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 ÊîäåêñûÒåõíè÷åñêîå ðåãóëèðîâàíèåÄîêóìåíòû Ïðàâèòåëüñòâà ÌîñêâûÃÒÊ ÐîññèèÐîñïàòåíòÃîññòðîé ÐîññèèÒåõíè÷åñêèå êîìèòåòûÊëàññèôèêàòîðûÃîñóäàðñòâåííûå ñòàíäàðòû ÐîññèèÃîññòàíäàðò ÐîññèèÃîñêîìýêîëîãèÿ ÐîññèèÃîñêîìñàíýïèäíàäçîð ÐîññèèÃîñãîðòåõíàäçîð ÐîññèèÌ×Ñ ÐîññèèÌèíýíåðãî ÐîññèèÌèíòðóä ÐîññèèÌèíòðàíñ ÐîññèèÂåòåðèíàðíî-ñàíèòàðíûå ïðàâèëàÌèíñåëüõîç ÐîññèèÌèíñâÿçè ÐîññèèÌÏÑ ÐîññèèÌÏÐ ÐîññèèÑàíÏèÍ, ÃÍ, ÌÓÊ, ÏÄÊ, ÎÁÓÂÌèíçäðàâ ÐîññèèÌÂÄ ÐîññèèÄîêóìåíòû ìåæäóíàðîäíûõ îðãàíèçàöèéÏðàâèëà è ïîðÿäêè ñåðòèôèêàöèè îäíîðîäíûõ âèäîâ ïðîäóêöèèÄîêóìåíòû Ñèñòåìû ñåðòèôèêàöèè ÃÎÑÒ ÐÎñíîâîïîëàãàþùèå äîêóìåíòû ïî ñåðòèôèêàöèèÄîêóìåíòû Ïðàâèòåëüñòâà Ðîññèéñêîé ÔåäåðàöèèÇàêîíû Ðîññèéñêîé ÔåäåðàöèèÓòðàòèëè ñèëó èëè îòìåíåíû |
+-------+ Îðãàí ïî ñåðòèôèêàöèè +¬ ¦ ¦ ¦ (ÎÑ) ¦+¬ ¦ ¦ +---------------------------+¦+-------¦ ¦ +---------------------------+¦ ¦ ¦ +---------------------------+ ¦ ¦ ¦ ¦ +---------------------------+ ¦ +-------+ Êîíòðîëüíàÿ +¬ ¦ ¦ ¦ (èñïûòàòåëüíàÿ) ¦++ ¦ ¦ ¦ ëàáîðàòîðèÿ ¦¦+-------+ ¦ +---------------------------+¦¦ ¦ ¦ +---------------------------+¦ ¦ ¦ +---------------------------+ ¦ ¦ ¦ ¦ +----------------------------+ ¦ ¦ ¦ Çàÿâèòåëü +¬ ¦ ¦ ¦ (îðãàíèçàöèÿ, ïðîèçâîäÿùàÿ ¦+¬ ¦ L------+ èëè ðåàëèçóþùàÿ ËÑ) ¦¦+-------+ +----------------------------+¦¦ +----------------------------+¦ +----------------------------+ Ïðèëîæåíèå 2 ê Ïîëîæåíèþ î Ñèñòåìå ñåðòèôèêàöèè ëåêàðñòâåííûõ ñðåäñòâ +----------------------------------------------------------------+ ¦ Ñèñòåìà ñåðòèôèêàöèè ÃÎÑÒ Ð ¦ ¦ ¦ ¦ Ìèíèñòåðñòâî çäðàâîîõðàíåíèÿ Ðîññèéñêîé Ôåäåðàöèè ¦ ¦ ¦ ¦ Óïðàâëåíèå Ãîñóäàðñòâåííîãî êîíòðîëÿ ¦ ¦ ëåêàðñòâåííûõ ñðåäñòâ è ìåäèöèíñêîé òåõíèêè ¦ ¦ ¦ ¦ ÑÅÐÒÈÔÈÊÀÒ ¦ ¦ ÑÎÎÒÂÅÒÑÒÂÈß ÏÐÎÈÇÂÎÄÑÒÂÀ ¦ ¦ ËÅÊÀÐÑÒÂÅÍÍÛÕ ÑÐÅÄÑÒ ¦ ¦ ¦ ¦ _____________________ ____________________ ¦ ¦ Ðåãèñòðàöèîííûé íîìåð Ó÷åòíûé íîìåð ¦ ¦ ñåðòèôèêàòà ñåðòèôèêàòà ¦ ¦ ¦ ¦ Äàòà âûäà÷è ____________________ ¦ ¦ ¦ ¦ ¦ ¦ Ìèíçäðàâ Ðîññèè ¦ ¦ íà îñíîâàíèè âûâîäîâ àêòà êîìèññèè ¦ ¦ óäîñòîâåðÿþò, ÷òî ïðåäïðèÿòèå ¦ ¦ ¦ ¦ âíåäðèëî è ïðèìåíÿåò â ïðîèçâîäñòâå ¦ ¦ ñèñòåìó êà÷åñòâà: ¦ +----------------------------------------------------------------¦ ¦ ñðîê äåéñòâèÿ ¦ ñåðòèôèêàò ¦ ñåðòèôèêàò ¦ ñåðòèôèêàò ¦ ¦ ñåðòèôèêàòà ¦ ïðîäëåí ¦ ïðîäëåí ¦ ïðîäëåí ¦ ¦äî "__" _______¦äî "__" _______¦äî "__" _______¦äî "__" ________¦ ¦ 19__ ã. ¦ 19__ ã. ¦ 19__ ã. ¦ 19__ ã. ¦ ¦ ÐÓÊÎÂÎÄÈÒÅËÜ ¦ ÐÓÊÎÂÎÄÈÒÅËÜ ¦ ÐÓÊÎÂÎÄÈÒÅËÜ ¦ ÐÓÊÎÂÎÄÈÒÅËÜ ¦ ¦ ÎÐÃÀÍÀ ¦ ÎÐÃÀÍÀ ¦ ÎÐÃÀÍÀ ¦ ÎÐÃÀÍÀ ¦ ¦ ÓÏÐÀÂËÅÍÈß ¦ ÓÏÐÀÂËÅÍÈß ¦ ÓÏÐÀÂËÅÍÈß ¦ ÓÏÐÀÂËÅÍÈß ¦ ¦ ___________ ¦ ___________ ¦ ___________ ¦ ___________ ¦ ¦ (ïîäïèñü) ¦ (ïîäïèñü) ¦ (ïîäïèñü) ¦ (ïîäïèñü) ¦ ¦ ¦ ¦ ¦ ¦ ¦ Ì.Ï. ¦ Ì.Ï. ¦ Ì.Ï. ¦ Ì.Ï. ¦ +----------------------------------------------------------------+ Ïðèëîæåíèå 3 ê Ïîëîæåíèþ î Ñèñòåìå ñåðòèôèêàöèè ëåêàðñòâåííûõ ñðåäñòâ +----------------------------------------------------------------+ ¦ Ñèñòåìà ñåðòèôèêàöèè ÃÎÑÒ Ð ¦ ¦ ¦ ¦ Ìèíèñòåðñòâî çäðàâîîõðàíåíèÿ Ðîññèéñêîé Ôåäåðàöèè ¦ ¦ ¦ ¦ Óïðàâëåíèå Ãîñóäàðñòâåííîãî êîíòðîëÿ ¦ ¦ ëåêàðñòâåííûõ ñðåäñòâ è ìåäèöèíñêîé òåõíèêè ¦ ¦ ¦ ¦ ÎÐÃÀÍ ÏÎ ÑÅÐÒÈÔÈÊÀÖÈÈ ¦ ¦ (ÍÀÇÂÀÍÈÅ) ¦ ¦ ¦ ¦ ÑÅÐÒÈÔÈÊÀÒ ÑÎÎÒÂÅÒÑÒÂÈß ¦ ¦ ¦ ¦ N _____ "__" __________ 199_ ã. ¦ ¦ ¦ ¦ Ñåðòèôèêàò ¦ ¦ âûäàí_________________________________________________________ ¦ ¦ (íàèìåíîâàíèå îðãàíèçàöèè, ôèðìû) ¦ ¦ Íàñòîÿùèé äîêóìåíò óäîñòîâåðÿåò, ÷òî ëåêàðñòâåííîå ñðåäñòâî __ ¦ ¦ ¦ ¦ ______________________________________________________________ ¦ ¦ (íàèìåíîâàíèå, ñåðèÿ) ¦ ¦ ïðîèçâîäñòâà _________________________________________________ ¦ ¦ (íàèìåíîâàíèå ïðåäïðèÿòèÿ - èçãîòîâèòåëÿ, ñòðàíà) ¦ ¦ Ñîîòâåòñòâóåò òðåáîâàíèÿì íîðìàòèâíîãî äîêóìåíòà __________ ¦ ¦ ______________________________________________________________ ¦ ¦ (îáîçíà÷åíèå äîêóìåíòà, ðåãèñòðàöèîííûé íîìåð) ¦ ¦ ¦ ¦ Îáëàñòü äåéñòâèÿ ñåðòèôèêàòà: ¦ ¦ Ñåðòèôèêàò âûäàí íà îñíîâàíèè ïðîòîêîëà àíàëèçà ______________ ¦ ¦ ______________________________________________________________ ¦ ¦ (íàçâàíèå àêêðåäèòîâàííîé ëàáîðàòîðèè (öåíòðà) êîíòðîëÿ, íîìåð ¦ ¦ ïðîòîêîëà àíàëèçà è äàòà åãî âûäà÷è) ¦ ¦ ¦ ¦ Ñðîê äåéñòâèÿ ñåðòèôèêàòà: äî "__" _____________ 199_ ã. ¦ ¦ ¦ ¦ Ðóêîâîäèòåëü îðãàíà ¦ ¦ ïî ñåðòèôèêàöèè ¦ ¦ ¦ ¦ Ì.Ï.__________________ ¦ ¦ (ïîäïèñü) ¦ ¦ Ýêñïåðò __________________ ¦ ¦ (ïîäïèñü) ¦ +----------------------------------------------------------------+ Ïðèëîæåíèå 4 ê Ïîëîæåíèþ î Ñèñòåìå ñåðòèôèêàöèè ëåêàðñòâåííûõ ñðåäñòâ +----------------------------------------------------------------------+ ¦ Ñèñòåìà ñåðòèôèêàöèè ÃÎÑÒ Ð ¦ ¦ ¦ ¦ Ìèíèñòåðñòâî çäðàâîîõðàíåíèÿ Ðîññèéñêîé Ôåäåðàöèè ¦ ¦ ¦ ¦ Óïðàâëåíèå Ãîñóäàðñòâåííîãî êîíòðîëÿ ¦ ¦ ëåêàðñòâåííûõ ñðåäñòâ è ìåäèöèíñêîé òåõíèêè ¦ ¦ ¦ ¦ ÀÒÒÅÑÒÀÖÈß ÀÊÊÐÅÄÈÒÀÖÈÈ ¦ ¦ ¦ ¦ ÎÐÃÀÍÀ ÏÎ ÑÅÐÒÈÔÈÊÀÖÈÈ ¦ ¦ (ÊÎÍÒÐÎËÜÍÎÉ ËÀÁÎÐÀÒÎÐÈÈ) ¦ ¦ ¦ ¦ Çàðåãèñòðèðîâàí â Ìèíçäðàâå Ðîññèè ¦ ¦ "__" ________________ 199_ ã. ¦ ¦ ÈÃÊ N _______________________ ¦ ¦ Äåéñòâèòåëåí äî "____"_____________199__ ã. ¦ ¦ ¦ ¦ Ìèíçäðàâ Ðîññèè óäîñòîâåðÿåò, ¦ ¦ ÷òî ______________________________________________________________ ¦ ¦ ____________________________________________________________________ ¦ ¦ íàèìåíîâàíèå îðãàíà ïî ñåðòèôèêàöèè (êîíòðîëüíîé ëàáîðàòîðèè), àäðåñ ¦ ¦ ¦ ¦ÑÎÎÒÂÅÒÑÒÂÓÅÒ ÒÐÅÁÎÂÀÍÈßÌ ÌÈÍÇÄÐÀÂÀ ÐÎÑÑÈÈ, ÏÐÅÄÚßÂËßÅÌÛÌ Ê ÎÐÃÀÍÀÌ ÏΦ ¦ÑÅÐÒÈÔÈÊÀÖÈÈ (ÊÎÍÒÐÎËÜÍÛÌ ËÀÁÎÐÀÒÎÐÈßÌ) È ÀÊÊÐÅÄÈÒÎÂÀÍ ÍÀ ÒÅÕÍÈ×ÅÑÊÓÞ¦ ¦ÊÎÌÏÅÒÅÍÒÍÎÑÒÜ. ¦ ¦ ¦ ¦Îáëàñòü àêêðåäèòàöèè ïðèâåäåíà â ïðèëîæåíèè ê àòòåñòàòó ¦ ¦ ¦ ¦ ¦ ¦Íà÷àëüíèê Óïðàâëåíèÿ ___________ ___________________ ¦ ¦ (ïîäïèñü) (èíèöèàëû, ôàìèëèÿ) ¦ ¦ ¦ ¦Ìåñòî ïå÷àòè ¦ +----------------------------------------------------------------------+ Ïðèëîæåíèå 5 ê Ïîëîæåíèþ î Ñèñòåìå ñåðòèôèêàöèè ëåêàðñòâåííûõ ñðåäñòâ ÇÍÀÊ ÑÎÎÒÂÅÒÑÒÂÈß ÑÈÑÒÅÌÛ ÑÅÐÒÈÔÈÊÀÖÈÈ ËÅÊÀÐÑÒÂÅÍÍÛÕ ÑÐÅÄÑÒ <*> -------------------------------- <*> Íå ïðèâîäèòñÿ. ÏÅÐÅ×ÅÍÜ ÑÅÐÒÈÔÈÖÈÐÓÅÌÛÕ ËÅÊÀÐÑÒÂÅÍÍÛÕ ÑÐÅÄÑÒ (ÏÎ ÎÑÍÎÂÍÛÌ ÃÐÓÏÏÀÌ) +----------------------------------------------------------------+ ¦ Ëåêàðñòâåííûå ñðåäñòâà ¦ Íîðìàòèâíûå äîêóìåíòû ¦ +---------------------------------------+------------------------¦ ¦ 1 ¦ 2 ¦ +---------------------------------------+------------------------¦ ¦1. Ëåêàðñòâåííûå ñðåäñòâà, äåéñòâóþùèå¦Ãîñóäàðñòâåííàÿ ¦ ¦ïðåèìóùåñòâåííî íà öåíòðàëüíóþ íåðâíóþ¦ôàðìàêîïåÿ; ¦ ¦ñèñòåìó: ¦Ôàðìàêîïåè ¦ ¦- ñðåäñòâà äëÿ íàðêîçà; ¦çàðóáåæíûõ ñòðàí; ¦ Ïåðåéòè íà ñòð.1Ïåðåéòè íà ñòð.2ñòð.3Ïåðåéòè íà ñòð.4 |