{"id":14501,"date":"2023-05-02T05:40:26","date_gmt":"2023-05-02T05:40:26","guid":{"rendered":"https:\/\/staging.registrarcorp.com\/drugs\/"},"modified":"2025-12-16T18:01:47","modified_gmt":"2025-12-16T18:01:47","slug":"drugs","status":"publish","type":"page","link":"https:\/\/dev.registrarcorp.com\/de\/industries\/drugs\/","title":{"rendered":"Medikamente"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743673117657{background-color: #ffffff !important;}&#8221; el_class=&#8221;pt-resp-topmost-section p-resp-section&#8221;][vc_row el_class=&#8221;hero-section d-block d-lg-flex max-breakpoint-md mb-mobile-48&#8243; css=&#8221;.vc_custom_1743774729943{margin-bottom: 96px !important;}&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;mb-mobile-48 mb-up-md-64&#8243;][vc_column_text css=&#8221;.vc_custom_1743675077415{margin-bottom: 48px !important;}&#8221; el_class=&#8221;rc-heading-m-resp mb-mobile-32&#8243;]\n<h1 class=\"text-neutral-900\">Einhaltung der Arzneimittel <span class=\"text-primary-500\">\u2028schnell und einfach<\/span><\/h1>\n[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743683569114{margin-bottom: 48px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;25&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-neutral-700 m-width-desktop-580 mb-mobile-32&#8243;]Die US-amerikanische FDA-Compliance l\u00e4sst keinen Spielraum f\u00fcr Fehler. Registrar Corp ist der vertrauensw\u00fcrdige Partner, der Arzneimittelherstellern, Vertriebsh\u00e4ndlern, API-\/Hilfsstofflieferanten und OTC-Marken hilft, die Compliance zu gew\u00e4hrleisten und einen reibungslosen Markteintritt nach der Zulassung zu gew\u00e4hrleisten.[\/vc_column_text][vc_btn title=&#8221;Bei der FDA registrieren&#8221; color=&#8221;primary&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;.vc_custom_1743775782958{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fde%2Fservices%2Ffda-registration%2Fdrugs%2F|&#8221; el_class=&#8221;rc-button-l-resp&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_video link=&#8221;https:\/\/www.youtube.com\/watch?v=L_7cdADyLY8&#8243; css=&#8221;.vc_custom_1751625450583{margin-bottom: 0px !important;}&#8221; el_class=&#8221;m-width-desktop-560 ms-xl-auto&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=&#8221;.vc_custom_1743683630763{margin-bottom: 32px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller fw-bolder text-center text-primary-700 m-width-desktop-950 mx-auto&#8221;]\n<h3>F\u00fchrende Arzneimittelunternehmen vertrauen der Registrar Corp.<\/h3>\n[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743683634968{margin-bottom: 64px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;25&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-neutral-700 mb-mobile-32 m-width-desktop-950 mx-auto&#8221;]Mit mehr als 20 Jahren Erfahrung haben wir mehr als 3.000 Arzneimittelunternehmen geholfen, die FDA-Compliance beim ersten Mal mit fachkundiger Unterst\u00fctzung richtig zu erreichen.[\/vc_column_text]<div class=\"mpc-carousel__wrapper mpc-waypoint\"><div id=\"mpc_carousel_image-856a29af8db7576\" class=\"mpc-carousel-image mpc-init mpc-layout--classic mpc-effect--none brand-carousel\"  data-mpcslick='{\"infinite\":true,\"autoplay\":true,\"slidesToShow\":8,\"slidesToScroll\":1,\"centerMode\":false,\"initialSlide\":0,\"autoplaySpeed\":700,\"speed\":1000}' data-slick-cols=\"8\"><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Amway-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Amway\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Amway-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Amway.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dsm-firmenich-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-dsm-firmenich\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dsm-firmenich-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dsm-firmenich.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dow-corning-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-dow-corning\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dow-corning-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dow-corning.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-DolceGabanna-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-DolceGabanna\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-DolceGabanna-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-DolceGabanna.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Cargill-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Cargill\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Cargill-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Cargill.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Ecolabs-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Ecolabs\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Ecolabs-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Ecolabs.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-gattefosse-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-gattefosse\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-gattefosse-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-gattefosse.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Dior-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Dior\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Dior-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Dior.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Walmart-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Walmart\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Walmart-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Walmart.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-MakeUpForever-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-MakeUpForever\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-MakeUpForever-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-MakeUpForever.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Fresnenius-Kabi-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"Icon Fresnenius Kabi\" title=\"logo-grey-Fresnenius-Kabi\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Fresnenius-Kabi-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Fresnenius-Kabi.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-AirLiquide-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-AirLiquide\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-AirLiquide-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-AirLiquide.webp 420w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><\/div><div class=\"mpc-navigation mpc-init mpc-align--left mpc-navigation--style_1  mpc-nav-preset--\" data-mpcslider=\"mpc_carousel_image-856a29af8db7576\"><div class=\"mpc-nav__arrow mpcslick-prev\"><div class=\"mpc-nav__icon mpc-transition\"><i class=\"\"><div class=\"mpc-nav__background mpc-transition mpc-effect-type--fade mpc-effect-side--in\"><\/div><\/i><\/div><\/div><div class=\"mpc-nav__arrow mpcslick-next\"><div class=\"mpc-nav__icon mpc-transition\"><i class=\"\"><div class=\"mpc-nav__background mpc-transition mpc-effect-type--fade mpc-effect-side--in\"><\/div><\/i><\/div><\/div><\/div><\/div>[\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743688713173{background-color: #EEF6FB !important;}&#8221; el_class=&#8221;p-resp-section&#8221;][vc_row][vc_column width=&#8221;1\/3&#8243; el_class=&#8221;mb-mobile-32&#8243;][vc_single_image image=&#8221;53721&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; css=&#8221;.vc_custom_1748606849501{margin-bottom: 0px !important;}&#8221;][\/vc_column][vc_column width=&#8221;2\/3&#8243;][vc_column_text css=&#8221;.vc_custom_1744049158172{margin-bottom: 48px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller fw-bolder text-center text-md-start text-primary-700 m-width-desktop-720 mx-auto mb-mobile-32&#8243;]\n<h2><span data-teams=\"true\">Ihr Arzneimittel ist bereit, aber k\u00f6nnen Sie es verkaufen?<\/span><\/h2>\n[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743701004429{margin-bottom: 0px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-primary-700 m-width-desktop-720 mx-auto&#8221;]Ihr Medikament kann von der FDA zugelassen werden, aber wenn Ihre Compliance-Infrastruktur nicht zugelassen ist, gehen Sie nirgendwo hin. Hinter jedem zugelassenen Produkt liegt eine komplexe Kette von Einreichungen, Auflistungen und Freigaben, die synchronisiert sein m\u00fcssen, bevor Sie versenden k\u00f6nnen. Ein verpasster Schritt, und Sie sehen sich mit Grenzsperren, Ablehnungen oder kostspieligen Verz\u00f6gerungen konfrontiert. Im heutigen Markt geht es beim Erfolg nicht nur darum, eine Genehmigung zu erhalten, sondern auch darum, wirklich startbereit zu sein.[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743688792068{background-color: #FFFFFF !important;}&#8221; el_class=&#8221;p-resp-section&#8221;][vc_row el_class=&#8221;mb-mobile-32&#8243; css=&#8221;.vc_custom_1743688084694{margin-bottom: 96px !important;}&#8221;][vc_column][vc_column_text css=&#8221;.vc_custom_1744049530589{margin-bottom: 0px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller text-center text-primary-700&#8243;]\n<h2>Strenge FDA-Anforderungen leicht gemacht<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=&#8221;requirement-columns&#8221;][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;FDA-Registrierungsanforderungen&#8221; style=&#8221;flat&#8221; css=&#8221;.vc_custom_1743776491385{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell requirement-columns__header&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fde%2Fservices%2Ffda-registration%2Fdrugs%2F|&#8221;][vc_column_text css=&#8221;.vc_custom_1744101867070{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Besorgen Sie sich eine DUNS-Nummer f\u00fcr die Registrierung der Einrichtung. Stellen Sie sicher, dass die DUNS-Daten aktuell sind, wenn Sie bereits eine Nummer haben.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101880675{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Registrieren Sie Ihre Einrichtung und halten Sie die Informationen auf dem neuesten Stand.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101910195{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Beantragen Sie einen Etikettiercode und listen Sie Ihre Produkte auf.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101942094{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Benennen Sie einen US-Vertreter, wenn Ihre Einrichtung au\u00dferhalb der USA ans\u00e4ssig ist.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101966335{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]F\u00fcllen Sie die GDUFA-Selbstidentifizierung aus, wenn dies durch die Anforderungen an Generika erforderlich ist.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101979888{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]GDUFA- und OMUFA-Geb\u00fchren vor F\u00e4lligkeitsterminen bezahlen, falls f\u00fcr Sie zutreffend.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Anforderungen an die Arzneimittelliste&#8221; style=&#8221;flat&#8221; css=&#8221;.vc_custom_1743762911659{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell requirement-columns__header&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fde%2Findustries%2Fdrugs%2Fservices%2Fproduct-listings%2F|&#8221;][vc_column_text css=&#8221;.vc_custom_1743687267225{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]F\u00fchren Sie alle Arzneimittelprodukte vor der Vermarktung bei der FDA auf.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687275859{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Reservieren Sie einen National Drug Code (NDC) f\u00fcr neue Produkte.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687284889{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Aktualisieren oder reaktivieren Sie Listen, wenn sich Formulierungen oder Details \u00e4ndern.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687299066{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Produkte, die nicht mehr vermarktet werden, aufheben.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687310871{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Melden Sie die Arzneimittelmengen j\u00e4hrlich gem\u00e4\u00df dem CARES Act.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687379427{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Stellen Sie jedes Jahr Listen neu fest, um die Compliance zu gew\u00e4hrleisten.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Anforderungen an Kennzeichnung und Zertifizierung&#8221; style=&#8221;flat&#8221; css=&#8221;.vc_custom_1743768208579{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell requirement-columns__header&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fde%2Fservices%2Flabel-ingredients-review%2F%23druglabel|&#8221;][vc_column_text css=&#8221;.vc_custom_1743688103633{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Stellen Sie sicher, dass die Etiketten korrekt, ausgewogen und nicht irref\u00fchrend sind.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688112341{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Reichen Sie Etiketten im Format der strukturierten Produktkennzeichnung (SPL) der FDA ein.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688119728{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Befolgen Sie das erforderliche Format des Drug Facts Panels f\u00fcr OTC-Medikamente.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688126628{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Einheitlichkeit \u00fcber alle Etikettenkomponenten (PI, PIL, \u2028CDS usw.).[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688136191{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Notwendige Warnungen und Sicherheitsinformationen einf\u00fcgen.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688149821{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Aktualisieren Sie die Etiketten umgehend f\u00fcr Sicherheits\u00e4nderungen.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Import- und Marktzugangsanforderungen&#8221; style=&#8221;flat&#8221; css=&#8221;.vc_custom_1743769043016{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell requirement-columns__header&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fde%2Fservices%2Fimport-alerts-dwpe%2F|&#8221;][vc_column_text css=&#8221;.vc_custom_1743688161737{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Registrieren Sie Ihre Einrichtung vor dem Import bei der FDA.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688171498{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]L\u00f6sen Sie Importwarnungen und -sperren umgehend auf.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688179347{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Stellen Sie sicher, dass OTC-Medikamente den Monographiestandards entsprechen.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688188003{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Jahresaussch\u00fcttung nach dem CARES Act melden.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744809232144{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Statuslizenzen f\u00fcr 3PL\/WDD-Operationen melden.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Einreichung der globalen Masterdatei&#8221; style=&#8221;flat&#8221; css=&#8221;.vc_custom_1743769068466{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell requirement-columns__header&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fde%2Fservices%2Fmaster-files%2F%23dmf|&#8221;][vc_column_text css=&#8221;.vc_custom_1743688222175{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Reichen Sie Master-Dateien im eCTD-Format ein, wie von der FDA und globalen Beh\u00f6rden gefordert.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688231243{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Halten Sie Dateien mit Updates, \u00c4nderungen und Jahresberichten auf dem neuesten Stand.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688239829{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Stellen Sie sicher, dass korrekte Letters of Authorization (LOAs) f\u00fcr Referenzantr\u00e4ge eingereicht werden.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688248252{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Schlie\u00dfen oder \u00fcbertragen Sie Dateien ordnungsgem\u00e4\u00df, um die regulatorische Ausrichtung aufrechtzuerhalten.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688276101{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Speichern und verfolgen Sie Einreichungen sicher mit Versionskontrolle.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688289474{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Rechtzeitige Beantwortung von Anfragen und M\u00e4ngeln der Beh\u00f6rde.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688305436{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Anpassung an Formatierungs- und technische Standards f\u00fcr jede Beh\u00f6rde (FDA, EMA, TGA usw.).[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688318328{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Aktualisieren Sie vorhandene Master-Dateien auf das eCTD 4.0-Format.[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=&#8221;mb-mobile-32&#8243; css=&#8221;.vc_custom_1743774037185{margin-bottom: 64px !important;}&#8221;][vc_column][vc_separator css=&#8221;.vc_custom_1743686255954{margin-top: 96px !important;margin-bottom: 96px !important;}&#8221; el_class=&#8221;my-mobile-32&#8243;][vc_column_text css=&#8221;.vc_custom_1743774018694{margin-bottom: 0px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller text-center text-primary-700&#8243;]\n<h2>Online-Schulung zur Arzneimittel-Compliance nach Belieben<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; el_class=&#8221;m-width-desktop-950 mx-auto&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;mb-mobile-32&#8243;][vc_single_image image=&#8221;53730&#8243; img_size=&#8221;large&#8221; alignment=&#8221;center&#8221; css=&#8221;.vc_custom_1748606902182{margin-bottom: 0px !important;}&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;.vc_custom_1743776824922{margin-bottom: 48px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-primary-700 mb-mobile-32&#8243;]Erzielen Sie mit unserer Online-Compliance-Schulung Spitzenleistungen in regulatorischen Standards.<\/p>\n<p>Schlie\u00dfen Sie sich mehr als 30.000 Fachleuten an, die ihre Schulungszertifikate durch unsere erstklassigen Kurse erhalten haben, die von erstklassigen Ausbildern vermittelt werden. Expertenwissen, das jederzeit und \u00fcberall zug\u00e4nglich ist.[\/vc_column_text][vc_btn title=&#8221;Trainings entdecken&#8221; color=&#8221;primary&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;.vc_custom_1743769382746{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fde%2Fcompliance-training%2Fdrugs%2F|&#8221; el_class=&#8221;rc-button-l-resp&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743717130756{background-color: #001C3A !important;}&#8221; el_class=&#8221;p-resp-section blue-gradient-section&#8211;color-bars&#8221;][vc_row content_placement=&#8221;middle&#8221; el_class=&#8221;text-neutral-000&#8243;][vc_column el_class=&#8221;m-width-desktop-1100 mx-auto&#8221;][vc_column_text css=&#8221;.vc_custom_1743699555749{margin-bottom: 48px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller text-center mb-mobile-32&#8243;]\n<h2>FDA-Anforderungen sind komplex, aber wir machen die Compliance einfach.<\/h2>\n[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743700270715{margin-bottom: 48px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp mb-mobile-32&#8243;]<span class=\"text-neutral-000 fw-bold\">Die Navigation durch Arzneimittelvorschriften muss nicht \u00fcberw\u00e4ltigend sein. Mit den richtigen Experten an Ihrer Seite k\u00f6nnen Sie Genauigkeit gew\u00e4hrleisten, Verz\u00f6gerungen vermeiden und die Compliance einhalten. Lassen Sie Registrar Corp Ihre FDA-Compliance-Anforderungen erf\u00fcllen.<\/span>[\/vc_column_text][vc_btn title=&#8221;Werden Sie noch heute konform&#8221; color=&#8221;primary&#8221; align=&#8221;center&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;.vc_custom_1743700512574{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fde%2Fcontact%2F|&#8221; el_class=&#8221;rc-button-l-resp rc-button&#8211;white&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743757252002{background-color: #FFFFFF !important;}&#8221; el_class=&#8221;p-resp-section&#8221;][vc_row el_class=&#8221;mb-mobile-32&#8243; css=&#8221;.vc_custom_1743688084694{margin-bottom: 96px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1743760299430{margin-bottom: 0px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1743760265671{margin-bottom: 0px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller text-center text-primary-700&#8243;]\n<h2>Bleiben Sie auf dem Laufenden<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=&#8221;mb-mobile-64&#8243; css=&#8221;.vc_custom_1743774520211{margin-bottom: 96px !important;}&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;mb-mobile-32&#8243;][vc_single_image image=&#8221;51603&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; onclick=&#8221;custom_link&#8221; css=&#8221;.vc_custom_1744043759623{margin-bottom: 0px !important;}&#8221; el_class=&#8221;image-link&#8221; link=&#8221;https:\/\/dev.registrarcorp.com\/de\/blog\/drugs-de\/drug-master-files-de\/submitting-amfs-to-the-uk-mhra\/&#8221;][vc_column_text css=&#8221;.vc_custom_1744043628251{margin-bottom: 0px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;image-link__overlay image-link__overlay&#8221;]Einreichung von ASMFs bei UK Medicines \u2028<br class=\"d-none d-md-block\" \/>und Zulassungsbeh\u00f6rde f\u00fcr Gesundheitsprodukte[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;.vc_custom_1743757738017{margin-bottom: 32px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;tiny text-primary-700&#8243;]\n<h3>Blogs<\/h3>\n[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743757780417{margin-bottom: 32px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-primary-700&#8243;]In unserem Blog finden Sie die neuesten Erkenntnisse zu FDA-Vorschriften, globalen Compliance-Updates, Expertentipps und mehr.[\/vc_column_text][vc_btn title=&#8221;Alle anzeigen&#8221; color=&#8221;primary&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;.vc_custom_1765888988322{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:%2Fde%2Fblog%2Fdrugs%2F&#8221; el_class=&#8221;rc-button-l-resp rc-button&#8211;blue-outline&#8221;][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;mb-mobile-32&#8243;][vc_single_image image=&#8221;51164&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; onclick=&#8221;custom_link&#8221; css=&#8221;.vc_custom_1765908100761{margin-bottom: 0px !important;}&#8221; el_class=&#8221;image-link&#8221; link=&#8221;\/de\/resources\/on-demand-webinars\/&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;.vc_custom_1743757984336{margin-bottom: 32px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;tiny text-primary-700&#8243;]\n<h3>Webinare<\/h3>\n[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743757994222{margin-bottom: 32px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-primary-700&#8243;]In unseren von Experten geleiteten Webinaren finden Sie die neuesten Updates zu FDA-Vorschriften, internationaler Compliance und sich entwickelnden Industriestandards.[\/vc_column_text][vc_btn title=&#8221;Alle anzeigen&#8221; color=&#8221;primary&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;.vc_custom_1765889008392{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:%2Fde%2Fresources%2Fon-demand-webinars%2F&#8221; el_class=&#8221;rc-button-l-resp rc-button&#8211;blue-outline&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743717481112{background-color: #EEF6FB !important;}&#8221; el_class=&#8221;p-resp-section faq-accordion-section&#8221;][vc_row][vc_column][vc_column_text css=&#8221;.vc_custom_1743717888148{margin-bottom: 64px !important;}&#8221; el_class=&#8221;rc-heading-s-resp text-center text-primary-700 mb-mobile-32&#8243;]\n<h2>H\u00e4ufig gestellte Fragen zur FDA-Arzneimittel-Compliance<\/h2>\n[\/vc_column_text][vc_tta_accordion section_title_tag=&#8221;h2&#8243; c_icon=&#8221;chevron&#8221; active_section=&#8221;1&#8243; no_fill=&#8221;true&#8221; collapsible_all=&#8221;true&#8221; el_class=&#8221;rc-body-paragraph-m-resp text-primary-700&#8243;][vc_tta_section title=&#8221;Wer muss sich f\u00fcr Arzneimittelinstitutionen registrieren?&#8221; tab_id=&#8221;who-must-register&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243; grad_text_color1=&#8221;#003873&#8243;]Inl\u00e4ndische oder ausl\u00e4ndische Eigent\u00fcmer oder Betreiber von Einrichtungen, die ein Arzneimittel\u00a0 herstellen, vermehren, oder verarbeiten und nicht als ausgenommen gelten, m\u00fcssen ihre Einrichtung gem\u00e4\u00df <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-207\/subpart-B\/section-207.17\" target=\"_blank\" rel=\"noopener\">dem Code of Federal Regulations bei der FDA registrieren<\/a>. Im Allgemeinen umfassen Ausnahmen Apotheken, fachlich zugelassene \u00c4rzte, Forscher, Lehrer, Analysten und Vertriebsh\u00e4ndler.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Welche Informationen sind f\u00fcr die Registrierung der Arzneimitteleinrichtung erforderlich?&#8221; tab_id=&#8221;what-information-is-required&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Zu den Informationen, die Sie im Rahmen Ihrer FDA-Einrichtungsregistrierung mit Ihrer SPL-Datei (Structured Product Labeling) einreichen m\u00fcssen, geh\u00f6ren:<\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Firmenname und vollst\u00e4ndige Adresse jeder Einrichtung<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Name, Adresse, Telefonnummer und E-Mail-Adresse des offiziellen Kontakts<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Art der Operation(en), die in jeder Einrichtung durchgef\u00fchrt werden<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">DUNS-Nummer<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Einrichtungskennung der Einrichtung (wenn zugewiesen)<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><br \/>\n<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Nicht. US-Einrichtungen m\u00fcssen auch Folgendes umfassen:<\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Name des benannten US-Agenten<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Name jedes Importeurs, der der Einrichtung bekannt ist, Name jedes Vertreters, Maklers oder einer anderen juristischen Person, au\u00dfer einer Fluggesellschaft, die zur Erleichterung des Imports ihres Medikaments in die USA verwendet wird.<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">DUNS-Nummer, Telefonnummer und E-Mail-Adresse f\u00fcr jede Eingabe angeben.<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Siehe <\/span><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-207\/subpart-B\/section-207.25\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Titel 21 des Code of Federal Regulations<\/span><\/a><span data-contrast=\"auto\"> f\u00fcr eine vollst\u00e4ndige Liste.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Wer muss Arzneimittellisten bereitstellen?&#8221; tab_id=&#8221;who-must-provide-drug-listings&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Alle Arzneimittelinstitutionen, die nicht als ausgenommen gelten und sich bei der FDA registrieren m\u00fcssen, m\u00fcssen ebenfalls erste Auflistungsinformationen f\u00fcr alle Arzneimittel, die sich zum Zeitpunkt ihrer urspr\u00fcnglichen FDA-Einrichtungsregistrierung im kommerziellen Vertrieb befinden, gem\u00e4\u00df dem Code of Federal Regulations einreichen<\/span><span data-contrast=\"auto\">.<\/span><\/p>\n<p><span data-contrast=\"auto\">Im Allgemeinen umfassen die Ausnahmen Apotheken, fachlich zugelassene \u00c4rzte, Forscher, Lehrer, Analysten und Vertriebsh\u00e4ndler.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Welche Informationen werden f\u00fcr eine Arzneimittelliste eingereicht?&#8221; tab_id=&#8221;what-information-is-submitted&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Zu den Informationen, die Sie im Rahmen Ihrer FDA-Arzneimittelliste einreichen m\u00fcssen, geh\u00f6ren:<\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Name der Einrichtung(en), die das aufgef\u00fchrte Medikament herstellen oder verarbeiten, und die Art der durchgef\u00fchrten Operation(en)<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">DEA-Zeitplan<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Verabreichungsweg(e)<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Darreichungsform<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Inhaltsstoffe (aktiv mit St\u00e4rkemengen und inaktiv)<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Marketinginformationen (z. B. Kategorie, Start-\/Enddatum)<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Informationen im Zusammenhang mit dem Antrag (z. B. Art und Jahr der Zulassung) oder OTC-Monographie-Zitatnummer<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Packungsgr\u00f6\u00dfe und -Typ<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">NDC-Produktcode f\u00fcr ein Medikament das neu verpackt oder neu gekennzeichnet wird<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Unique Ingredient Identifiers (UNII) und andere Codes\u00e4tze<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Unterscheidungsmerkmale bestimmter gelisteter Arzneimittel<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Artwork-Etikettierung<\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Nummer des National Drug Code (NDC)<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:720,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><br \/>\n<\/span><\/li>\n<\/ul>\n<p>Weitere Informationen <span data-contrast=\"auto\">finden Sie <\/span><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-207\/subpart-D\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">im Code of Federal Regulations<\/span><\/a>. [\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Was ist eine Masterdatei?&#8221; tab_id=&#8221;what-is-a-master-file&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Eine <\/span><a href=\"https:\/\/www.registrarcorp.com\/master-files\/\"><span data-contrast=\"none\">Masterdatei<\/span><\/a><span data-contrast=\"auto\"> ist eine sichere, vertrauliche Einreichung von gesch\u00fctzten Produktdaten bei einer Aufsichtsbeh\u00f6rde, wie der US-amerikanischen Food and Drug Administration (FDA) oder der National Medical Products Association (NMPA) in China.<\/span>[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743716164337{background-color: #003873 !important;}&#8221; el_class=&#8221;p-resp-section p-resp-section&#8211;smaller blue-gradient-section&#8211;color-bars&#8221;][vc_row content_placement=&#8221;middle&#8221; el_class=&#8221;text-neutral-000&#8243;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;m-width-desktop-1100 mx-auto order-last order-md-first&#8221;][vc_column_text css=&#8221;.vc_custom_1743775092024{margin-bottom: 64px !important;}&#8221; el_class=&#8221;rc-heading-m-resp mb-mobile-32&#8243;]\n<h2>Besseres Medikament erreichen <br class=\"d-none d-xl-block\" \/>Compliance leicht<\/h2>\n[\/vc_column_text][vc_btn title=&#8221;Loslegen&#8221; color=&#8221;primary&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;.vc_custom_1743775801447{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fde%2Fservices%2Ffda-registration%2Fdrugs%2F|&#8221; el_class=&#8221;rc-button-l-resp rc-button&#8211;bg-white&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;order-first order-md-last mb-mobile-32&#8243;][vc_single_image image=&#8221;53739&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; css=&#8221;.vc_custom_1748606953543{margin-bottom: 0px !important;}&#8221;][\/vc_column][\/vc_row][\/vc_section]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743673117657{background-color: #ffffff !important;}&#8221; el_class=&#8221;pt-resp-topmost-section p-resp-section&#8221;][vc_row el_class=&#8221;hero-section d-block d-lg-flex max-breakpoint-md mb-mobile-48&#8243; css=&#8221;.vc_custom_1743774729943{margin-bottom: 96px !important;}&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;mb-mobile-48 mb-up-md-64&#8243;][vc_column_text css=&#8221;.vc_custom_1743675077415{margin-bottom: 48px !important;}&#8221; el_class=&#8221;rc-heading-m-resp mb-mobile-32&#8243;] Einhaltung der Arzneimittel \u2028schnell und einfach [\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743683569114{margin-bottom: 48px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;25&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-neutral-700 m-width-desktop-580 mb-mobile-32&#8243;]Die US-amerikanische FDA-Compliance l\u00e4sst keinen Spielraum f\u00fcr Fehler. Registrar Corp ist der vertrauensw\u00fcrdige Partner, der Arzneimittelherstellern,<\/p>\n","protected":false},"author":33,"featured_media":0,"parent":14840,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/page-sidebar-none.php","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"class_list":["post-14501","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.registrarcorp.com\/de\/wp-json\/wp\/v2\/pages\/14501","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.registrarcorp.com\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/dev.registrarcorp.com\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/dev.registrarcorp.com\/de\/wp-json\/wp\/v2\/users\/33"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.registrarcorp.com\/de\/wp-json\/wp\/v2\/comments?post=14501"}],"version-history":[{"count":0,"href":"https:\/\/dev.registrarcorp.com\/de\/wp-json\/wp\/v2\/pages\/14501\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/dev.registrarcorp.com\/de\/wp-json\/wp\/v2\/pages\/14840"}],"wp:attachment":[{"href":"https:\/\/dev.registrarcorp.com\/de\/wp-json\/wp\/v2\/media?parent=14501"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}