{"id":63,"date":"2020-01-20T14:42:30","date_gmt":"2020-01-20T13:42:30","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=63"},"modified":"2026-05-15T11:42:50","modified_gmt":"2026-05-15T09:42:50","slug":"predkladanie-analytickych-certifikatov-a-vzoriek","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=63","title":{"rendered":"PREDKLADANIE ANALYTICK\u00ddCH CERTIFIK\u00c1TOV A VZORIEK VETERIN\u00c1RNEHO LIEKU"},"content":{"rendered":"\n<p>\u00da\u0160KVBL pripom\u00edna v\u00fdrobcom, odborn\u00fdm z\u00e1stupcom za zabezpe\u010denie kvality liekov, dr\u017eite\u013eom rozhodnutia o\u00a0registr\u00e1cii a\u00a0distrib\u00fatorom povinnosti vypl\u00fdvaj\u00face zo z\u00e1kona 362\/2011 Z. z. s\u00favisiace s predkladan\u00edm analytick\u00fdch certifik\u00e1tov a\u00a0zasielan\u00edm vzoriek veterin\u00e1rneho lieku.\u00a0<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"> <span class=\"has-inline-color has-blue-color\"><strong>Analytick\u00e9 certifik\u00e1ty \u0161ar\u017e\u00ed veterin\u00e1rnych liekov<\/strong> <\/span><\/h3>\n\n\n\n<p><strong><em>Dr\u017eite\u013e povolenia na v\u00fdrobu liekov <\/em><\/strong>je povinn\u00fd do siedmich dn\u00ed po skon\u010den\u00ed \u0161tvr\u0165roka predlo\u017ei\u0165 na \u00da\u0160KVBL analytick\u00e9 certifik\u00e1ty v\u0161etk\u00fdch prepusten\u00fdch \u0161ar\u017e\u00ed liekov dodan\u00fdch na dom\u00e1ci trh, ak ide o\u00a0imunologick\u00e9 lieky a\u00a0lieky vyroben\u00e9 z\u00a0krvi a\u00a0z\u00a0plazmy\u00a0 (\u00a7 15 ods.1, p\u00edsm. h) (2).<br>Analytick\u00e9 certifik\u00e1ty zasielajte na emailov\u00fa adresu: <a href=\"mailto:stanislava.drahosova@uskvbl.sk\">stanislava.drahosova@uskvbl.sk<\/a><\/p>\n\n\n\n<p><strong><em>Odborn\u00fd z\u00e1stupca zodpovedn\u00fd za zabezpe\u010dovanie kvality liekov<\/em><\/strong>je povinn\u00fd uchov\u00e1va\u0165 analytick\u00fd certifik\u00e1t o&nbsp;prepusten\u00ed \u0161ar\u017ee veterin\u00e1rneho lieku najmenej p\u00e4\u0165 rokov od prepustenia \u0161ar\u017ee a na po\u017eiadanie ho predlo\u017ei\u0165 na \u00da\u0160KVBL (\u00a7 16 ods. 2, p\u00edsm. d).&nbsp;<\/p>\n\n\n\n<p><strong><em>Dr\u017eite\u013e povolenia na ve\u013ekodistrib\u00faciu liekov<\/em>\u00a0<\/strong>je povinn\u00fd do siedmich dn\u00ed po dovoze liekov, predlo\u017ei\u0165 zoznam dovezen\u00fdch liekov s uveden\u00edm po\u010dtu a ve\u013ekosti balenia a \u010d\u00edsla \u0161ar\u017ee alebo v\u00fdrobn\u00e9ho \u010d\u00edsla a na po\u017eiadanie predlo\u017ei\u0165 ich analytick\u00e9 certifik\u00e1ty o\u00a0prepusten\u00ed \u0161ar\u017ee na \u00da\u0160KVBL (\u00a7 18 ods. 1, p\u00edsm. h) (1).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"has-inline-color has-blue-color\"><strong>Vzorky veterin\u00e1rnych liekov a\u00a0referen\u010dn\u00e9 l\u00e1tky potrebn\u00e9 na anal\u00fdzu<\/strong><\/span><\/h4>\n\n\n\n<p><strong>\u017diadate\u013e o registr\u00e1ciu veterin\u00e1rneho lieku<\/strong><br>\u00da\u0160KVBL m\u00f4\u017ee pri posudzovan\u00ed \u017eiadosti vy\u017eadova\u0165 od \u017eiadate\u013ea, aby poskytol vzorky, ktor\u00e9 s\u00fa potrebn\u00e9 na:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>vykonanie sk\u00fa\u0161ok veterin\u00e1rneho lieku, jeho vstupn\u00fdch surov\u00edn a, ak je to potrebn\u00e9, aj medziproduktov alebo in\u00fdch zlo\u017eiek v z\u00e1ujme zabezpe\u010denia toho, \u017ee kontroln\u00e9 met\u00f3dy pou\u017e\u00edvan\u00e9 v\u00fdrobcom a op\u00edsan\u00e9 v dokumentoch k \u017eiadosti s\u00fa posta\u010duj\u00face,<\/li>\n\n\n\n<li>overenie toho, \u017ee v pr\u00edpade veterin\u00e1rnych liekov ur\u010den\u00fdch pre zvierat\u00e1 ur\u010den\u00e9 na v\u00fdrobu potrav\u00edn analytick\u00e1 detek\u010dn\u00e1 met\u00f3da, ktor\u00fa navrhuje \u017eiadate\u013e na \u00fa\u010dely sk\u00fa\u0161ok depl\u00e9cie rez\u00eddu\u00ed, je posta\u010duj\u00faca a vhodn\u00e1 na odhalenie pr\u00edtomnosti hladiny rez\u00eddu\u00ed, najm\u00e4 ak rez\u00eddu\u00e1 prekra\u010duj\u00fa maxim\u00e1lne hladiny rez\u00eddu\u00ed farmakologicky \u00fa\u010dinn\u00fdch l\u00e1tok ur\u010den\u00e9 Komisiou v s\u00falade s nariaden\u00edm (ES) \u010d. 470\/2009, a na \u00faradn\u00e9 kontroly zvierat a produktov \u017eivo\u010d\u00ed\u0161neho p\u00f4vodu v s\u00falade s nariaden\u00edm (E\u00da) 2017\/625.<\/li>\n<\/ul>\n\n\n\n<p><strong><em>Dr\u017eite\u013e povolenia na v\u00fdrobu liekov<\/em><\/strong>&nbsp; je povinn\u00fd predlo\u017ei\u0165 na \u00da\u0160KVBL na kontrolu kvality vzorky prv\u00fdch piatich \u0161ar\u017e\u00ed imunologick\u00fdch a&nbsp;biologick\u00fdch veterin\u00e1rnych liekov nov\u00e9ho lieku prepusten\u00e9ho na trh v&nbsp;mno\u017estve potrebnom na tri kompletn\u00e9 anal\u00fdzy. (\u00a7 15 ods. 1, p\u00edsm. n).<\/p>\n\n\n\n<p><strong><em>Dr\u017eite\u013e rozhodnutia o registr\u00e1cii veterin\u00e1rneho lieku&nbsp;<\/em><\/strong>je povinn\u00fd<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>na po\u017eiadanie poskytn\u00fa\u0165 \u00da\u0160KVBL bezodkladne potrebn\u00fa s\u00fa\u010dinnos\u0165 vr\u00e1tane poskytnutia vzoriek veterin\u00e1rneho lieku a referen\u010dn\u00fdch l\u00e1tok v mno\u017estve potrebnom na vykonanie laborat\u00f3rnej kontroly vyroben\u00fdch \u0161ar\u017e\u00ed veterin\u00e1rneho lieku, pr\u00edpadne na opakovanie kontroly (\u00a7 98 ods. 1, p\u00edsm. b),<\/li>\n\n\n\n<li>na po\u017eiadanie poskytn\u00fa\u0165 \u00da\u0160KVBL vzorky ka\u017edej \u0161ar\u017ee imunologick\u00e9ho veterin\u00e1rneho lieku a biologick\u00e9ho veterin\u00e1rneho liek na vykonanie kontroly kvality pred ich prepusten\u00edm na trh, (\u00a7 108 ods. 2). Pre viac inform\u00e1cii vi\u010f\u00a0<strong>OCABR\/OBPR.<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong><em>Dr\u017eite\u013e povolenia na ve\u013ekodistrib\u00faciu<\/em><\/strong>&nbsp;liekov je povinn\u00fd do siedmich dn\u00ed po dovoze veterin\u00e1rneho lieku, doda\u0165 na po\u017eiadanie \u00da\u0160KVBL vzorky po\u017eadovan\u00fdch \u0161ar\u017e\u00ed liekov v mno\u017estve potrebnom na tri anal\u00fdzy (\u00a7 18 ods.1, p\u00edsm. h) (2).<\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00da\u0160KVBL pripom\u00edna v\u00fdrobcom, odborn\u00fdm z\u00e1stupcom za zabezpe\u010denie kvality liekov, dr\u017eite\u013eom rozhodnutia o\u00a0registr\u00e1cii a\u00a0distrib\u00fatorom povinnosti vypl\u00fdvaj\u00face zo z\u00e1kona 362\/2011 Z. z. s\u00favisiace s predkladan\u00edm analytick\u00fdch certifik\u00e1tov a\u00a0zasielan\u00edm vzoriek veterin\u00e1rneho lieku.\u00a0 Analytick\u00e9 certifik\u00e1ty \u0161ar\u017e\u00ed veterin\u00e1rnych liekov Dr\u017eite\u013e povolenia na v\u00fdrobu liekov je &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=63\">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-63","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/63","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=63"}],"version-history":[{"count":13,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/63\/revisions"}],"predecessor-version":[{"id":9621,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/63\/revisions\/9621"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=63"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}