{"id":3902,"date":"2026-11-03T22:39:24","date_gmt":"2026-11-03T21:39:24","guid":{"rendered":"https:\/\/slovhep.sk\/?p=3902"},"modified":"2026-11-03T22:44:43","modified_gmt":"2026-11-03T21:44:43","slug":"mz-sr-predpisovanie-liekov-mimo-schvalenej-indikacie","status":"publish","type":"post","link":"https:\/\/slovhep.sk\/en\/mz-sr-predpisovanie-liekov-mimo-schvalenej-indikacie","title":{"rendered":"MZ SR zjednocuje postup pri predpisovan\u00ed liekov mimo schv\u00e1lenej indik\u00e1cie"},"content":{"rendered":"<p><strong>Ministerstvo zdravotn\u00edctva SR 30. okt\u00f3bra 2026 informovalo o vydan\u00ed metodick\u00e9ho usmernenia, ktor\u00e9ho cie\u013eom je zjednoti\u0165 postup pri ozna\u010dovan\u00ed predpisovania registrovan\u00fdch hum\u00e1nnych liekov mimo schv\u00e1lenej terapeutickej indik\u00e1cie (tzv. off-label pou\u017eitie).<\/strong><\/p>\n<h2>\u010co sa men\u00ed od 1. novembra 2026?<\/h2>\n<p>Metodick\u00e9 usmernenie MZ SR \u010d. Z074902-2026 z 29. okt\u00f3bra 2026 stanovuje jednotn\u00fd postup pri vyzna\u010dovan\u00ed predp\u00edsania registrovan\u00e9ho hum\u00e1nneho lieku na terapeutick\u00fa indik\u00e1ciu, ktor\u00e1 nie je uveden\u00e1 v rozhodnut\u00ed o jeho registr\u00e1cii. Uplat\u0148uje sa <strong>bez oh\u013eadu na zaradenie lieku do zoznamu kategorizovan\u00fdch liekov (ZKL)<\/strong>.<\/p>\n<ul>\n<li><strong>Elektronick\u00fd recept:<\/strong> predpisuj\u00faci lek\u00e1r uvedie v pozn\u00e1mke preskrip\u010dn\u00e9ho z\u00e1znamu presn\u00fd text <strong>\u201eOFF-LABEL\u201c<\/strong>.<\/li>\n<li><strong>Listinn\u00fd recept:<\/strong> ozna\u010denie <strong>\u201eOFF-LABEL\u201c<\/strong> sa \u010ditate\u013ene uvedie na l\u00edcnej strane v \u010dasti <strong>\u201eRp.\u201c<\/strong>, na samostatnom riadku bezprostredne pod \u00fadajmi o predp\u00edsanom lieku a jeho d\u00e1vkovan\u00ed. Mus\u00ed by\u0165 zrejm\u00e9, ku ktor\u00e9mu lieku patr\u00ed; nesmie zasahova\u0165 do ostatn\u00fdch povinn\u00fdch \u00fadajov ani do priestoru na d\u00e1tum, pe\u010diatku a podpis lek\u00e1ra.<\/li>\n<li><strong>S\u00fabe\u017en\u00e9 vystavenie:<\/strong> ak sa vyhotovuje preskrip\u010dn\u00fd z\u00e1znam aj listinn\u00fd recept, ozna\u010denie treba uvies\u0165 <strong>v oboch<\/strong>.<\/li>\n<\/ul>\n<h2>Zmena \u00a7 46 z\u00e1kona o liekoch<\/h2>\n<p>Od <strong>1. novembra 2026<\/strong> sa z \u00a7 46 ods. 3 z\u00e1kona \u010d. 362\/2011 Z. z. vyp\u00fa\u0161\u0165a p\u00f4vodn\u00e9 p\u00edsmeno a), ktor\u00e9 umo\u017e\u0148ovalo pod\u00e1va\u0165 ministerstvu \u017eiados\u0165 o povolenie terapeutick\u00e9ho alebo diagnostick\u00e9ho pou\u017eitia registrovan\u00e9ho lieku na neschv\u00e1len\u00fa indik\u00e1ciu. P\u00f4vodn\u00e9 p\u00edsmen\u00e1 b) a\u017e e) sa pre\u010d\u00edsluj\u00fa na a) a\u017e d). Pod\u013ea \u010dl\u00e1nku III usmernenia tak od tohto d\u00e1tumu <strong>nie je povinn\u00e9 pod\u00e1va\u0165 ministerstvu \u017eiados\u0165 pod\u013ea p\u00f4vodn\u00e9ho \u00a7 46 ods. 3 p\u00edsm. a)<\/strong>. Postupy povo\u013eovania pod\u013ea ostatn\u00fdch ustanoven\u00ed \u00a7 46 ods. 3 v novom znen\u00ed t\u00fdm nie s\u00fa dotknut\u00e9.<\/p>\n<h2>\u00dahrada z verejn\u00e9ho zdravotn\u00e9ho poistenia<\/h2>\n<p>Samotn\u00e9 ozna\u010denie \u201eOFF-LABEL\u201c <strong>nezaklad\u00e1 n\u00e1rok na \u00fahradu<\/strong> lieku z verejn\u00e9ho zdravotn\u00e9ho poistenia a nenahr\u00e1dza ostatn\u00e9 povinn\u00e9 n\u00e1le\u017eitosti receptu. Ak m\u00e1 by\u0165 takto pou\u017eit\u00fd liek hraden\u00fd z verejn\u00e9ho zdravotn\u00e9ho poistenia, postupuje sa pod\u013ea pr\u00edslu\u0161n\u00fdch ustanoven\u00ed \u00a7 119 ods. 15 p\u00edsm. i) z\u00e1kona \u010d. 362\/2011 Z. z. a z\u00e1kona \u010d. 363\/2011 Z. z. Povinnos\u0165 poda\u0165 pr\u00edslu\u0161nej zdravotnej pois\u0165ovni \u017eiados\u0165 o \u00fahradu, ak ju z\u00e1kon vy\u017eaduje, zost\u00e1va zachovan\u00e1.<\/p>\n<h2>\u010co to znamen\u00e1 pre klinick\u00fa prax?<\/h2>\n<p>Off-label predpisovanie m\u00f4\u017ee by\u0165 relevantn\u00e9 aj v hepatol\u00f3gii a \u010fal\u0161\u00edch \u0161pecializ\u00e1ci\u00e1ch. Predpisuj\u00faci lek\u00e1r mus\u00ed pri registrovanom lieku pou\u017eitom mimo schv\u00e1lenej terapeutickej indik\u00e1cie uvies\u0165 ozna\u010denie \u201eOFF-LABEL\u201c pod\u013ea formy predpisu. Od 1. novembra 2026 sa z\u00e1rove\u0148 men\u00ed postup s\u00favisiaci so \u017eiados\u0165ami ministerstvu pod\u013ea p\u00f4vodn\u00e9ho \u00a7 46 ods. 3 p\u00edsm. a). T\u00e1to zmena v\u0161ak neodstra\u0148uje povinnosti pri \u017eiadostiach o \u00fahradu adresovan\u00fdch zdravotnej pois\u0165ovni.<\/p>\n<p>Pri konkr\u00e9tnom pacientovi je na\u010falej potrebn\u00e9 vych\u00e1dza\u0165 z platnej pr\u00e1vnej \u00fapravy, aktu\u00e1lneho znenia metodick\u00e9ho usmernenia a odbornej dokument\u00e1cie k lieku.<\/p>\n<h2>Zdroj a \u010fal\u0161ie inform\u00e1cie<\/h2>\n<p>Ministerstvo zdravotn\u00edctva SR: <a href=\"https:\/\/www.mzsr.sk\/Clanok?MZSR-vydava-MU-predpisovanie-liekov-mimo-schvalenej-terapeutickej-indikacie\" target=\"_blank\" rel=\"noopener noreferrer\">Ofici\u00e1lne ozn\u00e1menie MZ SR<\/a> (30. 10. 2026).<\/p>\n<p><strong>\u00dapln\u00e9 znenie dokumentu:<\/strong> <a href=\"https:\/\/www.mzsr.sk\/Zdroje?\/Sources\/dokumenty\/farmacia\/MU-predpisovanie-liekov-mimo-schvalenej-terapeutickej-indikacie.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Metodick\u00e9 usmernenie MZ SR \u010d. Z074902-2026 (PDF)<\/a>, vydan\u00e9 29. 10. 2026, \u00fa\u010dinn\u00e9 od 1. 11. 2026.<\/p>\n<p><em>Redak\u010dn\u00e1 pozn\u00e1mka: \u010cl\u00e1nok stru\u010dne sumarizuje metodick\u00e9 usmernenie; pre presn\u00e9 znenie povinnost\u00ed a ich aplik\u00e1ciu je rozhoduj\u00faci origin\u00e1lny dokument a \u00fa\u010dinn\u00e9 pr\u00e1vne predpisy.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ministerstvo zdravotn\u00edctva vydalo metodick\u00e9 usmernenie k jednotn\u00e9mu ozna\u010dovaniu predpisovania registrovan\u00fdch liekov mimo schv\u00e1lenej terapeutickej indik\u00e1cie v elektronick\u00fdch a listinn\u00fdch receptoch.<\/p>\n","protected":false},"author":247,"featured_media":3905,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[6],"tags":[],"class_list":["post-3902","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pre-verejnost"],"_links":{"self":[{"href":"https:\/\/slovhep.sk\/en\/wp-json\/wp\/v2\/posts\/3902","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/slovhep.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/slovhep.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/slovhep.sk\/en\/wp-json\/wp\/v2\/users\/247"}],"replies":[{"embeddable":true,"href":"https:\/\/slovhep.sk\/en\/wp-json\/wp\/v2\/comments?post=3902"}],"version-history":[{"count":4,"href":"https:\/\/slovhep.sk\/en\/wp-json\/wp\/v2\/posts\/3902\/revisions"}],"predecessor-version":[{"id":3908,"href":"https:\/\/slovhep.sk\/en\/wp-json\/wp\/v2\/posts\/3902\/revisions\/3908"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/slovhep.sk\/en\/wp-json\/wp\/v2\/media\/3905"}],"wp:attachment":[{"href":"https:\/\/slovhep.sk\/en\/wp-json\/wp\/v2\/media?parent=3902"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/slovhep.sk\/en\/wp-json\/wp\/v2\/categories?post=3902"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/slovhep.sk\/en\/wp-json\/wp\/v2\/tags?post=3902"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}