{"id":376,"date":"2020-03-02T14:48:15","date_gmt":"2020-03-02T13:48:15","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=376"},"modified":"2025-11-14T11:32:53","modified_gmt":"2025-11-14T10:32:53","slug":"kvalita-veterinarnych-liekov","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=376","title":{"rendered":"KVALITA VETERIN\u00c1RNYCH LIEKOV"},"content":{"rendered":"\n<p><\/p>\n\n\n\n<p>\u00da\u0160KVBL na z\u00e1klade \u00a7 134 ods. 2 p\u00edsm. c) z\u00e1kona \u010d. 362\/2011 Z.z. o liekoch a zdravotn\u00edckych pom\u00f4ckach a o zmene a doplnen\u00ed niektor\u00fdch z\u00e1konov a&nbsp;v&nbsp;zmysle \u00a7 108 tohto z\u00e1kona vykon\u00e1va laborat\u00f3rnu kontrolu lie\u010div, pomocn\u00fdch l\u00e1tok a&nbsp;veterin\u00e1rnych liekov ako \u00faradn\u00e9 laborat\u00f3rium na kontrolu veterin\u00e1rnych liekov.&nbsp;<br><\/p>\n\n\n\n<p>V&nbsp;zmysle uveden\u00e9ho z\u00e1kona sa kontrola vykon\u00e1va nez\u00e1visle od v\u00fdrobcov a&nbsp;to v laborat\u00f3ri\u00e1ch \u00da\u0160KVBL, ktor\u00e9 s\u00fa \u010dlenom siete eur\u00f3pskych OMCL (<em>Official Medicinal Control Laboratory<\/em>).&nbsp;<br>S\u00fa\u010das\u0165ou laborat\u00f3ri\u00ed je schv\u00e1len\u00e9 pokusn\u00e9 zariadenie \u00da\u0160KVBL.<\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-3ee97f00-83fa-43d8-aa27-897e8e44bac8\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/stanovy_etickej_komisie.pdf\">Stanovy Etickej komisie<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-763e4206-ebf1-4f3a-bc7e-886f95085c65\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/statut_poradneho_vyboru_uskvbl.pdf\">\u0160tat\u00fat Poradn\u00e9ho v\u00fdboru \u00da\u0160KVBL pre dobr\u00e9 \u017eivotn\u00e9 podmienky zvierat<\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<p>Syst\u00e9m kvality biologick\u00fdch laborat\u00f3ri\u00ed, chemick\u00fdch laborat\u00f3ri\u00ed a&nbsp;pokusn\u00e9ho zariadenie je atestovan\u00fd Eur\u00f3pskym riadite\u013estvom pre kvalitu liekov na&nbsp;s\u00falad s ISO\/IEC 17025.<br><\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-c2232e38-bfd9-44cf-8063-8f4eb5a0ac6c\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/Audit-Attestation-EDQM-MJA-177_MJA0422.pdf\">EDQM\/MJA certifik\u00e1t <\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\"><strong>Kontrola kvality lie\u010div, pomocn\u00fdch l\u00e1tok a&nbsp;veterin\u00e1rnych liekov<\/strong> <\/mark>sa vykon\u00e1va za \u00fa\u010delom:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>overenie kvality veterin\u00e1rneho lieku, \u00fa\u010dinnej alebo pomocnej l\u00e1tky v&nbsp;r\u00e1mci registra\u010dn\u00e9ho konania;<\/li>\n\n\n\n<li>overenie kvality v r\u00e1mci dozoru nad trhom (na z\u00e1klade ro\u010dn\u00e9ho pl\u00e1nu kontroly kvality liekov na trhu)<\/li>\n\n\n\n<li>overenie pri podozren\u00ed na nedostatok v&nbsp;kvalite veterin\u00e1rneho lieku pri hl\u00e1sen\u00ed o ne\u017eiaducom \u00fa\u010dinku veterin\u00e1rneho lieku (farmakovigilancia)<\/li>\n\n\n\n<li>preverenie pri hl\u00e1sen\u00ed o nekvalite liekov,<\/li>\n\n\n\n<li>na \u017eiados\u0165 z extern\u00e9ho prostredia<\/li>\n<\/ul>\n\n\n\n<p>Okrem uveden\u00e9ho, v&nbsp;zmysle \u010dl\u00e1nku 128 Nariadenia (E\u00da) 2019\/6 o veterin\u00e1rnych liekoch a o zru\u0161en\u00ed smernice 2001\/82\/ESh a \u00a7 108 z\u00e1kona 362\/2011 Z.z. o liekoch a zdravotn\u00edckych pom\u00f4ckach \u00da\u0160KVBL ako \u010dlen siete OMCL vykon\u00e1va <strong>\u00faradn\u00e9 prep\u00fa\u0161\u0165anie a certifik\u00e1ciu \u0161ar\u017e\u00ed imunologick\u00fdch veterin\u00e1rnych liekov<\/strong>:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Official Batch Protocol Review (OBPR) &#8211; dokumenta\u010dn\u00e1 kontrola a&nbsp;certifik\u00e1cia \u0161ar\u017e\u00ed imunologick\u00fdch veterin\u00e1rnych liekov&nbsp;<\/li>\n\n\n\n<li>Official Control Authority Batch Release (OCABR) &#8211; laborat\u00f3rna kontrola&nbsp; a&nbsp;certifik\u00e1cia \u0161ar\u017e\u00ed imunologick\u00fdch veterin\u00e1rnych liekov a&nbsp;ich certifik\u00e1cia<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00da\u0160KVBL na z\u00e1klade \u00a7 134 ods. 2 p\u00edsm. c) z\u00e1kona \u010d. 362\/2011 Z.z. o liekoch a zdravotn\u00edckych pom\u00f4ckach a o zmene a doplnen\u00ed niektor\u00fdch z\u00e1konov a&nbsp;v&nbsp;zmysle \u00a7 108 tohto z\u00e1kona vykon\u00e1va laborat\u00f3rnu kontrolu lie\u010div, pomocn\u00fdch l\u00e1tok a&nbsp;veterin\u00e1rnych liekov ako \u00faradn\u00e9 &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=376\">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-376","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/376","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=376"}],"version-history":[{"count":10,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/376\/revisions"}],"predecessor-version":[{"id":9322,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/376\/revisions\/9322"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=376"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}