{"id":14439,"date":"2023-05-02T05:40:26","date_gmt":"2023-05-02T05:40:26","guid":{"rendered":"https:\/\/staging.registrarcorp.com\/drugs\/"},"modified":"2026-05-06T10:34:31","modified_gmt":"2026-05-06T10:34:31","slug":"drugs","status":"publish","type":"page","link":"https:\/\/staging.registrarcorp.com\/it\/industries\/drugs\/","title":{"rendered":"Prodotti farmaceutici"},"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\">Conformit\u00e0 ai farmaci effettuata <span class=\"text-primary-500\">\u2028facile e veloce<\/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\u00e0 della FDA statunitense non lascia spazio a errori. Registrar Corp \u00e8 il partner di fiducia che aiuta i produttori di farmaci, i distributori, i fornitori di API\/eccipienti e i marchi OTC a mantenere la conformit\u00e0 e garantire un accesso agevole al mercato dopo l\u2019approvazione.[\/vc_column_text][vc_btn title=&#8221;Registrati presso 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%2Fit%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>Le principali aziende farmaceutiche si fidano di 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;]Con oltre 20 anni di esperienza, abbiamo aiutato pi\u00f9 di 3.000 aziende farmaceutiche a ottenere la conformit\u00e0 FDA giusta la prima volta con il supporto di esperti.[\/vc_column_text]<div class=\"mpc-carousel__wrapper mpc-waypoint\"><div id=\"mpc_carousel_image-196a30121850937\" class=\"mpc-carousel-image mpc-init mpc-layout--classic mpc-effect--none brand-carousel\"  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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-196a30121850937\"><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;53722&#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\">Il tuo prodotto farmaceutico \u00e8 pronto, ma puoi venderlo?<\/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;]Il tuo farmaco pu\u00f2 essere autorizzato dalla FDA, ma se la tua infrastruttura di conformit\u00e0 non lo \u00e8, non stai andando da nessuna parte. Dietro ogni prodotto approvato si trova una complessa catena di documenti, elenchi e autorizzazioni che devono essere sincronizzati prima di poter essere spediti. Un passo mancato e ti trovi di fronte a blocchi di frontiera, rifiuti o costosi ritardi. Nel mercato di oggi, il successo non riguarda solo l\u2019approvazione, ma anche il fatto di essere veramente pronti per il lancio.[\/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>Requisiti stringenti FDA semplificati<\/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;Requisiti di registrazione 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%2Fit%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;]Ottenere un numero DUNS per la registrazione della struttura. Assicurarsi che i dati DUNS siano aggiornati se si dispone gi\u00e0 di un numero.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101880675{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Registra la tua struttura e mantieni le informazioni aggiornate.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101910195{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Richiedi un codice etichettatore ed elenca i tuoi prodotti.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101942094{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Nomina un agente statunitense se la tua struttura ha sede al di fuori degli Stati Uniti[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101966335{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Completare l\u2019autoidentificazione GDUFA se richiesto dai requisiti generici del farmaco.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101979888{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Paga le commissioni GDUFA e OMUFA prima delle date di scadenza, se applicabili.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Requisiti per l\u2019elenco dei farmaci&#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%2Fit%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;]Elencare tutti i prodotti farmaceutici con la FDA prima della commercializzazione.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687275859{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Riservare un National Drug Code (NDC) per i nuovi prodotti.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687284889{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Aggiornare o riattivare gli elenchi man mano che le formulazioni o i dettagli cambiano.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687299066{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Elencare i prodotti che non sono pi\u00f9 commercializzati.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687310871{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Segnalare gli importi dei farmaci ogni anno ai sensi della legge CARES.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687379427{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Ricertificare gli annunci ogni anno per mantenere la conformit\u00e0.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Requisiti di etichettatura e certificazione&#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%2Fit%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;]Assicurarsi che le etichette siano accurate, bilanciate e non fuorvianti.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688112341{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Inviare le etichette nel formato SPL (Struttured Product Labeling) della FDA.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688119728{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Seguire il formato del pannello dei fatti farmacologici richiesto per i farmaci da banco.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688126628{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Mantenere la coerenza tra tutti i componenti dell\u2019etichetta (PI, PIL, \u2028CDS, ecc.).[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688136191{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Includere le avvertenze e le informazioni di sicurezza richieste.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688149821{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Aggiornare tempestivamente le etichette per le modifiche alla sicurezza.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Requisiti di importazione e accesso al mercato&#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%2Fit%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;]Registrare la propria struttura presso l\u2019FDA prima dell\u2019importazione.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688171498{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Risolvere tempestivamente gli avvisi di importazione e le detenzioni.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688179347{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Assicurarsi che i farmaci da banco soddisfino gli standard della monografia.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688188003{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Segnalare la distribuzione annuale ai sensi della legge CARES.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744809232144{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Segnalare le licenze di stato delle operazioni 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;Invio file master globale&#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%2Fit%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;]Inviare i file master in formato eCTD come richiesto dalla FDA e dalle agenzie globali.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688231243{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Mantieni i file aggiornati con aggiornamenti, modifiche e relazioni annuali.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688239829{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Assicurarsi che vengano archiviate lettere di autorizzazione (LOA) accurate per le domande di referenziazione.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688248252{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Chiudere o trasferire correttamente i file per mantenere l&#8217;allineamento normativo.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688276101{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Archivia e monitora in modo sicuro gli invii con il controllo delle versioni.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688289474{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Rispondere tempestivamente alle domande e alle carenze dell\u2019agenzia.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688305436{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]In linea con gli standard tecnici e di formattazione per ciascuna agenzia (FDA, EMA, TGA, ecc.).[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688318328{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Aggiornare i file master esistenti al formato 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>Formazione online sulla conformit\u00e0 ai farmaci a vostra comodit\u00e0<\/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;53731&#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;]Raggiungi l\u2019eccellenza negli standard normativi con la nostra formazione online sulla conformit\u00e0.<\/p>\n<p>Unisciti a pi\u00f9 di 30.000 professionisti che hanno ottenuto i loro certificati di formazione attraverso i nostri corsi premier tenuti da istruttori di livello mondiale. Conoscenza esperta accessibile in qualsiasi momento e ovunque.[\/vc_column_text][vc_btn title=&#8221;Esplorate i corsi di formazione&#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%2Fit%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>I requisiti FDA sono complessi, ma rendiamo la conformit\u00e0 facile.<\/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\">Navigare tra le normative sui farmaci non deve essere travolgente. Con gli esperti giusti al tuo fianco, puoi garantire precisione, evitare ritardi e rimanere conforme. Lasciate che Registrar Corp gestisca le vostre esigenze di conformit\u00e0 FDA.<\/span>[\/vc_column_text][vc_btn title=&#8221;Diventa subito conforme&#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%2Fit%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>Rimanere al corrente<\/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;51604&#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\/it\/blog\/drugs-it\/drug-master-files-it\/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;]Invio di ASMF ai farmaci del Regno Unito \u2028<br class=\"d-none d-md-block\" \/>e Agenzia di regolamentazione dei prodotti sanitari[\/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>Blog<\/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;]Esplora il nostro blog per le ultime informazioni sulle normative FDA, gli aggiornamenti sulla conformit\u00e0 globale, i consigli degli esperti e altro ancora.[\/vc_column_text][vc_btn title=&#8221;Visualizza tutto&#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_1778063661417{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:%2Fit%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;51165&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; onclick=&#8221;custom_link&#8221; css=&#8221;.vc_custom_1744103641561{margin-bottom: 0px !important;}&#8221; el_class=&#8221;image-link&#8221; link=&#8221;\/risorse\/binari-on-demand\/&#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>Webinar<\/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;]Esplora i nostri webinar guidati da esperti per gli ultimi aggiornamenti sulle normative FDA, sulla conformit\u00e0 internazionale e sugli standard di settore in evoluzione.[\/vc_column_text][vc_btn title=&#8221;Visualizza tutto&#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_1762954003131{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:%2Frisorse%2Fbinari-on-demand%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>Domande frequenti sulla conformit\u00e0 ai farmaci 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;Per le aziende farmaceutiche, chi deve registrarsi?&#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;]I proprietari o gli operatori nazionali o stranieri di stabilimenti che producono, preparano, propagano o elaborano prodotti farmaceutici e che non sono considerati esenti devono registrare il proprio stabilimento presso la FDA, secondo <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-207\/subpart-B\/section-207.17\" target=\"_blank\" rel=\"noopener\">il Codice delle normative federali <\/a>. In generale, le esenzioni includono farmacie, professionisti autorizzati, ricercatori, insegnanti, analisti e distributori.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Quali informazioni sono necessarie per la registrazione dello stabilimento farmaceutico?&#8221; tab_id=&#8221;what-information-is-required&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Le informazioni da inviare come parte della registrazione dello stabilimento presso la FDA grazie ai file SPL (Structured Product Labeling) includono:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/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\">Ragione sociale e indirizzo completo di ogni stabilimento<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Nome, indirizzo, numero di telefono e indirizzo e-mail del contatto ufficiale<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Tipo(i) di operazioni effettuate in ogni stabilimento<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Numero DUNS<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Facility Establishment Identifier (se assegnato)<\/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\">Se non statunitensi. Gli stabilimenti devono inoltre includere:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/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\">Nome dell&#8217;agente U.S. designato<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Nome di ciascun importatore notoNome di ciascun agente, broker o altra entit\u00e0, diverso da un vettore utilizzato per facilitare l\u2019importazione del proprio farmaco negli Stati Uniti.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Include il numero DUNS, numero di telefono e indirizzo e-mail per ogni entrata in dogana.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Vedere il <\/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\">Capitolo 21 del Codice delle normative<\/span><\/a><span data-contrast=\"auto\"> federali per la lista completa.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Chi deve fornire i listing dei prodotti farmaceutici?&#8221; tab_id=&#8221;who-must-provide-drug-listings&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Tutti gli stabilimenti farmaceutici che non sono considerati esenti e devono registrarsi presso la FDA devono inoltre presentare le informazioni iniziali di listing per tutti i farmaci in distribuzione commerciale al momento della loro registrazione originale presso la FDA, secondo <\/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\">il Codice delle normative federali <\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/span><\/p>\n<p><span data-contrast=\"auto\">In generale, le esenzioni includono farmacie, professionisti autorizzati, ricercatori, insegnanti, analisti e distributori.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Quali informazioni vengono inviate il listing dei farmaci?&#8221; tab_id=&#8221;what-information-is-submitted&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Le informazioni da inviare come parte dei listing di prodotti farmaceutici alla FDA includono:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/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\">Nome dello stabilimento (o degli stabilimenti) che produce o elabora il farmaco listato e il tipo (o i tipi) di operazione eseguita<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Programma DEA<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Via(e) di somministrazione<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Forma di dosaggio<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Ingredienti (attivi con quantit\u00e0 di forza e inattivi)<\/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}\"><\/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\">Informazioni di messa sul mercato (ad es. categoria, data di inizio\/fine)<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Informazioni relative alla domanda (ad es., tipo e anno di approvazione) o numero di citazione monografica OTC<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Dimensioni e tipo della confezione<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Codice prodotto NDC per un farmaco originale riconfezionato o rietichettato<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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) e altri set di codici<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Caratteristiche distintive di alcuni farmaci listati<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/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\">Copia dell\u2019etichetta<\/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}\"><\/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\">National Drug Code (NDC) del farmaco<\/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\"> Per maggiori dettagli<\/span>, consultare<span data-contrast=\"auto\"> <\/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\">il Codice dei regolamenti federali<\/span><\/a>.<span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Che cos&apos;\u00e8 un 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\"> \u00e8 un invio sicuro e riservato di dati proprietari sui prodotti a un\u2019agenzia regolatoria, come la FDA (Food and Drug Administration, FDA) o la National Medical Products Association (NMPA) in Cina.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/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>Ottenere farmaci migliori <br class=\"d-none d-xl-block\" \/>conformit\u00e0 facilmente<\/h2>\n[\/vc_column_text][vc_btn title=&#8221;Sottomettete la richiesta&#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%2Fit%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;53740&#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;] Conformit\u00e0 ai farmaci effettuata \u2028facile e veloce [\/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\u00e0 della FDA statunitense non lascia spazio a errori. Registrar Corp \u00e8 il partner<\/p>\n","protected":false},"author":33,"featured_media":0,"parent":14823,"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-14439","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/staging.registrarcorp.com\/it\/wp-json\/wp\/v2\/pages\/14439","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/staging.registrarcorp.com\/it\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/staging.registrarcorp.com\/it\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/it\/wp-json\/wp\/v2\/users\/33"}],"replies":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/it\/wp-json\/wp\/v2\/comments?post=14439"}],"version-history":[{"count":0,"href":"https:\/\/staging.registrarcorp.com\/it\/wp-json\/wp\/v2\/pages\/14439\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/it\/wp-json\/wp\/v2\/pages\/14823"}],"wp:attachment":[{"href":"https:\/\/staging.registrarcorp.com\/it\/wp-json\/wp\/v2\/media?parent=14439"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}