{"id":124,"date":"2020-01-20T14:51:42","date_gmt":"2020-01-20T13:51:42","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=124"},"modified":"2025-11-18T08:23:06","modified_gmt":"2025-11-18T07:23:06","slug":"drzitelia-rozhodnutia-o-registracii-veterinarneho-lieku","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=124","title":{"rendered":"DR\u017dITELIA ROZHODNUTIA O REGISTR\u00c1CII VETERIN\u00c1RNEHO LIEKU"},"content":{"rendered":"\n<p>S\u00fa\u010dasn\u00e9 po\u017eiadavky a&nbsp;povinnosti dr\u017eite\u013eov rozhodnutia o&nbsp;registr\u00e1cii (MAH) v&nbsp;oblasti farmakovigilancie s\u00fa stanoven\u00e9 Nariaden\u00edm Eur\u00f3pskeho parlamentu a&nbsp;Rady (E\u00da) 2019\/6 o&nbsp;veterin\u00e1rnych liekoch a Vykon\u00e1vac\u00edm nariaden\u00edm Komisie E\u00da 2021\/1281. ktor\u00fdmi sa ur\u010duj\u00fa &nbsp;pravidl\u00e1 uplat\u0148ovania nariadenia Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6, pokia\u013e ide o spr\u00e1vnu prax v oblasti farmakovigilan\u010dn\u00e9ho doh\u013eadu a o form\u00e1t, obsah a s\u00fahrn hlavn\u00e9ho dokumentu farmakovigilan\u010dn\u00e9ho syst\u00e9mu pre veterin\u00e1rne lieky. &nbsp;<\/p>\n\n\n\n<p>Nov\u00e9 zmeny oproti p\u00f4vodnej legislat\u00edve sa zameriavaj\u00fa na tieto oblasti:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Priebe\u017en\u00e9 riadenie sign\u00e1lov po\u010das cel\u00e9ho \u017eivotn\u00e9ho cyklu lieku na z\u00e1klade hl\u00e1sen\u00ed o ne\u017eiaducich udalostiach vo &#8222;farmakovigilan\u010dnej datab\u00e1ze \u00danie&#8220;<\/li>\n\n\n\n<li>Zavedenie hlavn\u00e9ho s\u00faboru syst\u00e9mu farmakovigilancie (PSMF) dr\u017eite\u013eom rozhodnutia o&nbsp;registr\u00e1cii<\/li>\n\n\n\n<li>Farmakovigilan\u010dn\u00e9 in\u0161pekcie zo strany n\u00e1rodn\u00fdch autor\u00edt (NCAs)<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Hlavn\u00fd s\u00fabor syst\u00e9mu farmakovigilancie (PSMF)<\/strong><\/h4>\n\n\n\n<p>V&nbsp;zmysle platnej legislat\u00edvy m\u00e1 MAH povinnos\u0165 zavies\u0165 &nbsp;syst\u00e9m na zber, porovn\u00e1vanie a&nbsp;vyhodnocovanie inform\u00e1ci\u00ed o&nbsp;podozreniach na ne\u017eiaduce udalosti &#8211; tzv. hlavn\u00fd s\u00fabor syst\u00e9mu farmakovigilancie (PSMF), ktor\u00fd je predmetom farmakovigilan\u010dn\u00fdch in\u0161pekci\u00ed. PSMF nahr\u00e1dza p\u00f4vodn\u00fd podrobn\u00fd opis syst\u00e9mu doh\u013eadu nad veterin\u00e1rnymi liekmi (DDPS) Jeho form\u00e1t, obsah a&nbsp;s\u00fahrn je definovan\u00fd vykon\u00e1vac\u00edm nariaden\u00edm komisie E\u00da&nbsp;2021\/1281). PSMF&nbsp;m\u00e1 by\u0165 umiestnen\u00fd na mieste, kde sa vykon\u00e1vaj\u00fa hlavn\u00e9 farmakovigilan\u010dn\u00e9 \u010dinnosti dr\u017eite\u013ea alebo kde m\u00e1 p\u00f4sobnos\u0165 osoba zodpovedn\u00e1 za farmakovigilanciu (QPPV).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Guidelines on veterinary good pharmacovigilance practices (VGVP)<\/strong><\/h4>\n\n\n\n<p>Moduly oh\u013eadom spr\u00e1vnej veterin\u00e1rnej farmakovigilan\u010dnej praxe (VGVP) nahr\u00e1dzaj\u00fa Notice to Applicants,&nbsp; Volume 9 B a s\u00fa zverejnen\u00e9 na web s\u00eddle EMA :<\/p>\n\n\n\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/veterinary-regulatory\/post-authorisation\/pharmacovigilance-veterinary-medicines\" target=\"_blank\" rel=\"noreferrer noopener\">Pharmacovigilance (veterinary medicines) | European Medicines Agency (europa.eu)<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Ne\u017eiaduce udalosti a&nbsp;pou\u017e\u00edvanie terminol\u00f3gie&nbsp; veterin\u00e1rneho slovn\u00edka (VeDDRA)<\/strong><\/h4>\n\n\n\n<p>Agent\u00fara EMA uverejnila dokument s ot\u00e1zkami a odpove\u010fami, v ktorom popisuje, ako by sa mali ne\u017eiaduce udalosti popisova\u0165 v&nbsp;SPC:<\/p>\n\n\n\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/other\/questions-answers-describing-adverse-events-product-information-summary-product-characteristics-spc_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL)) (europa.eu)<\/a><\/p>\n\n\n\n<p>Ne\u017eiaduce udalosti by mali by\u0165 pop\u00edsan\u00e9 &nbsp;pomocou schv\u00e1len\u00fdch term\u00ednov VeDDRA. Zoznam v s\u00fa\u010dasnosti schv\u00e1len\u00fdch term\u00ednov VeDDRA je uverejnen\u00fd na webovom s\u00eddle EMA:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><\/ul>\n\n\n\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/combined-veterinary-dictionary-drug-regulatory-activities-veddra-list-clinical-terms-reporting-suspected-adverse-events-animals-humans-veterinary-medicinal-products-rev15_en.pdf\">Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (europa.eu)<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>EudraVigilance Veterinary (EVVet)<\/strong><\/h4>\n\n\n\n<p>Povinnos\u0165ou MAH je zaznamen\u00e1va\u0165 do farmakovigilan\u010dnej datab\u00e1zy v\u0161etky podozrenia na ne\u017eiaduce udalosti, ktor\u00e9 im boli hl\u00e1sen\u00e9 a&nbsp;vyskytli sa na \u00fazem\u00ed \u010dlensk\u00fdch \u0161t\u00e1tov, kde je produkt registrovan\u00fd alebo v&nbsp;tretej krajine, alebo ktor\u00e9 boli uverejnen\u00e9 v&nbsp;odbornej literat\u00fare vo vz\u0165ahu k&nbsp;ich povolen\u00fdm liekom a&nbsp;to do 30 dn\u00ed od prijatia hl\u00e1senia. EudraVigilance Veterinary je sie\u0165 na spracovanie \u00fadajov a&nbsp;datab\u00e1za na spr\u00e1vu a&nbsp;anal\u00fdzu inform\u00e1ci\u00ed o&nbsp;podozreniach na na ne\u017eiaduce udalosti, ktor\u00e9 s\u00fa registrovan\u00e9 v&nbsp;E\u00da.<\/p>\n\n\n\n<p>Bli\u017e\u0161ie inform\u00e1cie vr\u00e1tane pr\u00edru\u010dky pre pou\u017e\u00edvate\u013ea EVVET3 s\u00fa uverejnen\u00e9 na webovom s\u00eddle EMA:<\/p>\n\n\n\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/veterinary-regulatory\/post-authorisation\/pharmacovigilance\/eudravigilance-veterinary\" target=\"_blank\" rel=\"noreferrer noopener\">EudraVigilance Veterinary | European Medicines Agency (europa.eu)<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Detekcia sign\u00e1lu<\/strong><\/h4>\n\n\n\n<p>Pravideln\u00e9 aktualizovan\u00e9 spr\u00e1vy o bezpe\u010dnosti (PSUR) sa u\u017e nevy\u017eaduj\u00fa. Namiesto toho je MAH povinn\u00fd vykon\u00e1va\u0165 proces riadenia sign\u00e1lov pre svoje veterin\u00e1rne lieky (\u010dl\u00e1nok 81 Nariadenia 2019\/6). Proces riadenia sign\u00e1lov umo\u017en\u00ed nepretr\u017eit\u00e9 monitorovanie pomeru pr\u00ednosov a riz\u00edk lieku a tvor\u00ed z\u00e1kladn\u00fd prvok farmakovigilan\u010dn\u00e9ho syst\u00e9mu.<\/p>\n\n\n\n<p>Detekcia sign\u00e1lu a anal\u00fdza \u00fadajov sa vykon\u00e1va prostredn\u00edcvom Data Warehouse (EVVet DWH) za pomoci pr\u00edru\u010dky <\/p>\n\n\n\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/other\/evvet-data-warehouse-user-manual_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">EVVET \u2013 Data warehouse user manual (europa.eu)<\/a><\/p>\n\n\n\n<p>Inform\u00e1cie o&nbsp;procese riadenia sign\u00e1lov a&nbsp;o&nbsp;predkladan\u00ed sign\u00e1lov s\u00fa uveden\u00e9 v&nbsp;module na webovej str\u00e1nke EMA,<\/p>\n\n\n\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/guideline-veterinary-good-pharmacovigilance-practices-vgvp-module-signal-management_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management (europa.eu)<\/a><\/p>\n\n\n\n<p>Je k\u00a0dispoz\u00edcii vzor spr\u00e1vy na pos\u00fadenie sign\u00e1lu (<em>template signal assessment report<\/em>), ktor\u00fd MAH pou\u017e\u00edvaj\u00fa \u00a0pri predkladan\u00ed sign\u00e1lu,<\/p>\n\n\n\n<p><a href=\"https:\/\/view.officeapps.live.com\/op\/view.aspx?src=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Ftemplate-form%2Fveterinary-signal-assessment-report-marketing-authorisation-holders_en.docx&amp;wdOrigin=BROWSELINK\" target=\"_blank\" rel=\"noreferrer noopener\">veterinary-signal-assessment-report-marketing-authorisation-holders_en.docx (live.com)<\/a><\/p>\n\n\n\n<p>MAH je povinn\u00fd aspo\u0148 raz ro\u010dne zaznamena\u0165 v\u0161etky v\u00fdsledky a v\u00fdstupy procesu riadenia sign\u00e1lov do farmakovigilan\u010dnej datab\u00e1zy \u00danie prostredn\u00edctvom IRIS:<\/p>\n\n\n\n<p>&nbsp;<a href=\"https:\/\/iris.ema.europa.eu\/\" target=\"_blank\" rel=\"noreferrer noopener\">Home &nbsp;\u00b7 IRIS (europa.eu)<\/a><\/p>\n\n\n\n<p>Pr\u00edru\u010dka pre u\u017e\u00edvate\u013eov IRIS:<\/p>\n\n\n\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/other\/iris-guide-applicants-how-create-submit-scientific-applications-industry-individual-applicants_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">iris-guide-applicants-how-create-submit-scientific-applications-industry-individual-applicants_en.pdf (europa.eu)<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>S\u00fa\u010dasn\u00e9 po\u017eiadavky a&nbsp;povinnosti dr\u017eite\u013eov rozhodnutia o&nbsp;registr\u00e1cii (MAH) v&nbsp;oblasti farmakovigilancie s\u00fa stanoven\u00e9 Nariaden\u00edm Eur\u00f3pskeho parlamentu a&nbsp;Rady (E\u00da) 2019\/6 o&nbsp;veterin\u00e1rnych liekoch a Vykon\u00e1vac\u00edm nariaden\u00edm Komisie E\u00da 2021\/1281. ktor\u00fdmi sa ur\u010duj\u00fa &nbsp;pravidl\u00e1 uplat\u0148ovania nariadenia Eur\u00f3pskeho parlamentu a Rady (E\u00da) 2019\/6, pokia\u013e ide o &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=124\">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-124","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/124","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=124"}],"version-history":[{"count":18,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/124\/revisions"}],"predecessor-version":[{"id":9346,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/124\/revisions\/9346"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=124"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}