{"id":14378,"date":"2023-05-02T05:40:26","date_gmt":"2023-05-02T05:40:26","guid":{"rendered":"https:\/\/staging.registrarcorp.com\/drugs\/"},"modified":"2025-12-16T18:04:09","modified_gmt":"2025-12-16T18:04:09","slug":"drugs","status":"publish","type":"page","link":"https:\/\/staging.registrarcorp.com\/fr\/industries\/drugs\/","title":{"rendered":"Produits pharmaceutiques"},"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\">Observance du m\u00e9dicament effectu\u00e9e <span class=\"text-primary-500\">\u2028rapide et facile<\/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;]La conformit\u00e9 \u00e0 la FDA des \u00c9tats-Unis ne laisse aucune place aux erreurs. Registrar Corp est un partenaire de confiance qui aide les fabricants de m\u00e9dicaments, les distributeurs, les fournisseurs d&#8217;API\/d&#8217;excipients et les marques de produits en vente libre \u00e0 maintenir la conformit\u00e9 et \u00e0 assurer une entr\u00e9e sur le march\u00e9 sans heurts apr\u00e8s l&#8217;approbation.[\/vc_column_text][vc_btn title=&#8221;S\u2019inscrire aupr\u00e8s de la FDA&#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%2Fstaging.registrarcorp.com%2Ffr%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>Les plus grandes soci\u00e9t\u00e9s pharmaceutiques font confiance \u00e0 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;]Avec plus de 20 ans d\u2019expertise, nous avons aid\u00e9 plus de 3 000 soci\u00e9t\u00e9s pharmaceutiques \u00e0 garantir la conformit\u00e9 \u00e0 la FDA d\u00e8s la premi\u00e8re fois avec l\u2019aide d\u2019experts.[\/vc_column_text]<div class=\"mpc-carousel__wrapper mpc-waypoint\"><div id=\"mpc_carousel_image-446a6c969cb94a4\" 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:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Amway-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Amway\" srcset=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Amway-300x94.webp 300w, https:\/\/staging.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:\/\/staging.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:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dsm-firmenich-300x94.webp 300w, https:\/\/staging.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:\/\/staging.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:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dow-corning-300x94.webp 300w, https:\/\/staging.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:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-DolceGabanna-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-DolceGabanna\" srcset=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-DolceGabanna-300x94.webp 300w, https:\/\/staging.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:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Cargill-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Cargill\" srcset=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Cargill-300x94.webp 300w, https:\/\/staging.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:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Ecolabs-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Ecolabs\" srcset=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Ecolabs-300x94.webp 300w, https:\/\/staging.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:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-gattefosse-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-gattefosse\" srcset=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-gattefosse-300x94.webp 300w, https:\/\/staging.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:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Dior-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Dior\" srcset=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Dior-300x94.webp 300w, https:\/\/staging.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:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Walmart-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Walmart\" srcset=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Walmart-300x94.webp 300w, https:\/\/staging.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:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-MakeUpForever-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-MakeUpForever\" srcset=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-MakeUpForever-300x94.webp 300w, https:\/\/staging.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:\/\/staging.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:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Fresnenius-Kabi-300x94.webp 300w, https:\/\/staging.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:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-AirLiquide-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-AirLiquide\" srcset=\"https:\/\/staging.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-AirLiquide-300x94.webp 300w, https:\/\/staging.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-446a6c969cb94a4\"><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;53720&#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\">Votre m\u00e9dicament est pr\u00eat, mais pouvez-vous le vendre\u00a0?<\/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;]Votre m\u00e9dicament peut \u00eatre autoris\u00e9 par la FDA, mais si votre infrastructure de conformit\u00e9 ne l\u2019est pas, vous n\u2019irez nulle part. Derri\u00e8re chaque produit approuv\u00e9 se trouve une cha\u00eene complexe de classements, de listes et d\u2019autorisations qui doivent \u00eatre synchronis\u00e9s avant que vous puissiez exp\u00e9dier. Une \u00e9tape manqu\u00e9e, et vous \u00eates confront\u00e9 \u00e0 des retenues aux fronti\u00e8res, des rejets ou des retards co\u00fbteux. Sur le march\u00e9 actuel, la r\u00e9ussite ne consiste pas seulement \u00e0 obtenir une approbation, mais aussi \u00e0 \u00eatre vraiment pr\u00eat pour le lancement.[\/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>Les exigences strictes de la FDA sont simplifi\u00e9es<\/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;Exigences d\u2019enregistrement de la FDA&#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%2Fstaging.registrarcorp.com%2Ffr%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;]Obtenir un num\u00e9ro DUNS pour l\u2019enregistrement de l\u2019\u00e9tablissement. Assurez-vous que les donn\u00e9es DUNS sont \u00e0 jour si vous avez d\u00e9j\u00e0 un num\u00e9ro.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101880675{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Enregistrez votre \u00e9tablissement et tenez les informations \u00e0 jour.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101910195{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Demandez un code d\u2019\u00e9tiqueteuse et r\u00e9pertoriez vos produits.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101942094{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]D\u00e9signez un agent am\u00e9ricain si votre \u00e9tablissement est bas\u00e9 en dehors des \u00c9tats-Unis.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101966335{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Remplir l\u2019auto-identification GDUFA si les exigences relatives aux m\u00e9dicaments g\u00e9n\u00e9riques l\u2019exigent.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101979888{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Payez les frais GDUFA et OMUFA avant les dates d\u2019\u00e9ch\u00e9ance, le cas \u00e9ch\u00e9ant.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Exigences relatives \u00e0 la liste des m\u00e9dicaments&#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%2Fstaging.registrarcorp.com%2Ffr%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;]\u00c9num\u00e9rer tous les m\u00e9dicaments aupr\u00e8s de la FDA avant la commercialisation.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687275859{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]R\u00e9server un code national des m\u00e9dicaments (National Drug Code, NDC) pour les nouveaux produits.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687284889{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Mettre \u00e0 jour ou r\u00e9activer les listes \u00e0 mesure que les formulations ou les d\u00e9tails changent.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687299066{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]D\u00e9sinscrire les produits qui ne sont plus commercialis\u00e9s.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687310871{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Signaler les quantit\u00e9s de m\u00e9dicaments chaque ann\u00e9e en vertu de la loi CARES.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687379427{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Recertifier les listes chaque ann\u00e9e pour maintenir la conformit\u00e9.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Exigences d\u2019\u00e9tiquetage et de certification&#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%2Fstaging.registrarcorp.com%2Ffr%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;]Assurez-vous que les \u00e9tiquettes sont exactes, \u00e9quilibr\u00e9es et non trompeuses.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688112341{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Soumettre les \u00e9tiquettes au format d\u2019\u00e9tiquetage structur\u00e9 du produit (SPL) de la FDA.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688119728{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Suivez le format de panneau Drug Facts requis pour les m\u00e9dicaments en vente libre.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688126628{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Maintenir la coh\u00e9rence entre tous les composants de l\u2019\u00e9tiquette (PI, PIL, \u2028CDS, etc.).[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688136191{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Inclure les avertissements et les informations de s\u00e9curit\u00e9 requis.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688149821{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Mettez rapidement \u00e0 jour les \u00e9tiquettes pour les changements de s\u00e9curit\u00e9.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Exigences relatives \u00e0 l\u2019importation et \u00e0 l\u2019acc\u00e8s au march\u00e9&#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%2Fstaging.registrarcorp.com%2Ffr%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;]Enregistrez votre \u00e9tablissement aupr\u00e8s de la FDA avant l\u2019importation.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688171498{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]R\u00e9solvez rapidement les alertes et les d\u00e9tentions \u00e0 l\u2019importation.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688179347{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]S\u2019assurer que les m\u00e9dicaments en vente libre r\u00e9pondent aux normes de la monographie.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688188003{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Rapporter la distribution annuelle en vertu de la loi CARES.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744809232144{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Licences d&#8217;\u00e9tat de rapport pour les op\u00e9rations 3PL\/WDD.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Soumission du fichier principal global&#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%2Fstaging.registrarcorp.com%2Ffr%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;]Soumettre les fichiers ma\u00eetres au format eCTD comme requis par la FDA et les agences mondiales.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688231243{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Tenez les fichiers \u00e0 jour avec les mises \u00e0 jour, les modifications et les rapports annuels.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688239829{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]S\u2019assurer que des lettres d\u2019autorisation (LOA) exactes sont d\u00e9pos\u00e9es pour les demandes de r\u00e9f\u00e9rencement.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688248252{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Fermer ou transf\u00e9rer les fichiers correctement pour maintenir l\u2019alignement r\u00e9glementaire.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688276101{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Stockez et suivez les soumissions en toute s\u00e9curit\u00e9 gr\u00e2ce au contr\u00f4le de version.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688289474{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]R\u00e9pondre aux questions et aux d\u00e9ficiences des agences en temps opportun.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688305436{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]S\u2019aligner sur les normes techniques et de formatage pour chaque agence (FDA, EMA, TGA, etc.).[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688318328{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Mettre \u00e0 jour les fichiers ma\u00eetres existants au format eCTD 4.0.[\/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>Formation en ligne sur l\u2019observance des m\u00e9dicaments \u00e0 votre convenance<\/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;53729&#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;]Atteignez l\u2019excellence en mati\u00e8re de normes r\u00e9glementaires gr\u00e2ce \u00e0 notre formation en ligne sur la conformit\u00e9.<\/p>\n<p>Rejoignez plus de 30 000 professionnels qui ont obtenu leurs certificats de formation gr\u00e2ce \u00e0 nos cours de premier plan dispens\u00e9s par des instructeurs de classe mondiale. Connaissances d\u2019experts accessibles \u00e0 tout moment, n\u2019importe o\u00f9.[\/vc_column_text][vc_btn title=&#8221;D\u00e9couvrir nos formations&#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%2Fstaging.registrarcorp.com%2Ffr%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>Les exigences de la FDA sont complexes, mais nous facilitons la conformit\u00e9.<\/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\">Comprendre les r\u00e9glementations sur les m\u00e9dicaments n\u2019a pas besoin d\u2019\u00eatre accablant. Avec les bons experts \u00e0 vos c\u00f4t\u00e9s, vous pouvez garantir la pr\u00e9cision, \u00e9viter les retards et rester en conformit\u00e9. Laissez Registrar Corp g\u00e9rer vos besoins en mati\u00e8re de conformit\u00e9 FDA.<\/span>[\/vc_column_text][vc_btn title=&#8221;Soyez conforme d\u00e8s aujourd\u2019hui&#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%2Fstaging.registrarcorp.com%2Ffr%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>Rester au courant<\/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;51602&#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:\/\/staging.registrarcorp.com\/fr\/blog\/drugs-fr\/drug-master-files-fr\/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;]Soumission des ASMF aux m\u00e9dicaments britanniques \u2028<br class=\"d-none d-md-block\" \/>et de l\u2019Agence de r\u00e9glementation des produits de sant\u00e9[\/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;]Explorez notre blog pour obtenir les derni\u00e8res informations sur les r\u00e9glementations de la FDA, les mises \u00e0 jour de la conformit\u00e9 mondiale, des conseils d\u2019experts et plus encore.[\/vc_column_text][vc_btn title=&#8221;Afficher tout&#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_1765889210872{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:%2Ffr%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;51163&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; onclick=&#8221;custom_link&#8221; css=&#8221;.vc_custom_1765908243188{margin-bottom: 0px !important;}&#8221; el_class=&#8221;image-link&#8221; link=&#8221;\/fr\/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>Webinaires<\/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;]D\u00e9couvrez nos webinaires dirig\u00e9s par des experts pour conna\u00eetre les derni\u00e8res mises \u00e0 jour sur les r\u00e9glementations de la FDA, la conformit\u00e9 internationale et l\u2019\u00e9volution des normes du secteur.[\/vc_column_text][vc_btn title=&#8221;Afficher tout&#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_1765889228326{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:%2Ffr%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>FAQ sur la conformit\u00e9 aux m\u00e9dicaments de la FDA<\/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;Pour les \u00e9tablissements pharmaceutiques, qui doit s\u2019inscrire ?&#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;]Les propri\u00e9taires ou op\u00e9rateurs nationaux ou \u00e9trangers d\u2019\u00e9tablissements qui fabriquent, pr\u00e9parent, transforment, assemblent ou conditionnent un ou plusieurs produits pharmaceutiques et qui ne sont pas consid\u00e9r\u00e9s comme exempt\u00e9s doivent enregistrer leur \u00e9tablissement aupr\u00e8s de <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-207\/subpart-B\/section-207.17\" target=\"_blank\" rel=\"noopener\">la FDA, conform\u00e9ment au Code of Federal Regulations<\/a>. En g\u00e9n\u00e9ral, les exemptions comprennent les pharmacies, les praticiens professionnels agr\u00e9\u00e9s, les chercheurs, les enseignants, les analystes et les distributeurs.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Quelles informations sont requises pour l\u2019enregistrement de l\u2019\u00e9tablissement pharmaceutique ?&#8221; tab_id=&#8221;what-information-is-required&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Les informations que vous devez soumettre dans l\u2019enregistrement de votre \u00e9tablissement \u00e0 la FDA dans le fichier SPL (Structured Product Labeling) comprennent\u00a0\u00a0:<\/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\">Nom de la soci\u00e9t\u00e9 et adresse compl\u00e8te de chaque \u00e9tablissement<\/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\">Nom, adresse, num\u00e9ro de t\u00e9l\u00e9phone et adresse e-mail du contact officiel<\/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\">Type(s) d\u2019op\u00e9ration r\u00e9alis\u00e9es dans chaque \u00e9tablissement<\/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\">Num\u00e9ro DUNS<\/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\">Identifiant Facility Establishment Identifier (si d\u00e9j\u00e0 attribu\u00e9)<\/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\">Non. Les \u00e9tablissements am\u00e9ricains doivent \u00e9galement inclure\u00a0:<\/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\">Nom de l\u2019Agent U.S. d\u00e9sign\u00e9<\/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\">Nom de chaque importateur connu de l\u2019\u00e9tablissement Nom de chaque agent, broker ou autre entit\u00e9, autre qu\u2019un transporteur utilis\u00e9 pour faciliter l\u2019importation de leur produit pharmaceutique aux \u00c9tats-Unis.<\/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\">Inclure le num\u00e9ro DUNS, le num\u00e9ro de t\u00e9l\u00e9phone et l\u2019adresse e-mail pour chaque entr\u00e9e.<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Voir le <\/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\">chapitre 21\u00a0du Code of Federal Regulations<\/span><\/a><span data-contrast=\"auto\"> pour une liste compl\u00e8te.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Qui doit soumettre les listings de produits pharmaceutiques ?&#8221; tab_id=&#8221;who-must-provide-drug-listings&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Tous les \u00e9tablissements pharmaceutiques qui ne sont pas consid\u00e9r\u00e9s comme exempt\u00e9s et qui doivent s\u2019enregistrer aupr\u00e8s de la FDA doivent \u00e9galement soumettre les listings de tous les produits pharmaceutiques en distribution commerciale au moment de l\u2019enregistrement initial de leur \u00e9tablissement aupr\u00e8s de <\/span><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-207\/subpart-D\/section-207.41\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">la FDA, conform\u00e9ment au Code of Federal Regulations<\/span><\/a><span data-contrast=\"auto\">.<\/span><\/p>\n<p><span data-contrast=\"auto\">En g\u00e9n\u00e9ral, les exemptions comprennent les pharmacies, les praticiens professionnels agr\u00e9\u00e9s, les chercheurs, les enseignants, les analystes et les distributeurs.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Quelles informations sont soumises dans un drug listing ?&#8221; tab_id=&#8221;what-information-is-submitted&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Les informations que vous devez soumettre dans les listings de produits pharmaceutiques \u00e0 la FDA comprennent\u00a0\u00a0:<\/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\">Nom de l\u2019\u00e9tablissement(s) fabriquant ou traitant le produit pharmaceutique soumis et le type d\u2019op\u00e9ration(s) effectu\u00e9es<\/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\">Calendrier DEA<\/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\">Voie(s) d\u2019administration<\/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\">Posologie<\/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\">Ingr\u00e9dients (actifs avec des quantit\u00e9s de concentration et inactifs)<\/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\">Informations marketing (par ex., cat\u00e9gorie, date de d\u00e9but\/fin)<\/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\">Informations relatives \u00e0 la demande (p. ex., type et ann\u00e9e d\u2019approbation) ou num\u00e9ro de citation de la monographie OTC<\/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\">Taille et type de packaging<\/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\">Code produit NDC pour un m\u00e9dicament source reconditionn\u00e9 ou r\u00e9\u00e9tiquet\u00e9<\/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\">Identifiants d\u2019ingr\u00e9dients uniques (Unique Ingredient Identifiers, Unii) et autres ensembles de codes<\/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\">Caract\u00e9ristiques distinctives de certains m\u00e9dicaments d\u00e9clar\u00e9s<\/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\">Fichier graphique d\u2019\u00e9tiquetage<\/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\">Num\u00e9ro de 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><span data-contrast=\"auto\">Voir <\/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\">le Code of Federal Regulations<\/span><\/a><span data-contrast=\"auto\"> pour plus de d\u00e9tails.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Qu\u2019est-ce qu\u2019un Master File ?&#8221; tab_id=&#8221;what-is-a-master-file&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Un <\/span><a href=\"https:\/\/www.registrarcorp.com\/master-files\/\"><span data-contrast=\"none\">Master File<\/span><\/a><span data-contrast=\"auto\"> est une soumission s\u00e9curis\u00e9e et confidentielle de donn\u00e9es de produits \u00e0 une agence r\u00e9glementaire, telle que la Food and Drug Administration (FDA) des \u00c9tats-Unis ou la National Medical Products Association (NMPA) en Chine.<\/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>Obtenir un meilleur m\u00e9dicament <br class=\"d-none d-xl-block\" \/>conformit\u00e9 facilement<\/h2>\n[\/vc_column_text][vc_btn title=&#8221;Commencer&#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%2Fstaging.registrarcorp.com%2Ffr%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;53738&#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;] Observance du m\u00e9dicament effectu\u00e9e \u2028rapide et facile [\/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;]La conformit\u00e9 \u00e0 la FDA des \u00c9tats-Unis ne laisse aucune place aux erreurs. Registrar Corp<\/p>\n","protected":false},"author":33,"featured_media":0,"parent":14867,"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-14378","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/staging.registrarcorp.com\/fr\/wp-json\/wp\/v2\/pages\/14378","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/staging.registrarcorp.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/staging.registrarcorp.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/fr\/wp-json\/wp\/v2\/users\/33"}],"replies":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/fr\/wp-json\/wp\/v2\/comments?post=14378"}],"version-history":[{"count":1,"href":"https:\/\/staging.registrarcorp.com\/fr\/wp-json\/wp\/v2\/pages\/14378\/revisions"}],"predecessor-version":[{"id":60005,"href":"https:\/\/staging.registrarcorp.com\/fr\/wp-json\/wp\/v2\/pages\/14378\/revisions\/60005"}],"up":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/fr\/wp-json\/wp\/v2\/pages\/14867"}],"wp:attachment":[{"href":"https:\/\/staging.registrarcorp.com\/fr\/wp-json\/wp\/v2\/media?parent=14378"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}