{"id":1314,"date":"2025-09-26T09:28:59","date_gmt":"2025-09-26T08:28:59","guid":{"rendered":"https:\/\/lepex-novum.com\/eu-rendelet\/"},"modified":"2026-01-06T15:03:01","modified_gmt":"2026-01-06T14:03:01","slug":"eu-rendelet","status":"publish","type":"page","link":"https:\/\/lepex-novum.com\/hu\/eu-rendelet\/","title":{"rendered":"EU rendelet"},"content":{"rendered":"\t\t
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Az \u00e1llati sperma tart\u00f3s\u00edt\u00f3 k\u00f6zegek szab\u00e1lyoz\u00e1s\u00e1r\u00f3l az EU-ban.<\/span><\/h2><\/div>

Az \u00e1llati sperma tart\u00f3s\u00edt\u00f3 k\u00f6zegek foly\u00e9kony oldatok, amelyeket az ejakul\u00e1tumok h\u00edg\u00edt\u00e1s\u00e1ra haszn\u00e1lnak, ez\u00e1ltal n\u00f6velve az ejakul\u00e1tum t\u00e9rfogat\u00e1t a mesters\u00e9ges megterm\u00e9keny\u00edt\u00e9shez sz\u00fcks\u00e9ges megfelel\u0151 spermiumkoncentr\u00e1ci\u00f3 el\u00e9r\u00e9s\u00e9hez. Tov\u00e1bb\u00e1, ezek a k\u00f6zegek a spermiumok megterm\u00e9keny\u00edt\u0151 k\u00e9pess\u00e9g\u00e9nek fenntart\u00e1s\u00e1ra szolg\u00e1lnak. S\u00f3k \u00e9s cukrok \u00f6sszet\u00e9tel\u00e9vel a sperma tart\u00f3s\u00edt\u00f3 k\u00f6zegek szab\u00e1lyozz\u00e1k a pH-t \u00e9s az ozmolarit\u00e1st, mik\u00f6zben antibiotikumokat is tartalmaznak a mikroorganizmusok elszaporod\u00e1s\u00e1nak megakad\u00e1lyoz\u00e1s\u00e1ra. Ezenk\u00edv\u00fcl sz\u00e1mos m\u00e1s anyag is be\u00e9p\u00edthet\u0151 ezekbe a k\u00f6zegekbe. <\/span><\/p>

Az \u00e1llatgy\u00f3gy\u00e1szati k\u00e9sz\u00edtm\u00e9nyekt\u0151l elt\u00e9r\u0151en jelenleg nincs olyan szab\u00e1lyoz\u00e1s, amely kifejezetten az \u00e1llati sperma tart\u00f3s\u00edt\u00f3 k\u00f6zegekre vonatkozna. P\u00e9ld\u00e1ul a sperma tart\u00f3s\u00edt\u00f3 k\u00f6zegek tartalmazhatnak antibiotikumokat, amelyek c\u00e9lja a spermiumok \u00e9letk\u00e9pess\u00e9g\u00e9nek fenntart\u00e1sa, nem pedig fiziol\u00f3giai hat\u00e1s kifejt\u00e9se a megterm\u00e9keny\u00edt\u00e9sen \u00e1tes\u0151 \u00e1llatra. Lehets\u00e9ges, hogy bizonyos, specifikus sperma tart\u00f3s\u00edt\u00f3 k\u00f6zegekben tal\u00e1lhat\u00f3 \u00f6sszetev\u0151k, legyenek azok kereskedelmi forgalomban kaphat\u00f3k vagy sem, \u00e1llatgy\u00f3gy\u00e1szati k\u00e9sz\u00edtm\u00e9nyk\u00e9nt kategoriz\u00e1lhat\u00f3k. Ha ezek az \u00f6sszetev\u0151k val\u00f3ban \u00e1llatgy\u00f3gy\u00e1szati k\u00e9sz\u00edtm\u00e9nyek, akkor val\u00f3sz\u00edn\u0171leg meg kell felelni\u00fck a vonatkoz\u00f3 szab\u00e1lyoz\u00e1si k\u00f6vetelm\u00e9nyeknek. <\/span><\/p>

<\/span>A sperma tart\u00f3s\u00edt\u00f3 k\u00f6zegek bizonyos \u00f6sszetev\u0151inek besorol\u00e1sa k\u00e9t\u00e9rtelm\u0171 lehet, bizonytalans\u00e1got okozva abban, hogy a k\u00f6zeget \u00e1llatgy\u00f3gy\u00e1szati k\u00e9sz\u00edtm\u00e9nyk\u00e9nt kell-e besorolni, vagy az \u00f6sszetev\u0151 nem gy\u00f3gy\u00e1szati anyagnak tekinthet\u0151. N\u00e9h\u00e1ny \u00f6sszetev\u0151 nem tart\u00f3s\u00edt\u00f3szerk\u00e9nt m\u0171k\u00f6dik, de m\u00e9gis szerepet j\u00e1tszik a megterm\u00e9keny\u00edt\u00e9sben. P\u00e9ld\u00e1ul a h\u00edg\u00edtott sperm\u00e1hoz hozz\u00e1adott anyagok, amelyek jav\u00edtj\u00e1k annak kevered\u00e9s\u00e9t a h\u00fcvelyi ny\u00e1kkal, potenci\u00e1lisan n\u00f6velhetik a fogamz\u00e1s es\u00e9lyeit, amint azt olyan fajokn\u00e1l, mint a sert\u00e9s \u00e9s a ny\u00fal, kimutatt\u00e1k. Vagy olyan anyagok, amelyeket a k\u00f6zeghez adnak a term\u00e9szetes ovul\u00e1ci\u00f3 folyamat\u00e1nak el\u0151seg\u00edt\u00e9s\u00e9re, mint p\u00e9ld\u00e1ul a Lepex-Novum ny\u00fal sperma tart\u00f3s\u00edt\u00f3 k\u00f6zeg eset\u00e9ben. <\/span><\/p>

Amikor az \u00f6sszetev\u0151k \u00e1llatgy\u00f3gy\u00e1szati k\u00e9sz\u00edtm\u00e9nyk\u00e9nt vagy nem gy\u00f3gy\u00e1szati sperma tart\u00f3s\u00edt\u00f3 adal\u00e9kk\u00e9nt val\u00f3 besorol\u00e1s\u00e1nak dilemm\u00e1j\u00e1val szembes\u00fcl\u00fcnk, besorol\u00e1st lehet k\u00e9rni az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) \u00c1llatgy\u00f3gy\u00e1szati K\u00e9sz\u00edtm\u00e9nyek K\u00f6lcs\u00f6n\u00f6s Elismer\u00e9si \u00e9s Decentraliz\u00e1lt Elj\u00e1r\u00e1sok Koordin\u00e1ci\u00f3s Csoportja (CMDv) \u00e1ltal l\u00e9trehozott Hat\u00e1rter\u00fcleti Munkacsoportt\u00f3l (BWG). A CMDv, amelyet a fel\u00fclvizsg\u00e1lt gy\u00f3gyszer\u00e9szeti jogszab\u00e1lyok alapj\u00e1n hoztak l\u00e9tre, az \u00e1llatgy\u00f3gy\u00e1szati k\u00e9sz\u00edtm\u00e9nyek forgalomba hozatali enged\u00e9ly\u00e9vel kapcsolatos k\u00e9rd\u00e9seket kezeli t\u00f6bb tag\u00e1llamban k\u00f6lcs\u00f6n\u00f6s elismer\u00e9si vagy decentraliz\u00e1lt elj\u00e1r\u00e1s \u00fatj\u00e1n. <\/span><\/p>

\u200b<\/span>A CMDv a k\u00f6vetkez\u0151 megb\u00edzat\u00e1st adta a BWG-nek.<\/span><\/p>

\u200b<\/span>1. Lelt\u00e1r k\u00e9sz\u00edt\u00e9se a nemzeti illet\u00e9kes hat\u00f3s\u00e1gokon bel\u00fcli relev\u00e1ns szem\u00e9lyzetr\u0151l, munkacsoportokr\u00f3l \u00e9s csapatokr\u00f3l egy eur\u00f3pai \u201ehat\u00e1rter\u00fcleti\u201d h\u00e1l\u00f3zat l\u00e9trehoz\u00e1sa c\u00e9lj\u00e1b\u00f3l. A vonatkoz\u00f3 jogszab\u00e1lyok, a 3. cikk (2) bekezd\u00e9s\u00e9ben eml\u00edtett bizotts\u00e1gi v\u00e9grehajt\u00e1si jogi aktusok \u00e9s az \u00fcggyel kapcsolatos eur\u00f3pai joggyakorlat azonos\u00edt\u00e1sa.<\/span><\/p>

2. A hat\u00e1rter\u00fcleti term\u00e9kek k\u00fcl\u00f6nb\u00f6z\u0151 ter\u00fcleteinek azonos\u00edt\u00e1sa.<\/span><\/p>

3. K\u00f6z\u00f6s \u00e1ll\u00e1spont kialak\u00edt\u00e1sa a tag\u00e1llamok k\u00f6z\u00f6tt a hat\u00e1rter\u00fcleti defin\u00edci\u00f3kr\u00f3l \u00e9s az azonos\u00edtott hat\u00e1rter\u00fcleti term\u00e9kek k\u00fcl\u00f6nb\u00f6z\u0151 ter\u00fcleteir\u0151l, a tag\u00e1llamok k\u00f6z\u00f6tti \u00e9rtelmez\u00e9si k\u00fcl\u00f6nbs\u00e9gek minimaliz\u00e1l\u00e1sa \u00e9rdek\u00e9ben.<\/span><\/p>

4. Aj\u00e1nl\u00e1sok megfogalmaz\u00e1sa egy term\u00e9k vagy term\u00e9kcsoport besorol\u00e1s\u00e1ra vonatkoz\u00f3an.<\/span><\/p>

5. Sz\u00fcks\u00e9g eset\u00e9n kommunik\u00e1ci\u00f3 az Eur\u00f3pai Bizotts\u00e1ggal egy konkr\u00e9t aj\u00e1nl\u00e1sr\u00f3l.<\/span><\/p>

6. A besorol\u00e1s a term\u00e9k funkci\u00f3j\u00e1nak \u00e9s megjelen\u00e9s\u00e9nek eseti \u00e9rt\u00e9kel\u00e9s\u00e9n alapul.<\/span><\/p>

Ezzel a megb\u00edzat\u00e1ssal a BWG aj\u00e1nl\u00e1sokat adhat ki az \u00e1llati sperma tart\u00f3s\u00edt\u00f3 k\u00f6zegek olyan \u00f6sszetev\u0151ire vonatkoz\u00f3an, amelyekre k\u00e9relmet ny\u00fajtottak be.<\/span><\/p><\/div>

Az Eur\u00f3pai Gy\u00f3gyszer\u00e9rt\u00e9kel\u0151 Test\u00fclet \u2013 \u00dcgyn\u00f6ks\u00e9g aj\u00e1nl\u00e1sa<\/span><\/span><\/h2><\/div>

2023 j\u00falius\u00e1ban k\u00e9t besorol\u00e1si k\u00e9relmet ny\u00fajtottak be a Hat\u00e1rter\u00fcleti Munkacsoporthoz (BWG), az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) \u00c1llatgy\u00f3gy\u00e1szati K\u00e9sz\u00edtm\u00e9nyek K\u00f6lcs\u00f6n\u00f6s Elismer\u00e9si \u00e9s Decentraliz\u00e1lt Elj\u00e1r\u00e1sok Koordin\u00e1ci\u00f3s Csoportja (CMDv) \u00e1ltal l\u00e9trehozott test\u00fclethez, a Pronexcell \u00e9s a Matrixcell, a Lepex-Novum k\u00e9t f\u0151 \u00f6sszetev\u0151je tekintet\u00e9ben.<\/span><\/p>

Ezenk\u00edv\u00fcl 2023 november\u00e9ben a Novum teljes recept\u00far\u00e1j\u00e1t tov\u00e1bb\u00edtott\u00e1k az \u00c1llatgy\u00f3gy\u00e1szati Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9ghez a Novum kieg\u00e9sz\u00edt\u0151 besorol\u00e1sa c\u00e9lj\u00e1b\u00f3l. A beny\u00fajt\u00e1s tartalmazta a Novum \u00f6sszes \u00f6sszetev\u0151j\u00e9re vonatkoz\u00f3 r\u00e9szleteket, valamint a mechanizmus magyar\u00e1zat\u00e1t az NGF feh\u00e9rje jelenl\u00e9te alapj\u00e1n, \u00f6sszhangban a jelenlegi weboldalon el\u00e9rhet\u0151 inform\u00e1ci\u00f3kkal. <\/span><\/p>

\u200b<\/span>A Szab\u00e1lyoz\u00e1si Projektvezet\u0151\/Holland K\u00e9pvisel\u0151 \u2013 az \u00c1llatgy\u00f3gy\u00e1szati K\u00e9sz\u00edtm\u00e9nyek Egys\u00e9g\u00e9nek CMDv tagja, a Gy\u00f3gyszer\u00e9rt\u00e9kel\u0151 Test\u00fclet-\u00dcgyn\u00f6ks\u00e9gt\u0151l \u2013 \u00edr\u00e1sbeli v\u00e1lasza a k\u00f6vetkez\u0151 volt.<\/span><\/p>

\u200b<\/span>Az (EU) 2019\/6 rendeletnek megfelel\u0151en az \u201e\u00e1llatgy\u00f3gy\u00e1szati k\u00e9sz\u00edtm\u00e9ny\u201d kifejez\u00e9s mag\u00e1ban foglal minden olyan anyagot vagy anyagok kombin\u00e1ci\u00f3j\u00e1t, amely legal\u00e1bb az al\u00e1bbi felt\u00e9telek egyik\u00e9nek megfelel:<\/span><\/p>

a) amelyet az \u00e1llatok betegs\u00e9geinek ter\u00e1pi\u00e1s vagy profilaktikus tulajdons\u00e1gaival rendelkez\u0151k\u00e9nt mutatnak be;<\/span><\/p>

b) amelyet \u00e1llatokban val\u00f3 alkalmaz\u00e1sra vagy \u00e1llatoknak t\u00f6rt\u00e9n\u0151 bead\u00e1sra sz\u00e1nnak a fiziol\u00f3giai funkci\u00f3k farmakol\u00f3giai, immunol\u00f3giai vagy metabolikus hat\u00e1s r\u00e9v\u00e9n t\u00f6rt\u00e9n\u0151 helyre\u00e1ll\u00edt\u00e1sa, jav\u00edt\u00e1sa vagy m\u00f3dos\u00edt\u00e1sa c\u00e9lj\u00e1b\u00f3l.<\/span><\/p>

A rendelkez\u00e9sre bocs\u00e1tott inform\u00e1ci\u00f3k alapj\u00e1n a Novum nem felel meg az \u00e1llatgy\u00f3gy\u00e1szati k\u00e9sz\u00edtm\u00e9ny fogalm\u00e1nak, ahogyan azt az (EU) 2019\/6 rendelet 4. cikk (1) bekezd\u00e9s a) vagy b) pontja meghat\u00e1rozza.<\/span><\/p><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Az \u00e1llati sperma tart\u00f3s\u00edt\u00f3 k\u00f6zegek szab\u00e1lyoz\u00e1s\u00e1r\u00f3l az EU-ban. Az \u00e1llati sperma tart\u00f3s\u00edt\u00f3 k\u00f6zegek foly\u00e9kony oldatok, amelyeket az ejakul\u00e1tumok h\u00edg\u00edt\u00e1s\u00e1ra haszn\u00e1lnak, […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"","ast-site-content-layout":"full-width-container","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-1314","page","type-page","status-publish","hentry"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/lepex-novum.com\/hu\/wp-json\/wp\/v2\/pages\/1314","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lepex-novum.com\/hu\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/lepex-novum.com\/hu\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/lepex-novum.com\/hu\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lepex-novum.com\/hu\/wp-json\/wp\/v2\/comments?post=1314"}],"version-history":[{"count":1,"href":"https:\/\/lepex-novum.com\/hu\/wp-json\/wp\/v2\/pages\/1314\/revisions"}],"predecessor-version":[{"id":1319,"href":"https:\/\/lepex-novum.com\/hu\/wp-json\/wp\/v2\/pages\/1314\/revisions\/1319"}],"wp:attachment":[{"href":"https:\/\/lepex-novum.com\/hu\/wp-json\/wp\/v2\/media?parent=1314"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}