Az\u0259rbaycanda d\u0259rman vasit\u0259l\u0259rinin \u0259lav\u0259 t\u0259sirl\u0259rinin izl\u0259nm\u0259si, qeydiyyata al\u0131nmas\u0131, qiym\u0259tl\u0259ndirilm\u0259si, m\u00fcvafiq t\u0259dqiqatlar\u0131n apar\u0131lmas\u0131 v\u0259 bu sah\u0259d\u0259 z\u0259ruri t\u0259dbirl\u0259rin g\u00f6r\u00fclm\u0259sin\u0259 dair icra mexanizml\u0259ri m\u00fc\u0259yy\u0259nl\u0259\u015fib.<\/p>\n
Bu, Nazirl\u0259r Kabinetinin t\u0259sdiql\u0259diyi “D\u0259rman vasit\u0259l\u0259rinin farmakon\u0259zar\u0259t Qaydas\u0131”nda \u0259ksini tap\u0131b.<\/p>\n
Bu Qayda 1 yanvar 2020-ci ild\u0259n q\u00fcvv\u0259y\u0259 minir. Bu Qayda m\u00fclkiyy\u0259t v\u0259 t\u0259\u015fkilati h\u00fcquqi formas\u0131ndan as\u0131l\u0131 olmayaraq b\u00fct\u00fcn m\u00fcalic\u0259-profilaktika m\u00fc\u0259ssis\u0259l\u0259ri, d\u0259rman vasit\u0259sinin d\u00f6vl\u0259t qeydiyyat\u0131 haqq\u0131nda v\u0259siq\u0259nin sahibi v\u0259 onun m\u00fcv\u0259kkil etdiyi \u015f\u0259xsl\u0259r\u0259 \u015famil olunur. Farmakon\u0259zar\u0259t d\u0259rman vasit\u0259l\u0259rinin istifad\u0259si zaman\u0131 yaranan \u0259lav\u0259 t\u0259sirl\u0259rin v\u0259 dig\u0259r arzuolunmaz n\u0259tic\u0259l\u0259rin, d\u0259rman vasit\u0259sinin s\u0259hv istifad\u0259si il\u0259 ba\u011fl\u0131 x\u0259tan\u0131n, kontrafakt v\u0259 effektivliyini, keyfiyy\u0259tini v\u0259 t\u0259hl\u00fck\u0259sizliyini m\u00fc\u0259yy\u0259n etm\u0259k m\u00fcmk\u00fcn olmayan (substandart) d\u0259rman vasit\u0259l\u0259rinin, d\u0259rman vasit\u0259sinin effektivliyinin, d\u0259rman vasit\u0259sind\u0259n sui-istifad\u0259 hallar\u0131n\u0131n v\u0259 d\u0259rman vasit\u0259l\u0259rinin qar\u015f\u0131l\u0131ql\u0131 t\u0259sirinin m\u00fc\u0259yy\u0259n edilm\u0259sini \u0259hat\u0259 edir. Farmakon\u0259zar\u0259t d\u00f6vl\u0259t qeydiyyat\u0131na al\u0131nm\u0131\u015f v\u0259 d\u00f6vl\u0259t qeydiyyat\u0131na al\u0131nmas\u0131 \u00fc\u00e7\u00fcn m\u00fcraci\u0259t edilmi\u015f d\u0259rman vasit\u0259l\u0259rin\u0259, \u00dcmumd\u00fcnya S\u0259hiyy\u0259 T\u0259\u015fkilat\u0131n\u0131n m\u00fcvafiq t\u0259sdiqedici s\u0259n\u0259di il\u0259 istifad\u0259si t\u00f6vsiy\u0259 olunan d\u0259rman vasit\u0259l\u0259rin\u0259, nadir hallarda rast g\u0259lin\u0259n v\u0259 spesifik m\u00fcalic\u0259 t\u0259l\u0259b ed\u0259n x\u0259st\u0259likl\u0259rin m\u00fcalic\u0259si \u00fc\u00e7\u00fcn n\u0259z\u0259rd\u0259 tutulan d\u0259rman vasit\u0259l\u0259rin\u0259, h\u0259m\u00e7inin bitki t\u0259rkibli d\u0259rman vasit\u0259l\u0259rin\u0259, \u0259n\u0259n\u0259vi d\u0259rman vasit\u0259l\u0259rin\u0259, bioloji d\u0259rman vasit\u0259l\u0259rin\u0259, vaksinl\u0259r\u0259, qan preparatlar\u0131na v\u0259 y\u00fcks\u0259k risk qrupuna daxil olan tibb vasit\u0259l\u0259rin\u0259 (invaziv tibb vasit\u0259l\u0259rin\u0259) \u015famil edilir. Farmakon\u0259zar\u0259t Etibarl\u0131 Farmakon\u0259zar\u0259t T\u0259cr\u00fcb\u0259sinin t\u0259l\u0259bl\u0259rin\u0259 uy\u011fun olaraq h\u0259yata ke\u00e7irilir. Etibarl\u0131 Farmakon\u0259zar\u0259t T\u0259cr\u00fcb\u0259si farmakon\u0259zar\u0259t \u00fczr\u0259 f\u0259aliyy\u0259tin h\u0259yata ke\u00e7irilm\u0259sin\u0259 dair S\u0259hiyy\u0259 Nazirliyinin t\u0259limat\u0131d\u0131r.<\/p>\n
Farmakon\u0259zar\u0259t \u00fczr\u0259 m\u0259sul \u015f\u0259xs m\u00fcalic\u0259-profilaktika m\u00fc\u0259ssis\u0259si, d\u0259rman vasit\u0259sinin d\u00f6vl\u0259t qeydiyyat\u0131 haqq\u0131nda v\u0259siq\u0259nin sahibi\u00a0 v\u0259 farmakon\u0259zar\u0259t \u00fczr\u0259 t\u0259dbirl\u0259ri h\u0259yata ke\u00e7ir\u0259n t\u0259\u015fkilat t\u0259r\u0259find\u0259n farmakon\u0259zar\u0259tl\u0259 ba\u011fl\u0131 bu Qayda il\u0259 m\u00fc\u0259yy\u0259n edilmi\u015f\u00a0 t\u0259dbirl\u0259ri h\u0259yata ke\u00e7irm\u0259k m\u0259qs\u0259dil\u0259 \u018fm\u0259k M\u0259c\u0259ll\u0259sin\u0259 uy\u011fun olaraq i\u015f\u0259 q\u0259bul edil\u0259n, \u0259sas (baza ali) tibb t\u0259hsilin\u0259 malik \u015f\u0259xsl\u0259rdir. Farmakon\u0259zar\u0259t sistemi is\u0259 v\u0259siq\u0259 sahibi v\u0259 S\u0259hiyy\u0259 Nazirliyinin “Analitik Ekspertiza M\u0259rk\u0259zi” M\u0259hdud M\u0259suliyy\u0259tli C\u0259miyy\u0259ti (qurum) t\u0259r\u0259find\u0259n bu Qaydada g\u00f6st\u0259ril\u0259n f\u0259aliyy\u0259tin h\u0259yata ke\u00e7irilm\u0259sind\u0259 istifad\u0259 edil\u0259n v\u0259 d\u0259rman vasit\u0259l\u0259rinin t\u0259hl\u00fck\u0259sizliyin\u0259 n\u0259zar\u0259t ed\u0259r\u0259k, fayda-risk nisb\u0259tind\u0259 ola bil\u0259c\u0259k b\u00fct\u00fcn d\u0259yi\u015fiklikl\u0259ri m\u00fc\u0259yy\u0259n etm\u0259k \u00fc\u00e7\u00fcn qurulmu\u015f sistemdir. Qurum x\u00fcsusi n\u0259zar\u0259td\u0259 olan d\u0259rman vasit\u0259l\u0259rinin siyah\u0131s\u0131n\u0131 haz\u0131rlay\u0131r v\u0259 t\u0259sdiql\u0259nm\u0259si \u00fc\u00e7\u00fcn Nazirliy\u0259 t\u0259qdim edir. T\u0259sdiql\u0259nmi\u015f x\u00fcsusi n\u0259zar\u0259td\u0259 olan d\u0259rman vasit\u0259l\u0259rinin siyah\u0131s\u0131nda olan d\u0259rman vasit\u0259l\u0259rinin t\u0259hl\u00fck\u0259sizliyin\u0259 Qurum n\u0259zar\u0259t edir. Qurum K\u0130V-d\u0259n istifad\u0259 ed\u0259r\u0259k insan sa\u011flaml\u0131\u011f\u0131 \u00fc\u00e7\u00fcn t\u0259hl\u00fck\u0259li d\u0259rman vasit\u0259l\u0259ri haqq\u0131nda ictimaiyy\u0259ti m\u0259lumatland\u0131r\u0131r, d\u0259rman t\u0259hl\u00fck\u0259sizliyi il\u0259 \u0259laq\u0259dar m\u0259lumatlar\u0131 v\u0259 tibb i\u015f\u00e7isini m\u0259lumatland\u0131rma m\u0259ktublar\u0131n\u0131 \u00f6z internet s\u0259hif\u0259sind\u0259 d\u0259rc edir. M\u00fclkiyy\u0259t v\u0259 t\u0259\u015fkilati h\u00fcquqi formas\u0131ndan as\u0131l\u0131 olmayaraq b\u00fct\u00fcn m\u00fcalic\u0259-profilaktika m\u00fc\u0259ssis\u0259l\u0259ri, d\u0259rman vasit\u0259sinin v\u0259siq\u0259 sahibi v\u0259 ya onun m\u00fcv\u0259kkil etdiyi \u015f\u0259xs d\u0259rman vasit\u0259l\u0259rinin t\u0259hl\u00fck\u0259siz istifad\u0259sinin t\u0259min edilm\u0259si \u00fc\u00e7\u00fcn bu Qaydaya v\u0259 Etibarl\u0131 Farmakon\u0259zar\u0259t T\u0259cr\u00fcb\u0259sinin t\u0259l\u0259bl\u0259rin\u0259 uy\u011fun olaraq farmakon\u0259zar\u0259t \u00fczr\u0259 t\u0259dbirl\u0259r g\u00f6r\u00fcr, o c\u00fcml\u0259d\u0259n farmakon\u0259zar\u0259t \u00fczr\u0259 m\u0259sul \u015f\u0259xs m\u00fc\u0259yy\u0259n edirl\u0259r. M\u00fcalic\u0259-profilaktika m\u00fc\u0259ssis\u0259l\u0259rinin farmakon\u0259zar\u0259t \u00fczr\u0259 m\u0259sul \u015f\u0259xsl\u0259ri, v\u0259siq\u0259 sahibi v\u0259 ya onun m\u00fcv\u0259kkil etdiyi \u015f\u0259xs d\u0259rman vasit\u0259l\u0259rinin istifad\u0259si zaman\u0131 yaranan \u0259lav\u0259 t\u0259sirl\u0259ri v\u0259 dig\u0259r arzuolunmaz n\u0259tic\u0259l\u0259r bar\u0259d\u0259 m\u0259lumatlar\u0131, h\u0259m\u00e7inin farmako-n\u0259zar\u0259t \u00fczr\u0259 m\u0259lumatlar\u0131 v\u0259 hesabat s\u0259n\u0259dl\u0259rini Quruma t\u0259qdim etm\u0259lidirl\u0259r. Farmakon\u0259zar\u0259t \u00fczr\u0259 m\u0259lumat v\u0259 hesabat s\u0259n\u0259dl\u0259ri (R\u0130P, DYTH, FS\u018fD) Az\u0259rbaycan, rus v\u0259 ya ingilis dill\u0259rind\u0259n birind\u0259\u00a0 ka\u011f\u0131z v\u0259 ya “Elektron imza v\u0259 elektron s\u0259n\u0259d haqq\u0131nda” qanununa uy\u011fun olaraq elektron s\u0259n\u0259d formas\u0131nda t\u0259qdim edilm\u0259lidir.<\/p>\n
Farmakon\u0259zar\u0259tin h\u0259yata ke\u00e7irilm\u0259si il\u0259 ba\u011fl\u0131 v\u0259siq\u0259 sahibi a\u015fa\u011f\u0131dak\u0131 v\u0259zif\u0259l\u0259ri yerin\u0259 yetirir:<\/p>\n
– d\u0259rman vasit\u0259l\u0259rinin t\u0259hl\u00fck\u0259sizliyinin davaml\u0131 monitorinqini apar\u0131r, d\u0259rman vasit\u0259sinin qeydiyyatda oldu\u011fu dig\u0259r \u00f6lk\u0259l\u0259rin s\u0259lahiyy\u0259tli orqanlar\u0131 t\u0259r\u0259find\u0259n qoyulmu\u015f qada\u011fa v\u0259 m\u0259hdudiyy\u0259tl\u0259r d\u0259 daxil olmaqla, d\u0259rman vasit\u0259sinin fayda-risk nisb\u0259tinin qiym\u0259tl\u0259n-dirilm\u0259sin\u0259 t\u0259sir ed\u0259 bil\u0259c\u0259k b\u00fct\u00fcn n\u00f6v d\u0259yi\u015fiklikl\u0259r bar\u0259d\u0259 Qurumu m\u0259lumatland\u0131r\u0131r v\u0259 d\u0259rman vasit\u0259si haqq\u0131nda olan m\u0259lumatlar\u0131n m\u00f6vcud elmi m\u0259lumatlar \u0259sas\u0131nda yenil\u0259nm\u0259sini t\u0259min edir;<\/p>\n
– farmakon\u0259zar\u0259t sistemini qurur v\u0259 bu sistem vasit\u0259sil\u0259 \u0259ld\u0259 etdiyi m\u0259lumatlar\u0131 qiym\u0259tl\u0259ndir\u0259r\u0259k riski minimalla\u015fd\u0131rmaq v\u0259 ya qar\u015f\u0131s\u0131n\u0131 almaq \u00fc\u00e7\u00fcn t\u0259dbirl\u0259r g\u00f6r\u00fcr;<\/p>\n
– d\u0259rman vasit\u0259l\u0259rinin yaratd\u0131\u011f\u0131 \u0259lav\u0259 t\u0259sirl\u0259ri t\u0259snifatla\u015f-d\u0131rark\u0259n MedDRA (Beyn\u0259lxalq Harmonizasiya Konfrans\u0131 (ICH) t\u0259r\u0259find\u0259n haz\u0131rlanan t\u0259nziml\u0259yici f\u0259aliyy\u0259tl\u0259r \u00fc\u00e7\u00fcn tibb l\u00fc\u011f\u0259ti) terminologiyas\u0131ndan istifad\u0259 edir;<\/p>\n
– farmakon\u0259zar\u0259t sistemind\u0259 sistemli audit apar\u0131r, onun n\u0259tic\u0259l\u0259rini farmakon\u0259zar\u0259t sisteminin \u0259sas dosyesin\u0259 qeyd kimi \u0259lav\u0259 edir v\u0259 h\u0259min n\u0259tic\u0259l\u0259r \u0259sas\u0131nda m\u00f6vcud probleml\u0259rin aradan qald\u0131r\u0131lmas\u0131na istiqam\u0259tl\u0259nmi\u015f f\u0259aliyy\u0259t plan\u0131n\u0131n haz\u0131rlanmas\u0131n\u0131 v\u0259 t\u0259tbiqini t\u0259min edir;<\/p>\n
– farmakon\u0259zar\u0259t \u00fczr\u0259 m\u0259sul \u015f\u0259xs v\u0259 onun m\u00fcavinini i\u015f\u0259 q\u0259bul edir.<\/p>\n
– Farmakon\u0259zar\u0259t \u00fczr\u0259 m\u0259sul \u015f\u0259xs v\u0259 onun m\u00fcavini bar\u0259d\u0259 m\u0259lumatlar\u0131 (ad\u0131, soyad\u0131, atas\u0131n\u0131n ad\u0131, t\u0259hsili v\u0259 i\u015f t\u0259cr\u00fcb\u0259si), o c\u00fcml\u0259d\u0259n \u0259laq\u0259 m\u0259lumatlar\u0131n\u0131 (\u00fcnvan, telefon, faks v\u0259 elekton po\u00e7t) v\u0259zif\u0259y\u0259 t\u0259yin olunduqlar\u0131 tarixd\u0259n etibar\u0259n \u0259n geci 7\u00a0 i\u015f g\u00fcn\u00fc m\u00fcdd\u0259tind\u0259 Quruma bildirir;<\/p>\n
– farmakon\u0259zar\u0259t \u00fczr\u0259 m\u0259sul \u015f\u0259xs v\u0259 onun m\u00fcavini d\u0259yi\u015fdirildiyi halda onlar\u0131n yerin\u0259 \u0259n geci 3 (y m\u00fcdd\u0259tind\u0259 yenil\u0259rini t\u0259yin edir v\u0259 Quruma m\u0259lumat verir;<\/p>\n
– farmakon\u0259zar\u0259t \u00fczr\u0259 m\u0259sul \u015f\u0259xs v\u0259 onun m\u00fcavininin Qurumun t\u0259\u015fkil etdiyi farmakon\u0259zar\u0259t m\u00f6vzusunda \u0259sas t\u0259lim proqram\u0131nda i\u015ftirak\u0131n\u0131 t\u0259min edir v\u0259 h\u0259min \u015f\u0259xsl\u0259rin farmakon\u0259zar\u0259t \u00fczr\u0259 dig\u0259r t\u0259liml\u0259rd\u0259 i\u015ftirak\u0131na d\u0259st\u0259k olur;<\/p>\n
– farmakon\u0259zar\u0259t sisteminin \u0259sas dosyesini haz\u0131rlay\u0131r v\u0259 Quruma t\u0259qdim edir;<\/p>\n
– risk idar\u0259etm\u0259 sistemini d\u0259rman vasit\u0259sil\u0259 ba\u011fl\u0131 m\u00f6vcud v\u0259 potensial riskl\u0259r\u0259, h\u0259m\u00e7inin qeydiyyatdan sonrak\u0131 t\u0259hl\u00fck\u0259sizlik m\u0259lumatlar\u0131n\u0131n t\u0259l\u0259bin\u0259 uy\u011fun haz\u0131rlay\u0131r v\u0259 yenil\u0259yir, yeni riskl\u0259rin olub-olmamas\u0131n\u0131, riskl\u0259rin d\u0259yi\u015fib-d\u0259yi\u015fm\u0259diyini v\u0259 ya d\u0259rman vasit\u0259sinin fayda-risk nisb\u0259tind\u0259 h\u0259r hans\u0131 bir d\u0259yi\u015fiklik olub-olmamas\u0131n\u0131 m\u00fc\u0259yy\u0259n etm\u0259k \u00fc\u00e7\u00fcn farmakon\u0259zar\u0259t m\u0259lumatlar\u0131n\u0131n monitorinqini apar\u0131r v\u0259 d\u0259yi\u015fiklik m\u00fc\u0259yy\u0259n edildikd\u0259 Qurumu m\u0259lumatland\u0131r\u0131r;<\/p>\n
– risk idar\u0259etm\u0259 plan\u0131na \u0259sas\u0259n g\u00f6r\u00fcl\u0259n t\u0259dbirl\u0259rin n\u0259tic\u0259l\u0259rin\u0259 n\u0259zar\u0259t edir;<\/p>\n
– \u0259m\u0259kda\u015flar\u0131n\u0131n farmakon\u0259zar\u0259t \u00fczr\u0259 t\u0259liml\u0259rd\u0259 i\u015ftirak\u0131n\u0131 t\u0259min edir v\u0259 t\u0259liml\u0259rin qeydiyyat\u0131n\u0131 apar\u0131r;<\/p>\n
– tibb v\u0259 \u0259cza\u00e7\u0131l\u0131q i\u015f\u00e7il\u0259ri, habel\u0259 istehlak\u00e7\u0131lar t\u0259r\u0259find\u0259n d\u0259rman vasit\u0259sinin \u0259lav\u0259 t\u0259sirl\u0259ri bar\u0259d\u0259 veril\u0259n m\u0259lumatlar\u0131n Quruma bildirilm\u0259si \u00fc\u00e7\u00fcn Etibarl\u0131 Farmakon\u0259zar\u0259t T\u0259cr\u00fcb\u0259sind\u0259 g\u00f6st\u0259ril\u0259n standart m\u0259tni d\u0259rman vasit\u0259sinin istifad\u0259 t\u0259limat\u0131na \u0259lav\u0259 edir;<\/p>\n
– x\u00fcsusi n\u0259zar\u0259td\u0259 olan d\u0259rman vasit\u0259l\u0259rin\u0259 dair Etibarl\u0131 Farmakon\u0259zar\u0259t T\u0259cr\u00fcb\u0259sind\u0259 g\u00f6st\u0259ril\u0259n t\u0259dbirl\u0259ri g\u00f6r\u00fcr;<\/p>\n
– d\u0259rman vasit\u0259sinin t\u0259hl\u00fck\u0259sizliyi il\u0259 ba\u011fl\u0131 probleml\u0259r a\u015fkar edildikd\u0259, h\u0259min d\u0259rman vasit\u0259sinin sat\u0131\u015f\u0131n\u0131n m\u00fcv\u0259qq\u0259ti dayand\u0131r\u0131lmas\u0131 v\u0259 ya qeydiyyata al\u0131nmas\u0131ndan imtina edilm\u0259si v\u0259 ya bu Qaydada n\u0259z\u0259rd\u0259 tutulmu\u015f dig\u0259r t\u0259dbirl\u0259ri\u00a0 planla\u015fd\u0131rd\u0131qda, d\u0259rhal Quruma bildirir;<\/p>\n
– Qurumun bu Qaydada n\u0259z\u0259rd\u0259 tutulmu\u015f t\u0259l\u0259bl\u0259rini vaxt\u0131nda v\u0259\u00a0 tam olaraq icra edir.<\/p>\n
armakon\u0259zar\u0259t sistemi bir ne\u00e7\u0259 v\u0259siq\u0259 sahibi t\u0259r\u0259find\u0259n birg\u0259 qurulduqda, onlar\u0131n farmakon\u0259zar\u0259t \u00fczr\u0259 vahid m\u0259sul \u015f\u0259xs t\u0259yin etm\u0259k h\u00fcququ var. V\u0259siq\u0259 sahibinin farmakon\u0259zar\u0259t \u00fczr\u0259 t\u0259dbirl\u0259ri farmako-n\u0259zar\u0259t \u00fczr\u0259 m\u0259sul \u015f\u0259xs t\u0259yin etm\u0259d\u0259n, t\u0259\u015fkilat vasit\u0259sil\u0259 h\u0259yata ke\u00e7irm\u0259k h\u00fcququ var. Farmakon\u0259zar\u0259tl\u0259 \u0259laq\u0259dar t\u0259dbirl\u0259rin t\u0259\u015fkilat vasit\u0259sil\u0259 qism\u0259n h\u0259yata ke\u00e7irildiyi hallarda v\u0259siq\u0259 sahibi t\u0259r\u0259find\u0259n farmakon\u0259zar\u0259t \u00fczr\u0259 m\u0259sul \u015f\u0259xsin t\u0259yin edilm\u0259si m\u0259cburidir. Farmakon\u0259zar\u0259t \u00fczr\u0259 m\u0259sul \u015f\u0259xsin v\u0259 onun m\u00fcavininin \u00f6z v\u0259zif\u0259l\u0259rini yerin\u0259 yetir\u0259rk\u0259n marketinq v\u0259 sat\u0131\u015f \u015f\u00f6b\u0259l\u0259rind\u0259 v\u0259zif\u0259 tutmas\u0131na yol verilmir.<\/p>\n
Pasiyentl\u0259rd\u0259 d\u0259rman vasit\u0259sinin istifad\u0259si il\u0259 \u0259laq\u0259dar yaranan \u0259lav\u0259 t\u0259sirl\u0259rin v\u0259 dig\u0259r arzuolunmaz hallar\u0131n Quruma spontan bildiri\u015fi h\u0259min hallar\u0131 m\u00fc\u015fahid\u0259 ed\u0259n tibb v\u0259 \u0259cza\u00e7\u0131l\u0131q i\u015f\u00e7isi t\u0259r\u0259find\u0259n h\u0259yata ke\u00e7irilir. Farmakon\u0259zar\u0259tin h\u0259yata ke\u00e7irilm\u0259si il\u0259 ba\u011fl\u0131 m\u00fcalic\u0259-profilaktika m\u00fc\u0259ssis\u0259l\u0259rinin v\u0259zif\u0259l\u0259ri a\u015fa\u011f\u0131dak\u0131lard\u0131r:<\/p>\n
– m\u00fc\u0259ssis\u0259daxili farmakon\u0259zar\u0259t sistemini qurmaq v\u0259 bu Qaydaya \u0259sas\u0259n f\u0259aliyy\u0259t g\u00f6st\u0259rm\u0259k;<\/p>\n
– m\u00fcalic\u0259-profilaktika m\u00fc\u0259ssis\u0259sinin farmakon\u0259zar\u0259t \u00fczr\u0259 m\u0259sul \u015f\u0259xsini t\u0259yin etm\u0259k v\u0259 onun bar\u0259sind\u0259 m\u0259lumatlar\u0131 Quruma bildirm\u0259k;<\/p>\n
– m\u00fcalic\u0259-profilaktika m\u00fc\u0259ssis\u0259sinin farmakon\u0259zar\u0259t \u00fczr\u0259 m\u0259sul \u015f\u0259xsinin farmakon\u0259zar\u0259t m\u00f6vzusunda Qurumun t\u0259\u015fkil etdiyi \u0259sas t\u0259lim proqram\u0131nda i\u015ftirak\u0131n\u0131 t\u0259min etm\u0259k v\u0259 h\u0259min \u015f\u0259xsin farmakon\u0259zar\u0259t \u00fczr\u0259 dig\u0259r t\u0259liml\u0259rd\u0259 i\u015ftirak\u0131na d\u0259st\u0259k olmaq;<\/p>\n
– farmakon\u0259zar\u0259tin h\u0259yata ke\u00e7irilm\u0259si il\u0259 ba\u011fl\u0131 Qurumun bu Qayda il\u0259 m\u00fc\u0259yy\u0259n edil\u0259n t\u0259l\u0259bl\u0259rini vaxt\u0131nda v\u0259 tam icra etm\u0259k.<\/p>\n
Farmakon\u0259zar\u0259tin h\u0259yata ke\u00e7irilm\u0259si il\u0259 ba\u011fl\u0131 Qurum a\u015fa\u011f\u0131dak\u0131 v\u0259zif\u0259l\u0259ri yerin\u0259 yetirir:<\/p>\n
– vahid farmakon\u0259zar\u0259t sistemini yarad\u0131r v\u0259 m\u00fcasir elmi texniki t\u0259r\u0259qqinin inki\u015faf\u0131na uy\u011fun t\u0259kmill\u0259\u015fdirir, habel\u0259 h\u0259min sistemd\u0259n d\u0259rman vasit\u0259l\u0259ri il\u0259 \u0259laq\u0259dar riskl\u0259r\u0259 dair m\u0259lumatlar\u0131 toplamaq \u00fc\u00e7\u00fcn istifad\u0259 edir;<\/p>\n
– farmakon\u0259zar\u0259t s\u0259n\u0259dl\u0259rinin (R\u0130P, DYTH, FS\u018fD) ekspertizas\u0131n\u0131 h\u0259yata ke\u00e7irir;<\/p>\n
– tibb v\u0259 \u0259cza\u00e7\u0131l\u0131q i\u015f\u00e7il\u0259rini, habel\u0259 istehlak\u00e7\u0131lar\u0131 d\u0259rman vasit\u0259l\u0259rinin \u0259lav\u0259 t\u0259sirl\u0259ri bar\u0259d\u0259 m\u0259lumatlar\u0131 Quruma bildirm\u0259l\u0259ri istiqam\u0259tind\u0259 maarifl\u0259ndirir;<\/p>\n
– d\u0259rman vasit\u0259l\u0259rinin t\u0259hl\u00fck\u0259siz istifad\u0259sinin t\u0259min edilm\u0259si m\u0259qs\u0259dil\u0259 onlar\u0131n\u00a0 istifad\u0259si zaman\u0131 yaranan \u0259lav\u0259 t\u0259sirl\u0259ri v\u0259 dig\u0259r arzuolunmaz n\u0259tic\u0259l\u0259ri, fayda-risk nisb\u0259tini sistemli olaraq izl\u0259yir, qeydiyyata al\u0131r, qiym\u0259tl\u0259ndirir, arxivl\u0259\u015fdirir, habel\u0259 bu m\u0259lumatlar\u0131 \u00dcmumd\u00fcnya S\u0259hiyy\u0259 T\u0259\u015fkilat\u0131n\u0131n D\u0259rman Vasit\u0259l\u0259rinin Monitorinqi M\u0259rk\u0259zin\u0259 g\u00f6nd\u0259rir;<\/p>\n
– d\u0259rman vasit\u0259l\u0259rinin ciddi \u0259lav\u0259 t\u0259sirl\u0259ri il\u0259 \u0259laq\u0259dar bildiri\u015fi ald\u0131qdan sonra 15 g\u00fcn m\u00fcdd\u0259tind\u0259 v\u0259siq\u0259 sahibin\u0259\u00a0 g\u00f6nd\u0259rir;<\/p>\n
– d\u0259rman vasit\u0259sinin t\u0259hl\u00fck\u0259siz istifad\u0259sini t\u0259min etm\u0259k m\u0259qs\u0259dil\u0259 tibb v\u0259 \u0259cza\u00e7\u0131l\u0131q i\u015f\u00e7il\u0259ri t\u0259r\u0259find\u0259n bu Qaydada n\u0259z\u0259rd\u0259 tutulan v\u0259zif\u0259l\u0259rin yerin\u0259 yetirilm\u0259sini t\u0259l\u0259b\u00a0 edir;<\/p>\n
– q\u0259bul etdiyi q\u0259rarlar bar\u0259d\u0259 v\u0259siq\u0259 sahibini x\u0259b\u0259rdar edir v\u0259 \u00dcmumd\u00fcnya S\u0259hiyy\u0259 T\u0259\u015fkilat\u0131n\u0131n D\u0259rman Vasit\u0259l\u0259rinin Monitorinqi M\u0259rk\u0259zin\u0259 g\u00f6rd\u00fcy\u00fc t\u0259dbir bar\u0259d\u0259 m\u0259lumat verir;<\/p>\n
– farmakon\u0259zar\u0259t m\u00f6vzusunda \u0259sas t\u0259lim proqramlar\u0131n\u0131 t\u0259\u015fkil edir;<\/p>\n
– x\u00fcsusi n\u0259zar\u0259td\u0259 olan d\u0259rman vasit\u0259l\u0259rinin siyah\u0131s\u0131n\u0131 haz\u0131rlay\u0131r v\u0259 t\u0259sdiql\u0259nm\u0259si \u00fc\u00e7\u00fcn Nazirliy\u0259 t\u0259qdim edir;<\/p>\n
– d\u00f6vl\u0259t qeydiyyat\u0131na al\u0131nm\u0131\u015f v\u0259 ya d\u00f6vl\u0259t qeydiyyat\u0131na al\u0131nmas\u0131 \u00fc\u00e7\u00fcn m\u00fcraci\u0259t edilmi\u015f d\u0259rman vasit\u0259sinin fayda-risk nisb\u0259tin\u0259 t\u0259sir ed\u0259n problem yarand\u0131qda, v\u0259siq\u0259 sahibind\u0259n risk idar\u0259etm\u0259 plan\u0131n\u0131n t\u0259qdim edilm\u0259sini t\u0259l\u0259b edir;<\/p>\n
– risk idar\u0259etm\u0259 plan\u0131nda edil\u0259n d\u0259yi\u015fiklikl\u0259ri qiym\u0259tl\u0259ndirir, riski minimuma endirm\u0259k istiqam\u0259tind\u0259 g\u00f6r\u00fcl\u0259n\u00a0 t\u0259dbirl\u0259rin n\u0259tic\u0259l\u0259rin\u0259 n\u0259zar\u0259t edir;<\/p>\n
– v\u0259siq\u0259 sahibind\u0259n fayda-risk nisb\u0259tinin s\u0259m\u0259r\u0259liliyinin qorundu\u011funu s\u00fcbut ed\u0259n m\u0259lumatlar\u0131 t\u0259l\u0259b edir;<\/p>\n
– v\u0259siq\u0259 sahibind\u0259n farmakon\u0259zar\u0259t sisteminin \u0259sas dosyesinin v\u0259 d\u0259rman t\u0259hl\u00fck\u0259sizliyinin qiym\u0259tl\u0259ndirilm\u0259si il\u0259 ba\u011fl\u0131 dig\u0259r farmakon\u0259zar\u0259t s\u0259n\u0259dl\u0259rinin 7 i\u015f g\u00fcn\u00fc m\u00fcdd\u0259tind\u0259 Quruma t\u0259qdim edilm\u0259sini t\u0259l\u0259b edir;<\/p>\n
– Qurum farmakon\u0259zar\u0259t sisteminin \u0259sas dosyesind\u0259ki m\u0259lumatlarda uy\u011funsuzluq a\u015fkar etdikd\u0259, v\u0259siq\u0259 sahibind\u0259n qeydiyyat kitab\u0131n\u0131n t\u0259qdim edilm\u0259sini t\u0259l\u0259b edir;<\/p>\n
– K\u0130V-d\u0259n istifad\u0259 ed\u0259r\u0259k insan sa\u011flaml\u0131\u011f\u0131 \u00fc\u00e7\u00fcn t\u0259hl\u00fck\u0259li d\u0259rman vasit\u0259l\u0259ri haqq\u0131nda ictimaiyy\u0259ti m\u0259lumatland\u0131r\u0131r, d\u0259rman t\u0259hl\u00fck\u0259sizliyi il\u0259 \u0259laq\u0259dar m\u0259lumatlar\u0131 v\u0259 tibb i\u015f\u00e7isini m\u0259lumat-land\u0131rma m\u0259ktublar\u0131n\u0131 \u00f6z internet s\u0259hif\u0259sind\u0259 yerl\u0259\u015fdirir.<\/p>\n
Ekspertiza d\u0259rman vasit\u0259sinin qeydiyyata al\u0131nd\u0131qdan sonra t\u0259qdim edil\u0259n farmakon\u0259zar\u0259t s\u0259n\u0259dl\u0259ri il\u0259 ba\u011fl\u0131 ke\u00e7irildikd\u0259 t\u0259r\u0259fl\u0259r aras\u0131nda m\u00fcnasib\u0259tl\u0259r, o c\u00fcml\u0259d\u0259n apar\u0131lacaq ekspertizan\u0131n h\u0259cmi, m\u00fcdd\u0259ti, xidm\u0259tin d\u0259y\u0259ri Qurum il\u0259 v\u0259siq\u0259 sahibi v\u0259 ya t\u0259\u015fkilat aras\u0131nda ba\u011flan\u0131lm\u0131\u015f m\u00fcqavil\u0259 il\u0259 t\u0259nziml\u0259nir. \u018fsas t\u0259lim proqramlar\u0131 \u00f6z\u0259l m\u00fcalic\u0259-profilaktika m\u00fc\u0259ssis\u0259l\u0259rinin, v\u0259siq\u0259 sahibinin v\u0259 t\u0259\u015fkilatlar\u0131n i\u015f\u00e7il\u0259ri \u00fc\u00e7\u00fcn t\u0259\u015fkil edildikd\u0259 t\u0259r\u0259fl\u0259r aras\u0131nda m\u00fcnasib\u0259tl\u0259r, o c\u00fcml\u0259d\u0259n apar\u0131lacaq t\u0259liml\u0259rin h\u0259cmi, m\u00fcdd\u0259ti, xidm\u0259tin d\u0259y\u0259ri Qurum il\u0259 h\u0259min subyektl\u0259r aras\u0131nda ba\u011flan\u0131lm\u0131\u015f m\u00fcqavil\u0259 il\u0259 t\u0259nziml\u0259nir.<\/p>\n
Tibb v\u0259 \u0259cza\u00e7\u0131l\u0131q i\u015f\u00e7il\u0259ri d\u0259rman vasit\u0259l\u0259rinin istifad\u0259si zaman\u0131 yaranan v\u0259 d\u0259rman vasit\u0259sinin istifad\u0259si il\u0259 ba\u011fl\u0131 olmas\u0131 ehtimal edil\u0259n \u0259lav\u0259 t\u0259sirl\u0259r bar\u0259d\u0259 bildiri\u015fl\u0259ri birba\u015fa v\u0259 ya m\u00fcalic\u0259-profilaktika m\u00fc\u0259ssis\u0259sinin farmakon\u0259zar\u0259t \u00fczr\u0259 m\u0259sul \u015f\u0259xsi vasit\u0259sil\u0259 15\u00a0 t\u0259qvim g\u00fcn\u00fc m\u00fcdd\u0259tind\u0259 Quruma g\u00f6nd\u0259rirl\u0259r. D\u0259rman vasit\u0259l\u0259rinin istifad\u0259si zaman\u0131 yaranan ciddi \u0259lav\u0259 t\u0259sirl\u0259r 48\u00a0 saat \u0259rzind\u0259 Quruma bildirilm\u0259lidir. V\u0259siq\u0259 sahibi d\u0259rman vasit\u0259sil\u0259 \u0259laq\u0259dar Az\u0259rbaycan Respublikas\u0131nda v\u0259 ya d\u0259rman vasit\u0259sinin sat\u0131\u015fa \u00e7\u0131xar\u0131ld\u0131\u011f\u0131 dig\u0259r \u00f6lk\u0259d\u0259 pasiyentl\u0259r v\u0259 ya tibb v\u0259 \u0259cza\u00e7\u0131l\u0131q i\u015f\u00e7il\u0259ri t\u0259r\u0259find\u0259n spontan olaraq bildirilmi\u015f v\u0259 ya qeydiyyatdan sonrak\u0131 t\u0259hl\u00fck\u0259sizlik t\u0259dqiqat\u0131 zaman\u0131 a\u015fkar edilmi\u015f b\u00fct\u00fcn \u0259lav\u0259 t\u0259sirl\u0259rin qeydiyyat\u0131n\u0131 apar\u0131r v\u0259 onlar\u0131 arxivl\u0259\u015fdirir,\u00a0 d\u0259rman vasit\u0259sinin Az\u0259rbaycan Respublikas\u0131nda istifad\u0259si il\u0259 ba\u011fl\u0131 yaranan b\u00fct\u00fcn \u0259lav\u0259 t\u0259sirl\u0259r bar\u0259d\u0259 m\u0259lumatlar\u0131, h\u0259m\u00e7inin, ilkin bildiri\u015fl\u0259rl\u0259 \u0259laq\u0259dar olan n\u0259zar\u0259t m\u0259lumatlar\u0131n\u0131\u00a0 \u0259ld\u0259 etdiyi g\u00fcnd\u0259n 15 t\u0259qvim g\u00fcn\u00fc m\u00fcdd\u0259tind\u0259 Quruma g\u00f6nd\u0259rir. Eyni zamanda d\u0259rman vasit\u0259sinin sat\u0131\u015fda oldu\u011fu dig\u0259r \u00f6lk\u0259l\u0259rd\u0259n \u0259ld\u0259 etdiyi bildiri\u015fl\u0259r d\u0259rman vasit\u0259sinin fayda-risk nisb\u0259tini d\u0259yi\u015fdirirs\u0259, h\u0259min m\u0259lumat\u0131 ald\u0131qdan d\u0259rhal sonra Quruma g\u00f6nd\u0259rir, d\u0259rman vasit\u0259sinin Az\u0259rbaycan Respublikas\u0131nda istifad\u0259si\u00a0 zaman\u0131 a\u015fkar edilmi\u015f b\u00fct\u00fcn \u0259lav\u0259 t\u0259sirl\u0259rin qeyd olundu\u011fu m\u0259nb\u0259l\u0259ri, o c\u00fcml\u0259d\u0259n elmi v\u0259 tibbi \u0259d\u0259biyyat bar\u0259d\u0259 15 t\u0259qvim g\u00fcn\u00fc m\u00fcdd\u0259tind\u0259 Quruma m\u0259lumat verir, pasiyentin bu v\u0259 ya dig\u0259r x\u0259st\u0259liy\u0259 d\u0259rman vasit\u0259sil\u0259 yoluxmas\u0131na \u015f\u00fcbh\u0259 olduqda, ald\u0131\u011f\u0131 m\u0259lumat\u0131 d\u0259rhal Quruma bildirir.<\/p>\n
V\u0259siq\u0259 sahibi a\u015fa\u011f\u0131dak\u0131 hallarda risk idar\u0259etm\u0259 plan\u0131n\u0131 t\u0259qdim edir:<\/p>\n
– Az\u0259rbaycan Respublikas\u0131nda \u0259vv\u0259ll\u0259r d\u00f6vl\u0259t qeydiyyat\u0131na al\u0131nmayan yeni t\u0259siredici madd\u0259 t\u0259rkibli, t\u0259siredici madd\u0259l\u0259rin yeni birl\u0259\u015fm\u0259si (kombinasiyas\u0131) t\u0259rkibli, biotexnoloji, ox\u015far bioloji d\u0259rman vasit\u0259si v\u0259 orijinal\u0131 \u00fc\u00e7\u00fcn \u0259lav\u0259 riskin\u00a0 minimuma endirilm\u0259si il\u0259 ba\u011fl\u0131 t\u0259dbirl\u0259rin g\u00f6r\u00fclm\u0259si\u00a0 z\u0259rur\u0259ti olduqda, generik d\u0259rman vasit\u0259l\u0259rinin qeydiyyat\u0131 \u00fc\u00e7\u00fcn m\u00fcraci\u0259t edildikd\u0259;<\/p>\n
– d\u0259rman vasit\u0259sinin d\u00f6vl\u0259t qeydiyyat s\u0259n\u0259dl\u0259rin\u0259 yeni istifad\u0259 qaydas\u0131 v\u0259 pediatrik g\u00f6st\u0259ri\u015fl\u0259rin \u0259lav\u0259 edilm\u0259si, istifad\u0259y\u0259 g\u00f6st\u0259ri\u015fl\u0259rd\u0259 \u0259h\u0259miyy\u0259tli d\u0259yi\u015fiklikl\u0259r edilm\u0259si, h\u0259m\u00e7inin biotexnoloji v\u0259 ya ox\u015far bioloji d\u0259rman vasit\u0259l\u0259ri \u00fc\u00e7\u00fcn yeni istehsal prosesind\u0259n istifad\u0259 edildikd\u0259;<\/p>\n
– d\u00f6vl\u0259t qeydiyyat\u0131ndan \u0259vv\u0259l v\u0259 ya sonra Qurum t\u0259r\u0259find\u0259n t\u0259l\u0259b edildikd\u0259;<\/p>\n
– d\u0259rman vasit\u0259sinin h\u0259yat tsiklinin ist\u0259nil\u0259n m\u0259rh\u0259l\u0259sind\u0259 onun t\u0259hl\u00fck\u0259sizliyi il\u0259 ba\u011fl\u0131 problem a\u015fkar edildikd\u0259 v\u0259 ya v\u0259siq\u0259 sahibinin t\u0259\u015f\u0259bb\u00fcs\u00fc olduqda;<\/p>\n
– d\u00f6vri olaraq yenil\u0259n\u0259n t\u0259hl\u00fck\u0259sizlik hesabatlar\u0131n\u0131 d\u0259rman vasit\u0259si Az\u0259rbaycan Respublikas\u0131nda d\u00f6vl\u0259t qeydiyyat\u0131na al\u0131nd\u0131qdan sonra ilk 2 il m\u00fcdd\u0259tind\u0259 alt\u0131 aydan bir, n\u00f6vb\u0259ti 2\u00a0 il m\u00fcdd\u0259tind\u0259 ild\u0259 bir d\u0259f\u0259, h\u0259m\u00e7inin d\u0259rman vasit\u0259si yenid\u0259n d\u00f6vl\u0259t qeydiyyat\u0131na al\u0131nd\u0131qdan sonra \u00fc\u00e7 ild\u0259n bir haz\u0131rlay\u0131r v\u0259 Quruma t\u0259qdim edir;<\/p>\n
– d\u00f6vri olaraq yenil\u0259n\u0259n t\u0259hl\u00fck\u0259sizlik hesabatlar\u0131n\u0131 d\u0259rman vasit\u0259si sat\u0131\u015fa \u00e7\u0131xar\u0131ld\u0131qdan 18 ay sonra v\u0259 ya d\u0259rman vasit\u0259sini istifad\u0259 ed\u0259n pasiyentl\u0259rin say\u0131 on min n\u0259f\u0259r\u0259 \u00e7atd\u0131\u011f\u0131 halda, h\u0259m\u00e7inin d\u0259rman vasit\u0259si yenid\u0259n d\u00f6vl\u0259t qeydiyyat\u0131na al\u0131nd\u0131\u011f\u0131 zaman Quruma t\u0259qdim edir;<\/p>\n
d\u0259rman vasit\u0259sinin v\u0259siq\u0259 sahibi d\u0259yi\u015fdikd\u0259, farmako-n\u0259zar\u0259t m\u0259lumatlar\u0131n\u0131n t\u0259qdimolunma d\u00f6vrl\u0259ri ilk qeydiyyat tarixi \u0259sas g\u00f6t\u00fcr\u00fcl\u0259r\u0259k davam edir;<\/p>\n
– d\u00f6vri olaraq yenil\u0259n\u0259n t\u0259hl\u00fck\u0259sizlik hesabatlar\u0131n\u0131 haz\u0131rlamaqla d\u0259rman vasit\u0259l\u0259rinin t\u0259hl\u00fck\u0259sizliyini sistemli qiym\u0259tl\u0259n-dirm\u0259y\u0259 davam edir v\u0259 fayda-risk nisb\u0259tin\u0259 v\u0259 ya d\u0259rman vasit\u0259sinin istifad\u0259 t\u0259limat\u0131n\u0131n d\u0259yi\u015fdirilm\u0259sin\u0259 t\u0259sir g\u00f6st\u0259r\u0259n yeni t\u0259hl\u00fck\u0259sizlik m\u0259lumatlar\u0131n\u0131 \u0259ld\u0259 etdikd\u0259, Quruma d\u0259yi\u015fiklik bar\u0259d\u0259 m\u00fcraci\u0259t edir;<\/p>\n
– d\u0259rman vasit\u0259l\u0259rinin istifad\u0259si il\u0259 \u0259laq\u0259dar olan t\u0259hl\u00fck\u0259sizlik probleml\u0259ri bar\u0259d\u0259 ictimaiyy\u0259ti m\u0259lumatland\u0131rmazdan \u0259vv\u0259l v\u0259 ya eyni zamanda bu bar\u0259d\u0259 Qurumu da m\u0259lumatland\u0131r\u0131r.<\/p>\n
Nazirl\u0259r Kabinetinin 2010-cu il 30 aprel tarixli 83 n\u00f6mr\u0259li Q\u0259rar\u0131 il\u0259 t\u0259sdiq edilmi\u015f “D\u0259rman vasit\u0259l\u0259rinin elmi t\u0259dqiqatlar\u0131n\u0131n, klinikaya q\u0259d\u0259r t\u0259dqiqatlar\u0131n\u0131n v\u0259 klinik s\u0131naqlar\u0131n\u0131n apar\u0131lmas\u0131 Qaydalar\u0131”na v\u0259 ya beyn\u0259lxalq s\u0259viyy\u0259d\u0259 tan\u0131nan klinikaya q\u0259d\u0259r t\u0259dqiqatlar\u0131n v\u0259 klinik s\u0131naqlar\u0131n\u0131n apar\u0131lmas\u0131 qaydalar\u0131na \u0259sas\u0259n Qurum v\u0259siq\u0259 sahibind\u0259n a\u015fa\u011f\u0131dak\u0131lar\u0131n yerin\u0259 yetirilm\u0259sini t\u0259l\u0259b edir:<\/p>\n
– d\u00f6vl\u0259t qeydiyyat\u0131na al\u0131nm\u0131\u015f d\u0259rman vasit\u0259sinin riskl\u0259ri il\u0259 \u0259laq\u0259dar d\u00f6vl\u0259t qeydiyyat\u0131ndan sonrak\u0131 t\u0259hl\u00fck\u0259sizlik t\u0259dqiqat\u0131n\u0131n apar\u0131lmas\u0131n\u0131;<\/p>\n
– d\u0259rman vasit\u0259sinin effektivliyinin s\u00fcbut olunmas\u0131 \u00fc\u00e7\u00fcn d\u00f6vl\u0259t qeydiyyat\u0131ndan sonrak\u0131 effektivlik t\u0259dqiqat\u0131n\u0131n apar\u0131lmas\u0131n\u0131.<\/p>\n
Qurum farmakon\u0259zar\u0259t sistemi vasit\u0259sil\u0259 b\u00fct\u00fcn m\u0259lumatlar\u0131 a\u015fa\u011f\u0131dak\u0131lar\u0131 n\u0259z\u0259r\u0259 almaqla, elmi c\u0259h\u0259td\u0259n qiym\u0259tl\u0259ndirir:<\/p>\n
risk idar\u0259etm\u0259 plan\u0131 \u00e7\u0259r\u00e7iv\u0259sind\u0259 riskin minimuma endirilm\u0259sin\u0259\u00a0 istiqam\u0259tl\u0259nmi\u015f t\u0259dbirl\u0259rin n\u0259tic\u0259l\u0259rini;<\/p>\n
risk idar\u0259etm\u0259 sistemind\u0259 edil\u0259n yenilikl\u0259ri;<\/p>\n
yeni riskl\u0259rin yaranma ehtimal\u0131n\u0131 v\u0259 ya bu riskl\u0259rin d\u0259yi\u015fm\u0259 v\u0259 ya fayda-risk nisb\u0259tin\u0259 t\u0259sirinin yaranma ehtimal\u0131n\u0131 m\u00fc\u0259yy\u0259nl\u0259\u015fdirm\u0259kl\u0259, d\u00f6vri olaraq yenil\u0259n\u0259n t\u0259hl\u00fck\u0259sizlik hesabat\u0131 da daxil olmaqla, qiym\u0259tl\u0259ndirm\u0259l\u0259rin apar\u0131lmas\u0131n\u0131.<\/p>\n
Qurum v\u0259 v\u0259siq\u0259 sahibi yeni riskl\u0259r yarand\u0131qda v\u0259 ya fayda-risk nisb\u0259tind\u0259 d\u0259yi\u015fiklik olduqda, bir-birl\u0259rini m\u0259lumatland\u0131r\u0131rlar.<\/p>\n
Apar\u0131lan qiym\u0259tl\u0259ndirm\u0259d\u0259n sonra Qurum v\u0259siq\u0259 sahibini m\u0259lumatland\u0131rmaqla a\u015fa\u011f\u0131dak\u0131 t\u0259dbirl\u0259rin g\u00f6r\u00fclm\u0259si bar\u0259d\u0259 q\u0259rar q\u0259bul edir:<\/p>\n
– v\u0259siq\u0259 sahibi t\u0259r\u0259find\u0259n d\u00f6vl\u0259t qeydiyyat\u0131ndan sonrak\u0131 t\u0259hl\u00fck\u0259sizlik t\u0259dqiqat\u0131n\u0131n apar\u0131lmas\u0131;<\/p>\n
– v\u0259siq\u0259 sahibi t\u0259r\u0259find\u0259n riskin minimuma endirilm\u0259si il\u0259 ba\u011fl\u0131 t\u0259dbirl\u0259rinin g\u00f6r\u00fclm\u0259si;<\/p>\n
– Nazirliy\u0259 m\u00fcraci\u0259t edilm\u0259si;<\/p>\n
– v\u0259siq\u0259 sahibi t\u0259r\u0259find\u0259n d\u0259rman vasit\u0259sinin m\u0259lumatlar\u0131nda yeni \u0259ks g\u00f6st\u0259ri\u015fin \u0259lav\u0259 edilm\u0259si, t\u00f6vsiy\u0259 edil\u0259n dozan\u0131n azald\u0131lmas\u0131 v\u0259 istifad\u0259y\u0259 g\u00f6st\u0259ri\u015fl\u0259rin m\u0259hdudla\u015fd\u0131r\u0131lmas\u0131 kimi d\u0259yi\u015fiklikl\u0259rin edilm\u0259si;<\/p>\n
– v\u0259siq\u0259 sahibi v\u0259 ya Qurum t\u0259r\u0259find\u0259n tibb i\u015f\u00e7isinin m\u0259lumatland\u0131rma m\u0259ktubunun haz\u0131rlanmas\u0131, tibb v\u0259 \u0259cza\u00e7\u0131l\u0131q i\u015f\u00e7il\u0259rin\u0259 t\u0259qdimat\u0131;<\/p>\n
– d\u0259rman vasit\u0259sinin geri \u00e7a\u011f\u0131r\u0131lmas\u0131.<\/p>\n
V\u0259siq\u0259 sahibi farmakon\u0259zar\u0259t t\u0259dbirl\u0259rin\u0259 aid m\u0259lumatlar\u0131n Etibarl\u0131 Farmakon\u0259zar\u0259t T\u0259cr\u00fcb\u0259sin\u0259 uy\u011fun olaraq saxlan\u0131lmas\u0131n\u0131 t\u0259min edir. V\u0259siq\u0259 sahibi farmakon\u0259zar\u0259t sisteminin \u0259sas dosyesind\u0259 t\u0259svir edil\u0259n sistem\u0259 r\u0259smi xitam verildikd\u0259n sonra m\u0259lumatlar\u0131n v\u0259 s\u0259n\u0259dl\u0259rin \u0259n az\u0131 5\u00a0 il m\u00fcdd\u0259tind\u0259 qorunmas\u0131 \u00fc\u00e7\u00fcn laz\u0131mi t\u0259dbirl\u0259r g\u00f6r\u00fcr. D\u0259rman vasit\u0259l\u0259ri il\u0259 \u0259laq\u0259dar farmakon\u0259zar\u0259t m\u0259lumatlar\u0131 v\u0259 s\u0259n\u0259dl\u0259ri d\u0259rman vasit\u0259sinin qeydiyyatda oldu\u011fu m\u00fcdd\u0259td\u0259 v\u0259 qeydiyyat m\u00fcdd\u0259ti ba\u015fa \u00e7atd\u0131qdan sonra \u0259n az\u0131 10 il m\u00fcdd\u0259tind\u0259 saxlan\u0131l\u0131r. Quruma g\u00f6nd\u0259ril\u0259n bildiri\u015fl\u0259rl\u0259 ba\u011fl\u0131 pasiyentin v\u0259 ya tibb v\u0259 \u0259cza\u00e7\u0131l\u0131q i\u015f\u00e7isin\u0259 dair m\u0259lumatlar\u0131n konfidensiall\u0131\u011f\u0131n\u0131n qorunmas\u0131 \u00fc\u00e7\u00fcn Qurum t\u0259r\u0259find\u0259n t\u0259dbirl\u0259r g\u00f6r\u00fcl\u00fcr v\u0259 h\u0259min \u015f\u0259xsl\u0259rin raz\u0131l\u0131\u011f\u0131 olmadan bu m\u0259lumatlar\u0131n Qanunda n\u0259z\u0259rd\u0259 tutulmu\u015f hallar istisna olmaqla, a\u00e7\u0131qlanmas\u0131na yol verilmir.<\/p>\n
Qurum v\u0259siq\u0259 sahibinin farmakon\u0259zar\u0259t sisteminin Etibarl\u0131 Farmakon\u0259zar\u0259t T\u0259cr\u00fcb\u0259sin\u0259 uy\u011funlu\u011funu m\u00fc\u0259yy\u0259n ed\u0259rk\u0259n bu Qaydan\u0131n t\u0259l\u0259bl\u0259ri il\u0259 ziddiyy\u0259t a\u015fkar edildikd\u0259, h\u0259min ziddiyy\u0259tl\u0259r bar\u0259d\u0259 d\u0259rhal Nazirliyi m\u0259lumatland\u0131r\u0131r v\u0259 Nazirlik ziddiyy\u0259tin aradan qald\u0131r\u0131lmas\u0131 \u00fc\u00e7\u00fcn ziddiyy\u0259tin x\u00fcsusiyy\u0259tind\u0259n as\u0131l\u0131 olaraq, v\u0259siq\u0259 sahibin\u0259 15 g\u00fcnd\u0259n az, 3\u00a0 aydan \u00e7ox olmayaraq m\u00fcdd\u0259t m\u00fc\u0259yy\u0259n edir v\u0259 bu m\u00fcdd\u0259td\u0259 ziddiyy\u0259t aradan qald\u0131r\u0131lmad\u0131qda v\u0259 t\u0259l\u0259b olunan s\u0259n\u0259dl\u0259r t\u0259qdim edilm\u0259dikd\u0259, d\u0259rman vasit\u0259sinin d\u00f6vl\u0259t qeydiyyat\u0131 l\u0259\u011fv edilir. M\u00fcalic\u0259-profilaktika m\u00fc\u0259ssis\u0259l\u0259rind\u0259, v\u0259siq\u0259 sahibl\u0259rind\u0259 v\u0259 t\u0259\u015fkilatlarda farmakon\u0259zar\u0259tin t\u0259\u015fkili il\u0259 ba\u011fl\u0131 a\u015fkar edil\u0259n n\u00f6qsanlar Etibarl\u0131 Farmakon\u0259zar\u0259t T\u0259cr\u00fcb\u0259sin\u0259 uy\u011fun olaraq aradan qald\u0131r\u0131l\u0131r.<\/p>\n","protected":false},"excerpt":{"rendered":"
Az\u0259rbaycanda d\u0259rman vasit\u0259l\u0259rinin \u0259lav\u0259 t\u0259sirl\u0259rinin izl\u0259nm\u0259si, qeydiyyata al\u0131nmas\u0131, qiym\u0259tl\u0259ndirilm\u0259si, m\u00fcvafiq t\u0259dqiqatlar\u0131n apar\u0131lmas\u0131 v\u0259 bu sah\u0259d\u0259 z\u0259ruri t\u0259dbirl\u0259rin g\u00f6r\u00fclm\u0259sin\u0259 dair icra mexanizml\u0259ri m\u00fc\u0259yy\u0259nl\u0259\u015fib. Bu, Nazirl\u0259r Kabinetinin t\u0259sdiql\u0259diyi “D\u0259rman vasit\u0259l\u0259rinin farmakon\u0259zar\u0259t Qaydas\u0131”nda \u0259ksini tap\u0131b. Bu Qayda 1 yanvar 2020-ci ild\u0259n q\u00fcvv\u0259y\u0259 minir. Bu Qayda m\u00fclkiyy\u0259t v\u0259 t\u0259\u015fkilati h\u00fcquqi formas\u0131ndan as\u0131l\u0131 olmayaraq b\u00fct\u00fcn m\u00fcalic\u0259-profilaktika m\u00fc\u0259ssis\u0259l\u0259ri, d\u0259rman vasit\u0259sinin d\u00f6vl\u0259t qeydiyyat\u0131 haqq\u0131nda v\u0259siq\u0259nin sahibi v\u0259 onun m\u00fcv\u0259kkil etdiyi \u015f\u0259xsl\u0259r\u0259 \u015famil olunur. Farmakon\u0259zar\u0259t d\u0259rman vasit\u0259l\u0259rinin istifad\u0259si zaman\u0131 yaranan \u0259lav\u0259 t\u0259sirl\u0259rin v\u0259 dig\u0259r arzuolunmaz n\u0259tic\u0259l\u0259rin, d\u0259rman vasit\u0259sinin s\u0259hv istifad\u0259si il\u0259 ba\u011fl\u0131 x\u0259tan\u0131n, kontrafakt v\u0259 effektivliyini, keyfiyy\u0259tini v\u0259…<\/p>\n","protected":false},"author":2,"featured_media":112776,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0},"categories":[1],"tags":[],"aioseo_notices":[],"gutentor_comment":0,"rttpg_featured_image_url":{"full":["https:\/\/arantv.az\/wp-content\/uploads\/2019\/12\/derman_384785786.jpg",800,600,false],"landscape":["https:\/\/arantv.az\/wp-content\/uploads\/2019\/12\/derman_384785786.jpg",800,600,false],"portraits":["https:\/\/arantv.az\/wp-content\/uploads\/2019\/12\/derman_384785786.jpg",800,600,false],"thumbnail":["https:\/\/arantv.az\/wp-content\/uploads\/2019\/12\/derman_384785786-150x150.jpg",150,150,true],"medium":["https:\/\/arantv.az\/wp-content\/uploads\/2019\/12\/derman_384785786-300x225.jpg",300,225,true],"large":["https:\/\/arantv.az\/wp-content\/uploads\/2019\/12\/derman_384785786.jpg",640,480,false],"1536x1536":["https:\/\/arantv.az\/wp-content\/uploads\/2019\/12\/derman_384785786.jpg",800,600,false],"2048x2048":["https:\/\/arantv.az\/wp-content\/uploads\/2019\/12\/derman_384785786.jpg",800,600,false],"post-thumbnail":["https:\/\/arantv.az\/wp-content\/uploads\/2019\/12\/derman_384785786-240x172.jpg",240,172,true],"advps-thumb-one":["https:\/\/arantv.az\/wp-content\/uploads\/2019\/12\/derman_384785786.jpg",800,600,false]},"rttpg_author":{"display_name":"V\u00fcsal Rafiqo\u011flu","author_link":"https:\/\/arantv.az\/?author=2"},"rttpg_comment":0,"rttpg_category":"C\u0259miyy\u0259t<\/a>","rttpg_excerpt":"Az\u0259rbaycanda d\u0259rman vasit\u0259l\u0259rinin \u0259lav\u0259 t\u0259sirl\u0259rinin izl\u0259nm\u0259si, qeydiyyata al\u0131nmas\u0131, qiym\u0259tl\u0259ndirilm\u0259si, m\u00fcvafiq t\u0259dqiqatlar\u0131n apar\u0131lmas\u0131 v\u0259 bu sah\u0259d\u0259 z\u0259ruri t\u0259dbirl\u0259rin g\u00f6r\u00fclm\u0259sin\u0259 dair icra mexanizml\u0259ri m\u00fc\u0259yy\u0259nl\u0259\u015fib. Bu, Nazirl\u0259r Kabinetinin t\u0259sdiql\u0259diyi “D\u0259rman vasit\u0259l\u0259rinin farmakon\u0259zar\u0259t Qaydas\u0131”nda \u0259ksini tap\u0131b. Bu Qayda 1 yanvar 2020-ci ild\u0259n q\u00fcvv\u0259y\u0259 minir. Bu Qayda m\u00fclkiyy\u0259t v\u0259 t\u0259\u015fkilati h\u00fcquqi formas\u0131ndan as\u0131l\u0131 olmayaraq b\u00fct\u00fcn m\u00fcalic\u0259-profilaktika m\u00fc\u0259ssis\u0259l\u0259ri, d\u0259rman vasit\u0259sinin d\u00f6vl\u0259t…","_links":{"self":[{"href":"https:\/\/arantv.az\/index.php?rest_route=\/wp\/v2\/posts\/112775"}],"collection":[{"href":"https:\/\/arantv.az\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/arantv.az\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/arantv.az\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/arantv.az\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=112775"}],"version-history":[{"count":0,"href":"https:\/\/arantv.az\/index.php?rest_route=\/wp\/v2\/posts\/112775\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/arantv.az\/index.php?rest_route=\/wp\/v2\/media\/112776"}],"wp:attachment":[{"href":"https:\/\/arantv.az\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=112775"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/arantv.az\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=112775"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/arantv.az\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=112775"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}