{"id":4490,"date":"2023-07-03T19:08:25","date_gmt":"2023-07-03T17:08:25","guid":{"rendered":"http:\/\/www.cechova.sk\/?p=4490"},"modified":"2023-07-03T19:08:25","modified_gmt":"2023-07-03T17:08:25","slug":"zmeny-v-liekovych-predpisoch-od-1-augusta-2023","status":"publish","type":"post","link":"https:\/\/www.cechova.sk\/sk\/zmeny-v-liekovych-predpisoch-od-1-augusta-2023\/","title":{"rendered":"Zmeny v liekov\u00fdch predpisoch od 1. augusta 2023"},"content":{"rendered":"<p>Z\u00e1kon o\u00a0liekoch a\u00a0s\u00favisiace predpisy \u010dakaj\u00fa v\u00fdznamn\u00e9 zmeny. Rozhodol o\u00a0tom parlament, ktor\u00fd 28. j\u00fana 2023 s\u00a0r\u00f4znymi \u00fapravami schv\u00e1lil dlho pripravovan\u00fd vl\u00e1dny n\u00e1vrh novely farmaceutick\u00fdch z\u00e1konov. Ak prezidentka z\u00e1kon podp\u00ed\u0161e, farmaceutick\u00fd priemysel sa bude musie\u0165 pripravi\u0165 na zmeny okrem niektor\u00fdch v\u00fdnimiek u\u017e od 1. augusta 2023. Stru\u010dn\u00fd sum\u00e1r najv\u00fdznamnej\u0161\u00edch zmien prin\u00e1\u0161ame v\u00a0tomto \u010dl\u00e1nku.<\/p>\n<ul>\n<li><strong>Nekomer\u010dn\u00e9 klinick\u00e9 sk\u00fa\u0161anie<\/strong>: Z\u00e1kon zav\u00e1dza nov\u00fd druh klinick\u00e9ho sk\u00fa\u0161ania, ktor\u00e9ho cie\u013eom je zv\u00fd\u0161i\u0165 podiel tzv. \u201einvestigator initiated studies\u201c spomedzi klinick\u00fdch sk\u00fa\u0161an\u00ed, ktor\u00fd na Slovensku oproti priemeru E\u00da v\u00fdrazne zaost\u00e1va. Poplatok za \u017eiados\u0165 o\u00a0povolenie nekomer\u010dn\u00e9ho klinick\u00e9ho bude iba p\u00e4\u0165 eur. Aby mohlo klinick\u00e9 sk\u00fa\u0161anie benefitova\u0165 zo zn\u00ed\u017een\u00e9ho poplatku, zad\u00e1vate\u013eom bude m\u00f4c\u0165 iba vysok\u00e1 \u0161kola, nemocnica, verejn\u00e1 v\u00fdskumn\u00e1 in\u0161tit\u00facia, neziskov\u00e1 organiz\u00e1cia, pacientska organiz\u00e1cia alebo individu\u00e1lny v\u00fdskumn\u00edk, a\u00a0z\u00e1rove\u0148 nesmie by\u0165 uzavret\u00e1 zmluva medzi zad\u00e1vate\u013eom a tre\u0165ou stranou, ktor\u00e1 by povo\u013eovala pou\u017eitie \u00fadajov na obchodn\u00fd cie\u013e.<\/li>\n<li><strong>Zmeny v\u00a0off-label a\u00a0pre-label lie\u010dbe<\/strong>: Novela roz\u0161iruje mo\u017enosti povolenia neregistrovan\u00e9ho lieku na sk\u00fa\u0161an\u00fd liek pre pacientov, ktor\u00ed neboli \u00fa\u010dastn\u00edkmi klinick\u00e9ho sk\u00fa\u0161ania, ak u\u017e bola podan\u00e1 \u017eiados\u0165 o\u00a0registr\u00e1ciu v\u00a0E\u00da alebo SR. Povolenia sa bud\u00fa po novom vyd\u00e1va\u0165 nielen na terapeutick\u00e9, ale aj diagnostick\u00e9 pou\u017eitie lieku. Pou\u017eitie biologick\u00e9ho lieku bude m\u00f4c\u0165 Ministerstvo zdravotn\u00edctva povoli\u0165 aj z\u00e1rove\u0148 s\u00a0ak\u00fdmko\u013evek biologicky podobn\u00fdm liekom. \u010eal\u0161ou novinkou je mo\u017enos\u0165 po\u017eiada\u0165 o\u00a0terapeutick\u00e9 alebo diagnostick\u00e9 povolenie neregistrovan\u00e9ho lieku alebo v\u00a0off-label pou\u017eitie v\u00a0r\u00e1mci tzv. lie\u010debn\u00e9ho programu, ktor\u00fd bude povo\u013eova\u0165 Ministerstvo zdravotn\u00edctva po vyjadren\u00ed \u0160\u00daKL. \u017diadate\u013e o\u00a0povolenie lie\u010debn\u00e9ho programu bude po jeho povolen\u00ed povinn\u00fd plni\u0165 viacer\u00e9 podmienky, vr\u00e1tane povinnosti zabezpe\u010di\u0165 liek pre \u00fa\u010dastn\u00edkov programu na vlastn\u00e9 n\u00e1klady, a\u00a0to nielen po\u010das trvania lie\u010debn\u00e9ho programu, ale aj po jeho skon\u010den\u00ed, a\u00a0to aj po registr\u00e1cii lieku, a\u017e do ukon\u010denia lie\u010dby.<\/li>\n<li><strong>O\u010dkovanie v\u00a0lek\u00e1r\u0148ach<\/strong>: Novela umo\u017e\u0148uje od roku 2024 vykon\u00e1vanie o\u010dkovania v\u00a0lek\u00e1r\u0148ach, av\u0161ak iba v\u00a0obmedzenom rozsahu. Povolen\u00e9 bude iba o\u010dkovanie os\u00f4b star\u0161\u00edch ako 18 rokov proti chr\u00edpke na p\u00edsomn\u00e9 odpor\u00fa\u010danie lek\u00e1ra, ktor\u00e9 nesmie by\u0165 star\u0161ie ako tri dni.<\/li>\n<li><strong>Zmeny v\u00a0internetovom v\u00fddaji<\/strong>: Zav\u00e1dza sa mo\u017enos\u0165 internetov\u00e9ho v\u00fddaja liekov pomocou mobilnej aplik\u00e1cie. Bude v\u0161ak plati\u0165 iba pre lek\u00e1rne, ktor\u00e9 uskuto\u010d\u0148uj\u00fa internetov\u00fd v\u00fddaj pomocou webovej str\u00e1nky. Internetov\u00fd v\u00fddaj iba pomocou aplik\u00e1cie bez webovej str\u00e1nky teda nebude mo\u017en\u00fd.<\/li>\n<li><strong>Zmeny v\u00a0predpisovan\u00ed liekov<\/strong>: Najd\u00f4le\u017eitej\u0161ou zmenou je n\u00e1vrat tzv. delegovanej preskripcie, t.j. opr\u00e1vnenia v\u0161eobecn\u00e9ho lek\u00e1ra alebo pediatra predp\u00edsa\u0165 liek na odpor\u00fa\u010danie \u0161pecialistu. Odpor\u00fa\u010danie mus\u00ed by\u0165 uveden\u00e9 v\u00a0elektronickej zdravotnej kni\u017eke, lek\u00e1rskej spr\u00e1ve alebo prep\u00fa\u0161\u0165acej spr\u00e1ve z\u00a0nemocnice, a\u00a0bude musie\u0165 obsahova\u0165 lehotu, po\u010das ktorej plat\u00ed. T\u00e1to lehota bude, okrem nieko\u013ek\u00fdch v\u00fdnimiek, najviac \u0161es\u0165 mesiacov pri odpor\u00fa\u010dan\u00ed ambulantn\u00e9ho \u0161pecialistu a\u00a0tri mesiace pri prepusten\u00ed z\u00a0nemocnice. Za v\u00fdber lieku bude zodpoveda\u0165 \u0161pecialista, ktor\u00fd vystavil odpor\u00fa\u010danie.<\/li>\n<\/ul>\n<p>Pri prepusten\u00ed z\u00a0\u00fastavnej starostlivosti bude nemocnica musie\u0165 predp\u00edsa\u0165 pacientovi liek v po\u010dte balen\u00ed potrebnom na lie\u010dbu. Ak m\u00e1 lie\u010dba trva\u0165 viac ako 28 dn\u00ed, liek sa predp\u00ed\u0161e najmenej na t\u00fato dobu. Ambulantn\u00fd lek\u00e1r bude v\u017edy povinn\u00fd prep\u00edsa\u0165 liek, ktor\u00fd indikoval. Lek\u00e1r v\u00a0nemocnici bude m\u00f4c\u0165 predpisovan\u00edm poveri\u0165 aj in\u00e9ho lek\u00e1ra zamestnan\u00e9ho v\u00a0rovnakej nemocnici, bude v\u0161ak na\u010falej zodpoveda\u0165 za v\u00fdber lieku.<\/p>\n<ul>\n<li><strong>Nadob\u00fadanie liekov \u0161t\u00e1tom<\/strong>: Roz\u0161\u00edrenie mo\u017enosti Ministerstva zdravotn\u00edctva obstar\u00e1va\u0165 lieky a\u00a0zdravotn\u00edcke pom\u00f4cky pre poskytovate\u013eov zdravotnej starostlivosti aj mimo kr\u00edzovej situ\u00e1cie sa do schv\u00e1lenej verzie z\u00e1kona nedostalo. Ministerstvo v\u0161ak bude m\u00f4c\u0165 nadob\u00fada\u0165 lieky a\u00a0pom\u00f4cky aj in\u00fdm sp\u00f4sobom, napr\u00edklad darovan\u00edm, pokia\u013e trv\u00e1 kr\u00edzov\u00e1 situ\u00e1cia.<\/li>\n<li><strong>Zmeny v\u00a0\u010dinnosti odborn\u00fdch z\u00e1stupcov<\/strong>: Odborn\u00fd z\u00e1stupca dr\u017eite\u013ea s dvomi miestami v\u00fdkonu \u010dinnosti bude m\u00f4c\u0165 p\u00f4sobi\u0165 na\u00a0obidvoch miestach, ak sa ich prev\u00e1dzkov\u00e9 \u010dasy neprekr\u00fdvaj\u00fa. Pri lek\u00e1r\u0148ach bude m\u00f4c\u0165 jeden z\u00e1stupca zastre\u0161ova\u0165 dve miesta v\u00fdkonu \u010dinnosti aj pri prekryt\u00ed ich prev\u00e1dzkov\u00fdch \u010dasov.<\/li>\n<li><strong>Zmeny v Z\u00e1kone o \u00fahrad\u00e1ch<\/strong>: Zav\u00e1dza sa mno\u017estvo drobn\u00fdch, ale v\u00fdznamn\u00fdch zmien v\u00a0Z\u00e1kone o\u00a0rozsahu a\u00a0sp\u00f4sobe \u00fahrady liekov:\n<ul>\n<li>Odstra\u0148uje sa rozpor medzi podmienkami na v\u00fdnimku z\u00a0n\u00e1kladovej efekt\u00edvnosti;<\/li>\n<li>Ochrana ustanoven\u00ed zml\u00fav o\u00a0podmienkach \u00fahrady liekov pred spr\u00edstupnen\u00edm a\u00a0zverejnen\u00edm sa\u00a0roz\u0161iruje na dojednanie o\u00a0z\u013eave;<\/li>\n<li>Zav\u00e1dza sa mo\u017enos\u0165 vyradenia lieku bez generick\u00fdch alebo biologicky podobn\u00fdch alternat\u00edv, ak \u00fahrada za\u0148 za 12 mesiacov prekro\u010dila 1,5 mili\u00f3na eur a\u00a0dr\u017eite\u013e registr\u00e1cie neuzatvoril s\u00a0Ministerstvom zdravotn\u00edctva zmluvu o\u00a0podmienkach \u00fahrady, a\u00a0to aj ke\u010f k\u00a0prekro\u010deniu 1,5-mili\u00f3nov\u00e9ho limitu d\u00f4jde po uplynut\u00ed prv\u00fdch troch rokov od zaradenia;<\/li>\n<li>Roz\u0161iruj\u00fa sa mo\u017enosti pre osobitn\u00fa cenov\u00fa regul\u00e1ciu, \u010do m\u00e1 umo\u017eni\u0165 zaradenie alebo n\u00e1vrat najm\u00e4 star\u0161\u00edch molek\u00fal do kategoriz\u00e1cie;<\/li>\n<li>Zmluva o\u00a0podmienkach \u00fahrady bude pri orphan liekoch a ATMP povinn\u00e1 iba ak sa zara\u010fuj\u00fa alebo sa roz\u0161iruje ich indika\u010dn\u00e9 alebo preskrip\u010dn\u00e9 obmedzenie na z\u00e1klade zv\u00fd\u0161enej prahovej hodnoty alebo v\u00fdnimky z\u00a0n\u00e1kladovej efekt\u00edvnosti. Rovnak\u00fd princ\u00edp bude plati\u0165 pri povinnosti predlo\u017ei\u0165 farmako-ekonomick\u00fd rozbor po strate orphan statusu;<\/li>\n<li>\u0160tandardn\u00e1 \u0161tvr\u0165ro\u010dn\u00e1 rev\u00edzia \u00fahrad sa nevykon\u00e1, k\u00fdm prv\u00fd generick\u00fd alebo biologicky podobn\u00fd liek nebude uveden\u00fd na trh;<\/li>\n<li>Limit v\u00fddavkov na lieky uhraden\u00e9 na v\u00fdnimku na aktu\u00e1lny rok sa od 1. augusta 2023 nebude uplat\u0148ova\u0165. V\u00a0roku 2024 bude plati\u0165 limit 3,9 %, v\u00a0roku 2025 limit 2,9 %, a\u00a0a\u017e od roku 2026 limit 1,9 %.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>Pre viac inform\u00e1ci\u00ed pros\u00edm kontaktujte na\u0161ich odborn\u00edkov na farmaceutick\u00e9 pr\u00e1vo Marka Holku (<a href=\"mailto:marek.holka@cechova.sk\">marek.holka@cechova.sk<\/a>) a Tom\u00e1\u0161a Ryb\u00e1ra (<a href=\"mailto:tomas.rybar@cechova.sk\">tomas.rybar@cechova.sk<\/a>).<\/p>\n<p style=\"text-align: center;\">***<\/p>\n<p><em>Tento s\u00fahrn bol pripraven\u00fd v\u00a0j\u00fali 2023 v\u00fdlu\u010dne za \u00fa\u010delom poskytnutia v\u0161eobecnej inform\u00e1cie a\u00a0nepredstavuje pr\u00e1vne poradenstvo. Uveden\u00fd s\u00fahrn nie je komplexn\u00fd a\u00a0poskytuje iba stru\u010dn\u00fd sum\u00e1r podstatn\u00fdch zmien v\u00a0z\u00e1konoch. V\u00a0pr\u00edpade ak\u00fdchko\u013evek ot\u00e1zok n\u00e1s nev\u00e1hajte kontaktova\u0165.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Z\u00e1kon o\u00a0liekoch a\u00a0s\u00favisiace predpisy \u010dakaj\u00fa v\u00fdznamn\u00e9 zmeny. Rozhodol o\u00a0tom parlament, ktor\u00fd 28. j\u00fana 2023 s\u00a0r\u00f4znymi \u00fapravami schv\u00e1lil dlho pripravovan\u00fd vl\u00e1dny&#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-4490","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>Zmeny v liekov\u00fdch predpisoch od 1. augusta 2023 - \u010cechov\u00e1 &amp; Partners<\/title>\n<meta name=\"description\" content=\"Z\u00e1kon o\u00a0liekoch a\u00a0s\u00favisiace predpisy \u010dakaj\u00fa v\u00fdznamn\u00e9 zmeny. Rozhodol o\u00a0tom parlament, ktor\u00fd 28.6.2023 schv\u00e1lil vl\u00e1dny n\u00e1vrh novely farmaceutick\u00fdch z\u00e1konov.\" \/>\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\/changes-in-the-pharmaceutical-laws-from-1-august-2023\/\" \/>\n<meta property=\"og:locale\" content=\"sk_SK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zmeny v liekov\u00fdch predpisoch od 1. augusta 2023 - \u010cechov\u00e1 &amp; Partners\" \/>\n<meta property=\"og:description\" content=\"Z\u00e1kon o\u00a0liekoch a\u00a0s\u00favisiace predpisy \u010dakaj\u00fa v\u00fdznamn\u00e9 zmeny. Rozhodol o\u00a0tom parlament, ktor\u00fd 28.6.2023 schv\u00e1lil vl\u00e1dny n\u00e1vrh novely farmaceutick\u00fdch z\u00e1konov.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.cechova.sk\/changes-in-the-pharmaceutical-laws-from-1-august-2023\/\" \/>\n<meta property=\"og:site_name\" content=\"\u010cechov\u00e1 &amp; Partners\" \/>\n<meta property=\"article:published_time\" content=\"2023-07-03T17:08:25+00:00\" \/>\n<meta name=\"author\" content=\"cechova\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Autor\" \/>\n\t<meta name=\"twitter:data1\" content=\"cechova\" \/>\n\t<meta name=\"twitter:label2\" content=\"Predpokladan\u00fd \u010das \u010d\u00edtania\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 min\u00faty\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.cechova.sk\/changes-in-the-pharmaceutical-laws-from-1-august-2023\/\",\"url\":\"https:\/\/www.cechova.sk\/changes-in-the-pharmaceutical-laws-from-1-august-2023\/\",\"name\":\"Zmeny v liekov\u00fdch predpisoch od 1. augusta 2023 - \u010cechov\u00e1 &amp; Partners\",\"isPartOf\":{\"@id\":\"https:\/\/www.cechova.sk\/#website\"},\"datePublished\":\"2023-07-03T17:08:25+00:00\",\"author\":{\"@id\":\"https:\/\/www.cechova.sk\/#\/schema\/person\/0815c9b657126cba96d63fbe4eabd0a8\"},\"description\":\"Z\u00e1kon o\u00a0liekoch a\u00a0s\u00favisiace predpisy \u010dakaj\u00fa v\u00fdznamn\u00e9 zmeny. 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