{"id":3764,"date":"2022-08-02T09:30:47","date_gmt":"2022-08-02T01:30:47","guid":{"rendered":"https:\/\/regask.com\/?p=3764"},"modified":"2024-10-25T00:45:40","modified_gmt":"2024-10-24T16:45:40","slug":"compliance-prioritaten-australien-2022","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/australia-compliance-priorities-2022\/","title":{"rendered":"Australien: Import-, Werbe- und Lieferkonformit\u00e4tspr\u2026"},"content":{"rendered":"<p>Der <a href=\"https:\/\/www.tga.gov.au\/\" target=\"_blank\" rel=\"noopener\">TGA<\/a> hat eine Liste mit Priorit\u00e4ten f\u00fcr die Einhaltung der Import-, Werbe- und Liefervorschriften vom 1. Juli 2022 bis zum 30. Juni 2023 ver\u00f6ffentlicht:<\/p>\n<ol>\n<li>Verhinderung und Bek\u00e4mpfung des illegalen Imports, der Werbung und der Lieferung von <strong>nicht zugelassene therapeutische Produkte im Zusammenhang mit COVID-19.<\/strong><\/li>\n<li>Unterbinden und bek\u00e4mpfen Sie den illegalen Import, die Werbung und die Lieferung von <strong>Nikotin-Vaping-Produkte.<\/strong><\/li>\n<li>Gew\u00e4hrleistung der Einhaltung der Anforderungen des Therapeutic Goods Act 1989 im gesamten\u00a0<strong>medizinische Cannabisindustrie<\/strong><\/li>\n<li>Unterbinden und bek\u00e4mpfen Sie den illegalen Import, die Herstellung, die Werbung und die Lieferung von <strong>nicht zugelassene leistungs- und imagesteigernde therapeutische Produkte, einschlie\u00dflich Sporterg\u00e4nzungsmittel, <\/strong>mit einem Schwerpunkt auf Produkten, die Gifte der Listen 4 und 8 enthalten.<\/li>\n<li>Verhinderung und Bek\u00e4mpfung des illegalen Imports, der Werbung und der Lieferung von <strong>nicht zugelassene therapeutische Produkte, die in der Sch\u00f6nheits- und kosmetischen Zahnmedizin verwendet werden.<\/strong><\/li>\n<li>Adressieren Sie die\u00a0<strong>unrechtm\u00e4\u00dfige Verwendung eingeschr\u00e4nkter und verbotener Darstellungen\u00a0<\/strong>in nicht genehmigter oder zugelassener Werbung, insbesondere in solchen, die sich an besonders gef\u00e4hrdete Verbraucher richten<\/li>\n<li>Verhinderung und Bek\u00e4mpfung der unerlaubten Werbung f\u00fcr\u00a0<strong>nicht zugelassene therapeutische G\u00fcter auf E-Commerce-Plattformen;\u00a0<\/strong>darunter Produkte f\u00fcr die Schwangerschaft und Schwangerschaftsvorsorge, Produkte zur Gewichtsabnahme und Mittel gegen Kater.<\/li>\n<\/ol>\n<div class=\"MuiGrid-root jss1499 MuiGrid-item MuiGrid-grid-md-12\">\n<div class=\"jss1501\">\n<div class=\"jss1521\">\n<div class=\"jss409 jss434 summaryParagraph\">\n<p>In Bezug auf Punkt 4 schl\u00e4gt die TGA vor, sich auf den Import, die Herstellung, die Werbung, die Zusammensetzung und den Vertrieb nicht zugelassener Produkte zu konzentrieren. Dies soll durch Verbraucheraufkl\u00e4rung und gezielte Ma\u00dfnahmen gegen Online-Plattformen, die f\u00fcr nicht zugelassene Sporterg\u00e4nzungsmittel werben, erg\u00e4nzt werden.<\/p>\n<p>In Bezug auf Punkt 6 konzentriert sich die TGA auf rechtswidrige Werbung, die sich auf schwere Krankheiten oder Zust\u00e4nde bezieht, f\u00fcr die der Sponsor keine geeigneten Nachweise besitzt und die Indikation nicht in die\u00a0<span class=\"css-1f9ifu9\">Australien<\/span>n Register der therapeutischen G\u00fcter.<\/p>\n<p>In Bezug auf Punkt 7 hat die TGA festgestellt, dass nicht zugelassene Komplement\u00e4rmedizin \u00fcber Online-Plattformen beworben und verkauft wird und dass diese unzul\u00e4ssige Erfahrungsberichte und unbegr\u00fcndete Indikationen enth\u00e4lt. Die Compliance-Ma\u00dfnahmen umfassen die \u00dcberwachung nicht zugelassener therapeutischer Produkte, zugelassener therapeutischer Produkte mit unzul\u00e4ssigen Indikationen und Werbeaussagen sowie unzul\u00e4ssiger Erfahrungsberichte, die nicht dem Werbekodex f\u00fcr therapeutische Produkte entsprechen. Schwerpunkte sind Schwangerschaft, Schwangerschaftsvorsorge, Gewichtsabnahme und Katerkuren.<\/p>\n<p>Weitere Compliance-Schwerpunkte k\u00f6nnen im Laufe des Jahres hinzukommen. Diese Schwerpunkte erg\u00e4nzen die regul\u00e4ren TGA-Compliance-Programme f\u00fcr Komplement\u00e4rmedizin (Post-Market-Reviews), die \u00dcberwachung und \u00dcberwachung der Aufnahme von Medizinprodukten, die Pharmakovigilanz- und Good-Clinical-Practice-Inspektionsprogramme sowie das GMP-Compliance-Programm.<\/p>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<p><a href=\"https:\/\/regask.com\/de\/kontakt\/\">Kontaktieren Sie RegASK, um mehr \u00fcber die \u00c4nderungen der australischen Vorschriften zu erfahren.\u00a0<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/span>\n\t<\/a>\n\n<a href=\"http:\/\/www.tga.gov.au\/import-advertising-and-supply-compliance-priorities-2022-23\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1045530402\">\n\n\t<div id=\"col-401337836\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/de\/fallstudien\/ressourcen-fallstudien-pharma-biotech\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Pharma- und Biotech-Industrie<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"MuiGrid-root jss1499 MuiGrid-item MuiGrid-grid-xs-12\">\n<div class=\"jss1500\">\n<div class=\"jss409 jss417 dataText\"><\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>The TGA has published a list of import, advertising, and supply compliance priorities from I July 2022 to 30 June 2023: Deter and address the unlawful import, advertising, and supply of unapproved therapeutic goods associated with COVID-19. Disrupt and address the unlawful import, advertising, and supply of nicotine vaping products. Ensure compliance with the requirements&#8230;<\/p>","protected":false},"author":39,"featured_media":2487,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[511,35],"tags":[40],"class_list":["post-3764","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-australia-regulations","category-pharma-biotech-latest-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.7 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Australia: Import, Ads &amp; Supply Compliance Priorities 2022 | RegASK<\/title>\n<meta name=\"description\" content=\"Australia&#039;s TGA has published a list of import, advertising and supply compliance priorities from I July 2022 to 30 June 2023.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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