{"id":412,"date":"2020-03-02T15:30:22","date_gmt":"2020-03-02T14:30:22","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=412"},"modified":"2026-02-23T11:18:47","modified_gmt":"2026-02-23T10:18:47","slug":"inspekcia","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=412","title":{"rendered":"IN\u0160PEKCIA"},"content":{"rendered":"\n<h3 class=\"wp-block-heading has-text-align-center\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">In\u0161pek\u010dn\u00e1 \u010dinnos\u0165 \u00dastavu \u0161t\u00e1tnej kontroly veterin\u00e1rnych bioprepar\u00e1tov a&nbsp;lie\u010div (\u00da\u0160KVBL)<\/mark><\/strong><\/h3>\n\n\n\n<p>In\u0161pektor\u00e1t \u00da\u0160KVBL pod\u013ea \u00a7 134 ods. 2 <strong>z\u00e1kona 362\/2011 Z.z., v<\/strong>&nbsp;s\u00falade s&nbsp;Vykon\u00e1vac\u00edm nariaden\u00edm Komisie (E\u00da) 2021\/1248 o&nbsp;opatreniach t\u00fdkaj\u00facich sa spr\u00e1vnej distribu\u010dnej praxe pre veterin\u00e1rne lieky a&nbsp;v s\u00falade &nbsp;s&nbsp;Nariaden\u00edm (E\u00da) 2019\/6 :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>vykon\u00e1va \u0161t\u00e1tny dozor na \u00faseku veterin\u00e1rnej farm\u00e1cie pod\u013ea tohto z\u00e1kona a osobitn\u00e9ho predpisu (Nariadenie (ES) \u010d.&nbsp;<a href=\"http:\/\/www.epi.sk\/eurlex-rule\/32004R0726.htm\">726\/2004<\/a>)&nbsp;&nbsp;a&nbsp;schva\u013euje prev\u00e1dzky pri \u010dinnostiach spojen\u00fdch s\n<ul class=\"wp-block-list\">\n<li>v\u00fdrobou veterin\u00e1rnych liekov (vr\u00e1tane autog\u00e9nnych vakc\u00edn a prezna\u010dovania)<\/li>\n\n\n\n<li>ve\u013ekodistrib\u00faciou veterin\u00e1rnych liekov<\/li>\n\n\n\n<li>sk\u00fa\u0161an\u00edm veterin\u00e1rnych liekov (kontroln\u00e9 laborat\u00f3ri\u00e1 v\u00fdrobcu veterin\u00e1rnych liekov)<\/li>\n\n\n\n<li>dovozom, v\u00fdrobou a distrib\u00faciou \u00fa\u010dinn\u00fdch l\u00e1tok<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>vykon\u00e1va in\u0161pekciu dodr\u017eiavania z\u00e1sad\n<ul class=\"wp-block-list\">\n<li>spr\u00e1vnej v\u00fdrobnej praxe (vr\u00e1tane kontroln\u00fdch laborat\u00f3ri\u00ed v\u00fdrobcu veterin\u00e1rnych liekov)<\/li>\n\n\n\n<li>spr\u00e1vnej distribu\u010dnej praxe pre veterin\u00e1rne lieky<\/li>\n\n\n\n<li>spr\u00e1vnej farmakovigilan\u010dnej praxe<\/li>\n\n\n\n<li>in\u0161pekciu dovozcov, v\u00fdrobcov a distrib\u00fatorov \u00fa\u010dinn\u00fdch l\u00e1tok,<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>prejedn\u00e1va spr\u00e1vne delikty a uklad\u00e1 pokuty za poru\u0161enie tohto z\u00e1kona<\/li>\n<\/ul>\n\n\n\n<p>In\u0161pektor\u00e1t \u00da\u0160KVBL pod\u013ea \u00a7 9 ods. 2 z\u00e1kona <strong>39\/2007 Z.z.<\/strong> a&nbsp;v&nbsp;s\u00favislosti s&nbsp;Nariaden\u00edm (E\u00da) 2019\/4 :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>vykon\u00e1va in\u0161pekciu a schva\u013euje prev\u00e1dzkarne na pr\u00edpravu a uv\u00e1dzanie medikovan\u00fdch krm\u00edv na trh,&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/li>\n\n\n\n<li>prejedn\u00e1va spr\u00e1vne delikty a uklad\u00e1 pokuty za poru\u0161enie tohto z\u00e1kona<\/li>\n<\/ul>\n\n\n\n<p>In\u0161pektor\u00e1t \u00da\u0160KVBL pod\u013ea \u00a7 25&nbsp; z\u00e1kona <strong>17\/2018 Z.z.<\/strong> vykon\u00e1va \u0161t\u00e1tny dozor a&nbsp;schva\u013euje prev\u00e1dzky pri \u010dinnostiach:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>spojen\u00fdch s ve\u013ekodistrib\u00faciou veterin\u00e1rnych pr\u00edpravkov a veterin\u00e1rnych technick\u00fdch pom\u00f4cok a v\u00fdrobou veterin\u00e1rnych pr\u00edpravkov<\/li>\n\n\n\n<li>prejedn\u00e1va spr\u00e1vne delikty a&nbsp;uklad\u00e1 pokuty za poru\u0161enie tohto z\u00e1kona<\/li>\n<\/ul>\n\n\n\n<p>In\u0161pektor\u00e1t \u00da\u0160KVBL v&nbsp;s\u00falade so z\u00e1konom <strong>362\/2011 Z.z. <\/strong>a&nbsp;v&nbsp;s\u00favislosti s&nbsp;Nariaden\u00edm (E\u00da) 2019\/6 \u010falej vyd\u00e1va<strong>:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>povolenia na pou\u017eitie neregistrovan\u00fdch veterin\u00e1rnych liekov<\/li>\n\n\n\n<li>povolenia na pou\u017eitia veterin\u00e1rnych autog\u00e9nnych vakc\u00edn,<\/li>\n\n\n\n<li>povolenia na s\u00fabe\u017en\u00fd dovoz<\/li>\n\n\n\n<li>povolenia na mimoriadne uvo\u013enenie \u0161ar\u017e\u00ed veterin\u00e1rnych liekov za v\u00fdnimo\u010dn\u00fdch okolnost\u00ed<\/li>\n\n\n\n<li>povolenia na v\u00fdnimky na dopredaj veterin\u00e1rneho lieku<\/li>\n\n\n\n<li>v\u00fdnimky na zmenu ozna\u010denia vn\u00fatorn\u00e9ho obalu a vonkaj\u0161ieho obalu veterin\u00e1rneho lieku<\/li>\n\n\n\n<li>v\u00fdnimky na dovoz mal\u00e9ho mno\u017estva veterin\u00e1rneho lieku v inom jazyku, ako je \u0161t\u00e1tny jazyk<\/li>\n\n\n\n<li>v\u00fdnimky na \u00fapravu vonkaj\u0161ieho obalu, vn\u00fatorn\u00e9ho obalu a p\u00edsomnej inform\u00e1cie pre pou\u017e\u00edvate\u013eov<\/li>\n\n\n\n<li>Certifik\u00e1t na veterin\u00e1rny liek (certificate of Pharmaceutical Product)<\/li>\n\n\n\n<li>Certifik\u00e1t pre vo\u013en\u00fd obchod (Free Sale Certificate)<\/li>\n\n\n\n<li>Certifik\u00e1t spr\u00e1vnej v\u00fdrobnej praxe<\/li>\n\n\n\n<li>Certifik\u00e1t spr\u00e1vnej distribu\u010dnej praxe<\/li>\n<\/ul>\n\n\n\n<p>In\u0161pektor\u00e1t \u00da\u0160KVBL pod\u013ea \u00a7 36d z\u00e1kona <strong>139\/1998 Z.z<\/strong> o&nbsp;omamn\u00fdch l\u00e1tkach,&nbsp;psychotropn\u00fdch l\u00e1tkach a&nbsp;pr\u00edpravkoch :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>kontroluje zaobch\u00e1dzanie s&nbsp;omamn\u00fdmi a&nbsp;psychotropn\u00fdmi l\u00e1tkami,<\/li>\n\n\n\n<li>vyd\u00e1va posudok o&nbsp;splnen\u00ed podmienok na zaobch\u00e1dzanie s&nbsp;omamn\u00fdmi a&nbsp;psychotropn\u00fdmi l\u00e1tkami,<\/li>\n\n\n\n<li>vykon\u00e1va in\u0161pekcie u&nbsp;dr\u017eite\u013eov povolenia a pod\u00e1va ministerstvu n\u00e1vrhy na do\u010dasn\u00e9 pozastavenie \u010dinnosti alebo na zru\u0161enie povolenia, ak pri kontrolnej \u010dinnosti zist\u00ed nedodr\u017eiavanie ustanoven\u00ed tohto z\u00e1kona a uklad\u00e1 pokuty za poru\u0161enie povinnost\u00ed ustanoven\u00fdch t\u00fdmto z\u00e1konom.<\/li>\n<\/ul>\n\n\n\n<p>In\u0161pektor\u00e1t \u00da\u0160KVBL pod\u013ea \u00a7 10 p\u00edsm. c) a \u00a7 11 ods. 1) z\u00e1kona <strong>147\/2001 Z.z.<\/strong> o&nbsp;reklame:<\/p>\n\n\n\n<p>vykon\u00e1va dozor nad dodr\u017eiavan\u00edm tohto z\u00e1kona a uklad\u00e1 pokuty za poru\u0161enie tohto z\u00e1kona.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>S\u00favisiaca legislat\u00edva a&nbsp;bli\u017e\u0161ie inform\u00e1cie<\/strong><\/h3>\n\n\n\n<p>Inform\u00e1cie o&nbsp;legislat\u00edvnom r\u00e1mci, usmernenia a&nbsp;postupy \u00da\u0160KVBL a&nbsp;formul\u00e1re \u017eiadost\u00ed s\u00fa detailne uveden\u00e9 v&nbsp;\u010fal\u0161\u00edch \u010dastiach.<\/p>\n\n\n\n<p>Inform\u00e1cie o pou\u017eit\u00ed veterin\u00e1rnych liekov za v\u00fdnimo\u010dn\u00fdch okolnost\u00ed vi\u010f \u010das\u0165 \u201eKr\u00edzov\u00e9 situ\u00e1cie\u201c<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Pod\u00e1vanie \u017eiadost\u00ed a&nbsp;zasielanie podnetov<\/strong><\/h3>\n\n\n\n<p>\u017diadosti s\u00favisiace s\u00a0vy\u0161\u0161ie uvedenou \u010dinnos\u0165ou odboru in\u0161pekcie a\u00a0<strong>podnety na pre\u0161etrenie<\/strong>\u00a0je potrebn\u00e9 posla\u0165 na \u00da\u0160KVBL\u00a0<strong>po\u0161tou<\/strong>\u00a0na adresu: \u00dastav \u0161t\u00e1tnej kontroly veterin\u00e1rnych bioprepar\u00e1tov a lie\u010div Nitra, Biovetsk\u00e134, 94901 Nitra, Slovensk\u00e1 republika alebo elektronicky\u00a0prostredn\u00edctvom port\u00e1lu verejnej spr\u00e1vy<strong> \u201eSlovensko.sk\u201c  <\/strong>alebo emailom <a href=\"mailto:podatelna@uskvbl.sk\">podatelna@uskvbl.sk<\/a><\/p>\n\n\n\n<p>V&nbsp;pr\u00edpade ot\u00e1zok alebo ch\u00fdbaj\u00facich inform\u00e1ci\u00ed, pros\u00edm za\u0161lite svoje ot\u00e1zky na email: <a href=\"mailto:hlasenia.inspekcia@uskvbl.sk\">hlasenia.inspekcia@uskvbl.sk<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In\u0161pek\u010dn\u00e1 \u010dinnos\u0165 \u00dastavu \u0161t\u00e1tnej kontroly veterin\u00e1rnych bioprepar\u00e1tov a&nbsp;lie\u010div (\u00da\u0160KVBL) In\u0161pektor\u00e1t \u00da\u0160KVBL pod\u013ea \u00a7 134 ods. 2 z\u00e1kona 362\/2011 Z.z., v&nbsp;s\u00falade s&nbsp;Vykon\u00e1vac\u00edm nariaden\u00edm Komisie (E\u00da) 2021\/1248 o&nbsp;opatreniach t\u00fdkaj\u00facich sa spr\u00e1vnej distribu\u010dnej praxe pre veterin\u00e1rne lieky a&nbsp;v s\u00falade &nbsp;s&nbsp;Nariaden\u00edm (E\u00da) 2019\/6 : &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=412\">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-412","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/412","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=412"}],"version-history":[{"count":12,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/412\/revisions"}],"predecessor-version":[{"id":9483,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/412\/revisions\/9483"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=412"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}