{"id":640,"date":"2020-03-06T10:03:54","date_gmt":"2020-03-06T09:03:54","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=640"},"modified":"2026-02-24T14:44:43","modified_gmt":"2026-02-24T13:44:43","slug":"kontrolne-laboratoria-pre-vyrobcov","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=640","title":{"rendered":"KONTROLN\u00c9 LABORAT\u00d3RI\u00c1 PRE V\u00ddROBCOV"},"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\">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&nbsp;liekoch a&nbsp;zdravotn\u00edckych pom\u00f4ckach a&nbsp;o&nbsp;zmene a&nbsp;doplnen\u00ed niektor\u00fdch z\u00e1konov v&nbsp;znen\u00ed neskor\u0161\u00edch predpisov (\u010falej len \u201cz\u00e1kon o&nbsp;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\">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:\/\/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 kontroln\u00fdch laborat\u00f3ri\u00ed pre v\u00fdrobcov<\/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) vykon\u00e1va \u0161t\u00e1tny dozor na \u00faseku veterin\u00e1rnej farm\u00e1cie pod\u013ea tohto z\u00e1kona a osobitn\u00e9ho predpisu pri \u010dinnostiach spojen\u00fdch so sk\u00fa\u0161an\u00edm veterin\u00e1rnych liekov<\/li>\n\n\n\n<li>p\u00edsmeno f) vyd\u00e1va\n<ul class=\"wp-block-list\">\n<li>2.rozhodnutie o povolen\u00ed, zmene povolenia, pozastaven\u00ed rozhodnutia a zru\u0161en\u00ed rozhodnutia na \u010dinnos\u0165 kontroln\u00e9ho laborat\u00f3ria veterin\u00e1rnych liekov,<\/li>\n\n\n\n<li>3.certifik\u00e1t spr\u00e1vnej v\u00fdrobnej praxe<\/li>\n<\/ul>\n<\/li>\n<\/ul>\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\">Povo\u013eovanie \u010dinnosti kontroln\u00e9ho laborat\u00f3ria v\u00fdrobcu veterin\u00e1rnych liekov<\/mark><\/strong><\/h3>\n\n\n\n<p>Kontrola veterin\u00e1rnych liekov je legislat\u00edvne ustanoven\u00e9 z\u00e1konom o&nbsp;liekoch nariaden\u00edm E\u00da 2019\/6 o&nbsp;veterin\u00e1rnych liekoch.<strong><\/strong><\/p>\n\n\n\n<p>Ustanovenia z\u00e1kona o&nbsp;liekoch t\u00fdkaj\u00face sa v\u00fdroby veterin\u00e1rnych liekov sa vz\u0165ahuj\u00fa aj na kontroln\u00e9 laborat\u00f3ri\u00e1 &#8211; povolenie na v\u00fdrobu liekov je potrebn\u00e9 aj pri kontrole kvality veterin\u00e1rnych liekov, kontrole kvality sk\u00fa\u0161an\u00fdch veterin\u00e1rnych produktov alebo kontrole kvality sk\u00fa\u0161an\u00fdch veterin\u00e1rnych liekov (\u00a7 12 ods. 3 p\u00edsm. f) z\u00e1kona 362\/2011 Z.z.)<\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-a5fce3eb-61a1-49e6-8f00-2db235371c0e\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/f71_ziadost_o_povolenie_na_cinnost_kl.docx\">\u017diados\u0165 o&nbsp;povolenie na \u010dinnos\u0165 kontroln\u00e9ho laborat\u00f3ria v\u00fdrobcu<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-53906763-5615-4fcb-b33b-41eefd529ccd\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/f73_ziadost_o_zmenu_v_povoleni_na_cinnost_kl.docx\">\u017diados\u0165 o&nbsp;zmenu v povolen\u00ed na \u010dinnos\u0165 kontroln\u00e9ho laborat\u00f3ria v\u00fdrobcu<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-9a5cb42f-4637-41cf-9310-4dd99943fad7\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/f99e_ziadost_o_pozastavenie_cinnosti_kl.docx\">\u017diados\u0165 o\u00a0pozastavenie \u010dinnosti  kontroln\u00e9ho laborat\u00f3ria v\u00fdrobcu <\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-007f8be2-9520-4249-a25f-d16dfee4f5d1\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/f100e_ziadost_o_zruseniei_cinnosti_kl.docx\">\u017diados\u0165 o\u00a0zru\u0161enie \u010dinnosti  kontroln\u00e9ho laborat\u00f3ria v\u00fdrobcu<\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<p>\u017diados\u0165 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\u00fd postup:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pre povo\u013eovanie v\u00fdroby \u2013 postupuje sa pod\u013ea \u010dl. 90 nariadenia E\u00da 2019\/6 a \u00a7 7 z\u00e1kona 362\/2011 Z.z.<\/li>\n\n\n\n<li>Pre zmeny povolenia v\u00fdroby&nbsp; &#8211; postupuje sa pod\u013ea \u010dl. 92 nariadenia E\u00da 2019\/6 a \u00a7 8 z\u00e1kona 362\/2011 Z.z.<\/li>\n<\/ul>\n\n\n\n<p>Rozsah \u010dinnosti kontroln\u00fdch laborat\u00f3ri\u00ed je definovan\u00fd v Compilation of Community Procedures on Inspections and Exchange of Information, <\/p>\n","protected":false},"excerpt":{"rendered":"<p>S\u00favisiaca legislat\u00edva Z\u00e1kon \u010d. 362\/2011 Z. z. o&nbsp;liekoch a&nbsp;zdravotn\u00edckych pom\u00f4ckach a&nbsp;o&nbsp;zmene a&nbsp;doplnen\u00ed niektor\u00fdch z\u00e1konov v&nbsp;znen\u00ed neskor\u0161\u00edch predpisov (\u010falej len \u201cz\u00e1kon o&nbsp;liekoch\u201c) Nariadenie Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6 o&nbsp;veterin\u00e1rnych liekoch a o zru\u0161en\u00ed smernice 2001\/82\/ES Usmernenie Eur\u00f3pskej komisie a Eur\u00f3pskej &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=640\">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-640","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/640","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=640"}],"version-history":[{"count":23,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/640\/revisions"}],"predecessor-version":[{"id":9491,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/640\/revisions\/9491"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=640"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}