{"id":2688,"date":"2021-10-15T12:57:29","date_gmt":"2021-10-15T10:57:29","guid":{"rendered":"https:\/\/blogs.dlapiper.com\/advocatus\/?p=2688"},"modified":"2022-01-07T15:07:23","modified_gmt":"2022-01-07T14:07:23","slug":"az-5-legfontosabb-tudnivalo-a-gyogyszerismertetessel-kapcsolatos-torveny-modositasarol","status":"publish","type":"post","link":"https:\/\/blogs.dlapiper.com\/advocatus\/2021\/10\/az-5-legfontosabb-tudnivalo-a-gyogyszerismertetessel-kapcsolatos-torveny-modositasarol\/","title":{"rendered":"Az 5 legfontosabb tudnival\u00f3 a gy\u00f3gyszerismertet\u00e9ssel kapcsolatos t\u00f6rv\u00e9ny m\u00f3dos\u00edt\u00e1s\u00e1r\u00f3l"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"2688\" class=\"elementor elementor-2688\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6b8ca40f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6b8ca40f\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1d0ab034\" data-id=\"1d0ab034\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa9170c elementor-widget elementor-widget-text-editor\" data-id=\"aa9170c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong style=\"font-size: 16px\">Az Orsz\u00e1gos Gy\u00f3gyszer\u00e9szeti \u00e9s \u00c9lelmez\u00e9s-eg\u00e9szs\u00e9g\u00fcgyi Int\u00e9zet (OGY\u00c9I) \u00f6sszefoglal\u00f3t tett k\u00f6zz\u00e9 a biztons\u00e1gos \u00e9s gazdas\u00e1gos gy\u00f3gyszer- \u00e9s gy\u00f3gy\u00e1szati seg\u00e9deszk\u00f6z ell\u00e1t\u00e1s, valamint a gy\u00f3gyszerforgalmaz\u00e1s \u00e1ltal\u00e1nos szab\u00e1lyair\u00f3l sz\u00f3l\u00f3 2006. \u00e9vi XCVIII. t\u00f6rv\u00e9ny (Gyftv.) legfrissebb m\u00f3dos\u00edt\u00e1sair\u00f3l.<\/strong><\/p>\n<ul>\n<li><strong>A 2021. j\u00fanius 29. \u00f3ta hat\u00e1lyos, els\u0151sorban gy\u00f3gyszerismertet\u00e9ssel kapcsolatos rendelkez\u00e9sek m\u00f3dos\u00edt\u00e1sait \u00e9s az ehhez kapcsol\u00f3d\u00f3 OGY\u00c9I \u00e9rtelmez\u00e9st a DLA Piper \u00fcgyv\u00e9di iroda szak\u00e9rt\u0151i \u00f6sszegezt\u00e9k.<\/strong><\/li>\n<\/ul>\n<p>A hat\u00f3s\u00e1g 2021. szeptember 20-\u00e1n k\u00f6zz\u00e9 tett \u00f6sszefoglal\u00f3ja sz\u00e1mos, a jogszab\u00e1ly-m\u00f3dos\u00edt\u00e1s hat\u00e1lyba l\u00e9p\u00e9se \u00f3ta fenn\u00e1ll\u00f3 nyitott k\u00e9rd\u00e9sre v\u00e1laszol, ugyanakkor t\u00f6bb ponton maradt tere a jog\u00e9rtelmez\u00e9snek is.<\/p>\n<p>A m\u00f3dos\u00edt\u00e1sok az al\u00e1bbi f\u0151 rendelkez\u00e9seket \u00e9rintik:<\/p>\n<p><strong>1. Kereskedelmi gyakorlat meghat\u00e1roz\u00e1s\u00e1nak kiterjeszt\u00e9se<\/strong>:<\/p>\n<p>A kereskedelmi gyakorlat t\u00f6rv\u00e9nyi defin\u00edci\u00f3j\u00e1ba m\u00e1r egy\u00e9rtelm\u0171en beletartozik a szakemberekkel t\u00f6rt\u00e9n\u0151 minden kommunik\u00e1ci\u00f3, \u00edgy a szakmai \u00e9s tudom\u00e1nyos kommunik\u00e1ci\u00f3 is. Ezzel \u00f6sszef\u00fcgg\u00e9sben az OGY\u00c9I \u00e1ltal k\u00f6zz\u00e9tett \u00f6sszefoglal\u00f3 hangs\u00falyozza, hogy a v\u00e1llalatok \u00e1ltal v\u00e9gzett k\u00fcl\u00f6nb\u00f6z\u0151 tev\u00e9kenys\u00e9gek prom\u00f3ci\u00f3s jelleg\u00e9nek meg\u00edt\u00e9l\u00e9sekor a hat\u00f3s\u00e1g nem csak a c\u00e9lt, hanem az eredm\u00e9nyt vagy hat\u00e1st is jogosult vizsg\u00e1lni.<\/p>\n<p><strong>2. Kib\u0151v\u00fclt az ismertet\u00e9s fogalma:<\/strong><\/p>\n<p>Egy\u00e9rtelm\u0171s\u00edt\u00e9sre ker\u00fclt, hogy minden a gy\u00f3gyszerekre, t\u00e1pszerekre, gy\u00f3gy\u00e1szati seg\u00e9deszk\u00f6z\u00f6kre vonatkoz\u00f3 kereskedelmi gyakorlat, kommunik\u00e1ci\u00f3, amely eg\u00e9szs\u00e9g\u00fcgyi szakembereknek sz\u00f3l, vagy vel\u00fck szemben alkalmaznak, ismertet\u00e9snek min\u0151s\u00fcl. Az ismertet\u00e9s t\u00e1rgy\u00e1t k\u00e9pez\u0151 term\u00e9kek kateg\u00f3ri\u00e1i is pontos\u00edt\u00e1sra ker\u00fcltek, \u00edgy bizonyos term\u00e9kek (pl. speci\u00e1lis gy\u00f3gy\u00e1szati c\u00e9l\u00fa \u00e9trend-kieg\u00e9sz\u00edt\u0151k, t\u00e1pszerek) csak akkor tartoznak az ismertet\u00e9s hat\u00e1lya al\u00e1, ha azok k\u00f6zfinansz\u00edroz\u00e1sban r\u00e9szes\u00fclnek. Az \u00f6sszefoglal\u00f3 tov\u00e1bb\u00e1 ahhoz is t\u00e1mpontot ny\u00fajt, hogy mi nem min\u0151s\u00fcl tov\u00e1bbra sem ismertet\u00e9snek (pl.: kereskedelmi \u00e1rlista).<\/p>\n<p><strong>3. Ismertet\u00e9st seg\u00edt\u0151 rendezv\u00e9nyek meghat\u00e1roz\u00e1sa<\/strong>:<\/p>\n<p>A m\u00f3dos\u00edt\u00f3 csomag legnagyobb port kavart rendelkez\u00e9se a rendezv\u00e9nyek k\u00f6lts\u00e9g\u00e9re vonatkoz\u00f3 megszor\u00edt\u00e1s volt, amely az ipar\u00e1gi szerepl\u0151k sz\u00e1m\u00e1ra jelent\u0151s \u00e9rtelmez\u00e9si probl\u00e9m\u00e1kat vetett fel.<\/p>\n<blockquote>\n<p><em>Ezzel \u00f6sszef\u00fcgg\u00e9sben az OGY\u00c9I \u00f6sszefoglal\u00f3 megadja a m\u00f3dos\u00edt\u00e1s hat\u00e1lyba l\u00e9p\u00e9sekor hi\u00e1nyolt \u201eismertet\u00e9st seg\u00edt\u0151 rendezv\u00e9ny\u201d defin\u00edci\u00f3j\u00e1t is, amely az ismertet\u00e9si tev\u00e9kenys\u00e9get folytat\u00f3k saj\u00e1t szervez\u00e9s\u0171 rendezv\u00e9nyeinek \u00f6sszefoglal\u00f3 elnevez\u00e9se. Egy\u00fattal r\u00f6gz\u00edt\u00e9sre ker\u00fcl az is, hogy ilyen rendezv\u00e9nyek kiz\u00e1r\u00f3lag szakmai, tudom\u00e1nyos, oktat\u00e1si c\u00e9llal szervezhet\u0151k, arra kiz\u00e1r\u00f3lag eg\u00e9szs\u00e9g\u00fcgyi szakemberek h\u00edvhat\u00f3k meg meghat\u00e1rozott m\u00e9rt\u00e9k\u0171 vend\u00e9gl\u00e1t\u00e1s biztos\u00edt\u00e1sa mellett, valamint ezek a rendezv\u00e9nyek kiv\u00e9tel n\u00e9lk\u00fcl bejelent\u00e9sk\u00f6teles esem\u00e9nyek<\/em><\/p>\n<\/blockquote>\n<p><strong>4. K\u00f6lts\u00e9glimit \u00e9rtelmez\u00e9se rendezv\u00e9nyek eset\u00e9n:<\/strong><\/p>\n<p>Az ismertet\u00e9st seg\u00edt\u0151 rendezv\u00e9nyek megengedett k\u00f6lts\u00e9g\u00e9re vonatkoz\u00f3 m\u00f3dos\u00edt\u00e1st illet\u0151en az \u00f6sszefoglal\u00f3 r\u00f6gz\u00edti, hogy a hat\u00f3s\u00e1g a rendezv\u00e9ny k\u00f6lts\u00e9ge kifejez\u00e9st sz\u0171ken \u00e9rtelmezi, \u00e9s a rendezv\u00e9ny k\u00f6lts\u00e9g\u00e9be csak a vend\u00e9gl\u00e1t\u00e1shoz szorosan kapcsol\u00f3d\u00f3 (pl. teremb\u00e9rlet, projektor stb.) t\u00e9teleket sz\u00e1m\u00edtja bele, de p\u00e9ld\u00e1ul az el\u0151ad\u00f3i d\u00edjakat nem tekinti a rendezv\u00e9ny k\u00f6lts\u00e9g\u00e9be tartoz\u00f3nak. Azon rendezv\u00e9nyek eset\u00e9ben pedig, ahol nem ker\u00fcl sor vend\u00e9gl\u00e1t\u00e1s biztos\u00edt\u00e1s\u00e1ra (pl. online rendezv\u00e9nyek), a rendezv\u00e9ny egy nap\/f\u0151re es\u0151 k\u00f6lts\u00e9glimitje nem is alkalmazand\u00f3.<\/p>\n<p><strong>5. \u00d6sszef\u00e9rhetetlens\u00e9gi szab\u00e1ly az eg\u00e9szs\u00e9g\u00fcgyi szakemberek tekintet\u00e9ben<\/strong>:<\/p>\n<p>Egy \u00faj bekezd\u00e9s (Gyftv. 13. \u00a7 (2) bek.) is beker\u00fclt a t\u00f6rv\u00e9nybe, amelynek c\u00e9lja egy kifejezett tilalom megfogalmaz\u00e1sa annak \u00e9rdek\u00e9ben, hogy a rendel\u00e9sre jogosult szakemberek ne ker\u00fclhessenek p\u00e9nz\u00fcgyi ellent\u00e9telez\u00e9s\u00e9rt bevon\u00e1sra az ismertet\u00e9si tev\u00e9kenys\u00e9get folytat\u00f3k kereskedelmi gyakorlat\u00e1nak kialak\u00edt\u00e1s\u00e1ba, form\u00e1l\u00e1s\u00e1ba, amely tilalom al\u00f3l \u00e9rtelemszer\u0171en a tudom\u00e1nyos vagy a szerz\u0151i jog \u00e1ltal v\u00e9dett tev\u00e9kenys\u00e9g kiv\u00e9telt k\u00e9pez.<\/p>\n<blockquote>\n<p><em>Az OGY\u00c9I a tudom\u00e1nyos tev\u00e9kenys\u00e9gek k\u00f6r\u00e9t t\u00e1gan \u00e9rtelmezi, az \u00f6sszefoglal\u00f3 \u00e9rtelm\u00e9ben ide soroland\u00f3 t\u00f6bbek k\u00f6z\u00f6tt az \u00f6n\u00e1ll\u00f3 szakmai tud\u00e1s felhaszn\u00e1l\u00e1s\u00e1val v\u00e9gzett valamennyi olyan tev\u00e9kenys\u00e9g, amely h\u00e9tk\u00f6znapi \u00e9rtelemben v\u00e9ve tudom\u00e1nyos \u00e9rt\u00e9kkel b\u00edr, \u00e9s\/vagy tudom\u00e1nyos eredm\u00e9nyt keletkeztet (pl.: betegeknek sz\u00f3l\u00f3 eduk\u00e1ci\u00f3s anyag, szakmai lektor\u00e1l\u00e1s)<\/em><\/p>\n<\/blockquote>\n<p>Az OGY\u00c9I \u00f6sszefoglal\u00f3ja <a href=\"https:\/\/www.ogyei.gov.hu\/dynamic\/osszefoglalo_Gyftv_modositasok_vegleges_honlapra.pdf\">ITT<\/a> el\u00e9rhet\u0151.<\/p><p><i>Szerz\u0151k: Papp G\u00e1bor \u00e9s Varga Eszter<\/i><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a2c984d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a2c984d\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-ef5dc44\" data-id=\"ef5dc44\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1ac0263 elementor-flip-box--direction-left elementor-flip-box--effect-flip elementor-widget elementor-widget-global elementor-global-2901 elementor-widget-flip-box\" data-id=\"1ac0263\" data-element_type=\"widget\" data-widget_type=\"flip-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-flip-box\" tabindex=\"0\">\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__front\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__image\">\n\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/blogs.dlapiper.com\/advocatus\/files\/2021\/10\/Nevtelen-terv-29.png\" title=\"\" alt=\"\" loading=\"lazy\" \/>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\t\tPapp G\u00e1bor*\t\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\t\tLife Sciences csoport t\u00e1rsvezet\u0151je\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__back\">\n\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\t Papp G\u00e1bor\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\tPapp G\u00e1bor 2011 \u00f3ta dolgozik \u00fcgyv\u00e9dk\u00e9nt. 2014-ben csatlakozott az iroda t\u00e1rsas\u00e1gi jogi \u00e9s M&amp;A csoportj\u00e1hoz vezet\u0151 \u00fcgyv\u00e9dk\u00e9nt. Szakmai tev\u00e9kenys\u00e9ge kiterjed t\u00e1rsas\u00e1gi jogi \u00fcgyekre, M&amp;A tranzakci\u00f3kra, compliance \u00fcgyekre, gy\u00f3gyszerjogra, munkajogra, k\u00f6zigazgat\u00e1si jogra, illetve kodifik\u00e1ci\u00f3s\/szab\u00e1lyoz\u00e1si k\u00e9rd\u00e9sekre is. \t\t\t\t\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-flip-box__button elementor-button elementor-size-xs\" href=\"mailto:gabor.papp@dlapiper.com\">\n\t\t\t\t\t\t\tE-mailt k\u00fcld\u00f6k\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-ed5b134\" data-id=\"ed5b134\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Az Orsz\u00e1gos Gy\u00f3gyszer\u00e9szeti \u00e9s \u00c9lelmez\u00e9s-eg\u00e9szs\u00e9g\u00fcgyi Int\u00e9zet (OGY\u00c9I) \u00f6sszefoglal\u00f3t tett k\u00f6zz\u00e9 a biztons\u00e1gos \u00e9s gazdas\u00e1gos gy\u00f3gyszer- \u00e9s gy\u00f3gy\u00e1szati seg\u00e9deszk\u00f6z ell\u00e1t\u00e1s, valamint a gy\u00f3gyszerforgalmaz\u00e1s \u00e1ltal\u00e1nos szab\u00e1lyair\u00f3l sz\u00f3l\u00f3 t\u00f6rv\u00e9ny legfrissebb m\u00f3dos\u00edt\u00e1sair\u00f3l. A v\u00e1ltoz\u00e1sokat \u00e9s az ehhez kapcsol\u00f3d\u00f3 OGY\u00c9I \u00e9rtelmez\u00e9st a DLA Piper \u00fcgyv\u00e9di iroda szak\u00e9rt\u0151i \u00f6sszegezt\u00e9k.<\/p>\n","protected":false},"author":1,"featured_media":2692,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","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":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","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":"","background-image":"","background-repeat":"repeat","background-position":"center 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