{"id":4054,"date":"2022-12-13T09:00:49","date_gmt":"2022-12-13T01:00:49","guid":{"rendered":"https:\/\/regask.com\/?p=4054"},"modified":"2024-09-27T10:30:28","modified_gmt":"2024-09-27T02:30:28","slug":"ctr-anderung-imp-kennzeichnung","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/ctr-amendment-imp-labeling\/","title":{"rendered":"EU: \u00c4nderung der Verordnung \u00fcber klinische Pr\u00fcfungen (Clinical Trials Regulation, CTR) o\u2026"},"content":{"rendered":"
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Die Europ\u00e4ische Kommission (EK)<\/a> Die Europ\u00e4ische Kommission hat die aktuellen Kennzeichnungsvorschriften der Verordnung \u00fcber klinische Pr\u00fcfungen (Clinical Trials Regulation, CTR) f\u00fcr Pr\u00fcfpr\u00e4parate (IMPs) hinsichtlich der Verfallsdaten mittels einer delegierten Verordnung \u00fcberarbeitet. Die Verordnung wurde nun im Amtsblatt der Europ\u00e4ischen Union ver\u00f6ffentlicht.<\/div>\n
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Die CTR gilt ab dem 31. Januar 2022. Damit einher geht eine Trennung der GMP-Anforderungen f\u00fcr IMPs von denen f\u00fcr zugelassene Arzneimittel. Bei noch nicht zugelassenen Produkten sind die Stabilit\u00e4ts- und Haltbarkeitsstudien h\u00e4ufig noch nicht abgeschlossen und im Laufe der Entwicklungsphase ergeben sich neue Informationen zum Verfallsdatum des IMPs. Dies f\u00fchrt dazu, dass bereits ausgelieferte und patientenindividuelle IMPs nachtr\u00e4glich mit dem neuen Verfallsdatum neu gekennzeichnet werden m\u00fcssen.<\/div>\n
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Die aktuellen Vorschriften schreiben eine Kennzeichnung sowohl auf der Innen- als auch auf der Au\u00dfenverpackung vor. Bei einer \u00c4nderung m\u00fcssen die Verpackungen daher auch ge\u00f6ffnet werden, um die Informationen auf der Innenverpackung zu aktualisieren. H\u00e4ufige Aktualisierungen des Verfallsdatums auf der Prim\u00e4rverpackung nicht zugelassener, in klinischen Studien verwendeter Arzneimittel k\u00f6nnen in bestimmten F\u00e4llen potenzielle Risiken f\u00fcr die Qualit\u00e4t und Sicherheit dieser Produkte bergen (z. B. durch die Notwendigkeit, die Verpackung zu \u00f6ffnen, wobei Sicherheitssiegel aufgebrochen und mehrschichtige Sets auseinandergenommen werden m\u00fcssen, oder durch l\u00e4ngere Licht- oder Temperatureinwirkung bei diesbez\u00fcglich empfindlichen Arzneimitteln).<\/div>\n
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Die EU-Kommission ist daher der Ansicht, dass es in bestimmten F\u00e4llen angesichts der Art und des Ausma\u00dfes des Risikos angemessen und verh\u00e4ltnism\u00e4\u00dfig ist, das Verfallsdatum auf der Prim\u00e4rverpackung wegzulassen. Um diese M\u00f6glichkeit in den CTR-Rechtsrahmen zu integrieren, hat die EU-Kommission mit der Delegierten Verordnung 2022\/2239 eine \u00c4nderung der CTR ver\u00f6ffentlicht.<\/div>\n<\/div>\n
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Kontaktieren Sie RegASK, um mehr \u00fcber regulatorische \u00c4nderungen in der EU 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\n\t\tKontaktieren Sie RegASK f\u00fcr weitere Details<\/span>\n\t<\/a>\n\n\n\t\tMehr lesen<\/span>\n\t<\/a>\n\n

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\n\t\t\t\n\t\t\t\n\n\t\tLesen 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
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Die Europ\u00e4ische Kommission (EK) hat die geltenden Kennzeichnungsvorschriften der Verordnung \u00fcber klinische Pr\u00fcfungen (CTR) f\u00fcr Pr\u00fcfpr\u00e4parate (IMPs) hinsichtlich des Verfallsdatums mittels einer delegierten Verordnung \u00fcberarbeitet. Die Verordnung wurde nun im Amtsblatt der Europ\u00e4ischen Union ver\u00f6ffentlicht. Die CTR gilt ab dem 31. Januar 2022.<\/p>","protected":false},"author":39,"featured_media":4047,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35],"tags":[40],"class_list":["post-4054","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","tag-latest-insights"],"acf":[],"yoast_head":"\nEU Clinical Trials Regulation: IMP Labeling Update | RegASK<\/title>\n<meta name=\"description\" content=\"The EU Clinical Trials Regulation (CTR) has amended current labelling requirements regarding investigational medicinal products (IMP).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/de\/ctr-anderung-imp-kennzeichnung\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: Amendment to the Clinical Trials Regulation (CTR) on Investigational Medicinal Products (IMPs) Labelling\" \/>\n<meta property=\"og:description\" content=\"The EU Clinical Trials Regulation (CTR) has amended current labelling requirements regarding investigational medicinal products (IMP).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/ctr-anderung-imp-kennzeichnung\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-12-13T01:00:49+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-09-27T02:30:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png\" 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