{"id":98,"date":"2020-01-20T14:44:28","date_gmt":"2020-01-20T13:44:28","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=98"},"modified":"2025-11-18T10:59:37","modified_gmt":"2025-11-18T09:59:37","slug":"uvedenia-prerusenia-a-zruseia-dodavok-vet-liekov-v-sr","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=98","title":{"rendered":"V\u00ddROBA, DOVOZ ALEBO DISTRIB\u00daCIA VETERIN\u00c1RNEJ \u00da\u010cINNEJ L\u00c1TKY"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Z\u00e1kladn\u00e9 pojmy<\/mark><\/strong><\/h3>\n\n\n\n<p>\u201e\u00da\u010dinn\u00e1 l\u00e1tka\u201c je ak\u00e1ko\u013evek l\u00e1tka alebo zmes l\u00e1tok ur\u010den\u00e1 na pou\u017eitie pri v\u00fdrobe veterin\u00e1rneho lieku, ktor\u00e1 sa pri jeho v\u00fdrobe stane \u00fa\u010dinnou zlo\u017ekou tohto lieku (\u010dl. 4 ods. 3 nariadenia E\u00da 2019\/6).<\/p>\n\n\n\n<p>\u00da\u010dinn\u00e1 l\u00e1tka mus\u00ed by\u0165 vyroben\u00e1 v&nbsp;s\u00falade s&nbsp;po\u017eiadavkami spr\u00e1vnej v\u00fdrobnej praxe a&nbsp;distribuovan\u00e1 v&nbsp;s\u00falade s&nbsp;po\u017eiadavkami spr\u00e1vnej ve\u013ekodistribu\u010dnej praxe alebo spr\u00e1vnej distribu\u010dnej praxe pre veterin\u00e1rne lieky (\u00a7 12a ods. 1 z\u00e1kona 362\/2011 Z.z.).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">S\u00favisiaca legislat\u00edva<\/mark><\/strong><\/h3>\n\n\n\n<p><a href=\"https:\/\/www.zakonypreludi.sk\/zz\/2011-362\" target=\"_blank\" rel=\"noreferrer noopener\">Z\u00e1kon \u010d. 362\/2011 Z. z. o liekoch a zdravotn\u00edckych pom\u00f4ckach a o zmene a doplnen\u00ed niektor\u00fdch z\u00e1konov (\u010falej ako \u201ez\u00e1kon o liekoch\u201c)<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/SK\/TXT\/PDF\/?uri=CELEX:32019R0006&amp;from=EN\" target=\"_blank\" rel=\"noreferrer noopener\">\u010cl\u00e1nok 95 nariadenie Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6 o&nbsp;veterin\u00e1rnych liekoch a o zru\u0161en\u00ed smernice 2001\/82\/ES<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en\" target=\"_blank\" rel=\"noreferrer noopener\">Usmernenie Eur\u00f3pskej komisie a Eur\u00f3pskej agent\u00fary pre lieky (EMA) pre SVP<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/2014-08_gmp_part1_0.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">EudraLex \u2013 Volume 4, Part II &#8211; Basic Requirements for Active Substances used as Starting Materials<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32021R1280\" target=\"_blank\" rel=\"noreferrer noopener\">Vykon\u00e1vacie nariadenie Komisie (E\u00da) 2021\/1280 o z\u00e1sad\u00e1ch spr\u00e1vnej distribu\u010dnej praxe, pokia\u013e ide o \u00fa\u010dinn\u00e9 l\u00e1tky pou\u017eit\u00e9 do liekov na veterin\u00e1rne pou\u017eitie<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/compliance-research-development\/good-manufacturing-practice\/compilation-union-procedures-inspections-exchange-information\" target=\"_blank\" rel=\"noreferrer noopener\">Compilation of Union Procedures on Inspections and Exchange of Information<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">P\u00f4sobnos\u0165 U\u0160KVBL v&nbsp;oblasti v\u00fdroby, dovozu a&nbsp;distrib\u00facie \u00fa\u010dinn\u00fdch l\u00e1tok<\/mark><\/strong><\/h3>\n\n\n\n<p>\u00dastav \u0161t\u00e1tnej kontroly veterin\u00e1rnych bioprepar\u00e1tov a lie\u010div pod\u013ea \u00a7 134 ods. 2 z\u00e1kona 362\/2011 Z.z. :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>p\u00edsmeno a) &nbsp;vykon\u00e1va \u0161t\u00e1tny dozor na \u00faseku veterin\u00e1rnej farm\u00e1cie pod\u013ea tohto z\u00e1kona a osobitn\u00e9ho predpisu&nbsp;pri \u010dinnostiach spojen\u00fdch s dovozom \u00fa\u010dinn\u00fdch l\u00e1tok, v\u00fdrobou \u00fa\u010dinn\u00fdch l\u00e1tok a distrib\u00faciou \u00fa\u010dinn\u00fdch l\u00e1tok<\/li>\n\n\n\n<li>p\u00edsmeno b)&nbsp; vykon\u00e1va in\u0161pekciu dodr\u017eiavania z\u00e1sad spr\u00e1vnej v\u00fdrobnej praxe, spr\u00e1vnej distribu\u010dnej praxe pre veterin\u00e1rne lieky a spr\u00e1vnej farmakovigilan\u010dnej praxe a in\u0161pekciu dovozcov, v\u00fdrobcov a distrib\u00fatorov \u00fa\u010dinn\u00fdch l\u00e1tok,<\/li>\n\n\n\n<li>p\u00edsmeno g)&nbsp; naria\u010fuje pozastavenie distrib\u00facie veterin\u00e1rneho lieku, stiahnutie veterin\u00e1rneho lieku alebo \u00fa\u010dinnej l\u00e1tky z trhu,<\/li>\n\n\n\n<li>p\u00edsmeno s)&nbsp; registruje dovozcov, v\u00fdrobcov a distrib\u00fatorov \u00fa\u010dinn\u00fdch l\u00e1tok pou\u017e\u00edvan\u00fdch ako vstupn\u00e9 suroviny pre veterin\u00e1rne lieky, ktor\u00ed s\u00fa usaden\u00ed v Slovenskej republike<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\"><strong>Registr\u00e1cia v\u00fdrobcu, dovozcu alebo distrib\u00fatora \u00fa\u010dinnej l\u00e1tky (pre veterin\u00e1rne lieky)<\/strong><\/mark><\/h3>\n\n\n\n<p>V\u00fdrobca\/dovozca\/distrib\u00fator \u00fa\u010dinnej l\u00e1tky s&nbsp;miestom podnikania alebo so s\u00eddlom v&nbsp;Slovenskej republike je <em><u>povinn\u00fd najmenej 60 dn\u00ed pred za\u010dat\u00edm \u010dinnosti <\/u><\/em>p\u00edsomne ozn\u00e1mi\u0165 \u00da\u0160KVBL z\u00e1mer vykon\u00e1va\u0165 v\u00fdrobu, dovoz alebo distrib\u00faciu \u00fa\u010dinnej l\u00e1tky (\u00a7 12a ods. 2 z\u00e1kona 362\/2011)<\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-db04ef8b-de16-45e4-8550-43adc6733469\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/f188_oznamenie_zameru.docx\">Formul\u00e1r na ozn\u00e1menie z\u00e1meru vykon\u00e1va\u0165 v\u00fdrobu, dovoz alebo distrib\u00faciu \u00fa\u010dinnej l\u00e1tky pre veterin\u00e1rne lieky<\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<p>Oznamovac\u00ed formul\u00e1r je potrebn\u00e9 posla\u0165 na \u00da\u0160KVBL po\u0161tou na adresu: \u00dastav \u0161t\u00e1tnej kontroly veterin\u00e1rnych bioprepar\u00e1tov a lie\u010div Nitra, Biovetsk\u00e134, 94901 Nitra, Slovensk\u00e1 republika alebo elektronicky prostredn\u00edctvom port\u00e1lu verejnej spr\u00e1vy \u201eSlovensko.sk\u201c<\/p>\n\n\n\n<p>N\u00e1sledn\u00e9 kroky:<\/p>\n\n\n\n<p>\u00da\u0160KVBL m\u00f4\u017ee na z\u00e1klade ozn\u00e1menia vykona\u0165 in\u0161pekciu u&nbsp;v\u00fdrobcu\/dovozcu\/distrib\u00fatora \u00fa\u010dinnej l\u00e1tky. Ak do 60 dn\u00ed od prijatia ozn\u00e1menia \u00da\u0160KVBL ozn\u00e1mi v\u00fdrobcovi\/dovozcovi\/distrib\u00fatorovi, \u017ee vykon\u00e1 in\u0161pekciu, v\u00fdrobca\/dovozca\/distrib\u00fator \u00fa\u010dinnej l\u00e1tky vykon\u00e1vanie \u010dinnosti nesmie za\u010da\u0165.<\/p>\n\n\n\n<p>\u00da\u0160KVBL, m\u00f4\u017ee v&nbsp;tejto lehote ozn\u00e1mi\u0165 v\u00fdrobcovi\/dovozcovi\/distrib\u00fatorovi \u00fa\u010dinnej l\u00e1tky, \u017ee \u010dinnos\u0165 m\u00f4\u017ee za\u010da\u0165 vykon\u00e1va\u0165 (\u00a7 12a ods.4 z\u00e1kona 362\/2011 Z.z.). Ak \u00da\u0160KVBL neozn\u00e1mi do 60 dn\u00ed od prijatia ozn\u00e1menia, \u017ee vykon\u00e1 in\u0161pekciu, m\u00f4\u017ee v\u00fdrobca\/dovozca\/distrib\u00fator \u00fa\u010dinnej l\u00e1tky za\u010da\u0165 \u010dinnos\u0165 vykon\u00e1va\u0165 (\u00a7 12a ods. 5 z\u00e1kona 362\/2011 Z.z.).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Povinnosti v\u00fdrobcu, dovozcu a&nbsp;distrib\u00fatora \u00fa\u010dinn\u00fdch l\u00e1tok<\/mark><\/strong><\/h3>\n\n\n\n<p><strong>V\u00fdrobca<\/strong> \u00fa\u010dinn\u00fdch l\u00e1tok sa riadi usmerneniami SVP E\u00da pod\u013ea EudraLex \u2013 Volume 4, &nbsp;a mus\u00ed dodr\u017eiava\u0165 po\u017eiadavky SVP uveden\u00e9 v&nbsp;usmernen\u00ed: Part II &#8211; Basic Requirements for Active Substances used as Starting Materials.<\/p>\n\n\n\n<p>V\u00fdrobca \u00fa\u010dinnej l\u00e1tky je povinn\u00fd (\u00a7 12a ods. 7 z\u00e1kona 362\/2011 Z.z.)<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>p\u00edsmeno b) by\u0165 dr\u017eite\u013eom osved\u010denia o&nbsp;dodr\u017eiavan\u00ed po\u017eiadaviek spr\u00e1vnej v\u00fdrobnej praxe vydan\u00e9ho \u00fastavom kontroly veterin\u00e1rnych lie\u010div pod\u013ea \u00a7&nbsp;126a ods.&nbsp;5 prvej vety, ak \u00fa\u010dinn\u00fa l\u00e1tku vyr\u00e1ba a&nbsp;dod\u00e1va v\u00fdrobcovi veterin\u00e1rneho lieku, c) vy\u0161etri\u0165 p\u00edsomn\u00e9 s\u0165a\u017enosti v\u00fdrobcov liekov, ktor\u00fdm \u00fa\u010dinn\u00fa l\u00e1tku dod\u00e1va, t\u00fdkaj\u00face sa kvality vyr\u00e1banej \u00fa\u010dinnej l\u00e1tky a&nbsp;uchov\u00e1va\u0165 tieto s\u0165a\u017enosti a&nbsp;z\u00e1znamy o&nbsp;ich vy\u0161etren\u00ed najmenej p\u00e4\u0165 rokov,<\/li>\n\n\n\n<li>p\u00edsmeno d) vytvori\u0165 \u0161tandardn\u00fd opera\u010dn\u00fd postup na zabezpe\u010denie stiahnutia \u00fa\u010dinnej l\u00e1tky z&nbsp;trhu,<\/li>\n\n\n\n<li>p\u00edsmeno e) bezodkladne ozn\u00e1mi\u0165 v\u00fdrobcom liekov, ktor\u00fdm \u00fa\u010dinn\u00fa l\u00e1tku dod\u00e1va,&nbsp;\u00fastavu kontroly veterin\u00e1rnych lie\u010div, ak ide o&nbsp;veterin\u00e1rne lieky, ak\u00e9ko\u013evek zmeny v\u00fdrobn\u00e9ho procesu, ktor\u00e9 m\u00f4\u017eu ma\u0165 vplyv na kvalitu \u00fa\u010dinnej l\u00e1tky,<\/li>\n\n\n\n<li>p\u00edsmeno f) bezodkladne stiahnu\u0165 z&nbsp;trhu \u00fa\u010dinn\u00fa l\u00e1tku po nariaden\u00ed \u0161t\u00e1tnym \u00fastavom alebo \u00fastavom kontroly veterin\u00e1rnych lie\u010div.<\/li>\n<\/ul>\n\n\n\n<p>V\u00fdrobca \u00fa\u010dinnej l\u00e1tky, dovozca \u00fa\u010dinnej l\u00e1tky alebo distrib\u00fator \u00fa\u010dinnej l\u00e1tky je povinn\u00fd bezodkladne ozn\u00e1mi\u0165 \u00fastavu kontroly veterin\u00e1rnych lie\u010div, ak ide o&nbsp;veterin\u00e1rne lieky,<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ka\u017ed\u00fa zmenu, ktor\u00e1 m\u00f4\u017ee ovplyvni\u0165 kvalitu alebo bezpe\u010dnos\u0165 \u00fa\u010dinnej l\u00e1tky, ktor\u00fa vyr\u00e1ba, dov\u00e1\u017ea alebo distribuuje,<\/li>\n\n\n\n<li>ka\u017ed\u00e9 stiahnutie \u00fa\u010dinnej l\u00e1tky z\u00a0trhu (\u00a7 12a ods. 6 z\u00e1kona o lieku).<\/li>\n<\/ul>\n\n\n\n<p>V\u00fdrobca \u00fa\u010dinnej l\u00e1tky, dovozca \u00fa\u010dinnej l\u00e1tky alebo distrib\u00fator \u00fa\u010dinnej l\u00e1tky je povinn\u00fd ka\u017edoro\u010dne do 31. decembra predlo\u017ei\u0165 \u00fastavu kontroly veterin\u00e1rnych lie\u010div, ak ide o&nbsp;veterin\u00e1rne lieky, zoznam vykonan\u00fdch zmien v&nbsp;\u00fadajoch v&nbsp;ozn\u00e1men\u00ed pod\u013ea \u00a7 12a ods. 3 z\u00e1kona o lieku (\u00a7 12a ods. 8 z\u00e1kona o lieku).<\/p>\n\n\n\n<p><strong>Dovozca<\/strong> m\u00f4\u017ee dov\u00e1\u017ea\u0165 \u00fa\u010dinn\u00fa l\u00e1tku v zmysle \u00a7 12b z\u00e1kona o lieku a&nbsp;\u010dl\u00e1nku 95 nariadenia E\u00da 2019\/6.<\/p>\n\n\n\n<p><strong>Distrib\u00fator<\/strong> mus\u00ed dodr\u017eiava\u0165 po\u017eiadavky spr\u00e1vnej ve\u013ekodistribu\u010dnej praxe v s\u00falade s&nbsp;\u010dl\u00e1nkom 95 nariadenia E\u00da 2019\/6 a&nbsp;vykon\u00e1vacieho nariadenia Komisie (E\u00da) 2021\/1280 o z\u00e1sad\u00e1ch spr\u00e1vnej distribu\u010dnej praxe, pokia\u013e ide o \u00fa\u010dinn\u00e9 l\u00e1tky pou\u017eit\u00e9 do liekov na veterin\u00e1rne pou\u017eitie.<\/p>\n\n\n\n<p>Dovozcovia, v\u00fdrobcovi a distrib\u00fatori \u00fa\u010dinn\u00fdch l\u00e1tok s\u00fa registrovan\u00ed v&nbsp;datab\u00e1ze \u00danie pre v\u00fdrobu, dovoz a&nbsp;ve\u013ekoobchodn\u00fa distrib\u00faciu (\u010dl\u00e1nok 91 bod 2 nariadenia E\u00da 2019\/6).<\/p>\n\n\n\n<p>Cel\u00fd rozsah \u010dinnost\u00ed v\u00fdrobcu, dovozcu alebo distrib\u00fatora ako aj uniformnos\u0165 formul\u00e1rov je definovan\u00e9 v Compilation of Community Procedures on Inspections and Exchange of Information<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Z\u00e1kladn\u00e9 pojmy \u201e\u00da\u010dinn\u00e1 l\u00e1tka\u201c je ak\u00e1ko\u013evek l\u00e1tka alebo zmes l\u00e1tok ur\u010den\u00e1 na pou\u017eitie pri v\u00fdrobe veterin\u00e1rneho lieku, ktor\u00e1 sa pri jeho v\u00fdrobe stane \u00fa\u010dinnou zlo\u017ekou tohto lieku (\u010dl. 4 ods. 3 nariadenia E\u00da 2019\/6). \u00da\u010dinn\u00e1 l\u00e1tka mus\u00ed by\u0165 vyroben\u00e1 v&nbsp;s\u00falade &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=98\">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-98","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/98","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=98"}],"version-history":[{"count":11,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/98\/revisions"}],"predecessor-version":[{"id":9369,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/98\/revisions\/9369"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=98"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}