{"id":395,"date":"2020-03-02T15:09:26","date_gmt":"2020-03-02T14:09:26","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=395"},"modified":"2025-12-08T09:47:12","modified_gmt":"2025-12-08T08:47:12","slug":"medzinarodna-spolupraca","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=395","title":{"rendered":"MEDZIN\u00c1RODN\u00c1 SPOLUPR\u00c1CA"},"content":{"rendered":"\n<p>\u00dastav v&nbsp;rozsahu ustanovenom v&nbsp;r\u00e1mci zverenej p\u00f4sobnosti spolupracuje s&nbsp;pr\u00edslu\u0161n\u00fdmi org\u00e1nmi \u010dlensk\u00fdch \u0161t\u00e1tov Eur\u00f3pskej \u00fanie a&nbsp;agent\u00farami, najm\u00e4 Eur\u00f3pskou liekovou agent\u00farou, a zabezpe\u010duje vykon\u00e1vanie \u00faloh vypl\u00fdvaj\u00facich z&nbsp;medzin\u00e1rodn\u00fdch dohovorov a doh\u00f4d, najm\u00e4 pod\u013ea:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Doh\u00f4d o&nbsp;vz\u00e1jomnom uznan\u00ed medzi eur\u00f3pskym spolo\u010denstvom&nbsp; a&nbsp;tret\u00edmi krajinami (Mutual Recognition Agreements medicinal products GMP inspection and Batch certification between EU and the respective parties, Australia, Canada, New Zeland, the USA and Switzerland),<\/li>\n\n\n\n<li>Dohovoru o vypracovan\u00ed Eur\u00f3pskeho liekopisu,<\/li>\n\n\n\n<li>Dohody o&nbsp;spolupr\u00e1ci s&nbsp;Eur\u00f3pskou liekovou agent\u00farou,<\/li>\n\n\n\n<li>Dohody o spolupr\u00e1ci s&nbsp;Eur\u00f3pskym riadite\u013estvom pre kvalitu liekov a zdravotn\u00fa starostlivos\u0165&nbsp;<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><strong>Organiz\u00e1cie na \u010dinnosti ktor\u00fdch sa \u00da\u0160KVBL podie\u013ea<\/strong>: <\/strong><\/h3>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><span class=\"has-inline-color has-blue-color\">Heads of Medicines Agencies (HMA)<\/span><\/strong><\/h3>\n\n\n\n<p>Riaditelia kompetentn\u00fdch autor\u00edt \u010dlensk\u00fdch \u0161t\u00e1tov sa pravidelne stret\u00e1vaj\u00fa so zameran\u00edm na vedenie a koordin\u00e1ciu vo vn\u00fatri syst\u00e9mu regul\u00e1cie hum\u00e1nnych a&nbsp;veterin\u00e1rnych liekov.<\/p>\n\n\n\n<p>MVDr. Katar\u00edna Mass\u00e1nyiov\u00e1, PhD.<\/p>\n\n\n\n<p><strong>Koordina\u010dn\u00e1 skupina pre postupy vz\u00e1jomn\u00e9ho uzn\u00e1vania a decentralizovan\u00fdch postupov \u2013 veterin\u00e1rna (CMDv)<\/strong><\/p>\n\n\n\n<p>Zodpovedn\u00e1 za presk\u00famanie a koordin\u00e1ciu ot\u00e1zok t\u00fdkaj\u00facich sa povolenia na uvedenie veterin\u00e1rnych liekov na trh v dvoch alebo viacer\u00fdch \u010dlensk\u00fdch \u0161t\u00e1toch v s\u00falade so vz\u00e1jomn\u00fdm uzn\u00e1van\u00edm alebo decentralizovan\u00fdm postupom.<\/p>\n\n\n\n<p>\u010clen: Ing. M\u00e1ria Hazuchov\u00e1; Alternant: MVDr. Marta Wagnerov\u00e1<\/p>\n\n\n\n<p><strong>CTWG \u2013 Clinical Trial Working Group\/Pracovn\u00e1 skupina pre klinick\u00e9 sk\u00fa\u0161anie<\/strong><\/p>\n\n\n\n<p>\u010clen: MVDr. Marek Chlustik<\/p>\n\n\n\n<p><strong>WGQM &#8211; Working group of quality managers\/Pracovn\u00e1 skupina pre mana\u017e\u00e9rov kvality<\/strong><\/p>\n\n\n\n<p>\u010clen: Mgr. R. Kov\u00e1\u010dov\u00e1, PhD.; Ing.Zuzana D\u017eupinov\u00e1, PhD.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><span class=\"has-inline-color has-blue-color\">Eur\u00f3pska liekov\u00e1 agent\u00fara (EMA)<\/span><\/strong><\/h3>\n\n\n\n<p><strong>The Committee for Medicinal Products for Veterinary Use \/V\u00fdbor pre lieky na veterin\u00e1rne pou\u017eitie (CVMP)<\/strong><\/p>\n\n\n\n<p>\u00da\u010das\u0165 a \u010dlenstvo z\u00e1stupcu Slovenskej republiky vo vedeckom v\u00fdbore \u2013 V\u00fdbore pre lieky na veterin\u00e1rne pou\u017eitie (CVMP) pri EMA vypl\u00fdva z&nbsp;Nariadenia eur\u00f3pskeho parlamentu a rady (ES) \u010d. 726\/2004. V\u00fdbor vyd\u00e1va odborn\u00e9 hodnotenie liekov registrovan\u00fdch centralizovanou proced\u00farou, pr\u00edpadne in\u00e9 odborn\u00e9 posudky pre veterin\u00e1rne lie\u010div\u00e1 a&nbsp;lieky v&nbsp;r\u00e1mci Eur\u00f3pskej \u00fanie.<\/p>\n\n\n\n<p>\u010clen: MVDr. Eva Chobotov\u00e1, PhD; Alternant: MVDr. Katar\u00edna Mass\u00e1nyiov\u00e1, PhD.<\/p>\n\n\n\n<p><strong>Pharmacovigilance Working Group (PhVWP)<\/strong><\/p>\n\n\n\n<p>Pracovn\u00e1 skupina pre farmakovigilanciu (PhVWP-V) poskytuje poradenstvo V\u00fdboru pre lieky na veterin\u00e1rne pou\u017eitie (CVMP), pokia\u013e ide o koordin\u00e1ciu a doh\u013ead nad farmakovigilanciou centr\u00e1lne registrovan\u00fdch veterin\u00e1rnych liekov, ako aj liekov registrovan\u00fdch prostredn\u00edctvom postupu vz\u00e1jomn\u00e9ho uzn\u00e1vania alebo liekov registrovan\u00fdch n\u00e1rodnou proced\u00farou.<\/p>\n\n\n\n<p>\u010clen: MVDr. Tatiana Holkov\u00e1<\/p>\n\n\n\n<p><strong>Batch Release Testing Operational Experts Group (BRT&nbsp;OEG)<\/strong><\/p>\n\n\n\n<p>Pracovn\u00e1 skupina s&nbsp;mand\u00e1tom identifikova\u0165 a podporova\u0165, pokia\u013e je to mo\u017en\u00e9 v spolupr\u00e1ci s dr\u017eite\u013emi registra\u010dn\u00e9ho rozhodnutia, implement\u00e1ciu met\u00f3d vyhovuj\u00facich 3Rs pri kontrole kvality a testovan\u00ed \u0161ar\u017e\u00ed centr\u00e1lne registrovan\u00fdch hum\u00e1nnych a veterin\u00e1rnych liekov pri ich uvo\u013enen\u00ed na trh.<\/p>\n\n\n\n<p>Predsedn\u00ed\u010dka: Mgr. R. Kov\u00e1\u010dov\u00e1, PhD.<\/p>\n\n\n\n<p><strong>The Working Group on Quality Review of Documents (QRD)<\/strong><\/p>\n\n\n\n<p>Pracovn\u00e1 skupina, ktor\u00e1 sa zaober\u00e1 lingvistickou str\u00e1nkou inform\u00e1ci\u00ed o liekoch \u2013 SPC, PIL, obaly<\/p>\n\n\n\n<p>\u010clen: MVDr. Marta Wagnerov\u00e1<\/p>\n\n\n\n<p><strong>ESUAvet &#8211; European Sales and Use of Antimicrobials for Veterinary Medicine Working Group\/<\/strong><strong> <\/strong>Pracovn\u00e1 skupina ESUAvetv&nbsp;r\u00e1mci projektu ASU zhroma\u017e\u010fuje inform\u00e1cie o tom, ako sa antimikrobi\u00e1lne lieky&nbsp; pou\u017e\u00edvaj\u00fa&nbsp; u zvierat&nbsp; v celej Eur\u00f3pskej \u00danii (E\u00da). Tento typ inform\u00e1ci\u00ed je nevyhnutn\u00fd na identifik\u00e1ciu mo\u017en\u00fdch rizikov\u00fdch faktorov, ktor\u00e9 by mohli vies\u0165 k rozvoju a \u0161\u00edreniu antimikrobi\u00e1lnej rezistencie u zvierat.<\/p>\n\n\n\n<p>Alternant: Mgr. Zuzana Dur\u00e1niov\u00e1<\/p>\n\n\n\n<p><strong>The Antimicrobial Sales and Use (ASU) Platform<\/strong>&nbsp; podporuj\u00faca zber \u00fadajov \u010dlensk\u00fdmi \u0161t\u00e1tmi o predaji a pou\u017e\u00edvan\u00ed antimikrobi\u00e1lnych l\u00e1tok u zvierat.<\/p>\n\n\n\n<p>\u010clen: Mgr. Zuzana Duraniov\u00e1 (ASU national contact point); Alternant: Mgr. Zuzana Duraniov\u00e1 (ASU Data manager\/ ASU Change liaison)<\/p>\n\n\n\n<p><strong>GMDP IWG &#8211; GMP\/GDP Inspectors Working Group\/Pracovn\u00e1 skupina in\u0161pektorov GMP\/GDP<\/strong><\/p>\n\n\n\n<p>\u010clen: Mgr. M\u00e1ria Z\u00e1humensk\u00e1<\/p>\n\n\n\n<p><strong>PhV IWG &#8211; Pharmacovigilance Inspectors Working Group<\/strong><\/p>\n\n\n\n<p>\u010clen: Mgr. Zuzana Dur\u00e1niov\u00e1<\/p>\n\n\n\n<p>EMA\/HMA \u2013 spolo\u010dn\u00e1 iniciat\u00edva &#8211; <strong>EU NTC \u2013 European Network Training Centre<\/strong><\/p>\n\n\n\n<p>Eur\u00f3pske \u0161koliace centrum (EU NTC) pre E\u00da sie\u0165 regula\u010dn\u00fdch org\u00e1nov v oblasti hum\u00e1nnych a veterin\u00e1rnych liekov sa vyu\u017e\u00edva na zdie\u013eanie vedomost\u00ed, zlep\u0161enie profesion\u00e1lneho rozvoja a podporu v\u00fdmeny osved\u010den\u00fdch postupov v r\u00e1mci siete t\u00fdm, \u017ee v\u0161etk\u00fdm zamestnancom siete a medzin\u00e1rodn\u00fdm regula\u010dn\u00fdm org\u00e1nom pon\u00faka mo\u017enosti vysoko kvalitnej odbornej pr\u00edpravy v oblasti vedy a regul\u00e1cie.<\/p>\n\n\n\n<p>&nbsp;\u010clen: Mgr. R. Kov\u00e1\u010dov\u00e1, PhD.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><span class=\"has-inline-color has-blue-color\">EDQM<\/span><\/strong><\/h3>\n\n\n\n<p><strong>European PharmacopoeiaCommission (EPC)\/Eur\u00f3pska liekopisn\u00e1 komisia<\/strong><\/p>\n\n\n\n<p>Hlavnou \u00falohou EPC je pr\u00edprava a schva\u013eovanie v\u0161eobecn\u00fdch a \u0161peci\u00e1lnych eur\u00f3pskych liekopisn\u00fdch \u010dl\u00e1nkov, ktor\u00e9 s\u00fa publikovan\u00e9 v Eur\u00f3pskom liekopise. Pod\u013ea Dohovoru o vypracovan\u00ed Eur\u00f3pskeho liekopisu&nbsp; s\u00fa \u010dlensk\u00e9 krajiny povinn\u00e9 Eur\u00f3psky liekopis implementova\u0165 do n\u00e1rodnej legislat\u00edvy a dodr\u017eiava\u0165 jeho ustanovenia pri kontrole a posudzovan\u00ed lie\u010div a liekov.<\/p>\n\n\n\n<p>Alternat\u00edvny \u010dlen: Mgr. R. Kov\u00e1\u010dov\u00e1, PhD.\/MVDr. K. Mass\u00e1nyiov\u00e1, PhD.<\/p>\n\n\n\n<p><strong>Group of Experts 15V (Veterinary Vaccines and Sera)<\/strong><\/p>\n\n\n\n<p>Hlavnou \u00falohou skupiny je pr\u00edprava, navrhovanie a&nbsp;rev\u00edzia&nbsp; eur\u00f3pskych liekopisn\u00fdch \u010dl\u00e1nkov v oblasti imunologick\u00fdch veterin\u00e1rnych liekov, ktor\u00e9&nbsp; bud\u00fa a s\u00fa&nbsp; publikovan\u00e9 v Eur\u00f3pskom liekopise.<\/p>\n\n\n\n<p>\u010clen: Mgr. R. Kov\u00e1\u010dov\u00e1, PhD.<\/p>\n\n\n\n<p><strong>The Advisory Group of the Veterinary Batch Release Network (VBRN)<\/strong><\/p>\n\n\n\n<p>Poradn\u00e1 skupina pre sie\u0165 veterin\u00e1rnych agent\u00far a&nbsp;OMCL laborat\u00f3ri\u00ed z&nbsp;E\u00da\/EHP a&nbsp;in\u00fdch kraj\u00edn s form\u00e1lnou dohodou o vz\u00e1jomnom uzn\u00e1van\u00ed s&nbsp;E\u00da, ktor\u00e1 zah\u0155\u0148a ofici\u00e1lne uvo\u013e\u0148ovanie \u0161ar\u017e\u00ed imunologick\u00fdch veterin\u00e1rnych liekov (OBPR\/OCABR) a d\u00f4vern\u00fa v\u00fdmenu inform\u00e1ci\u00ed o&nbsp;kvalite imunologick\u00fdch veterin\u00e1rnych liekov, technick\u00fdch inform\u00e1ci\u00ed a s\u00favisiacich met\u00f3d.<\/p>\n\n\n\n<p>\u010clen: Mgr. R. Kov\u00e1\u010dov\u00e1, PhD.<\/p>\n\n\n\n<p><strong>Quality Management Programme \u2013 MJA (Mutual Joint Audit)<\/strong><\/p>\n\n\n\n<p>\u00dalohou je vykon\u00e1vanie auditov laborat\u00f3ri\u00ed za\u010dlenen\u00fdch do eur\u00f3pskej siete OMCL<\/p>\n\n\n\n<p>Technick\u00fd aud\u00edtor: Ing. Zuzana D\u017eupinov\u00e1, PhD.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><span class=\"has-inline-color has-blue-color\">Eur\u00f3pska komisia<\/span><\/strong><\/h3>\n\n\n\n<p><strong>Standing Committee for Veterinary Medicinal Products<\/strong><\/p>\n\n\n\n<p>Pracovn\u00e1 skupina pri Eur\u00f3pskej komisii, na ktorej sa prejedn\u00e1va legislat\u00edva E\u00da a&nbsp;registr\u00e1cia veterin\u00e1rnych liekov registrovan\u00fdch centralizovan\u00fdm postupom, pr\u00edpadne in\u00e9 legislat\u00edvne z\u00e1le\u017eitosti t\u00fdkaj\u00face sa veterin\u00e1rnych liekov<\/p>\n\n\n\n<p>MVDr. Eva Chobotov\u00e1, PhD.\/ MVDr. Katar\u00edna Mass\u00e1nyiov\u00e1, PhD.<\/p>\n\n\n\n<p><strong>Veterin\u00e1rny farmaceutick\u00fd v\u00fdbor<\/strong><\/p>\n\n\n\n<p>Veterin\u00e1rny farmaceutick\u00fd v\u00fdbor prejedn\u00e1va v\u0161etky ot\u00e1zky t\u00fdkaj\u00face sa veterin\u00e1rnych liekov vr\u00e1tane z\u00e1le\u017eitost\u00ed t\u00fdkaj\u00facich sa pr\u00edpravy nov\u00fdch legislat\u00edvnych n\u00e1vrhov.<\/p>\n\n\n\n<p>MVDr. Katar\u00edna Mass\u00e1nyiov\u00e1, PhD.\/ MVDr. Eva Chobotov\u00e1, PhD.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><span class=\"has-inline-color has-blue-color\">Svetov\u00e1 organiz\u00e1cia pre zdravie zvierat (WOAH)<\/span><\/strong><\/h3>\n\n\n\n<p><strong>National focal point for Veterinary Products\/ N\u00e1rodn\u00e9 kontaktn\u00e9 miesto WOAH pre veterin\u00e1rne produkty<\/strong><\/p>\n\n\n\n<p>Opatrenia prijat\u00e9 \u010dlensk\u00fdmi \u0161t\u00e1tmi WOAH koordinuj\u00fa n\u00e1rodn\u00e9 kontaktn\u00e9 miesta WOAH pre veterin\u00e1rne produkty, ktor\u00e9 poskytuj\u00fa technick\u00fa pomoc n\u00e1rodn\u00fdm deleg\u00e1tom pri zlep\u0161ovan\u00ed a harmoniz\u00e1cii vn\u00fatro\u0161t\u00e1tnych polit\u00edk t\u00fdkaj\u00facich sa veterin\u00e1rnych produktov.<\/p>\n\n\n\n<p>MVDr. Katar\u00edna Mass\u00e1nyiov\u00e1, PhD.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Projekty EU4Health<\/mark><\/strong><\/h3>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-82a5cf98-3fad-4d26-a997-4dcff802a190\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/vyhlasenie_eu4h11.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">EU4H 11 &#8211; spolo\u010dn\u00e1 iniciat\u00edva zameran\u00e1 na kvalitu liekov a implement\u00e1ciu farmaceutickej legislat\u00edvy\/strat\u00e9gie<\/a><\/div>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00dastav v&nbsp;rozsahu ustanovenom v&nbsp;r\u00e1mci zverenej p\u00f4sobnosti spolupracuje s&nbsp;pr\u00edslu\u0161n\u00fdmi org\u00e1nmi \u010dlensk\u00fdch \u0161t\u00e1tov Eur\u00f3pskej \u00fanie a&nbsp;agent\u00farami, najm\u00e4 Eur\u00f3pskou liekovou agent\u00farou, a zabezpe\u010duje vykon\u00e1vanie \u00faloh vypl\u00fdvaj\u00facich z&nbsp;medzin\u00e1rodn\u00fdch dohovorov a doh\u00f4d, najm\u00e4 pod\u013ea: Organiz\u00e1cie na \u010dinnosti ktor\u00fdch sa \u00da\u0160KVBL podie\u013ea: Heads of Medicines Agencies &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=395\">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-395","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/395","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=395"}],"version-history":[{"count":12,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/395\/revisions"}],"predecessor-version":[{"id":9412,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/395\/revisions\/9412"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=395"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}