{"id":408,"date":"2020-03-02T15:16:47","date_gmt":"2020-03-02T14:16:47","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=408"},"modified":"2025-04-25T11:54:53","modified_gmt":"2025-04-25T09:54:53","slug":"pravne-predpisy-eu","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=408","title":{"rendered":"PR\u00c1VNE PREDPISY EUR\u00d3PSKEJ \u00daNIE"},"content":{"rendered":"\n<ul class=\"wp-block-list\"><\/ul>\n\n\n\n<p>Pr\u00e1vne predpisy Eur\u00f3pskej \u00fanie s\u00fa publikovan\u00e9 v&nbsp;\u00faradnom Vestn\u00edku Eur\u00f3pskej \u00fanie a&nbsp;mo\u017eno ich n\u00e1js\u0165 na: <a href=\"http:\/\/www.eur-lex.europa.eu\" target=\"_blank\" rel=\"noreferrer noopener\">http:\/\/www.eur-lex.europa.eu<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong><span class=\"has-inline-color has-blue-color\"><strong>Hlavn\u00e9 pr\u00e1vne predpisy Eur\u00f3pskej \u00fanie t\u00fdkaj\u00face sa \u010dinnosti \u00da\u0160KVBL s\u00fa:<\/strong><\/span><\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Nariadenie Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6 o veterin\u00e1rnych liekoch a o zru\u0161en\u00ed smernice 2001\/82\/ES,<\/li>\n\n\n\n<li>Nariadenie Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/4 o v\u00fdrobe, uv\u00e1dzan\u00ed na trh a pou\u017e\u00edvan\u00ed medikovan\u00fdch krm\u00edv a o zmene nariadenia Eur\u00f3pskeho parlamentu a Rady (ES) \u010d. 183\/2005 a zru\u0161en\u00ed smernice Rady 90\/167\/EHS,<\/li>\n\n\n\n<li>Nariadenie Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/5, ktor\u00fdm sa men\u00ed nariadenie (ES) \u010d. 726\/2004, ktor\u00fdm sa stanovuj\u00fa postupy Spolo\u010denstva pri povo\u013eovan\u00ed liekov na hum\u00e1nne pou\u017eitie a na veterin\u00e1rne pou\u017eitie a pri vykon\u00e1van\u00ed dozoru nad t\u00fdmito liekmi a ktor\u00fdm sa zria\u010fuje Eur\u00f3pska agent\u00fara pre lieky, nariadenie (ES) \u010d. 1901\/2006 o liekoch na pediatrick\u00e9 pou\u017eitie a smernica 2001\/83\/ES, ktorou sa ustanovuje z\u00e1konn\u00edk Spolo\u010denstva o hum\u00e1nnych liekoch,<\/li>\n\n\n\n<li>Nariadenie Eur\u00f3pskeho parlamentu a&nbsp;Rady (ES) \u010d.&nbsp;726\/2004, ktor\u00fdm sa stanovuj\u00fa postupy spolo\u010denstva pri povo\u013eovan\u00ed liekov na&nbsp;hum\u00e1nne pou\u017eitie a&nbsp;na veterin\u00e1rne pou\u017eitie a&nbsp;pri vykon\u00e1van\u00ed dozoru nad t\u00fdmito liekmi a&nbsp;ktor\u00fdm sa zria\u010fuje Eur\u00f3pska agent\u00fara pre liek<\/li>\n\n\n\n<li>Nariadenie Eur\u00f3pskeho Parlamentu a Rady (E\u00da) 2017\/625 o&nbsp;\u00faradn\u00fdch kontrol\u00e1ch a&nbsp;in\u00fdch \u00faradn\u00fdch \u010dinnostiach vykon\u00e1van\u00fdch na zabezpe\u010denie uplat\u0148ovania potravinov\u00e9ho a&nbsp;krmivov\u00e9ho pr\u00e1va a&nbsp;pravidiel pre zdravie zvierat a&nbsp;dobr\u00e9 \u017eivotn\u00e9 podmienky zvierat, pre zdravie rastl\u00edn a&nbsp;pre pr\u00edpravky na ochranu rastl\u00edn, o&nbsp;zmene nariaden\u00ed Eur\u00f3pskeho parlamentu a&nbsp;Rady (ES) \u010d.&nbsp;999\/2001, (ES) \u010d.&nbsp;396\/2005, (ES) \u010d.&nbsp;1069\/2009, (ES) \u010d.&nbsp;1107\/2009, (E\u00da) \u010d.&nbsp;1151\/2012, (E\u00da) \u010d.&nbsp;652\/2014, (E\u00da) 2016\/429 a&nbsp;(E\u00da) 2016\/2031, nariaden\u00ed Rady (ES) \u010d.&nbsp;1\/2005 a&nbsp;(ES) \u010d.&nbsp;1099\/2009 a&nbsp;smern\u00edc Rady 98\/58\/ES, 1999\/74\/ES, 2007\/43\/ES, 2008\/119\/ES a&nbsp;2008\/120\/ES a&nbsp;o&nbsp;zru\u0161en\u00ed nariaden\u00ed Eur\u00f3pskeho parlamentu a&nbsp;Rady (ES) \u010d.&nbsp;854\/2004 a&nbsp;(ES) \u010d.&nbsp;882\/2004, smern\u00edc Rady 89\/608\/EHS, 89\/662\/EHS, 90\/425\/EHS, 91\/496\/EHS, 96\/23\/ES, 96\/93\/ES a&nbsp;97\/78\/ES a&nbsp;rozhodnutia Rady 92\/438\/EHS (nariadenie o&nbsp;\u00faradn\u00fdch kontrol\u00e1ch)<\/li>\n\n\n\n<li>Nariadenie Eur\u00f3pskeho parlamentu a Rady (ES) 470\/2009 o stanoven\u00ed postupov Spolo\u010denstva na ur\u010denie limitov rez\u00eddu\u00ed farmakologicky \u00fa\u010dinn\u00fdch l\u00e1tok v potravin\u00e1ch \u017eivo\u010d\u00ed\u0161neho p\u00f4vodu, o zru\u0161en\u00ed nariadenia Rady (EHS) \u010d. 2377\/90 a o zmene a doplnen\u00ed smernice Eur\u00f3pskeho parlamentu a Rady 2001\/82\/ES a nariadenia Eur\u00f3pskeho parlamentu a Rady (ES) \u010d. 726\/2004<\/li>\n\n\n\n<li>Nariadenie Eur\u00f3pskeho parlamentu a Rady (ES) 1069\/2009 ktor\u00fdm sa ustanovuj\u00fa zdravotn\u00e9 predpisy t\u00fdkaj\u00face sa ved\u013eaj\u0161\u00edch \u017eivo\u010d\u00ed\u0161nych produktov a odvoden\u00fdch produktov neur\u010den\u00fdch na \u013eudsk\u00fa spotrebu a&nbsp; ktor\u00fdm sa zru\u0161uje nariadenie (ES) \u010d.&nbsp; 1774\/2002 (nariadenie o&nbsp; ved\u013eaj\u0161\u00edch \u017eivo\u010d\u00ed\u0161nych produktoch)<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2021\/1248 o opatreniach t\u00fdkaj\u00facich sa spr\u00e1vnej distribu\u010dnej praxe pre veterin\u00e1rne lieky v s\u00falade s nariaden\u00edm Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6,<\/li>\n\n\n\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2021\/16 ktor\u00fdm sa stanovuj\u00fa potrebn\u00e9 opatrenia a praktick\u00e9 opatrenia t\u00fdkaj\u00face sa datab\u00e1zy veterin\u00e1rnych liekov \u00danie (datab\u00e1za liekov \u00danie),<\/li>\n\n\n\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2021\/17, ktor\u00fdm sa stanovuje zoznam zmien, ktor\u00e9 si nevy\u017eaduj\u00fa pos\u00fadenie, v s\u00falade s nariaden\u00edm Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6,<\/li>\n\n\n\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2021\/1280 o opatreniach t\u00fdkaj\u00facich sa spr\u00e1vnej distribu\u010dnej praxe pre \u00fa\u010dinn\u00e9 l\u00e1tky pou\u017e\u00edvan\u00e9 ako vstupn\u00e9 suroviny vo veterin\u00e1rnych liekoch v s\u00falade s nariaden\u00edm Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6,<\/li>\n\n\n\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2021\/1281, ktor\u00fdm sa stanovuj\u00fa pravidl\u00e1 uplat\u0148ovania nariadenia Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6, pokia\u013e ide o spr\u00e1vnu prax v oblasti farmakovigilan\u010dn\u00e9ho doh\u013eadu a o form\u00e1t, obsah a s\u00fahrn hlavn\u00e9ho dokumentu farmakovigilan\u010dn\u00e9ho syst\u00e9mu pre veterin\u00e1rne lieky,<\/li>\n\n\n\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2022\/209, ktor\u00fdm sa stanovuje form\u00e1t \u00fadajov, ktor\u00e9 sa maj\u00fa zbiera\u0165 a nahlasova\u0165 s cie\u013eom ur\u010di\u0165 objem predaja a pou\u017e\u00edvania antimikrobi\u00e1lnych liekov u zvierat v s\u00falade s nariaden\u00edm Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6,<\/li>\n\n\n\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2022\/1255, ktor\u00fdm sa v s\u00falade s nariaden\u00edm Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6 ur\u010duj\u00fa antimikrobik\u00e1 alebo skupiny antimikrob\u00edk vyhraden\u00e9 na lie\u010dbu ur\u010dit\u00fdch infekci\u00ed u \u013eud\u00ed,<\/li>\n\n\n\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2024\/875, ktor\u00fdm sa prij\u00edma zoznam skratiek a piktogramov spolo\u010dn\u00fdch pre cel\u00fa \u00daniu, ktor\u00e9 sa maj\u00fa pou\u017e\u00edva\u0165 na obaloch veterin\u00e1rnych liekov na \u00fa\u010dely \u010dl\u00e1nku 10 ods. 2 a \u010dl\u00e1nku 11 ods. 3 nariadenia Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6,<\/li>\n\n\n\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2024\/878, ktor\u00fdm sa prij\u00edmaj\u00fa jednotn\u00e9 pravidl\u00e1 t\u00fdkaj\u00face sa ve\u013ekosti mal\u00fdch vn\u00fatorn\u00fdch obalov veterin\u00e1rnych liekov pod\u013ea \u010dl\u00e1nku 12 nariadenia Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6,<\/li>\n\n\n\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2024\/916, ktor\u00fdm sa men\u00ed vykon\u00e1vacie nariadenie (E\u00da) 2021\/17, ktor\u00fdm sa stanovuje zoznam zmien, ktor\u00e9 si nevy\u017eaduj\u00fa pos\u00fadenie, v s\u00falade s nariaden\u00edm Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6.<\/li>\n\n\n\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2025\/163 ktor\u00fdm sa men\u00ed vykon\u00e1vacie nariadenie (E\u00da)&nbsp;2021\/17, ktor\u00fdm sa stanovuje zoznam zmien, ktor\u00e9 si nevy\u017eaduj\u00fa pos\u00fadenie, v&nbsp;s\u00falade s&nbsp;nariaden\u00edm Eur\u00f3pskeho parlamentu a&nbsp;Rady (E\u00da)&nbsp;2019\/6<\/li>\n\n\n\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 202\/1973 ktor\u00fdm sa stanovuje zoznam antimikrob\u00edk, ktor\u00e9 sa nesm\u00fa pou\u017e\u00edva\u0165 v&nbsp;s\u00falade s&nbsp;\u010dl\u00e1nkami 112 a&nbsp;113 nariadenia Eur\u00f3pskeho parlamentu a&nbsp;Rady (E\u00da)&nbsp;2019\/6 alebo ktor\u00e9 sa sm\u00fa v&nbsp;s\u00falade s&nbsp;uveden\u00fdmi \u010dl\u00e1nkami pou\u017e\u00edva\u0165 len za ur\u010dit\u00fdch podmienok<\/li>\n\n\n\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2023\/997, ktor\u00fdm sa men\u00ed vykon\u00e1vacie nariadenie (E\u00da) 2021\/17, ktor\u00fdm sa stanovuje zoznam zmien, ktor\u00e9 si nevy\u017eaduj\u00fa pos\u00fadenie, v s\u00falade s nariaden\u00edm Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6<\/li>\n\n\n\n<li>Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2018\/470 o podrobn\u00fdch pravidl\u00e1ch t\u00fdkaj\u00facich sa maxim\u00e1lneho limitu rez\u00eddu\u00ed, ktor\u00e9 sa ber\u00fa do \u00favahy na kontroln\u00e9 \u00fa\u010dely pre potraviny vyroben\u00e9 zo zvierat, ktor\u00e9 boli lie\u010den\u00e9 v E\u00da pod\u013ea \u010dl\u00e1nku 11 smernice 2001\/82\/ES<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Delegovan\u00e9 nariadenie Komisie (E\u00da) 2021\/1760, ktor\u00fdm sa dop\u013a\u0148a nariadenie Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6 stanoven\u00edm krit\u00e9ri\u00ed na ur\u010dovanie antimikrob\u00edk, ktor\u00e9 maj\u00fa by\u0165 vyhraden\u00e9 na lie\u010dbu ur\u010dit\u00fdch infekci\u00ed u \u013eud\u00ed,<\/li>\n\n\n\n<li>Delegovan\u00e9 nariadenie Komisie (E\u00da) 2023\/183, ktor\u00fdm sa men\u00ed nariadenie Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6, pokia\u013e ide o po\u017eiadavky t\u00fdkaj\u00face sa s\u00faladu so spr\u00e1vnou laborat\u00f3rnou praxou v pr\u00edpade veterin\u00e1rnych liekov stanoven\u00fdch v pr\u00edlohe II k uveden\u00e9mu nariadeniu,<\/li>\n\n\n\n<li>Delegovan\u00e9 nariadenie Komisie (E\u00da) 2021\/578, ktor\u00fdm sa dop\u013a\u0148a nariadenie Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6, pokia\u013e ide o po\u017eiadavky na zber \u00fadajov o objeme predaja a o pou\u017e\u00edvan\u00ed antimikrobi\u00e1lnych liekov u zvierat,<\/li>\n\n\n\n<li>Delegovan\u00e9 nariadenie Komisie (E\u00da) 2021\/805, ktor\u00fdm sa men\u00ed pr\u00edloha II k nariadeniu Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6,<\/li>\n\n\n\n<li>Delegovan\u00e9 nariadenie Komisie (E\u00da) 2024\/1159, ktor\u00fdm sa dop\u013a\u0148a nariadenie Eur\u00f3pskeho parlamentu a&nbsp;Rady (E\u00da)&nbsp;2019\/6 stanoven\u00edm pravidiel t\u00fdkaj\u00facich sa primeran\u00fdch opatren\u00ed na zaistenie \u00fa\u010dinn\u00e9ho a&nbsp;bezpe\u010dn\u00e9ho pou\u017e\u00edvania veterin\u00e1rnych liekov povolen\u00fdch a&nbsp;predp\u00edsan\u00fdch na peror\u00e1lne pod\u00e1vanie in\u00fdmi cestami ako prostredn\u00edctvom medikovan\u00e9ho krmiva a&nbsp;pod\u00e1van\u00fdch dr\u017eite\u013eom zvierat zvierat\u00e1m ur\u010den\u00fdm na v\u00fdrobu potrav\u00edn<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Nariadenie Komisie 2018\/782&nbsp; ktor\u00fdm sa stanovuj\u00fa metodick\u00e9 princ\u00edpy t\u00fdkaj\u00face sa hodnotenia rizika a odpor\u00fa\u010dan\u00ed v oblasti riadenia rizika pod\u013ea nariadenia (ES) \u010d. 470\/2009<\/li>\n\n\n\n<li>Nariadenie Komisie (E\u00da) 37\/2010 o farmakologicky \u00fa\u010dinn\u00fdch l\u00e1tkach a&nbsp; ich klasifik\u00e1cii, pokia\u013e ide o&nbsp; maxim\u00e1lne limity rez\u00eddu\u00ed v potravin\u00e1ch \u017eivo\u010d\u00ed\u0161neho p\u00f4vodu<\/li>\n\n\n\n<li>Nariadenie Komisie (ES) \u010d. 1950\/2006 ktor\u00fdm sa v s\u00falade so smernicou Eur\u00f3pskeho parlamentu a Rady 2001\/82\/ES, ktorou sa ustanovuje Z\u00e1konn\u00edk Spolo\u010denstva o veterin\u00e1rnych liekoch, zav\u00e1dza zoznam l\u00e1tok nevyhnutn\u00fdch na lie\u010dbu zvierat \u010de\u013eade ko\u0148ovit\u00fdch a l\u00e1tok prin\u00e1\u0161aj\u00facich v\u00e4\u010d\u0161\u00ed klinick\u00fd prospech<\/li>\n\n\n\n<li>Nariadenie Komisie (E\u00da) 2017\/880 ktor\u00fdm sa v&nbsp;s\u00falade s&nbsp;nariaden\u00edm Eur\u00f3pskeho parlamentu a Rady (ES) \u010d.&nbsp;470\/2009 stanovuj\u00fa pravidl\u00e1 pou\u017e\u00edvania maxim\u00e1lneho limitu rez\u00eddu\u00ed stanoven\u00e9ho pre farmakologicky \u00fa\u010dinn\u00fa l\u00e1tku v&nbsp;konkr\u00e9tnej potravine na in\u00fa potravinu z\u00edskan\u00fa z&nbsp;rovnak\u00e9ho druhu a&nbsp;pravidl\u00e1 pou\u017e\u00edvania maxim\u00e1lneho limitu rez\u00eddu\u00ed stanoven\u00e9ho pre farmakologicky \u00fa\u010dinn\u00fa l\u00e1tku v&nbsp;jednom alebo viacer\u00fdch druhoch na in\u00e9 druhy<\/li>\n\n\n\n<li>Nariadenie Komisie (E\u00da) 2018\/781 ktor\u00fdm sa men\u00ed nariadenie (ES) \u010d.&nbsp;847\/2000, pokia\u013e ide o&nbsp;vymedzenie pojmu \u201epodobn\u00fd liek\u201c<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Smernica 91\/412\/EHS ktorou sa stanovuj\u00fa z\u00e1sady a metodick\u00e9 pokyny spr\u00e1vnej v\u00fdrobnej praxe pre veterin\u00e1rne lieky<\/li>\n\n\n\n<li>Smernica 2001\/18\/ES Eur\u00f3pskeho parlamentu a&nbsp;Rady o z\u00e1mernom uvo\u013enen\u00ed geneticky modifikovan\u00fdch organizmov do \u017eivotn\u00e9ho prostredia a o zru\u0161en\u00ed smernice Rady 90\/220\/EHS<\/li>\n\n\n\n<li>Smernica 2003\/74\/ES Eur\u00f3pskeho Parlamentu a&nbsp;Rady ktorou sa men\u00ed a dop\u013a\u0148a smernica Rady 96\/22\/ES o z\u00e1kaze pou\u017e\u00edvania niektor\u00fdch l\u00e1tok s hormon\u00e1lnym alebo tyrostatick\u00fdm \u00fa\u010dinkom a beta-agonistov pri chove dobytka<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Pr\u00e1vne predpisy Eur\u00f3pskej \u00fanie s\u00fa publikovan\u00e9 v&nbsp;\u00faradnom Vestn\u00edku Eur\u00f3pskej \u00fanie a&nbsp;mo\u017eno ich n\u00e1js\u0165 na: http:\/\/www.eur-lex.europa.eu Hlavn\u00e9 pr\u00e1vne predpisy Eur\u00f3pskej \u00fanie t\u00fdkaj\u00face sa \u010dinnosti \u00da\u0160KVBL s\u00fa:<\/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-408","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/408","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=408"}],"version-history":[{"count":12,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/408\/revisions"}],"predecessor-version":[{"id":8944,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/408\/revisions\/8944"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=408"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}