{"id":371,"date":"2020-03-02T14:43:27","date_gmt":"2020-03-02T13:43:27","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=371"},"modified":"2025-11-18T08:25:36","modified_gmt":"2025-11-18T07:25:36","slug":"krizove-situacie","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=371","title":{"rendered":"KR\u00cdZOV\u00c9 SITU\u00c1CIE"},"content":{"rendered":"\n<p>\u00da\u0160KVBL m\u00e1 zaveden\u00fd <strong>syst\u00e9m r\u00fdchlej v\u00fdstrahy<\/strong> za \u00fa\u010delom nepretr\u017eit\u00e9ho prij\u00edmania a vyhodnocovania ozn\u00e1men\u00ed o podozreniach na nedostatky v&nbsp;kvalite a&nbsp;ne\u017eiaduce \u00fa\u010dinky veterin\u00e1rnych liekov. Syst\u00e9m r\u00fdchlej v\u00fdstrahy umo\u017e\u0148uje stiahnutie veterin\u00e1rneho lieku z trhu na z\u00e1klade rozhodnutia \u00da\u0160KVBL.<br><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong><span style=\"color:#e70606\" class=\"has-inline-color\">SYST\u00c9M R\u00ddCHLEJ V\u00ddSTRAHY<\/span><\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Nedostatky v kvalite &nbsp;&nbsp;&nbsp;&nbsp;&nbsp; email: <a href=\"mailto:ras-vet_sk@uskvbl.sk\">ras-vet_sk@uskvbl.sk<\/a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/li>\n\n\n\n<li>Ne\u017eiaduce \u00fa\u010dinky&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; email: <a href=\"mailto:neziaduce_ucinky@uskvbl.sk\">neziaduce_ucinky@uskvbl.sk<\/a><\/li>\n\n\n\n<li>Tel.: \u00a0\u00a0\u00a0 +421 907 884 565<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\"><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><span class=\"has-inline-color has-blue-color\">Nedostatky v&nbsp;kvalite veterin\u00e1rnych liekov&nbsp;<\/span><\/strong><\/h3>\n\n\n\n<p>Ak existuje podozrenie, \u017ee veterin\u00e1rny liek, ktor\u00fd m\u00e1 nedostatky v kvalite, predstavuje v\u00e1\u017ene riziko pre zdravie zvierat,&nbsp; pre \u010dloveka ako pou\u017e\u00edvate\u013ea lieku (o\u0161etrovate\u013e, veterin\u00e1rny lek\u00e1r), \u010dloveka ako konzumenta potrav\u00edn zo zvierat o\u0161etren\u00fdch tak\u00fdmto liekom alebo pre \u017eivotn\u00e9 prostredie, \u00da\u0160KVBL bezodkladne vyd\u00e1 ozn\u00e1menie o&nbsp;r\u00fdchlej v\u00fdstrahe a o jeho vydan\u00ed bezodkladne informuje dr\u017eite\u013ea registr\u00e1cie pr\u00edslu\u0161n\u00e9ho veterin\u00e1rneho lieku, dr\u017eite\u013eov povolenia na ve\u013ekodistrib\u00faciu liekov a pr\u00edslu\u0161n\u00e9 org\u00e1ny in\u00fdch \u010dlensk\u00fdch \u0161t\u00e1tov.<br><\/p>\n\n\n\n<p>Ak je predpoklad, \u017ee tak\u00fdto veterin\u00e1rny liek bol u\u017e vydan\u00fd na pou\u017eitie, \u00da\u0160KVBL v&nbsp;\u010do najkrat\u0161om \u010dase&nbsp; vykon\u00e1 verejn\u00e9 ozn\u00e1menie s cie\u013eom stiahnu\u0165 tak\u00fdto veterin\u00e1rny liek od pou\u017e\u00edvate\u013eov. Toto ozn\u00e1menie obsahuje inform\u00e1ciu o podozren\u00ed, \u017ee veterin\u00e1rny liek m\u00e1 nedostatky v&nbsp;kvalite a&nbsp;nesmie by\u0165 dod\u00e1van\u00fd a pou\u017e\u00edvan\u00fd. \u00da\u0160KVBL m\u00f4\u017ee pr\u00edslu\u0161n\u00fd z\u00e1kaz dod\u00e1vania a pou\u017e\u00edvania alebo jeho stiahnutie z trhu obmedzi\u0165 len na sporn\u00e9 v\u00fdrobn\u00e9 \u0161ar\u017ee.<\/p>\n\n\n\n<p>Podozrenie na nedostatky v&nbsp;kvalite veterin\u00e1rneho lieku, ktor\u00e9 bolo zisten\u00e9 na \u00fazem\u00ed Slovenskej republiky, m\u00f4\u017ee hl\u00e1si\u0165 ktoko\u013evek (napr\u00edklad veterin\u00e1rny lek\u00e1r, chovate\u013e zvierat, lek\u00e1rnik, distrib\u00fator veterin\u00e1rnych liekov, v\u00fdrobca at\u010f.)<br><\/p>\n\n\n\n<p>Sp\u00f4sob hl\u00e1senia podozrenia na nedostatky v&nbsp;kvalite veterin\u00e1rnych liekov s\u00fa uveden\u00e9 v \u010dasti \u201eAko postupova\u0165 pri podozren\u00ed na nedostatok v&nbsp;kvalite veterin\u00e1rneho lieku\u201c.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><span class=\"has-inline-color has-blue-color\">Povinnos\u0165 hl\u00e1si\u0165 ne\u017eiaduce udalosti veterin\u00e1rnych liekov<\/span><\/strong><\/h3>\n\n\n\n<p>Povinnos\u0165 hl\u00e1si\u0165 ne\u017eiaducu udaalos\u0165 veterin\u00e1rneho lieku vypl\u00fdva zo z\u00e1kona \u010d. 362\/2011 Z.z. pre:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Osobu opr\u00e1vnenu predpisova\u0165 veterin\u00e1rne lieky a vyd\u00e1va\u0165 veterin\u00e1rne lieky &#8211; \u00a7 122 ods. 18<\/li>\n\n\n\n<li>Chovate\u013ea potravinov\u00e9ho zviera\u0165a alebo in\u0161pektora zdravia v\u010diel &#8211; \u00a7 102 ods.12<\/li>\n\n\n\n<li>Dr\u017eite\u013ea povolenia na v\u00fdrobu liekov &#8211; \u00a7 15 ods. 1 p\u00edsm. f) 2<\/li>\n\n\n\n<li>Dr\u017eite\u013ea povolenia na ve\u013ekodistrib\u00faciu liekov &#8211; \u00a7 18 ods. 1 j)<\/li>\n\n\n\n<li>Dr\u017eite\u013ea povolenia na poskytovanie lek\u00e1renskej starostlivosti &#8211; \u00a7 23 ods. 1 p\u00edsm. p)<\/li>\n\n\n\n<li>Dr\u017eite\u013es povolenia na maloobchodn\u00fd predaj veterin\u00e1rnych liekov &#8211; \u00a7 124a ods. 4 p\u00edsm. e)<\/li>\n\n\n\n<li>Dr\u017eite\u013ea rozhodnutia o registr\u00e1cii \u2013 \u010dl. 76 ods. 2 Nariadenia 2019\/6 o veterin\u00e1rnych liekoch<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><span class=\"has-inline-color has-blue-color\">Nedostupnos\u0165 registrovan\u00fdch veterin\u00e1rnych liekov&nbsp;<\/span><\/strong><\/h3>\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). Av\u0161ak 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<p>Podrobn\u00e9 inform\u00e1cie o&nbsp;sp\u00f4sobe rie\u0161enia dostupnosti veterin\u00e1rnych liekov s\u00fa uveden\u00e9 v \u010dasti \u201ePou\u017eitie neregistrovan\u00fdch veterin\u00e1rnych liekov v&nbsp;osobit\u00fdch pr\u00edpadoch\u201c.<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00da\u0160KVBL m\u00e1 zaveden\u00fd syst\u00e9m r\u00fdchlej v\u00fdstrahy za \u00fa\u010delom nepretr\u017eit\u00e9ho prij\u00edmania a vyhodnocovania ozn\u00e1men\u00ed o podozreniach na nedostatky v&nbsp;kvalite a&nbsp;ne\u017eiaduce \u00fa\u010dinky veterin\u00e1rnych liekov. Syst\u00e9m r\u00fdchlej v\u00fdstrahy umo\u017e\u0148uje stiahnutie veterin\u00e1rneho lieku z trhu na z\u00e1klade rozhodnutia \u00da\u0160KVBL. SYST\u00c9M R\u00ddCHLEJ V\u00ddSTRAHY Nedostatky v&nbsp;kvalite &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=371\">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-371","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/371","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=371"}],"version-history":[{"count":9,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/371\/revisions"}],"predecessor-version":[{"id":9347,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/371\/revisions\/9347"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=371"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}