{"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":"2025-11-18T09:34:20","modified_gmt":"2025-11-18T08:34:20","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&nbsp;registr\u00e1cii a&nbsp;distrib\u00fatorom povinnosti vypl\u00fdvaj\u00face zo z\u00e1kona 362\/2011 Z.z. s\u00favisiace s predkladan\u00edm analytick\u00fdch certifik\u00e1tov a&nbsp;zasielan\u00edm vzoriek veterin\u00e1rneho lieku.&nbsp;<\/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&nbsp;imunologick\u00e9 lieky a&nbsp;lieky vyroben\u00e9 z&nbsp;krvi a&nbsp;z&nbsp;plazmy&nbsp; (\u00a7 15 ods.1, p\u00edsm. h)<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><em> <\/em>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;<br><\/p>\n\n\n\n<p><strong><em>Dr\u017eite\u013e povolenia na ve\u013ekodistrib\u00faciu liekov<\/em><\/strong><strong> <\/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&nbsp;prepusten\u00ed \u0161ar\u017ee na \u00da\u0160KVBL (\u00a7 18 ods. 1, p\u00edsm. h 1)<br><\/p>\n\n\n\n<p>Medzin\u00e1rodne harmonizovan\u00e9 po\u017eiadavky na certifik\u00e1ciu \u0161ar\u017e\u00ed v kontexte doh\u00f4d o vz\u00e1jomnom uzn\u00e1van\u00ed, doh\u00f4d o posudzovan\u00ed zhody a uzn\u00e1van\u00ed priemyseln\u00fdch v\u00fdrobkov a in\u00fdch vhodn\u00fdch dojednan\u00ed o SVP s Eur\u00f3pskou \u00faniou vr\u00e1tane po\u017eiadaviek na obsah analytick\u00e9ho certifik\u00e1tu veterin\u00e1rneho lieku m\u00f4\u017eete n\u00e1js\u0165 na webovej str\u00e1nke&nbsp; Eur\u00f3pskej liekovej agent\u00fary (EMA):&nbsp; <a href=\"http:\/\/ec.europa.eu\/health\/files\/eudralex\/vol-4\/mra_batch-certificate_05-2011.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">http:\/\/ec.europa.eu\/health\/files\/eudralex\/vol-4\/mra_batch-certificate_05-2011.pdf<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"has-inline-color has-blue-color\"> <strong>Vzorky veterin\u00e1rnych liekov a&nbsp;referen\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><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><em>Dr\u017eite\u013e rozhodnutia o registr\u00e1cii veterin\u00e1rneho lieku <\/em><\/strong>je povinn\u00fd<strong><em>&nbsp;<\/em><\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>na po\u017eiadanie poskytn\u00fa\u0165 \u00da\u0160KVBL 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).<\/li>\n<\/ul>\n\n\n\n<p>Pre viac inform\u00e1cii vi\u010f <strong>OCABR\/OBPR.<\/strong><br><\/p>\n\n\n\n<p><strong><em>Dr\u017eite\u013e povolenia na ve\u013ekodistrib\u00faciu<\/em><\/strong> 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)<\/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&nbsp;registr\u00e1cii a&nbsp;distrib\u00fatorom povinnosti vypl\u00fdvaj\u00face zo z\u00e1kona 362\/2011 Z.z. s\u00favisiace s predkladan\u00edm analytick\u00fdch certifik\u00e1tov a&nbsp;zasielan\u00edm vzoriek veterin\u00e1rneho lieku.&nbsp; Analytick\u00e9 certifik\u00e1ty \u0161ar\u017e\u00ed veterin\u00e1rnych liekov Dr\u017eite\u013e povolenia na v\u00fdrobu liekovje povinn\u00fd do &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":11,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/63\/revisions"}],"predecessor-version":[{"id":9363,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/63\/revisions\/9363"}],"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}]}}