{"id":541,"date":"2020-03-05T10:16:03","date_gmt":"2020-03-05T09:16:03","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=541"},"modified":"2020-10-15T08:39:20","modified_gmt":"2020-10-15T06:39:20","slug":"mimoriadny-dovoz","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=541","title":{"rendered":"MIMORIADNY DOVOZ"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\"><strong>MIMORIADNY DOVOZ<\/strong><\/h3>\n\n\n\n<p>\u00dastav \u0161t\u00e1tnej kontroly veterin\u00e1rnych bioprepar\u00e1tov a&nbsp;lie\u010div (\u010falej len \u00da\u0160KVBL) ako org\u00e1n \u0161t\u00e1tnej spr\u00e1vy pod\u013ea \u00a7 134 ods. 2 p\u00edsm. a) a&nbsp;p\u00edsm. f) z\u00e1kona \u010d. 362\/2011 Z. z. o&nbsp;liekoch a&nbsp;zdravotn\u00edckych pom\u00f4ckach&nbsp; a&nbsp;o&nbsp;zmene a&nbsp;doplnen\u00ed niektor\u00fdch z\u00e1konov (\u010falej len \u201ez\u00e1kon o&nbsp;liekoch\u201c) a&nbsp;v s\u00falade so z\u00e1konom \u010d. 138\/2004 Z. z. o&nbsp;spr\u00e1vnom konan\u00ed&nbsp; (\u010falej len \u201ez\u00e1kon o&nbsp;spr\u00e1vnom konan\u00ed\u201c) vykon\u00e1va \u0161t\u00e1tny dozor na \u00faseku veterin\u00e1rnej farm\u00e1cie a&nbsp;vyd\u00e1va povolenie na registr\u00e1ciu veterin\u00e1rneho lieku.                                                                                      \u00da\u0160KVBL na z\u00e1klade \u00a7 84 ods. 4 a \u00a7 106 ods. 4&nbsp; z\u00e1kona o liekoch povo\u013euje pou\u017eitie veterin\u00e1rnych liekov, ktor\u00e9 nepodliehaj\u00fa registr\u00e1cii a&nbsp;to: <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Veterin\u00e1rne lieky\nur\u010den\u00e9 na vedeck\u00e9, v\u00fdskumn\u00e9 a&nbsp;kontroln\u00e9 \u00fa\u010dely, ak s\u00fa registrovan\u00e9\nv&nbsp;inom \u010dlenskom \u0161t\u00e1te<\/li><li>Veterin\u00e1rne lieky\nregistrovan\u00e9 v&nbsp;inom \u010dlenskom \u0161t\u00e1te, ak v&nbsp;Slovenskej republike nie s\u00fa\ndostupn\u00e9 porovnate\u013en\u00e9 registrovan\u00e9 veterin\u00e1rne lieky, ktor\u00e9 s\u00fa ur\u010den\u00e9 na\npou\u017eitie pre jedno zviera alebo skupinu zvierat pri ohrozen\u00ed \u017eivota alebo\nrizika z\u00e1va\u017en\u00e9ho zhor\u0161enia zdravotn\u00e9ho stavu zviera\u0165a<\/li><\/ul>\n\n\n\n<p>Toto usmernenie upres\u0148uje postupy pri pod\u00e1van\u00ed \u017eiadost\u00ed o&nbsp;mimoriadny dovoz veterin\u00e1rnych farmaceutick\u00fdch liekov na trh Slovenskej republiky a&nbsp;po\u017eiadavky na predkladanie sprievodnej dokument\u00e1cie. Je ur\u010den\u00e9 predov\u0161etk\u00fdm pre \u017eiadate\u013eov o&nbsp;mimoriadny dovoz veterin\u00e1rnych farmaceutick\u00fdch liekov, ktor\u00e9 nie s\u00fa registrovan\u00e9 na \u00fazem\u00ed SR a dr\u017eite\u013eom rozhodnutia o&nbsp;registr\u00e1cii (DRR) t\u00fdchto veterin\u00e1rnych liekov.                            Postupy uveden\u00e9 v&nbsp;tomto usmernen\u00ed s\u00fa zaveden\u00e9 za \u00fa\u010delom objasnenia pravidiel pri pod\u00e1van\u00ed \u017eiadost\u00ed o&nbsp;mimoriadny dovoz veterin\u00e1rnych liekov. Usmernenie z\u00e1rove\u0148 definuje \u00falohu \u00da\u0160KVBL v&nbsp;tomto procese.  <\/p>\n\n\n\n<p><strong>Veterin\u00e1rny liek nem\u00f4\u017ee by\u0165 umiestnen\u00fd na trh SRbez toho aby bolo vydan\u00e9 rozhodnutie o&nbsp;jeho registr\u00e1cii alebo bez toho aby \u00da\u0160KVBL povolil mimoriadny dovoz veterin\u00e1rneho lieku.<\/strong><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>PREDKLADANIE \u017dIADOSTI O MIMORIADNY DOVOZ FARMACEUTICK\u00c9HO VETERIN\u00c1RNEHO LIEKU (VL); SPRIEVODN\u00c1 DOKUMENT\u00c1CIA<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>\u017diados\u0165 o&nbsp;mimoriadny dovoz neregistrovan\u00e9ho veterin\u00e1rneho lieku sa predklad\u00e1 na <strong>\u00dastav \u0161t\u00e1tnej kontroly veterin\u00e1rnych bioprepar\u00e1tov a&nbsp;lie\u010div, Biovetsk\u00e1 34, 949 01 Nitra, Slovensk\u00e1 republika v&nbsp;<\/strong>papierovej verzii. <\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>\u017diados\u0165 mus\u00ed by\u0165 predlo\u017een\u00e1 na z\u00e1klade \u017eiadosti\nfyzickej alebo pr\u00e1vnickej osoby, ktor\u00e1 bude veterin\u00e1rny liek pou\u017e\u00edva\u0165 alebo\nktor\u00e1 lie\u010dbu indikuje.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Spolu so \u017eiados\u0165ou o&nbsp;mimoriadny dovoz\n\u017eiadate\u013e predlo\u017e\u00ed predlo\u017ei\u0165 sprievodn\u00fa dokument\u00e1ciu uveden\u00fa v&nbsp;pr\u00edloh\u00e1ch\n\u017eiadosti.&nbsp; <\/li><\/ul>\n\n\n\n<div class=\"wp-block-file\"><a href=\"http:\/\/www2.uskvbl.sk\/wp-content\/uploads\/2020\/03\/ziadost_mimoriadny_dovoz.docx\">F 34  \u017diados\u0165 o povolenie mimoriadneho dovozu farmaceutick\u00fdch veterin\u00e1rnych liekov<\/a><\/div>\n\n\n\n<p><strong>Po\u017eiadavka na doplnenie inform\u00e1ci\u00ed<\/strong> <\/p>\n\n\n\n<p>V&nbsp;pr\u00edpade potreby doplnenia inform\u00e1ci\u00ed bude \u00da\u0160KVBL kontaktova\u0165 \u017eiadate\u013ea emailom.&nbsp; \u00da\u0160KVBL odpor\u00fa\u010da \u017eiadate\u013eovi odpoveda\u0165 na dopl\u0148uj\u00face ot\u00e1zky v&nbsp;ur\u010denej lehote, aby nedoch\u00e1dzalo k&nbsp;neopodstatnen\u00e9mu predl\u017eovaniu rozhodovania o&nbsp;povolen\u00ed mimoriadneho dovozu. Z&nbsp;toho d\u00f4vodu je nevyhnutn\u00e9 uv\u00e1dza\u0165 v&nbsp;\u017eiadosti kontaktn\u00e9 \u00fadaje na \u017eiadate\u013ea vr\u00e1tane telefonick\u00e9ho spojenia a&nbsp;e-mailov\u00e9ho spojenia.<\/p>\n\n\n\n<p><strong>V&nbsp;pr\u00edpade potreby \u010fal\u0161\u00edch inform\u00e1ci\u00ed kontaktujte odbor in\u0161pekcie \u00da\u0160KVBL <\/strong><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>VYDANIE ROZHODNUTIA<\/strong><\/h4>\n\n\n\n<p>\u00da\u0160KVBL pos\u00fadi, \u010di \u017eiadate\u013e splnil podmienky stanoven\u00e9\nt\u00fdmto usmernen\u00edm a z\u00e1konom pre povolenie MD a&nbsp; vyd\u00e1 rozhodnutie. S\u00fa\u010das\u0165ou\nrozhodnutia s\u00fa stanoven\u00e9 podmienky, za ak\u00fdch m\u00f4\u017ee by\u0165 neregistrovan\u00fd\nveterin\u00e1rny liek dovezen\u00fd a&nbsp;pou\u017eit\u00fd.&nbsp;\n<\/p>\n\n\n\n<p>Ak \u017eiadate\u013e nesplnil podmienky stanoven\u00e9 z\u00e1konom o&nbsp;liekoch a&nbsp;po\u017eiadavky \u00da\u0160KVBL, konanie sa preru\u0161\u00ed najdlh\u0161ie na dobu 30 dn\u00ed. Proti Rozhodnutiu o&nbsp;preru\u0161en\u00ed konania sa nemo\u017eno odvola\u0165. Pokia\u013e je konanie preru\u0161en\u00e9, lehoty pod\u013ea z\u00e1kona o&nbsp;spr\u00e1vnom konan\u00ed neplyn\u00fa.<\/p>\n\n\n\n<p><strong>Rozhodnutie<\/strong>                                                                                                                                                    <\/p>\n\n\n\n<p>Rozhodnutie o&nbsp;povolen\u00ed mimoriadneho dovozu neregistrovan\u00e9ho veterin\u00e1rneho lieku vyd\u00e1va \u00da\u0160KVBL Nitra po uhraden\u00ed spr\u00e1vneho poplatku (Z\u00e1kon \u010d. 145\/1995 Z. z. o&nbsp;spr\u00e1vnych poplatkoch v&nbsp;znen\u00ed neskor\u0161\u00edch predpisov, polo\u017eka 152, p\u00edsm. u). Rozhodnutie bude \u017eiadate\u013eovi ozn\u00e1men\u00e9 do 30 dn\u00ed od za\u010datia konania, najdlh\u0161ie do 60 dn\u00ed. O&nbsp;rozhodnut\u00ed bude \u017eiadate\u013e informovan\u00fd v&nbsp;zmysle \u00a7 49 z\u00e1kona o&nbsp;spr\u00e1vnom konan\u00ed. Rozhodnutie sa vyhotovuje v&nbsp;dvoch v\u00fdtla\u010dkoch, jeden je archivovan\u00fd na \u00da\u0160KVBL, druh\u00fd je zasielan\u00fd \u017eiadate\u013eovi. \u00da\u0160KVBL zasiela k\u00f3piu&nbsp; rozhodnutia: \u0160VPS SR,&nbsp;Komore veterin\u00e1rnych lek\u00e1rov a&nbsp;pr\u00edslu\u0161n\u00fdm RVPS. T\u00fato lehotu m\u00f4\u017ee \u00da\u0160KVBL pred\u013a\u017ei\u0165, ak si to presk\u00famanie sprievodn\u00fdch dokumentov vy\u017eaduje.<\/p>\n\n\n\n<p><strong>Zamietnutie<\/strong>                                                                                                                                                        <\/p>\n\n\n\n<p>V&nbsp;pr\u00edpade, \u017ee \u017eiados\u0165 o mimoriadny dovoz nie je v&nbsp;s\u00falade so z\u00e1konom o liekoch a zdravotn\u00edckych pom\u00f4ckach alebo je v&nbsp;rozpore s&nbsp;po\u017eiadavkami tohto usmernenia, bude mimoriadny dovoz a pou\u017eitie neregistrovan\u00e9ho veterin\u00e1rneho lieku zamietnut\u00e9. <\/p>\n\n\n\n<p><strong>Poplatky<\/strong>                                                                                                                                                               <\/p>\n\n\n\n<p>Na odbore ekonomiky bude \u017eiadate\u013eovi vystaven\u00fd elektronick\u00fd platobn\u00fd predpis a&nbsp; poslan\u00fd&nbsp;&nbsp;na e-mailov\u00fa adresu \u017eiadate\u013ea alebo uveden\u00e9ho platite\u013ea spr\u00e1vneho poplatku.&nbsp;<\/p>\n\n\n\n<p>Platobn\u00fd predpis je jedine\u010dn\u00fd a sl\u00fa\u017ei na \u00fahradu \u00fakonu ozna\u010den\u00e9ho na platobnom predpise. Platobn\u00e9 \u00fadaje nie je mo\u017en\u00e9 pou\u017ei\u0165 na opakovan\u00fd \u00fakon.  <\/p>\n\n\n\n<p>Platobn\u00fd predpis bude obsahova\u0165 variabiln\u00fd symbol, \u010d\u00edslo \u00fa\u010dtu, n\u00e1zov \u00fakonu. \u00dahradu platobn\u00e9ho predpisu m\u00f4\u017ee klient vykona\u0165 nieko\u013ek\u00fdmi sp\u00f4sobmi: &#8211; Prevodom na \u00fa\u010det, ktor\u00fd je uveden\u00fd na platobnom predpise, vr\u00e1tane ostatn\u00fdch platobn\u00fdch in\u0161trukci\u00ed (variabiln\u00fd, kon\u0161tantn\u00fd a \u0161pecifick\u00fd symbol), pri\u010dom variabiln\u00fd symbol je nevyhnutn\u00fdm \u00fadajom pre zrealizovanie \u017eiadost\u00ed, &#8211; alebo zaplaten\u00edm po\u0161tovou pouk\u00e1\u017ekou na pobo\u010dk\u00e1ch Slovenskej po\u0161ty a.s.,&nbsp; ktor\u00e1 je s\u00fa\u010das\u0165ou platobn\u00e9ho predpisu.    <\/p>\n\n\n\n<p>Doklad o \u00fahrade nie je potrebn\u00e9 zasiela\u0165 na&nbsp; \u00da\u0160KVBL, t\u00e1to inform\u00e1cia sa automaticky zobraz\u00ed po zaplaten\u00ed spr\u00e1vneho poplatku v centr\u00e1lnom syst\u00e9me Slovenskej po\u0161ty, a.s.  <\/p>\n\n\n\n<p>Pri \u00fahrade prevodom na \u00fa\u010det je nevyhnutn\u00e9 spr\u00e1vne uvies\u0165&nbsp; \u010d\u00edslo \u00fa\u010dtu a variabiln\u00fd symbol uveden\u00fd na platobnom predpise.<\/p>\n\n\n\n<p>Je nutn\u00e9 striktne dodr\u017eiava\u0165 d\u00e1tum splatnosti uveden\u00fd na platobnom predpise. Pri \u00fahrade po d\u00e1tume splatnosti uvedenom na platobnom predpise, pri chybne zadanom \u010d\u00edsle \u00fa\u010dtu alebo variabilnom symbole, bude poplatok automaticky vr\u00e1ten\u00fd sp\u00e4\u0165. Spr\u00e1vne poplatky bude vraca\u0165 sp\u00e4\u0165 Slovensk\u00e1 po\u0161ta, a.s.                                                                                  <\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>DOVOZ  DO  SLOVENSKEJ  REPUBLIKY<\/strong><\/h4>\n\n\n\n<h4 class=\"wp-block-heading\">Dovoz neregistrovan\u00e9ho veterin\u00e1rneho lieku mus\u00ed by\u0165 realizovan\u00fd prostredn\u00edctvom schv\u00e1len\u00e9ho ve\u013ekodistrib\u00fatora s&nbsp;platn\u00fdm povolen\u00edm na ve\u013ekodistrib\u00faciu v&nbsp;SR<strong>.<\/strong><\/h4>\n\n\n\n<p><strong>Povinnosti ve\u013ekodistrib\u00fatora<\/strong>                                                                                                                      <\/p>\n\n\n\n<p>Ve\u013ekodistrib\u00fator&nbsp; po dovoze neregistrovan\u00e9ho veterin\u00e1rneho lieku, na ktor\u00fd bolo vydan\u00e9 Rozhodnutie o&nbsp;povolen\u00ed mimoriadneho dovozu nahl\u00e1si do 7 dn\u00ed po dovoze na \u00da\u0160KVBL \u010d\u00edslo dovezenej \u0161ar\u017ee, mno\u017estvo dovezenej \u0161ar\u017ee a&nbsp;miesta, kde bude veterin\u00e1rny liek pou\u017e\u00edvan\u00fd. Z\u00e1rove\u0148 v&nbsp;hl\u00e1sen\u00ed o&nbsp;dovoze uvedie \u010d\u00edslo Rozhodnutia o&nbsp;povolen\u00ed na mimoriadny dovoz a&nbsp;prilo\u017e\u00ed certifik\u00e1t \u0161ar\u017ee, ktor\u00e1 bola do SR dovezen\u00e1.&nbsp;  <\/p>\n\n\n\n<p><strong>Povinnosti veterin\u00e1rneho lek\u00e1ra, ktor\u00fd bude veterin\u00e1rny liek pou\u017e\u00edva\u0165<\/strong>                             <\/p>\n\n\n\n<p>Osoba opr\u00e1vnen\u00e1 na poskytovanie odborn\u00fdch veterin\u00e1rnych \u010dinnost\u00ed, ktor\u00e1 bude neregistrovan\u00fd liek pou\u017e\u00edva\u0165 mus\u00ed dodr\u017eiava\u0165 ustanovenia z\u00e1kona o&nbsp;liekoch a&nbsp;zdravotn\u00edckych pom\u00f4ckach a v&nbsp;pr\u00edpade podozrenia na v\u00fdskyt z\u00e1va\u017en\u00fdch ne\u017eiaducich \u00fa\u010dinkov u&nbsp;zvierat a&nbsp;neo\u010dak\u00e1van\u00fdch ne\u017eiaducich \u00fa\u010dinkov, ktor\u00e9 sa v&nbsp;s\u00favislosti s&nbsp;pou\u017eit\u00edm veterin\u00e1rneho lieku vyskytli v&nbsp;s\u00falade s&nbsp;legislat\u00edvnymi predpismi hl\u00e1si\u0165 tieto podozrenia na \u00da\u0160KVBL na formul\u00e1ri uvedenom na str\u00e1nke.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>MIMORIADNY DOVOZ \u00dastav \u0161t\u00e1tnej kontroly veterin\u00e1rnych bioprepar\u00e1tov a&nbsp;lie\u010div (\u010falej len \u00da\u0160KVBL) ako org\u00e1n \u0161t\u00e1tnej spr\u00e1vy pod\u013ea \u00a7 134 ods. 2 p\u00edsm. a) a&nbsp;p\u00edsm. f) z\u00e1kona \u010d. 362\/2011 Z. z. o&nbsp;liekoch a&nbsp;zdravotn\u00edckych pom\u00f4ckach&nbsp; a&nbsp;o&nbsp;zmene a&nbsp;doplnen\u00ed niektor\u00fdch z\u00e1konov (\u010falej len \u201ez\u00e1kon o&nbsp;liekoch\u201c) &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=541\">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-541","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/541","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=541"}],"version-history":[{"count":9,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/541\/revisions"}],"predecessor-version":[{"id":4552,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/541\/revisions\/4552"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=541"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}