{"id":2556,"date":"2019-12-10T11:41:51","date_gmt":"2019-12-10T10:41:51","guid":{"rendered":"http:\/\/www.cechova.sk\/?p=2556"},"modified":"2019-12-10T11:43:29","modified_gmt":"2019-12-10T10:43:29","slug":"novela-zakona-o-liekoch-ucinna-od-1-1-2020","status":"publish","type":"post","link":"https:\/\/www.cechova.sk\/sk\/novela-zakona-o-liekoch-ucinna-od-1-1-2020\/","title":{"rendered":"Novela Z\u00e1kona o liekoch \u00fa\u010dinn\u00e1 od 1.1.2020"},"content":{"rendered":"<p>16. okt\u00f3bra 2019 N\u00e1rodn\u00e1 rada Slovenskej republiky schv\u00e1lila novelu &#8211; z\u00e1kon \u010d. 383\/2019 Z. z., ktorou sa vo viacer\u00fdch podstatn\u00fdch \u010dastiach men\u00ed pr\u00e1vna \u00faprava v z\u00e1kone \u010d. 362\/2011 Z.z. o liekoch a zdravotn\u00edckych pom\u00f4ckach. Ni\u017e\u0161ie zh\u0155\u0148ame najpodstatnej\u0161ie zmeny.<\/p>\n<p><span style=\"font-size: 14pt;\"><strong>Reexport liekov<\/strong><\/span><\/p>\n<p>Novela spr\u00eds\u0148uje podmienky v\u00fdvozu kategorizovan\u00fdch liekov, \u010d\u00edm reaguje na naj\u010dastej\u0161ie sp\u00f4soby obch\u00e1dzania s\u00fa\u010dasnej pr\u00e1vnej \u00fapravy:<\/p>\n<ul>\n<li>Okrem dr\u017eite\u013ea registr\u00e1cie a\u00a0ve\u013ekodistrib\u00fatora, ktor\u00e9ho na to p\u00edsomne splnomocni dr\u017eite\u013e registr\u00e1cie, bude opr\u00e1vnen\u00fd vyviez\u0165 kategorizovan\u00fd liek iba dr\u017eite\u013e povolenia na v\u00fdrobu liekov, ktor\u00fd liek vyrobil, za ktor\u00e9ho sa nepova\u017euje dr\u017eite\u013e povolenia na v\u00fdrobu liekov, ak vykonal len v\u00fdrobn\u00e9 postupy s\u00favisiace s\u00a0delen\u00edm, balen\u00edm a\u00a0\u00fapravou balenia;<\/li>\n<li>Lek\u00e1rne bud\u00fa opr\u00e1vnen\u00e9 preda\u0165 inej lek\u00e1rni iba menej ako p\u00e4\u0165 balen\u00ed kategorizovan\u00e9ho lieku alebo lieku s \u00faradne ur\u010denou cenou s\u00a0rovnak\u00fdm \u0160\u00daKL k\u00f3dom za kalend\u00e1rny mesiac (z\u00e1rove\u0148 sa ru\u0161\u00ed obmedzenie \u010fal\u0161ieho predaja lieku medzi lek\u00e1r\u0148ami na \u010das tri mesiace od dodania lieku od ve\u013ekodistrib\u00fatora). Na z\u00e1klade povolenia na poskytovanie lek\u00e1renskej starostlivosti nebude mo\u017en\u00e9 dod\u00e1va\u0165 lieky ve\u013ekodistrib\u00fatorovi \u010di lek\u00e1rni v\u00a0inom \u010dlenskom \u0161t\u00e1te E\u00da, a\u00a0kategorizovan\u00e9 lieky a\u00a0lieky s\u00a0\u00faradne ur\u010denou cenou inej lek\u00e1rni v\u00a0po\u010dte v\u00e4\u010d\u0161om ako p\u00e4\u0165 balen\u00ed lieku s\u00a0rovnak\u00fdm \u0160\u00daKL k\u00f3dom za kalend\u00e1rny mesiac;<\/li>\n<li>Lek\u00e1r\u0148am sa uklad\u00e1 povinnos\u0165 na po\u017eiadanie spr\u00edstupni\u0165 \u0161t\u00e1tnym org\u00e1nom evidenciu a doklady o\u00a0nadobudnut\u00ed, v\u00fddaji a dodan\u00ed\u00a0 kategorizovan\u00fdch liekov a liekov s \u00faradne ur\u010denou cenou a Ministerstvu zdravotn\u00edctva z\u00e1znamy o\u00a0pr\u00edjme, dod\u00e1vkach, sp\u00e4tnom predaji a vr\u00e1ten\u00ed kategorizovan\u00fdch liekov v elektronickej podobe v\u00a0lehote nie krat\u0161ej ako p\u00e4\u0165 dn\u00ed;<\/li>\n<li>Lek\u00e1r\u0148am sa zakazuje uzatv\u00e1ra\u0165 zmluvu o ulo\u017een\u00ed vec\u00ed, predmetom ktorej je ulo\u017eenie kategorizovan\u00e9ho lieku alebo lieku s\u00a0\u00faradne ur\u010denou cenou, okrem liekov, ktor\u00e9 s\u00fa predmetom centr\u00e1lneho n\u00e1kupu zdravotnej pois\u0165ovne, a\u00a0stanovuje sa povinnos\u0165 skladova\u0165 kategorizovan\u00e9 lieky a\u00a0lieky s \u00faradne ur\u010denou cenou v\u00a0priestoroch miesta v\u00fdkonu lek\u00e1renskej \u010dinnosti uveden\u00e9ho na povolen\u00ed.<\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\"><strong>Nov\u00e9 povinnosti v\u00a0oblasti farmakovigilancie<\/strong><\/span><\/p>\n<p>Rozsah farmakovigilan\u010dn\u00fdch povinnost\u00ed dr\u017eite\u013ea registr\u00e1cie lieku sa roz\u0161iruje o\u00a0nov\u00e9 ozn\u00e1menia \u0160t\u00e1tnemu \u00fastavu pre kontrolu lie\u010div (\u0160\u00daKL) a\u00a0povinnosti, formulovan\u00e9 pomerne \u0161iroko, zasahuj\u00face aj udalosti v\u00a0zahrani\u010d\u00ed:<\/p>\n<ul>\n<li>Ozn\u00e1menie ka\u017ed\u00e9ho stiahnutia hum\u00e1nneho lieku z\u00a0trhu, ktor\u00e9 nariadil pr\u00edslu\u0161n\u00fd org\u00e1n \u010dlensk\u00e9ho \u0161t\u00e1tu E\u00da alebo pr\u00edslu\u0161n\u00fd org\u00e1n v tretej krajine alebo sa tak\u00e9to opatrenie prijalo dobrovo\u013ene;<\/li>\n<li>Ozn\u00e1menie ka\u017edej p\u00edsomne podanej s\u0165a\u017enosti alebo reklam\u00e1cie, ktor\u00e1 sa t\u00fdka kvalitat\u00edvneho nedostatku registrovan\u00e9ho hum\u00e1nneho lieku predstavuj\u00faceho v\u00e1\u017ene riziko pre zdravie \u013eud\u00ed najnesk\u00f4r v nasleduj\u00faci pracovn\u00fd de\u0148 od prijatia s\u0165a\u017enosti alebo reklam\u00e1cie;<\/li>\n<li>Ozn\u00e1menie v\u00fdsledkov vlastn\u00e9ho pre\u0161etrovania kvality registrovan\u00e9ho hum\u00e1nneho lieku v nadv\u00e4znosti na s\u0165a\u017enos\u0165 alebo reklam\u00e1ciu, ktor\u00fa hl\u00e1sil \u0160\u00daKL.<\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\"><strong>\u00a0<\/strong><strong>Zdravotn\u00edcke pom\u00f4cky<\/strong><\/span><\/p>\n<p>Novela konsoliduje pr\u00e1vnu \u00fapravu zdravotn\u00edckych pom\u00f4cok vzh\u013eadom na prijatie nariadenia E\u00da \u010d. 2017\/745 o zdravotn\u00edckych pom\u00f4ckach. Pr\u00e1vna \u00faprava diagnostick\u00fdch pom\u00f4cok in vitro bude rie\u0161en\u00e1 samostatnou novelou.<\/p>\n<p>Nad r\u00e1mec nariaden\u00ed sa novelou upravuj\u00fa podmienky klinick\u00e9ho sk\u00fa\u0161ania zdravotn\u00edckej pom\u00f4cky vr\u00e1tane zapojenia etick\u00fdch komisi\u00ed do povolenia klinick\u00e9ho sk\u00fa\u0161ania zdravotn\u00edckej pom\u00f4cky. Zvy\u0161uj\u00fa sa spr\u00e1vne poplatky za povolenie klinick\u00e9ho sk\u00fa\u0161ania zdravotn\u00edckej pom\u00f4cky a zav\u00e1dzaj\u00fa sa nov\u00e9 s\u00favisiace spr\u00e1vne poplatky .<\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u010eal\u0161ie zmeny<\/strong><\/span><\/p>\n<p>Novela prin\u00e1\u0161a mno\u017estvo \u010diastkov\u00fdch zmien v\u00a0\u010fal\u0161\u00edch oblastiach:<\/p>\n<ul>\n<li>Upravuj\u00fa sa podmienky realiz\u00e1cie \u0161t\u00fadi\u00ed o\u00a0bezpe\u010dnosti lieku po registr\u00e1cii (PASS) tak, \u017ee protokol \u0161t\u00fadie sa bude predklada\u0165 V\u00fdboru pre hodnotenie riz\u00edk doh\u013eadu nad liekmi Eur\u00f3pskej liekovej agent\u00fary, ak sa \u0161t\u00fadia vykon\u00e1va vo viacer\u00fdch \u010dlensk\u00fdch \u0161t\u00e1toch E\u00da, a\u00a0\u0160\u00daKL, ak sa \u0161t\u00fadia vykon\u00e1va len na \u00fazem\u00ed Slovenskej republiky na z\u00e1klade vy\u017eiadania \u0160\u00daKL ako podmienky registr\u00e1cie lieku alebo z vlastn\u00e9ho podnetu dr\u017eite\u013ea registr\u00e1cie;<\/li>\n<li>Predpisuj\u00facemu lek\u00e1rovi sa zakazuje vy\u017eadova\u0165 od pacienta, aby sa pred predp\u00edsan\u00edm lieku, zdravotn\u00edckej pom\u00f4cky alebo dietetickej potraviny preskrip\u010dn\u00fdm z\u00e1znamom zaregistroval na webovej str\u00e1nke tretej osoby. Zdravotnej pois\u0165ovni sa zakazuje ur\u010dova\u0165 pacientovi, v ktorej verejnej lek\u00e1rni alebo v\u00fddajni zdravotn\u00edckych pom\u00f4cok si m\u00e1 predp\u00edsan\u00fd liek, zdravotn\u00edcku pom\u00f4cku alebo dietetick\u00fa potravinu vybra\u0165, okrem lieku, zdravotn\u00edckej pom\u00f4cky alebo dietetickej potraviny, ktor\u00e9 s\u00fa predmetom centr\u00e1lneho n\u00e1kupu zdravotnej pois\u0165ovne;<\/li>\n<li>Upravuj\u00fa sa povinnosti vykon\u00e1va\u0165 lek\u00e1rensk\u00fa pohotovostn\u00fa slu\u017ebu a podmienky internetov\u00e9ho v\u00fddaja liekov.<\/li>\n<\/ul>\n<p>V\u0161eobecn\u00e1 \u00fa\u010dinnos\u0165 novely je stanoven\u00e1 na 1. janu\u00e1ra 2020. Ustanovenia t\u00fdkaj\u00face sa zdravotn\u00edckych pom\u00f4cok bud\u00fa \u00fa\u010dinn\u00e9 od 26. m\u00e1ja 2020, kedy nadobudne \u00fa\u010dinnos\u0165 Nariadenie o zdravotn\u00edckych pom\u00f4ckach. Klinick\u00e9 sk\u00fa\u0161ania\/\u0161t\u00fadie a konania o \u017eiadosti o povolenie klinick\u00e9ho sk\u00fa\u0161ania zdravotn\u00edckej pom\u00f4cky dovtedy za\u010dat\u00e9 a pr\u00e1voplatne neskon\u010den\u00e9 sa dokon\u010dia pod\u013ea predpisov \u00fa\u010dinn\u00fdch do 26. m\u00e1ja 2020.<\/p>\n<p>***<\/p>\n<p>Tento pr\u00e1vny preh\u013ead bol pripraven\u00fd v decembri 2019 v\u00fdlu\u010dne na \u00fa\u010dely poskytnutia v\u0161eobecnej inform\u00e1cie a nem\u00e1 by\u0165 pova\u017eovan\u00fd za pr\u00e1vne poradenstvo. Vy\u0161\u0161ie uveden\u00fd preh\u013ead nie je komplexn\u00fd a iba stru\u010dne sumarizuje pr\u00edslu\u0161n\u00e9 zmeny pr\u00e1vnej \u00fapravy. V pr\u00edpade ak m\u00e1te z\u00e1ujem o podrobnej\u0161ie inform\u00e1cie o vy\u0161\u0161ie uvedenej legislat\u00edvnej zmene, nev\u00e1hajte, pros\u00edm, kontaktova\u0165 ktor\u00fako\u013evek Va\u0161u kontaktn\u00fa osobu v \u010cechov\u00e1 &amp; Partners.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>16. okt\u00f3bra 2019 N\u00e1rodn\u00e1 rada Slovenskej republiky schv\u00e1lila novelu &#8211; z\u00e1kon \u010d. 383\/2019 Z. z., ktorou sa vo viacer\u00fdch podstatn\u00fdch&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"episode_type":"","audio_file":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","date_recorded":"","explicit":"","block":"","itunes_episode_number":"","itunes_title":"","itunes_season_number":"","itunes_episode_type":"","filesize_raw":"","footnotes":""},"categories":["1","2","11","12","20","21","32","33"],"class_list":{"0":"post-2556","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"hentry","6":"category-dalsie-publikacie","8":"category-financial-law-news","9":"category-european-community-law-news","10":"category-aktuality","11":"category-pravne-novinky"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Novela Z\u00e1kona o liekoch \u00fa\u010dinn\u00e1 od 1.1.2020 - \u010cechov\u00e1 &amp; Partners<\/title>\n<meta name=\"description\" content=\"Novela spr\u00eds\u0148uje podmienky v\u00fdvozu kategorizovan\u00fdch liekov, men\u00ed rozsah farmakovigilan\u010dn\u00fdch povinnost\u00ed, konsoliduje pr\u00e1vnu \u00fapravu zdravotn\u00edckych pom\u00f4cok a in\u00e9 \u010diastkov\u00e9 zmeny.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.cechova.sk\/sk\/novela-zakona-o-liekoch-ucinna-od-1-1-2020\/\" \/>\n<meta property=\"og:locale\" content=\"sk_SK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Novela Z\u00e1kona o liekoch \u00fa\u010dinn\u00e1 od 1.1.2020 - \u010cechov\u00e1 &amp; Partners\" \/>\n<meta property=\"og:description\" content=\"Novela spr\u00eds\u0148uje podmienky v\u00fdvozu kategorizovan\u00fdch liekov, men\u00ed rozsah farmakovigilan\u010dn\u00fdch povinnost\u00ed, konsoliduje pr\u00e1vnu \u00fapravu zdravotn\u00edckych pom\u00f4cok a in\u00e9 \u010diastkov\u00e9 zmeny.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.cechova.sk\/sk\/novela-zakona-o-liekoch-ucinna-od-1-1-2020\/\" \/>\n<meta property=\"og:site_name\" content=\"\u010cechov\u00e1 &amp; 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