{"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":"2026-05-15T12:16:31","modified_gmt":"2026-05-15T10:16:31","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\u00a0s\u00fa\u010dasnosti\u00a0<strong>nevy\u017eaduje<\/strong>\u00a0aby pred umiestnen\u00edm ka\u017edej \u0161ar\u017ee imunologick\u00e9ho veterin\u00e1rneho lieku na trh Slovenskej republiky dr\u017eite\u013e rozhodnutia o\u00a0registr\u00e1cii zasielal notifik\u00e1ciu o\u00a0z\u00e1mere umiestni\u0165 dan\u00fa \u0161ar\u017eu na trh, ani protokol o\u00a0prepusten\u00ed \u0161ar\u017ee (Manufacturer\u2019s protocol for OBPR\/OCABR) resp.\u00a0eur\u00f3psky certifik\u00e1t o\u00a0uvo\u013enen\u00ed \u0161ar\u017ee (OBPR\/OCABR) vydan\u00fd in\u00fdm \u010dlensk\u00fdm \u0161t\u00e1tom E\u00da.\u00a0\u00a0<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><a href=\"https:\/\/www.edqm.eu\/en\/veterinary-biologicals-ocabr\/obpr\">Podrobn\u00e9 inform\u00e1cie k\u00a0OCABR\/OBPR<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pred umiestnen\u00edm \u0161ar\u017ee imunologick\u00e9ho veterin\u00e1rneho lieku na trh \u00da\u0160KVBL v\u00a0s\u00fa\u010dasnosti\u00a0nevy\u017eaduje\u00a0aby pred umiestnen\u00edm ka\u017edej \u0161ar\u017ee imunologick\u00e9ho veterin\u00e1rneho lieku na trh Slovenskej republiky dr\u017eite\u013e rozhodnutia o\u00a0registr\u00e1cii zasielal notifik\u00e1ciu o\u00a0z\u00e1mere umiestni\u0165 dan\u00fa \u0161ar\u017eu na trh, ani protokol o\u00a0prepusten\u00ed \u0161ar\u017ee (Manufacturer\u2019s protocol for OBPR\/OCABR) &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":15,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/65\/revisions"}],"predecessor-version":[{"id":9625,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/65\/revisions\/9625"}],"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}]}}