{"id":2104,"date":"2020-03-01T12:23:02","date_gmt":"2020-03-01T11:23:02","guid":{"rendered":"https:\/\/phrstaging.pharmaroad.hu\/?p=2104"},"modified":"2025-07-16T13:23:09","modified_gmt":"2025-07-16T12:23:09","slug":"a-stabilizacios-idoszak-masodk-fazisa","status":"publish","type":"post","link":"https:\/\/pharmaroad.hu\/en\/2020\/03\/01\/a-stabilizacios-idoszak-masodk-fazisa\/","title":{"rendered":"STABILIZ\u00c1CI\u00d3S ID\u0150SZAK M\u00c1SODIK F\u00c1ZISA"},"content":{"rendered":"<h3><strong>Szigorod\u00f3 felt\u00e9telek a gy\u00f3gyszer-nagykeresked\u0151k sz\u00e1m\u00e1ra<\/strong><\/h3>\n<h3><strong>2020.02.28. \/ Budapest, Magyarorsz\u00e1g<\/strong><\/h3>\n<p>A hamis\u00edtott gy\u00f3gyszerekr\u0151l sz\u00f3l\u00f3 2011\/62\/EU ir\u00e1nyelvvel \u00e9s az EU\/2016\/161 felhatalmaz\u00e1son alapul\u00f3 bizotts\u00e1gi rendelettel \u00f6sszhangban 2019.02.09-t\u0151l Magyarorsz\u00e1gon is jelent\u0151sen bonyol\u00f3dtak a lakoss\u00e1gi gy\u00f3gyszerell\u00e1t\u00e1sban r\u00e9szt vev\u0151 szem\u00e9lyeknek \u00e9s az ell\u00e1t\u00e1si l\u00e1nc k\u00fcl\u00f6nb\u00f6z\u0151 r\u00e9sztvev\u0151inek a feladatai.\u00a0 Ett\u0151l az id\u0151pontt\u00f3l elkezdve a v\u00e9nyk\u00f6teles gy\u00f3gyszereket egyedi azonos\u00edt\u00f3val (2D k\u00f3d) \u00e9s manipul\u00e1l\u00e1s elleni eszk\u00f6zzel (d\u00e9zsmaz\u00e1r) kell a gy\u00f3gyszergy\u00e1rt\u00f3knak ell\u00e1tni. Ezen fel\u00fcl bizonyos feladatok kapcs\u00e1n (gy\u00f3gyszerek expedi\u00e1l\u00e1sa, vissz\u00e1ru kezel\u00e9se, stb.), az ell\u00e1t\u00f3i l\u00e1nc k\u00fcl\u00f6nb\u00f6z\u0151 r\u00e9sztvev\u0151inek (gy\u00f3gyszer-nagykeresked\u0151k, k\u00f6zforgalm\u00fa- \u00e9s int\u00e9zm\u00e9nyi gy\u00f3gyszert\u00e1rak, stb.), a gy\u00f3gyszerek egyedi azonos\u00edt\u00f3j\u00e1t le kell olvasniuk az eredetis\u00e9g ellen\u0151rz\u00e9se, illetve az adatb\u00e1zisb\u00f3l val\u00f3 deaktiv\u00e1l\u00e1suk c\u00e9lj\u00e1b\u00f3l.<\/p>\n<p>Az eur\u00f3pai gy\u00f3gyszerazonos\u00edt\u00f3 rendszer teljesk\u00f6r\u0171 integr\u00e1l\u00e1sa sokr\u00e9sztvev\u0151s \u00e9s magas technikai h\u00e1tt\u00e9rt\u00e1mogat\u00e1st ig\u00e9nyl\u0151 kih\u00edv\u00e1snak bizonyult. Ebb\u0151l ad\u00f3d\u00f3an az EU sz\u00e1mos orsz\u00e1g\u00e1ban \u2019\u00e1tmeneti int\u00e9zked\u00e9sek\u2019 vagy \u2019stabiliz\u00e1ci\u00f3s id\u0151szakok\u2019 keretein bel\u00fcl ker\u00fclt bevezet\u00e9sre. A Magyarorsz\u00e1gon \u00e9rv\u00e9nyben l\u00e9v\u0151 stabiliz\u00e1ci\u00f3s id\u0151szak l\u00e9nyege, hogy (a) az adatt\u00e1rol\u00f3 rendszerb\u0151l \u00e9rkez\u0151 riaszt\u00e1sok ellen\u00e9re az \u00e9rintett gy\u00f3gyszerek m\u00e9g nem tekinthet\u0151k automatikusan hamis\u00edtottnak, (b) a technikai jelleg\u0171 hib\u00e1kb\u00f3l ered\u0151 jelz\u00e9sek bizonyos esetekben fel\u00fclb\u00edr\u00e1lhat\u00f3k \u00e9s (c) a gy\u00f3gyszerek ilyen esetekben betegell\u00e1t\u00e1s c\u00e9lj\u00e1ra felhaszn\u00e1lhat\u00f3k.\u00a0 A stabiliz\u00e1ci\u00f3s id\u0151szak bevezet\u00e9s\u00e9vel az OGY\u00c9I c\u00e9lja az volt, hogy biztos\u00edtsa a gy\u00f3gyszerell\u00e1t\u00e1s folyamatoss\u00e1g\u00e1t \u00e9s elegend\u0151 felk\u00e9sz\u00fcl\u00e9si id\u0151t adjon minden \u00e9rintettnek a szerializ\u00e1ci\u00f3b\u00f3l ered\u0151 k\u00f6telezetts\u00e9gek teljes\u00edt\u00e9s\u00e9re.<\/p>\n<p>A stabiliz\u00e1ci\u00f3s id\u0151szak fokozatos megsz\u00fcntet\u00e9se \u00e9rdek\u00e9ben az OGY\u00c9I 2020.02.28-t\u00f3l \u00faj elj\u00e1r\u00e1si szab\u00e1lyokat vezet be, melyek c\u00e9lja az \u00e9rv\u00e9nyes jogszab\u00e1lyok min\u00e9l gyorsabban megval\u00f3sul\u00f3 teljesk\u00f6r\u0171 implement\u00e1ci\u00f3ja.\u00a0 Az \u00faj elj\u00e1r\u00e1si rend r\u00e9szletesen tartalmazza a gy\u00f3gyszert\u00e1rak, gy\u00f3gyszer-nagykeresked\u0151k \u00e9s forgalombahozatali enged\u00e9ly jogosultak feladatait a gy\u00f3gyszerazonos\u00edt\u00f3 rendszerb\u0151l \u00e9rkez\u0151 riaszt\u00e1sok \/ hiba\u00fczenetek kapcs\u00e1n.\u00a0 Az \u00faj elj\u00e1r\u00e1si protokoll intenz\u00edvebb kommunik\u00e1ci\u00f3s k\u00f6vetelm\u00e9nyeket t\u00e1maszt a gy\u00f3gyszer-nagykeresked\u0151k fel\u00e9, amennyiben jelent\u0151sen kisz\u00e9les\u00edti azon riaszt\u00e1sok sk\u00e1l\u00e1j\u00e1t, melyek kapcs\u00e1n a nemzet\u00e1llami gy\u00f3gyszerhat\u00f3s\u00e1gokat mindenk\u00e9ppen t\u00e1j\u00e9koztatni kell.<\/p>\n<p>Az OGY\u00c9I hivatalos t\u00e1j\u00e9koztat\u00e1sa a hamis\u00edtott gy\u00f3gyszerekr\u0151l sz\u00f3l\u00f3 2011\/62\/EU ir\u00e1nyelv szerinti biztons\u00e1gi elemek alkalmaz\u00e1s\u00e1r\u00f3l \u00e9s a stabiliz\u00e1ci\u00f3s id\u0151szak elj\u00e1r\u00e1srendj\u00e9r\u0151l az al\u00e1bbi linkr\u0151l t\u00f6lthet\u0151 le:<\/p>\n<h3><span style=\"color: #00ccff;\"><strong><a style=\"color: #00ccff;\" href=\"https:\/\/www.ogyei.gov.hu\/tajekoztatas_a_hamisitott_gyogyszerekrol_szolo_201162eu_iranyelv__szerinti_biztonsagi_elemek_alkalmazasarol_es_a_stabilizacios_idoszak_eljarasrendjerol_ervenyes_2020_februar_28_tol_visszavonasig\" target=\"_blank\" rel=\"noopener noreferrer\">OGYEI K\u00d6ZLEM\u00c9NY<\/a><\/strong><\/span><\/h3>","protected":false},"excerpt":{"rendered":"<p>Szigorod\u00f3 felt\u00e9telek a gy\u00f3gyszer-nagykeresked\u0151k sz\u00e1m\u00e1ra 2020.02.28. \/ Budapest, Magyarorsz\u00e1g A hamis\u00edtott gy\u00f3gyszerekr\u0151l sz\u00f3l\u00f3 2011\/62\/EU ir\u00e1nyelvvel \u00e9s az EU\/2016\/161 felhatalmaz\u00e1son alapul\u00f3 bizotts\u00e1gi rendelettel \u00f6sszhangban 2019.02.09-t\u0151l Magyarorsz\u00e1gon is jelent\u0151sen bonyol\u00f3dtak a lakoss\u00e1gi gy\u00f3gyszerell\u00e1t\u00e1sban r\u00e9szt vev\u0151 szem\u00e9lyeknek \u00e9s az ell\u00e1t\u00e1si l\u00e1nc k\u00fcl\u00f6nb\u00f6z\u0151 r\u00e9sztvev\u0151inek a feladatai.\u00a0 Ett\u0151l az id\u0151pontt\u00f3l elkezdve a v\u00e9nyk\u00f6teles gy\u00f3gyszereket egyedi azonos\u00edt\u00f3val (2D k\u00f3d) \u00e9s manipul\u00e1l\u00e1sLeer M\u00e1s<\/p>","protected":false},"author":1,"featured_media":2105,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[92],"tags":[51,62],"class_list":["post-2104","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-szakmai-hirek","tag-gyogyszer","tag-gyogyszer-hamisitas"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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