{"id":3206,"date":"2025-01-31T10:27:39","date_gmt":"2025-01-31T09:27:39","guid":{"rendered":"https:\/\/bktlegal.com\/?p=3206"},"modified":"2025-03-24T09:13:18","modified_gmt":"2025-03-24T08:13:18","slug":"chinas-verordnung-zum-sicherheitsmanagement-von-netzwerkdaten-konkretisierte-datenschutz-und-sicherheitspflichten-2-4-5","status":"publish","type":"post","link":"https:\/\/bktlegal.com\/index.php\/2025\/01\/31\/chinas-verordnung-zum-sicherheitsmanagement-von-netzwerkdaten-konkretisierte-datenschutz-und-sicherheitspflichten-2-4-5\/","title":{"rendered":"Regelungen f\u00fcr Verantwortliche Personen im Arzneimittelsektor"},"content":{"rendered":"\n
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Artikel von Rainer Burkardt & Ondrej Zapletal in der Fachzeitschrift Arzneimittel & Recht<\/h3><\/div>\n\n\n\n

Am 13. November 2024 hat die Nationale Arzneimittelbeh\u00f6rde Chinas (National Medical Products Administration \u201eNMPA\u201c) die vorl\u00e4ufigen<\/em> Bestimmungen zur Verwaltung der Benennung einer inl\u00e4ndischen verantwortlichen Person durch ausl\u00e4ndische Inhaber von Arzneimittelzulassungen<\/em> (\u201eBestimmungen\u201c) ver\u00f6ffentlicht.<\/p>\n\n\n\n

Die Bestimmungen betreffen alle ausl\u00e4ndischen Inhaber von Arzneimittelzulassungen (Foreign Drug Market Authorization Holders<\/em> \u201eMAHs\u201c), deren Arzneimittel auf dem chinesischen Markt verkauft werden.<\/p>\n\n\n\n

Die Bestimmungen, die vier Jahre nach der Ver\u00f6ffentlichung des ersten Entwurfs erlassen wurden, legen konkrete Regelungen zum Verfahren zur Ernennung sowie die erforderlichen Qualifikationen und Verpflichtungen der verantwortlichen Person fest und sehen gesamtschuldnerische Haftung des MAH und der verantwortlichen Person vor.<\/p>\n\n\n\n

Die Bestimmungen treten am 1. Juli 2025 in Kraft und gew\u00e4hren den ausl\u00e4ndischen Pharmaunternehmen mit dem Datum der Ver\u00f6ffentlichung eine achtmonatige Frist zur Umsetzung.<\/p>\n\n\n\n

Mehr Informationen zu den Bestimmungen, inklusive Pflichten und Haftungsrisiken des MAH und der verantwortlichen Person, finden Sie in unserem Artikel, den Sie \u00fcber den nachstehenden Button \u201cZum Artikel\u201c abrufen k\u00f6nnen.<\/p>\n\n\n\n

Sollten Sie zu den Bestimmungen oder anderen Themen mit China-Bezug Fragen haben, so z\u00f6gern Sie nicht, uns jederzeit per E-Mail unter info@bktlegal.com<\/a> zu kontaktieren!<\/p>\n\n\n\n

Ihr Burkardt & Partner Team<\/strong><\/p>\n\n\n\n

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ZUM ARTIKEL<\/div><\/a><\/div><\/div>\n<\/div><\/div>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

Am 13. November 2024 hat die Nationale Arzneimittelbeh\u00f6rde Chinas (National Medical Products Administration \u201eNMPA\u201c) die\u00a0vorl\u00e4ufigen\u00a0Bestimmungen zur Verwaltung der Benennung einer inl\u00e4ndischen verantwortlichen Person durch ausl\u00e4ndische Inhaber von Arzneimittelzulassungen\u00a0(\u201eBestimmungen\u201c) ver\u00f6ffentlicht.<\/p>\n","protected":false},"author":1,"featured_media":3207,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","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":"","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-4)","background-image":"","background-repeat":"repeat","background-position":"center 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