                                         │ëåêàðñòâåííûìè     

                                         │ïðåïàðàòàìè äëÿ    

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                         │_____ <*> õðàíåíèå 

                                         │ëåêàðñòâåííûõ      

                                         │ïðåïàðàòîâ äëÿ     

                                         │ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

                                                            

   │6. Èíûå îðãàíèçàöèè,                  │_____ <*> õðàíåíèå 

   │îñóùåñòâëÿþùèå                        │ëåêàðñòâåííûõ      

   │îáðàùåíèå ëåêàðñòâåííûõ│               │ïðåïàðàòîâ äëÿ     

   │ñðåäñòâ                               ìåäèöèíñêîãî       

                                         │ïðèìåíåíèÿ         

└───┴───────────────────────┴───────────────┴────────────────────┘

 

1.2. Ïóíêòû 4, 5, 6, 7 Îïèñè äîêóìåíòîâ èçëîæèòü â ñëåäóþùåé ðåäàêöèè:

"4. Êîïèè äîêóìåíòîâ, ïîäòâåðæäàþùèõ ïðàâî ñîáñòâåííîñòè èëè èíîå çàêîííîå îñíîâàíèå èñïîëüçîâàíèÿ ïîìåùåíèé äëÿ îñóùåñòâëåíèÿ ëèöåíçèðóåìîé äåÿòåëüíîñòè (çà èñêëþ÷åíèåì ìåäèöèíñêèõ îðãàíèçàöèé);

5. Êîïèè äîêóìåíòîâ, ïîäòâåðæäàþùèõ ïðàâî ñîáñòâåííîñòè èëè èíîå çàêîííîå îñíîâàíèå èñïîëüçîâàíèÿ îáîðóäîâàíèÿ äëÿ îñóùåñòâëåíèÿ ëèöåíçèðóåìîé äåÿòåëüíîñòè (çà èñêëþ÷åíèåì ìåäèöèíñêèõ îðãàíèçàöèé);

6. Êîïèÿ ñàíèòàðíî-ýïèäåìèîëîãè÷åñêîãî çàêëþ÷åíèÿ î ñîîòâåòñòâèè ïîìåùåíèé òðåáîâàíèÿì ñàíèòàðíûõ ïðàâèë (çà èñêëþ÷åíèåì ìåäèöèíñêèõ îðãàíèçàöèé), âûäàííîãî â óñòàíîâëåííîì ïîðÿäêå;

7. Êîïèè äîêóìåíòîâ î âûñøåì èëè ñðåäíåì ôàðìàöåâòè÷åñêîì îáðàçîâàíèè è ñåðòèôèêàòà ñïåöèàëèñòà - äëÿ îñóùåñòâëåíèÿ ôàðìàöåâòè÷åñêîé äåÿòåëüíîñòè â ñôåðå îáðàùåíèÿ ëåêàðñòâåííûõ ñðåäñòâ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ (çà èñêëþ÷åíèåì îáîñîáëåííûõ ïîäðàçäåëåíèé ìåäèöèíñêèõ îðãàíèçàöèé).

Êîïèÿ äîêóìåíòà î äîïîëíèòåëüíîì ïðîôåññèîíàëüíîì îáðàçîâàíèè â ÷àñòè ðîçíè÷íîé òîðãîâëè ëåêàðñòâåííûìè ïðåïàðàòàìè äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ - äëÿ îñóùåñòâëåíèÿ ôàðìàöåâòè÷åñêîé äåÿòåëüíîñòè â ñôåðå îáðàùåíèÿ ëåêàðñòâåííûõ ñðåäñòâ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ â îáîñîáëåííûõ ïîäðàçäåëåíèÿõ ìåäèöèíñêèõ îðãàíèçàöèé".

1.3. Îïèñü äîêóìåíòîâ äîïîëíèòü ñíîñêîé <**> ñëåäóþùåãî ñîäåðæàíèÿ:

"<**> Àáçàö âòîðîé ïóíêòà 7 Îïèñè äîêóìåíòîâ âñòóïàåò â ñèëó ñ 1 ñåíòÿáðÿ 2011 ã.".

1.4. Îïèñü äîêóìåíòîâ äîïîëíèòü ïóíêòîì 9 ñëåäóþùåãî ñîäåðæàíèÿ:

"9. Êîïèÿ ëèöåíçèè íà îñóùåñòâëåíèå ìåäèöèíñêîé äåÿòåëüíîñòè (äëÿ ìåäèöèíñêèõ îðãàíèçàöèé)".

2. Êîíòðîëü çà èñïîëíåíèåì íàñòîÿùåãî Ïðèêàçà îñòàâëÿþ çà ñîáîé.

 

Âðèî ðóêîâîäèòåëÿ

Å.À.ÒÅËÜÍÎÂÀ