{"id":65,"date":"2020-01-20T14:42:30","date_gmt":"2020-01-20T13:42:30","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=65"},"modified":"2025-11-14T11:46:43","modified_gmt":"2025-11-14T10:46:43","slug":"ocabr-obpr","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=65","title":{"rendered":"SP\u00d4SOB UVO\u013d\u0147OVANIA \u0160AR\u017d\u00cd IMUNOLOGICK\u00ddCH VETERIN\u00c1RNYCH LIEKOV NA TRH (OCABR\/OBPR)"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\"><strong><span class=\"has-inline-color has-blue-color\">Pred umiestnen\u00edm \u0161ar\u017ee imunologick\u00e9ho veterin\u00e1rneho lieku na trh<\/span><\/strong> <\/h3>\n\n\n\n<p>\u00da\u0160KVBL v&nbsp;s\u00fa\u010dasnosti <strong>nevy\u017eaduje<\/strong> aby pred umiestnen\u00edm ka\u017edej \u0161ar\u017ee imunologick\u00e9ho veterin\u00e1rneho lieku na trh Slovenskej republiky dr\u017eite\u013e rozhodnutia o&nbsp;registr\u00e1cii zasielal notifik\u00e1ciu o&nbsp;z\u00e1mere umiestni\u0165 dan\u00fa \u0161ar\u017eu na trh, ani protokol o&nbsp;prepusten\u00ed \u0161ar\u017ee (Manufacturer\u2019s protocol for OBPR\/OCABR) resp.&nbsp;eur\u00f3psky certifik\u00e1t o&nbsp;uvo\u013enen\u00ed \u0161ar\u017ee (OBPR\/OCABR) vydan\u00fd in\u00fdm \u010dlensk\u00fdm \u0161t\u00e1tom E\u00da.&nbsp;<br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><span class=\"has-inline-color has-blue-color\">Vydanie eur\u00f3pskeho OBPR\/OCABR certifik\u00e1tu o&nbsp;uvo\u013enen\u00ed \u0161ar\u017ee&nbsp;<\/span><\/strong> <\/h3>\n\n\n\n<p>Vyd\u00e1vanie Eur\u00f3pskych certifik\u00e1tov o&nbsp;\u00faradnom uvo\u013enen\u00ed \u0161ar\u017ee imunologick\u00e9ho veterin\u00e1rneho lieku v&nbsp;zmysle \u010dl\u00e1nku 128 Nariadenia (E\u00da) 2019\/6 o veterin\u00e1rnych liekoch a o zru\u0161en\u00ed smernice 2001\/82\/ES (OBPR\/OCABR) je v&nbsp;s\u00fa\u010dasnosti obmedzen\u00e9 len pre imunologick\u00e9 veterin\u00e1rne lieky vyr\u00e1ban\u00e9 a&nbsp;z\u00e1rove\u0148 registrovan\u00e9 v&nbsp;Slovenskej republike a&nbsp;to na po\u017eiadanie.<br><\/p>\n\n\n\n<p>\u00da\u0160KVBL vykon\u00e1va retestovanie \u0161ar\u017e\u00ed imunologick\u00e9ho veterin\u00e1rneho lieku (OCABR) nasledovn\u00fdch typov vakc\u00edn:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>vakc\u00edny proti pseudomoru hydiny \u017eiv\u00e1&nbsp;<\/li>\n\n\n\n<li>vakc\u00edny proti pseudomoru hydiny inaktivovan\u00e1&nbsp;<\/li>\n<\/ul>\n\n\n\n<p>Pri vykon\u00e1van\u00ed laborat\u00f3rnej kontroly vakc\u00edn \u00da\u0160KVBL uplat\u0148uje redukovan\u00fa testovaciu sch\u00e9mu ods\u00fahlasen\u00fa \u010dlensk\u00fdmi \u0161t\u00e1tmi E\u00da &nbsp;&#8211; pod\u013ea tzv. \u201e<em>Short list of IVMPs for which a restricted test list for OMCLs has been agreed\u201c.<\/em>&nbsp;<br>\u017diados\u0165 o&nbsp;\u00faradn\u00e9 uvo\u013enenie \u0161ar\u017ee a&nbsp;vydanie EU certifik\u00e1tu mus\u00ed obsahova\u0165 <em>\u017eiados\u0165, protokol o&nbsp;prepusten\u00ed \u0161ar\u017ee<\/em> (Manufacturer\u2019s protocol for OBPR\/OCABR), <em>sprievodn\u00fd list<\/em>&nbsp; <em>a&nbsp;potrebn\u00e9 mno\u017estvo vzoriek <\/em>&nbsp;\u0161ar\u017ee imunologick\u00e9ho veterin\u00e1rneho lieku.<\/p>\n\n\n\n<p>Vzory prep\u00fa\u0161\u0165ac\u00edch protokolov pre jednotliv\u00e9 typy imunologick\u00fdch liekov a&nbsp;\u010fal\u0161ie inform\u00e1cie o&nbsp;OCABR\/OBPR m\u00f4\u017eete n\u00e1js\u0165 na webovej str\u00e1nke Eur\u00f3pskeho riadite\u013estva pre kvalitu liekov (EDQM):  <a href=\"http:\/\/www.edqm.eu\/en\/Veterinary-OCABR-Guidelines-1531.html#adminpro\" target=\"_blank\" rel=\"noreferrer noopener\">http:\/\/www.edqm.eu\/en\/Veterinary-OCABR-Guidelines-1531.html#adminpro<\/a><\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-35cb00cd-f383-4458-93f9-ae33dbd5e62c\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/short_list_of_ivmps.pdf\">Short list of IVMPs for which a restricted test list for OMCLs has been agreed<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-640aefcb-bf78-4f29-9446-19322f8b3098\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/mnozstvo_vzoriek_pozadovanych_na_testovanie.pdf\">Mno\u017estvo vzoriek po\u017eadovan\u00fdch na testovanie<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-10ed6b6b-1d6b-4a53-a4a1-c8a193e595b2\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/ziadost_o_uradne_uvolnenie_sarze_imuno_vet_lieku.docx\">\u017diados\u0165 o \u00faradn\u00e9 uvo\u013enenie \u0161ar\u017ee imunologick\u00e9ho veterin\u00e1rneho lieku <\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Pred umiestnen\u00edm \u0161ar\u017ee imunologick\u00e9ho veterin\u00e1rneho lieku na trh \u00da\u0160KVBL v&nbsp;s\u00fa\u010dasnosti nevy\u017eaduje aby pred umiestnen\u00edm ka\u017edej \u0161ar\u017ee imunologick\u00e9ho veterin\u00e1rneho lieku na trh Slovenskej republiky dr\u017eite\u013e rozhodnutia o&nbsp;registr\u00e1cii zasielal notifik\u00e1ciu o&nbsp;z\u00e1mere umiestni\u0165 dan\u00fa \u0161ar\u017eu na trh, ani protokol o&nbsp;prepusten\u00ed \u0161ar\u017ee (Manufacturer\u2019s protocol &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=65\">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-65","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/65","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=65"}],"version-history":[{"count":13,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/65\/revisions"}],"predecessor-version":[{"id":9327,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/65\/revisions\/9327"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=65"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}