{"id":71,"date":"2020-01-20T14:42:31","date_gmt":"2020-01-20T13:42:31","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=71"},"modified":"2026-02-27T12:51:56","modified_gmt":"2026-02-27T11:51:56","slug":"veikodistribucia-vd","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=71","title":{"rendered":"VE\u013dKODISTRIB\u00daCIA veterin\u00e1rnych liekov, veterin\u00e1rnych pr\u00edpravkov a tecnick\u00fdch pom\u00f4cok a\u00a0medikovan\u00fdch krm\u00edv"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">S\u00favisiaca legislat\u00edva<\/mark><\/strong><\/h3>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/SK\/TXT\/PDF\/?uri=CELEX:32019R0006&amp;from=EN\" target=\"_blank\" rel=\"noreferrer noopener\">Nariadenie Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6 o&nbsp;veterin\u00e1rnych liekoch a o zru\u0161en\u00ed smernice 2001\/82\/ES<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/SK\/TXT\/PDF\/?uri=CELEX:32021R1248\" target=\"_blank\" rel=\"noreferrer noopener\">Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2021\/1248 z 29. j\u00fala 2021 o opatreniach t\u00fdkaj\u00facich sa spr\u00e1vnej distribu\u010dnej praxe pre veterin\u00e1rne lieky v s\u00falade s nariaden\u00edm Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.zakonypreludi.sk\/zz\/2011-362\" target=\"_blank\" rel=\"noreferrer noopener\">Z\u00e1kon \u010d. 362\/2011 Z. z. o&nbsp;liekoch a&nbsp;zdravotn\u00edckych pom\u00f4ckach a&nbsp;o&nbsp;zmene a&nbsp;doplnen\u00ed niektor\u00fdch z\u00e1konov v&nbsp;znen\u00ed neskor\u0161\u00edch predpisov (\u010falej len \u201cz\u00e1kon o&nbsp;liekoch\u201c)<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.zakonypreludi.sk\/zz\/2011-362\" target=\"_blank\" rel=\"noreferrer noopener\">Z\u00e1kon \u010d. 17\/2018 Z. z. o&nbsp;veterin\u00e1rnych pr\u00edpravkov a&nbsp;veterin\u00e1rnych technick\u00fdch pom\u00f4ckach a&nbsp;o&nbsp;zmene z\u00e1kona N\u00e1rodnej rady Slovenskej republiky \u010d. 145\/1995 Z. z. o&nbsp;spr\u00e1vnych poplatkoch v&nbsp;znen\u00ed neskor\u0161\u00edch predpisov (\u010falej len \u201cz\u00e1kon o&nbsp;veterin\u00e1rnych pr\u00edpravkov\u201c)<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.zakonypreludi.sk\/zz\/2012-128\" target=\"_blank\" rel=\"noreferrer noopener\">Vyhl\u00e1\u0161ka Ministerstva zdravotn\u00edctva Slovenskej republiky \u010d. 128\/2012 Z. z. Vyhl\u00e1\u0161ka o po\u017eiadavk\u00e1ch na spr\u00e1vnu v\u00fdrobn\u00fa prax a po\u017eiadavk\u00e1ch na spr\u00e1vnu ve\u013ekodistribu\u010dn\u00fa prax<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/compliance-research-development\/good-manufacturing-practice\/compilation-union-procedures-inspections-exchange-information\" target=\"_blank\" rel=\"noreferrer noopener\">Compilation of Union Procedures on Inspections and Exchange of Information<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/SK\/TXT\/?uri=CELEX:32019R0004\" target=\"_blank\" rel=\"noreferrer noopener\">Nariadenie Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/4 o v\u00fdrobe, uv\u00e1dzan\u00ed na trh a pou\u017e\u00edvan\u00ed medikovan\u00fdch krm\u00edv a o zmene nariadenia Eur\u00f3pskeho parlamentu a Rady (ES) \u010d. 183\/2005 a zru\u0161en\u00ed smernice Rady 90\/167\/EHS<\/a>&nbsp;<\/p>\n\n\n\n<p><a href=\"https:\/\/www.zakonypreludi.sk\/zz\/2004-41\" target=\"_blank\" rel=\"noreferrer noopener\">Nariadenie vl\u00e1dy \u010d. 41\/2004 Z. z., ktor\u00fdm sa ustanovuj\u00fa po\u017eiadavky na pr\u00edpravu, uv\u00e1dzanie na trh a pou\u017e\u00edvanie medikovan\u00fdch krm\u00edv (obsolentn\u00fd<\/a>)<\/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>P\u00f4sobnos\u0165 U\u0160KVBL v oblasti ve\u013ekodistrib\u00facie<\/strong><\/mark><\/h3>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Veterin\u00e1rne lieky (VL)<\/strong><\/h4>\n\n\n\n<p>\u00da\u0160KVBL pod\u013ea \u00a7 134 ods. 2 z\u00e1kona 362\/2011 Z. z.:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>p\u00edsmeno a) vykon\u00e1va \u0161t\u00e1tny dozor na \u00faseku veterin\u00e1rnej farm\u00e1cie, pod\u013ea tohto z\u00e1kona a osobitn\u00e9ho predpisu pri \u010dinnostiach spojen\u00fdch s&nbsp;v\u00fdrobou a ve\u013ekodistrib\u00faciou veterin\u00e1rnych liekov, sk\u00fa\u0161an\u00edm veterin\u00e1rnych liekov, dovozom \u00fa\u010dinn\u00fdch l\u00e1tok, v\u00fdrobou \u00fa\u010dinn\u00fdch l\u00e1tok a distrib\u00faciou \u00fa\u010dinn\u00fdch l\u00e1tok (inform\u00e1cie s\u00fa uveden\u00e9 na webovej str\u00e1nke \u00da\u0160KVBL v&nbsp;\u010dasti v\u00fdroba, dovoz a&nbsp;distrib\u00facia vet. \u00fa\u010dinnej l\u00e1tky)<\/li>\n\n\n\n<li>p\u00edsmeno b) vykon\u00e1va in\u0161pekciu spr\u00e1vnej distribu\u010dnej praxe pre veterin\u00e1rne lieky<\/li>\n\n\n\n<li>p\u00edsmeno f) vyd\u00e1va (4) rozhodnutie o povolen\u00ed, zmen\u00e1ch povolenia, pozastaven\u00ed rozhodnutia a zru\u0161en\u00ed rozhodnutia ve\u013ekodistrib\u00facie veterin\u00e1rnych liekov<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Veterin\u00e1rne pr\u00edpravky a&nbsp;veterin\u00e1rne technick\u00e9 pom\u00f4cky (VP a&nbsp;VTP)<\/strong><\/h4>\n\n\n\n<p>\u00da\u0160KVBL v&nbsp;s\u00falade s z\u00e1konom 17\/2018 Z. z vykon\u00e1va \u0161t\u00e1tny dozor nad:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>zaobch\u00e1dzan\u00edm s&nbsp;VP a&nbsp;VTP (\u00a7 24 ods.1)<\/li>\n\n\n\n<li>zaobch\u00e1dzan\u00edm s&nbsp;VP a&nbsp;VTP u&nbsp;v\u00fdrobcu veterin\u00e1rneho pr\u00edpravku alebo veterin\u00e1rnej technickej pom\u00f4cky a&nbsp;ve\u013ekodistrib\u00fatora (\u00a7 25 ods.1, p\u00edsm. c)<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Medikovan\u00e9 krmiv\u00e1 (MK)<\/strong><\/h4>\n\n\n\n<p>\u00da\u0160KVBL v&nbsp;zmysle&nbsp;nariadenia 41\/2004 Z. z schva\u013euje ve\u013ekodistrib\u00fatorov medikovan\u00fdch krm\u00edv (\u00a7 9)<\/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>Povolenia na ve\u013ekoobchodn\u00fa distrib\u00faciu<\/strong><\/mark><\/h3>\n\n\n\n<p>Ve\u013ekodistrib\u00faciu VL a\/alebo VP a&nbsp;VTP a\/alebo MK je mo\u017en\u00e9 vykon\u00e1va\u0165 len na z\u00e1klade platn\u00e9ho povolenia vydan\u00e9ho \u00da\u0160KVBL.<\/p>\n\n\n\n<p>\u00da\u0160KVBL schv\u00e1li ve\u013ekodistrib\u00faciu VL a\/alebo VP a&nbsp;VTP a\/alebo MK na z\u00e1klade \u017eiadosti fyzickej alebo pr\u00e1vnickej osoby, ak sp\u013a\u0148a priestorov\u00e9, technick\u00e9, materi\u00e1lne, person\u00e1lne a in\u00e9 podmienky na po\u017eadovan\u00fd druh a rozsah \u010dinnost\u00ed v&nbsp;s\u00falade s&nbsp;vy\u0161\u0161ie uvedenou legislat\u00edvou.<\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-e007d815-9fec-41e8-bb90-db7beae8bd95\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/f_58_ziadost_o_povolenie_velkodistribucie_vet_liekov.docx\">\u017diados\u0165 o&nbsp;povolenie ve\u013ekodistrib\u00facie VL a\/alebo VP a&nbsp;VTP a\/alebo MK<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-7cfe735e-6780-4043-a0aa-04eeb154a223\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/f_60_ziadost_o_zmenu_povolenia_na_velkodistribuciu_vet_liekov.docx\">\u017diados\u0165 o&nbsp;zmenu povolenia ve\u013ekodistrib\u00facie VL a\/alebo VP a&nbsp;VTP a\/alebo MK<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-b5df3fb3-46bc-40a7-872b-73eb10c1ae35\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/f99a_ziadost_o_pozastavenie_cinnosti_VD_VL-VP-VTP-MK.docx\">\u017diados\u0165 o&nbsp;pozastavenie \u010dinnosti ve\u013ekodistrib\u00facie VL a\/alebo VP a&nbsp;VTP a\/alebo MK<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-97d8dd41-2e04-4ac7-b442-b4f89584c933\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/f100a_ziadost_o_zrusenie_povolenia_VD-VL-VP-VT-MK.docx\">\u017diados\u0165 o&nbsp;zru\u0161enie povolenia na ve\u013ekodistrib\u00faciu VL a\/alebo VP a&nbsp;VTP a\/alebo MK<\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<p>\u017diados\u0165 je potrebn\u00e9 posla\u0165 na \u00da\u0160KVBL po\u0161tou na adresu: \u00dastav \u0161t\u00e1tnej kontroly veterin\u00e1rnych bioprepar\u00e1tov a lie\u010div Nitra, Biovetsk\u00e1 34, 949 01 Nitra, Slovensk\u00e1 republika alebo elektronicky prostredn\u00edctvom port\u00e1lu verejnej spr\u00e1vy \u201eSlovensko.sk\u201c<\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-928fc4a4-a992-4e91-9717-ebcc94e287a4\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/usmernenie_pre_ziadatelov_o_zmenu_povolenia_na_distribuciu_VL-VP-VTP-MK.pdf\">Usmernenie pre \u017eiadate\u013eov o\u00a0zmenu povolenia na ve\u013ekodistrib\u00faciu veterin\u00e1rnych liekov a\/alebo\u00a0 veterin\u00e1rnych pr\u00edpravkov a technick\u00fdch pom\u00f4cok a\/alebo\u00a0medikovan\u00fdch krm\u00edv<\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>UPOZORNENIE<\/strong> \u2013 Oznamovacia povinnos\u0165 pre ve\u013ekodistrib\u00fatorov veterin\u00e1rnych liekov s&nbsp;povolen\u00edm vydan\u00fdm in\u00fdm \u010dlensk\u00fdm \u0161t\u00e1tom E\u00da<\/p>\n\n\n\n<p>S&nbsp;oh\u013eadom na uplat\u0148ovanie \u010dl\u00e1nku 99 ods. 3 nariadenia (EU) 2019\/6&nbsp; a&nbsp;v s\u00favislosti s&nbsp; \u00a7 18 ods. 6 z\u00e1kona 362\/2011 Z. z. o&nbsp;liekoch, \u00da\u0160KVBL upozor\u0148uje ve\u013ekoobchodn\u00fdch distrib\u00fatorov, ktor\u00ed maj\u00fa povolenie na ve\u013ekodistrib\u00faciu VL vydan\u00e9 in\u00fdm \u010dlensk\u00fdm \u0161t\u00e1tom E\u00da a&nbsp;zam\u00fd\u0161\u013eaj\u00fa vykon\u00e1va\u0165 distrib\u00faciu VL na \u00fazem\u00ed SR na oznamovaciu povinnos\u0165 v&nbsp;s\u00favislosti s&nbsp;t\u00fdmto z\u00e1merom. Z\u00e1rove\u0148 upozor\u0148ujeme, \u017ee povinnosti ve\u013ekodistrib\u00fatorov VL pod\u013ea \u00a7 18 z\u00e1kona 362\/2011 Z .z.&nbsp; sa vz\u0165ahuj\u00fa na v\u0161etk\u00fdch ve\u013ekodistrib\u00fatorov VL bez oh\u013eadu na to, \u010di s\u00fa usaden\u00fd v&nbsp;SR alebo inom \u010dlenskom \u0161t\u00e1te E\u00da a to vr\u00e1tane pod\u00e1vania hl\u00e1sen\u00ed pod\u013ea ods. 1 p\u00edsm. h) a&nbsp;o). Ozn\u00e1menie o&nbsp;\u00famysle vykon\u00e1va\u0165 ve\u013ekodistrib\u00faciu VL na \u00fazem\u00ed SR je potrebn\u00e9 zasla\u0165 pred za\u010diatkom v\u00fdkonu tejto \u010dinnosti na tla\u010dive \u00da\u0160KVBL bu\u010f klasickou po\u0161tou na adresu \u00da\u0160KVBL, Biovetsk\u00e1 34, 949 01 Nitra, Slovensk\u00e1 republika alebo emailom na <a href=\"mailto:hlasenia.inspekcia@uskvbl.sk\">hlasenia.inspekcia@uskvbl.sk<\/a><\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-a673a494-a01f-4ae9-8873-5aa80c1610bb\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/Oznamovacia-povinnost-pre-velkodistributorov-EN.pdf\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>UPOZORNENIE<\/strong> \u2013 Oznamovacia povinnos\u0165 pre ve\u013ekodistrib\u00fatorov veterin\u00e1rnych liekov s&nbsp;povolen\u00edm vydan\u00fdm in\u00fdm \u010dlensk\u00fdm \u0161t\u00e1tom E\u00da &#8211; Anglick\u00fd text<\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-4c492dd4-3d5a-4bc7-b1b3-d3f99217ac88\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/f149_notification.doc\">Notification of intention to carry out the wholesale distribution of VMPs in SR-registration form<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-1592568e-f5ee-4cab-8725-8baa7adca4f3\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/notification-of-a-change_wholesale-distribution.doc\">Notification of a change in the implementation of wholesale distribution of VMPs in the territory of Slovak Republic<\/a><\/div>\n\n\n\n<p><\/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\">Povinnosti dr\u017eite\u013eov povolenia na ve\u013ekodistrib\u00faciu<\/mark><\/strong><\/h3>\n\n\n\n<p>V&nbsp;s\u00falade s&nbsp;legislat\u00edvou uvedenou vy\u0161\u0161ie.<\/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\">Hl\u00e1senia dr\u017eite\u013eov povolenia na ve\u013ekodistrib\u00faciu<\/mark><\/strong><\/h3>\n\n\n\n<p>Dr\u017eite\u013e povolenia na ve\u013ekodistrib\u00faciu veterin\u00e1rnych liekov je povinn\u00fd okrem in\u00e9ho:<\/p>\n\n\n\n<p> do siedmich dn\u00ed po skon\u010den\u00ed \u0161tvr\u0165roka poda\u0165 na \u00da\u0160KVBL hl\u00e1senie o&nbsp;mno\u017estve a&nbsp;druhu veterin\u00e1rnych liekov dodan\u00fdch na dom\u00e1ci a&nbsp;zahrani\u010dn\u00fd trh.<\/p>\n\n\n\n<p>Dr\u017eite\u013e povolenia na ve\u013ekodistrib\u00faciu medikovan\u00fdch krm\u00edv&nbsp; liekov je povinn\u00fd okrem in\u00e9ho:<\/p>\n\n\n\n<p> do siedmich dn\u00ed po dovoze medikovan\u00fdch krm\u00edv z tret\u00edch \u0161t\u00e1tov a pri obchodovan\u00ed s nimi s in\u00fdmi \u010dlensk\u00fdmi \u0161t\u00e1tmi predlo\u017ei\u0165 k\u00f3piu sprievodn\u00e9ho certifik\u00e1tu na pr\u00edslu\u0161n\u00fa region\u00e1lnu veterin\u00e1rnu a potravinov\u00fa spr\u00e1vu a \u00fastav kontroly veterin\u00e1rnych lie\u010div (\u00a7 18 ods. 1, p\u00edsm. n) z\u00e1kona \u010d. 362\/2011 Z. z.)<\/p>\n\n\n\n<p>Tieto hl\u00e1senia je potrebn\u00e9 zasiela\u0165 elektronickou po\u0161tou na email: <a href=\"mailto:hlasenia.inspekcia@uskvbl.sk\">hlasenia.inspekcia@uskvbl.sk<\/a><\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-a18a1e95-ab8f-4ef2-9098-21105608c2c7\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/usmernenie_posielani_stvrtrocnych_hlaseni_o_predaji_a_dovoze_VL.pdf\">Usmernenie o posielan\u00ed \u0161tvr\u0165ro\u010dn\u00e9ho hl\u00e1senia o\u00a0dovozoch a\u00a0predajoch veterin\u00e1rnych liekov<\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>S\u00favisiaca legislat\u00edva Nariadenie Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6 o&nbsp;veterin\u00e1rnych liekoch a o zru\u0161en\u00ed smernice 2001\/82\/ES Vykon\u00e1vacie Nariadenie Komisie (E\u00da) 2021\/1248 z 29. j\u00fala 2021 o opatreniach t\u00fdkaj\u00facich sa spr\u00e1vnej distribu\u010dnej praxe pre veterin\u00e1rne lieky v s\u00falade s nariaden\u00edm Eur\u00f3pskeho &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=71\">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-71","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/71","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=71"}],"version-history":[{"count":35,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/71\/revisions"}],"predecessor-version":[{"id":9513,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/71\/revisions\/9513"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=71"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}