{"id":382,"date":"2020-03-02T14:51:48","date_gmt":"2020-03-02T13:51:48","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=382"},"modified":"2025-11-14T11:47:42","modified_gmt":"2025-11-14T10:47:42","slug":"registracia-a-schvalovanie","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=382","title":{"rendered":"REGISTR\u00c1CIA A SCHVA\u013dOVANIE"},"content":{"rendered":"\n

Registr\u00e1cia veterin\u00e1rnych liekov<\/span><\/strong><\/h4>\n\n\n\n

V s\u00falade s ustanoveniami z\u00e1kona \u010d. 362\/2011 Z.z. o liekoch a zdravotn\u00edckych pom\u00f4ckach a o zmene a doplnen\u00ed niektor\u00fdch z\u00e1konov, podliehaj\u00fa veterin\u00e1rne lieky pred uveden\u00edm na trh registr\u00e1cii \u00dastavom \u0161t\u00e1tnej kontroly veterin\u00e1rnych bioprepar\u00e1tov a lie\u010div Nitra (\u00da\u0160KVBL) – NP, MRP, DCP, alebo registr\u00e1cii centralizovan\u00fdm postupom Spolo\u010denstva (ES) pod\u013ea nariadenia Eur\u00f3pskeho parlamentu a Rady \u010d. 726\/2004. <\/p>\n\n\n\n

\u00da\u0160KVBL vyd\u00e1 rozhodnutie o registr\u00e1cii, pokia\u013e s\u00fa splnen\u00e9 po\u017eiadavky kvality, bezpe\u010dnosti a \u00fa\u010dinnosti veterin\u00e1rneho lieku na registr\u00e1ciu, stanoven\u00e9 z\u00e1konom \u010d. 362\/2011 o liekoch a s\u00fa v s\u00falade s pr\u00e1vnymi predpismi Spolo\u010denstva (Smernica Eur\u00f3pskeho parlamentu a Rady 2001\/82\/ES, v znen\u00ed neskor\u0161\u00edch predpisov). Rozhodnutie o registr\u00e1cii plat\u00ed 5 rokov odo d\u0148a nadobudnutia pr\u00e1voplatnosti. Dr\u017eite\u013e rozhodnutia o registr\u00e1cii (DRR) m\u00f4\u017ee po\u017eiada\u0165 o pred\u013a\u017eenie platnosti rozhodnutia o registr\u00e1cii a to najmenej 6 mesiacov pre uplynut\u00edm jeho platnosti. Na z\u00e1klade opodstatnen\u00fdch d\u00f4vodov s\u00favisiacich s doh\u013eadom nad veterin\u00e1rnymi liekmi m\u00f4\u017ee \u00da\u0160KVBL rozhodn\u00fa\u0165 o pred\u013a\u017een\u00ed platnosti registr\u00e1cie veterin\u00e1rneho lieku na p\u00e4\u0165 rokov, inak vyd\u00e1 rozhodnutie o pred\u013a\u017een\u00ed platnosti registr\u00e1cie veterin\u00e1rneho lieku bez \u010dasov\u00e9ho obmedzenia. DRR je tie\u017e povinn\u00fd ozn\u00e1mi\u0165 \u00da\u0160KVBL zmenu, alebo vopred po\u017eiada\u0165 o schv\u00e1lenie pripravovanej zmeny. <\/p>\n\n\n\n

\u00da\u0160KVBL vedie zoznam registrovan\u00fdch veterin\u00e1rnych liekov a zverej\u0148uje ich na svojom webovom s\u00eddle. 
<\/p>\n\n\n\n

Schva\u013eovanie veterin\u00e1rnych pr\u00edpravkov a veterin\u00e1rnych technick\u00fdch pom\u00f4cok<\/span><\/strong><\/h4>\n\n\n\n

Podmienky schv\u00e1lenia uv\u00e1dzania veterin\u00e1rnych pr\u00edpravkov a ozn\u00e1menia uv\u00e1dzania veterin\u00e1rnych technick\u00fdch pom\u00f4cok na trh, ako aj podmienky zaobch\u00e1dzania s veterin\u00e1rnymi pr\u00edpravkami a veterin\u00e1rnymi technick\u00fdmi pom\u00f4ckami upravuje  z\u00e1kon \u010d. 17\/2018 Z.z. o veterin\u00e1rnych pr\u00edpravkoch a veterin\u00e1rnych technick\u00fdch pom\u00f4ckach. \u00da\u0160KVBL rozhoduje o schv\u00e1len\u00ed, zmene, pred\u013a\u017een\u00ed, pozastaven\u00ed a zru\u0161en\u00ed schv\u00e1lenia veterin\u00e1rneho pr\u00edpravku. \u00da\u0160KVBL vedie zoznam schv\u00e1len\u00fdch veterin\u00e1rnych pr\u00edpravkov a zoznam veterin\u00e1rnych technick\u00fdch pom\u00f4cok a zverej\u0148uje ich na svojom webovom s\u00eddle. 
<\/p>\n\n\n\n

Klinick\u00e9 hodnotenie<\/span><\/strong><\/h4>\n\n\n\n

V zmysle \u00a7 78 a\u017e \u00a7 81 z\u00e1kona \u010d. 362\/2011 Z.z. o liekoch, mus\u00ed ka\u017ed\u00e9 klinick\u00e9 hodnotenie veterin\u00e1rneho lieku<\/strong> povoli\u0165 \u00da\u0160KVBL. Povolenie sa vyd\u00e1va na z\u00e1klade predlo\u017eenia vyplnen\u00e9ho formul\u00e1ra a pr\u00edslu\u0161n\u00fdch podkladov po pos\u00faden\u00ed ich \u00faplnosti. <\/p>\n\n\n\n

Pod\u013ea \u00a7 20 a\u017e \u00a7 22 z\u00e1kona \u010d. 17\/2018 Z.z. o veterin\u00e1rnych pr\u00edpravkoch a veterin\u00e1rnych technick\u00fdch pom\u00f4ckach, mus\u00ed ka\u017ed\u00e9 klinick\u00e9 hodnotenie veterin\u00e1rneho pr\u00edpravku<\/strong> a veterin\u00e1rnej technickej pom\u00f4cky<\/strong> povoli\u0165 \u00da\u0160KVBL. Povolenie sa vyd\u00e1va na z\u00e1klade predlo\u017eenia vyplnen\u00e9ho formul\u00e1ra a pr\u00edslu\u0161n\u00fdch podkladov po pos\u00faden\u00ed ich \u00faplnosti.<\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Registr\u00e1cia veterin\u00e1rnych liekov V s\u00falade s ustanoveniami z\u00e1kona \u010d. 362\/2011 Z.z. o liekoch a zdravotn\u00edckych pom\u00f4ckach a o zmene a doplnen\u00ed niektor\u00fdch z\u00e1konov, podliehaj\u00fa veterin\u00e1rne lieky pred uveden\u00edm na trh registr\u00e1cii \u00dastavom \u0161t\u00e1tnej kontroly veterin\u00e1rnych bioprepar\u00e1tov a lie\u010div Nitra (\u00da\u0160KVBL) – NP, MRP, … Pokra\u010dova\u0165 v \u010d\u00edtan\u00ed →<\/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-382","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/382","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=382"}],"version-history":[{"count":5,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/382\/revisions"}],"predecessor-version":[{"id":9328,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/382\/revisions\/9328"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=382"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}