{"id":114,"date":"2020-01-20T14:48:10","date_gmt":"2020-01-20T13:48:10","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=114"},"modified":"2026-01-23T12:31:39","modified_gmt":"2026-01-23T11:31:39","slug":"pouzitie-neregistrovaneho-vl-v-osobitych-pripadoch","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=114","title":{"rendered":"POU\u017dITIE NEREGISTROVAN\u00ddCH VETERIN\u00c1RNYCH LIEKOV V OSOBIT\u00ddCH PR\u00cdPADOCH \u2013 DOSTUPNOS\u0164 LIEKOV"},"content":{"rendered":"\n<p><\/p>\n\n\n\n<p>Pod\u013ea z\u00e1kona 362\/2011 Z.z. o liekoch a zdravotn\u00edckych pom\u00f4ckach mo\u017eno hromadne vyr\u00e1ban\u00fd veterin\u00e1rny liek uvies\u0165 na trh Slovenskej republiky len na z\u00e1klade povolenia na uvedenie na trh (registr\u00e1cia). V&nbsp;pr\u00edpadoch kedy adekv\u00e1tny registrovan\u00fd liek nie je dostupn\u00fd (napr. pri v\u00fdpadku vo v\u00fdrobe pri\u010dom adekv\u00e1tna n\u00e1hrada za liek nie registrovan\u00e1 at\u010f.) m\u00f4\u017ee \u00da\u0160KVBL na prechodn\u00e9 obdobie povoli\u0165 pou\u017eitie neregistrovan\u00e9ho lieku.<br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><span class=\"has-inline-color has-blue-color\">Mimoriadne&nbsp;pou\u017eitie neregistrovan\u00e9ho veterin\u00e1rneho lieku<\/span><\/strong><\/h3>\n\n\n\n<p>V zmysle \u00a7 84 ods. 3 a ods. 4 a \u00a7 134 ods. 2 p\u00edsm. f) \u00da\u0160KVBL povo\u013euje mimoriadne pou\u017eitie veterin\u00e1rnych liekov (a s t\u00fdm s\u00favisiaci dovoz), pre:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>veterin\u00e1rne lieky ur\u010den\u00e9 na v\u00fdskum a v\u00fdvoj,<\/li>\n\n\n\n<li>imunologick\u00e9 veterin\u00e1rne lieky, ktor\u00e9 nie s\u00fa registrovan\u00e9 v Eur\u00f3pskej \u00fanii, ur\u010den\u00e9 na podanie v pr\u00edpade prepuknutia novej choroby* alebo choroby pod\u013ea osobitn\u00e9ho predpisu* ak nie s\u00fa k dispoz\u00edcii veterin\u00e1rne lieky pod\u013ea bodu d)<\/li>\n\n\n\n<li>imunologick\u00e9 veterin\u00e1rne lieky, ktor\u00e9 nie s\u00fa k dispoz\u00edcii v r\u00e1mci Eur\u00f3pskej \u00fanie na chorobu, ktor\u00e1 nie je novou chorobou* alebo chorobou pod\u013ea osobitn\u00e9ho predpisu* ale ktor\u00e1 sa u\u017e v Eur\u00f3pskej \u00fanii vyskytuje, ak ide o individu\u00e1lne pr\u00edpady v z\u00e1ujme zdravia zvierat, dobr\u00fdch \u017eivotn\u00fdch podmienok zvierat a verejn\u00e9ho zdravia,<\/li>\n\n\n\n<li>veterin\u00e1rne lieky registrovan\u00e9 v inom \u010dlenskom \u0161t\u00e1te, ak v Slovenskej republike nie s\u00fa dostupn\u00e9 porovnate\u013en\u00e9 registrovan\u00e9 veterin\u00e1rne lieky, ktor\u00e9 s\u00fa ur\u010den\u00e9 na podanie pre jednotliv\u00e9 zviera alebo skupinu zvierat, ak si to vy\u017eaduje zdravotn\u00fd stav zviera\u0165a alebo stav verejn\u00e9ho zdravia,<\/li>\n\n\n\n<li>Pri v\u00fdvoze zviera\u0165a do tretieho \u0161t\u00e1tu m\u00f4\u017ee \u00fastav kontroly veterin\u00e1rnych lie\u010div povoli\u0165 pou\u017e\u00edvanie neregistrovan\u00e9ho imunologick\u00e9ho veterin\u00e1rneho lieku pre jednotliv\u00e9 zviera, ak je tento liek registrovan\u00fd v tre\u0165om \u0161t\u00e1te.<\/li>\n<\/ul>\n\n\n\n<p>*\u010cl. 5 a \u010dl. 6 nariadenia (E\u00da) 2016\/429<\/p>\n\n\n\n<p>Pou\u017eitie neregistrovan\u00fdch veterin\u00e1rnych liekov povo\u013euje \u00da\u0160KVBL na z\u00e1klade \u017eiadosti. Rozhodnutie \u00da\u0160KVBL vyd\u00e1va po uhraden\u00ed poplatku.<br><\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-e6412708-b0fa-48a0-ab15-d56b7884cd8d\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/ziadost_o_md_farmaceutickych_vet_liekov.docx\">\u017diados\u0165 o&nbsp;povolenie pou\u017eitia neregistrovan\u00e9ho veterin\u00e1rneho lieku (in\u00e9 ako imunologick\u00e9 lieky)<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-90f1a6ea-4140-4715-9ad8-fecc34e24c8f\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/ziadost_o_povolenie_pouzitia_-nereg_imunologic.docx\">\u017diados\u0165 o&nbsp;povolenie dovozu a pou\u017eitia neregistrovan\u00e9ho Imunologick\u00e9ho veterin\u00e1rneho lieku<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-dde630b7-9d79-4236-a12e-b49a0db703d3\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/ziadost_o_md_premixu_vo_forme_MK.docx\">\u017diados\u0165 o&nbsp;povolenie dovozu a pou\u017eitia neregistrovan\u00e9ho veterin\u00e1rneho lieku vo forme medikovan\u00e9ho krmiva (mk)<\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><span class=\"has-inline-color has-blue-color\">Povolenie pou\u017eitia veterin\u00e1rnej autog\u00e9nnej vakc\u00edny<\/span><\/strong><\/h3>\n\n\n\n<p>V zmysle \u00a7 84 ods. 2 p\u00edsm. h), a \u00a7 134 ods. 2 p\u00edsm. f) \u00da\u0160KVBL povo\u013euje mimoriadne pou\u017eitie inaktivovan\u00fdch imunologick\u00fdch veterin\u00e1rnych liekov, ktor\u00e9 sa vyr\u00e1baj\u00fa z patog\u00e9nov a antig\u00e9nov z\u00edskan\u00fdch zo zviera\u0165a alebo zvierat v epidemiologickej jednotke a pou\u017e\u00edvaj\u00fa sa na lie\u010denie tohto zviera\u0165a alebo t\u00fdchto zvierat v rovnakej epidemiologickej jednotke alebo na lie\u010denie zviera\u0165a alebo zvierat v jednotke, ktor\u00e1 m\u00e1 potvrden\u00fa epidemiologick\u00fa s\u00favislos\u0165. Pou\u017eitie autog\u00e9nnej vakc\u00edny mo\u017eno povoli\u0165 len v&nbsp;pr\u00edpade nedostupnosti registrovan\u00e9ho imunologick\u00e9ho veterin\u00e1rneho lieku (\u010dl 106 ods.5 nariadenia (E\u00da) 2019\/6.).<\/p>\n\n\n\n<p>Pou\u017eitie autog\u00e9nnej vakc\u00edny povo\u013euje \u00da\u0160KVBL na z\u00e1klade \u017eiadosti. Rozhodnutie \u00da\u0160KVBL vyd\u00e1va po uhraden\u00ed poplatku.<br><\/p>\n\n\n\n<p>V\u00fdroba, dovoz, distrib\u00facia, predpisovanie, kontrola a pou\u017e\u00edvanie veterin\u00e1rnych autog\u00e9nnych vakc\u00edn sa riadi nariaden\u00edm (E\u00da) 2019\/6 a z\u00e1konom 362\/2011 v aktu\u00e1lnom znen\u00ed)<\/p>\n\n\n\n<p><em>Nahlasovanie dovozu autog\u00e9nnej vakc\u00edny \u2013 zasielanie analytick\u00fdch certifik\u00e1tov:&nbsp;<\/em><\/p>\n\n\n\n<p>Po ukon\u010den\u00ed v\u0161etk\u00fdch kontroln\u00fdch testov a pred resp. s\u00fa\u010dasne s&nbsp;dodan\u00edm autog\u00e9nnej vakc\u00edny veterin\u00e1rnemu lek\u00e1rovi mus\u00ed jej v\u00fdrobca predlo\u017ei\u0165 na \u00da\u0160KVBL analytick\u00fd certifik\u00e1t prepustenej \u0161ar\u017ee. \u0160ar\u017ea produktu ktor\u00e1 nevyhovela po\u017eiadavke na prepustenie nem\u00f4\u017ee by\u0165 uvo\u013enen\u00e1 na trh.&nbsp;<\/p>\n\n\n\n<p>Analytick\u00e9 certifik\u00e1ty zasielajte elektronicky<\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-6ffe0192-4ac8-4c11-88d6-659bb69a2d33\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/ziadost_o_povolenie_pouzitia_autogennej_vakciny.docx\">\u017diados\u0165 o\u00a0povolenie pou\u017eitia autog\u00e9nnej vakc\u00edny<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-20eba790-acc8-49bf-84be-f249209fd17e\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/lekarsky_predpis_na_vyrobu_autogennej_vakciny.docx\">Veterin\u00e1rny predpis na v\u00fdrobu veterin\u00e1rnej autog\u00e9nnej vakc\u00edny<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-7d3f3597-2e38-44be-8375-e56935d9885b\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/vzor_pisomnej_informacie_pre_pouzivatelov_autogennej_vakciny.docx\">Vzor p\u00edsomnej inform\u00e1cie pre pou\u017e\u00edvate\u013eov pre veterin\u00e1rne autog\u00e9nne vakc\u00edny<\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><span style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">In\u00e9 \u017eiadosti o&nbsp;povolenie mimoriadneho pou\u017eitia registrovan\u00e9ho veterin\u00e1rneho lieku<\/span><\/strong><\/h3>\n\n\n\n<p>In\u00e9 \u017eiadosti o&nbsp;povolenie mimoriadneho pou\u017eitia veterin\u00e1rneho lieku&nbsp; je vhodn\u00e9 vopred konzultova\u0165 s&nbsp;pracovn\u00edkom odboru in\u0161pekcie (farmaceutik\u00e1) resp. ved\u00facim odboru bioprepar\u00e1tov (imunologick\u00e9 veterin\u00e1rne lieky).<\/p>\n\n\n\n<p>Pou\u017eitie veterin\u00e1rnych liekov povo\u013euje \u00da\u0160KVBL na z\u00e1klade \u017eiadosti fyzickej osoby alebo pr\u00e1vnickej osoby po uhraden\u00ed poplatku.<strong>&nbsp;<\/strong><br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pod\u013ea z\u00e1kona 362\/2011 Z.z. o liekoch a zdravotn\u00edckych pom\u00f4ckach mo\u017eno hromadne vyr\u00e1ban\u00fd veterin\u00e1rny liek uvies\u0165 na trh Slovenskej republiky len na z\u00e1klade povolenia na uvedenie na trh (registr\u00e1cia). V&nbsp;pr\u00edpadoch kedy adekv\u00e1tny registrovan\u00fd liek nie je dostupn\u00fd (napr. pri v\u00fdpadku vo &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=114\">Pokra\u010dova\u0165 v \u010d\u00edtan\u00ed <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-114","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/114","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=114"}],"version-history":[{"count":25,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/114\/revisions"}],"predecessor-version":[{"id":9451,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/114\/revisions\/9451"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=114"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}