{"id":14371,"date":"2023-05-02T05:40:26","date_gmt":"2023-05-02T05:40:26","guid":{"rendered":"https:\/\/staging.registrarcorp.com\/drugs\/"},"modified":"2025-12-16T18:05:54","modified_gmt":"2025-12-16T18:05:54","slug":"drugs","status":"publish","type":"page","link":"https:\/\/staging.registrarcorp.com\/pt-br\/industries\/drugs\/","title":{"rendered":"Medicamentos"},"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\">Ader\u00eancia ao medicamento foi feita <span class=\"text-primary-500\">\u2028r\u00e1pido e f\u00e1cil<\/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;]A conformidade com a FDA dos EUA n\u00e3o deixa espa\u00e7o para erros. A Registrar Corp \u00e9 a parceira confi\u00e1vel que ajuda fabricantes de medicamentos, distribuidores, fornecedores de API\/excipientes e marcas OTC a manter a conformidade e garantir uma entrada no mercado tranquila ap\u00f3s a aprova\u00e7\u00e3o.[\/vc_column_text][vc_btn title=&#8221;Registre-se com a 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%2Fpt-br%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>Principais empresas de medicamentos Trust 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;]Com mais de 20 anos de experi\u00eancia, ajudamos mais de 3.000 empresas farmac\u00eauticas a obter a conformidade com a FDA corretamente desde a primeira vez com suporte especializado.[\/vc_column_text]<div class=\"mpc-carousel__wrapper mpc-waypoint\"><div id=\"mpc_carousel_image-4269dcb14d4c952\" class=\"mpc-carousel-image mpc-init mpc-layout--classic mpc-effect--none brand-carousel\"  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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\" 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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-4269dcb14d4c952\"><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;53725&#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\">Seu medicamento est\u00e1 pronto, mas voc\u00ea pode vend\u00ea-lo?<\/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;]Seu medicamento pode ser liberado pela FDA, mas se sua infraestrutura de conformidade n\u00e3o for, voc\u00ea n\u00e3o vai a lugar nenhum. Por tr\u00e1s de cada produto aprovado est\u00e1 uma cadeia complexa de arquivamentos, listagens e libera\u00e7\u00f5es que devem estar em sincronia antes que voc\u00ea possa enviar. Uma etapa perdida e voc\u00ea est\u00e1 enfrentando reten\u00e7\u00f5es de fronteiras, rejei\u00e7\u00f5es ou atrasos dispendiosos. No mercado de hoje, o sucesso n\u00e3o se trata apenas de ser aprovado, mas de estar realmente pronto para o lan\u00e7amento.[\/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>Requisitos rigorosos da FDA facilitados<\/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;Requisitos de registro da 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%2Fpt-br%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;]Obtenha um n\u00famero DUNS para registro da instala\u00e7\u00e3o. Certifique-se de que os dados do DUNS estejam atualizados se voc\u00ea j\u00e1 tiver um n\u00famero.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101880675{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Registre suas instala\u00e7\u00f5es e mantenha as informa\u00e7\u00f5es atualizadas.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101910195{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Solicite um c\u00f3digo de etiqueta e liste seus produtos.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101942094{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Nomeie um agente dos EUA se sua instala\u00e7\u00e3o estiver localizada fora dos EUA.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101966335{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Concluir a autoidentifica\u00e7\u00e3o do GDUFA, se exigido pelas exig\u00eancias de medicamentos gen\u00e9ricos.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101979888{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Pague as taxas GDUFA e OMUFA antes das datas de vencimento, se aplic\u00e1vel a voc\u00ea.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Requisitos de listagem de medicamentos&#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%2Fpt-br%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;]Liste todos os medicamentos com a FDA antes da comercializa\u00e7\u00e3o.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687275859{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Reserve um C\u00f3digo Nacional de Medicamentos (NDC) para novos produtos.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687284889{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Atualizar ou reativar listagens conforme as formula\u00e7\u00f5es ou detalhes mudam.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687299066{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Retirar da lista produtos que n\u00e3o s\u00e3o mais comercializados.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687310871{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Relatar as quantidades de medicamentos anualmente de acordo com a Lei CARES.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687379427{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Recertificar listagens todos os anos para manter a conformidade.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Requisitos de rotulagem e certifica\u00e7\u00e3o&#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%2Fpt-br%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;]Certifique-se de que os r\u00f3tulos sejam precisos, equilibrados e n\u00e3o enganosos.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688112341{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Enviar r\u00f3tulos no formato de rotulagem estruturada do produto (SPL) da FDA.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688119728{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Siga o formato do painel Fatos sobre medicamentos para medicamentos OTC.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688126628{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Manter a consist\u00eancia em todos os componentes do r\u00f3tulo (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;]Inclua os avisos e informa\u00e7\u00f5es de seguran\u00e7a necess\u00e1rios.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688149821{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Atualize os r\u00f3tulos imediatamente para altera\u00e7\u00f5es de seguran\u00e7a.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Requisitos de importa\u00e7\u00e3o e acesso ao mercado&#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%2Fpt-br%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;]Registre suas instala\u00e7\u00f5es com a FDA antes de importar.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688171498{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Resolver alertas de importa\u00e7\u00e3o e deten\u00e7\u00f5es imediatamente.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688179347{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Garantir que os medicamentos OTC atendam aos padr\u00f5es da monografia.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688188003{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Relatar a distribui\u00e7\u00e3o anual de acordo com a Lei CARES.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744809232144{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]O estado do relat\u00f3rio licencia opera\u00e7\u00f5es 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;Envio de arquivo mestre 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%2Fpt-br%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;]Enviar arquivos mestre no formato eCTD, conforme exigido pela FDA e ag\u00eancias globais.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688231243{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Mantenha os arquivos atualizados com atualiza\u00e7\u00f5es, altera\u00e7\u00f5es e relat\u00f3rios anuais.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688239829{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Garantir que cartas de autoriza\u00e7\u00e3o (Letters of Authorization, LOAs) precisas sejam arquivadas para fazer refer\u00eancia a solicita\u00e7\u00f5es.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688248252{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Feche ou transfira arquivos adequadamente para manter o alinhamento regulat\u00f3rio.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688276101{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Armazene e rastreie envios com seguran\u00e7a com controle de vers\u00e3o.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688289474{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Responder \u00e0s consultas e defici\u00eancias da ag\u00eancia em tempo h\u00e1bil.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688305436{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Alinhar com os padr\u00f5es de formata\u00e7\u00e3o e t\u00e9cnicos para cada ag\u00eancia (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;]Atualize os arquivos mestre existentes para o 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>Treinamento on-line sobre conformidade de medicamentos para sua conveni\u00eancia<\/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;53734&#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;]Alcance excel\u00eancia em padr\u00f5es regulat\u00f3rios com nosso treinamento de conformidade on-line.<\/p>\n<p>Junte-se a mais de 30.000 profissionais que ganharam seus certificados de treinamento por meio de nossos principais cursos ministrados por instrutores de n\u00edvel internacional. Conhecimento especializado acess\u00edvel a qualquer hora, em qualquer lugar.[\/vc_column_text][vc_btn title=&#8221;Explorar treinamentos&#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%2Fpt-br%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>Os requisitos da FDA s\u00e3o complexos, mas facilitamos a conformidade.<\/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\">Navegar pelas regulamenta\u00e7\u00f5es de medicamentos n\u00e3o precisa ser complicado. Com os especialistas certos ao seu lado, voc\u00ea pode garantir precis\u00e3o, evitar atrasos e manter a conformidade. Deixe a Registrar Corp lidar com suas necessidades de conformidade com a FDA.<\/span>[\/vc_column_text][vc_btn title=&#8221;Fique em conformidade hoje&#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%2Fpt-br%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>Fique por dentro<\/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;51607&#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\/pt-br\/blog\/drugs-pt-br\/drug-master-files-pt-br\/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;]Envio de ASMFs para medicamentos do Reino Unido \u2028<br class=\"d-none d-md-block\" \/>e Ag\u00eancia Reguladora de Produtos de Sa\u00fade[\/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;]Explore nosso blog para obter as informa\u00e7\u00f5es mais recentes sobre regulamentos da FDA, atualiza\u00e7\u00f5es de conformidade global, dicas de especialistas e muito mais.[\/vc_column_text][vc_btn title=&#8221;Exibir tudo&#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_1765889557940{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:%2Fpt-br%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;51168&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; onclick=&#8221;custom_link&#8221; css=&#8221;.vc_custom_1765908349874{margin-bottom: 0px !important;}&#8221; el_class=&#8221;image-link&#8221; link=&#8221;\/pt-br\/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>Webinars<\/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;]Explore nossos webinars conduzidos por especialistas para obter as \u00faltimas atualiza\u00e7\u00f5es sobre regulamentos da FDA, conformidade internacional e padr\u00f5es em evolu\u00e7\u00e3o do setor.[\/vc_column_text][vc_btn title=&#8221;Exibir tudo&#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_1765889530504{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:%2Fpt-br%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>Perguntas frequentes sobre conformidade de medicamentos da 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;Para Estabelecimentos de Medicamentos, quem deve se registrar?&#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;]Propriet\u00e1rios ou operadores nacionais ou estrangeiros de estabelecimentos que fabricam, preparam, propagam, comp\u00f5e ou processam um medicamento ou medicamentos e n\u00e3o s\u00e3o considerados isentos devem registrar suas instala\u00e7\u00f5es na FDA, de acordo com <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-207\/subpart-B\/section-207.17\" target=\"_blank\" rel=\"noopener\">o C\u00f3digo de Regulamentos Federais<\/a>. Em geral, as isen\u00e7\u00f5es incluem farm\u00e1cias, profissionais licenciados, pesquisadores, professores, analistas e distribuidores.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Quais informa\u00e7\u00f5es s\u00e3o necess\u00e1rias para o registro de estabelecimento de medicamentos?&#8221; tab_id=&#8221;what-information-is-required&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">As informa\u00e7\u00f5es que voc\u00ea deve enviar como parte do registro da instala\u00e7\u00e3o da FDA com seu arquivo de rotulagem estruturada de produtos (SPL) incluem:<\/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\">Nome da empresa e endere\u00e7o completo de cada estabelecimento<\/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, endere\u00e7o, n\u00famero de telefone e endere\u00e7o de e-mail do contato oficial<\/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(s) de opera\u00e7\u00e3o realizada em cada estabelecimento<\/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\">N\u00famero 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\">Identificador de estabelecimento da instala\u00e7\u00e3o (quando atribu\u00eddo)<\/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\">N\u00e3o. Estabelecimentos nos EUA tamb\u00e9m devem incluir:<\/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 do agente dos EUA designado<\/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 de cada importador conhecido pelo estabelecimentoNome de cada agente, corretor ou outra entidade, al\u00e9m de uma transportadora usada para facilitar a importa\u00e7\u00e3o de seu medicamento para os EUA.<\/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\">Inclua n\u00famero DUNS, n\u00famero de telefone e endere\u00e7o de e-mail para cada entrada.<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Consulte <\/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\">o <span data-contrast=\"none\">T\u00edtulo 21 do C\u00f3digo de Regulamenta\u00e7\u00f5es Federais<\/span><\/a><span data-contrast=\"auto\"> para obter uma lista completa.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Quem deve fornecer listagens de medicamentos?&#8221; tab_id=&#8221;who-must-provide-drug-listings&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Todos os estabelecimentos de medicamentos que n\u00e3o s\u00e3o considerados isentos e devem se registrar junto \u00e0 FDA tamb\u00e9m devem enviar informa\u00e7\u00f5es de listagem inicial para todos os medicamentos em distribui\u00e7\u00e3o comercial no momento do registro original nas instala\u00e7\u00f5es da FDA, de acordo com <\/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\">o C\u00f3digo de Regulamenta\u00e7\u00f5es Federais<\/span><\/a><span data-contrast=\"auto\">.<\/span><\/p>\n<p><span data-contrast=\"auto\">Em geral, as isen\u00e7\u00f5es incluem farm\u00e1cias, profissionais licenciados, pesquisadores, professores, analistas e distribuidores.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Quais informa\u00e7\u00f5es s\u00e3o enviadas para uma listagem de medicamentos?&#8221; tab_id=&#8221;what-information-is-submitted&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">As informa\u00e7\u00f5es que voc\u00ea deve enviar como parte da sua lista de medicamentos da FDA incluem:<\/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 do estabelecimento(s) que fabrica ou processa o medicamento listado e o tipo de opera\u00e7\u00e3o(\u00f5es) realizada<\/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\">Programa\u00e7\u00e3o 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\">Via(s) de administra\u00e7\u00e3o<\/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 de dosagem<\/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\">Ingredientes (ativos com quantidades de for\u00e7a e inativos)<\/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\">Informa\u00e7\u00f5es de marketing (por exemplo, categoria, data de in\u00edcio\/t\u00e9rmino)<\/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\">Informa\u00e7\u00f5es relacionadas \u00e0 solicita\u00e7\u00e3o (por exemplo, tipo e ano de aprova\u00e7\u00e3o) ou n\u00famero de cita\u00e7\u00e3o da monografia 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\">Tamanho e tipo do pacote<\/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\">C\u00f3digo do produto NDC para um medicamento de origem reembalado ou rerotulado<\/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\">Identificadores exclusivos de ingredientes (UNII) e outros conjuntos de c\u00f3digos<\/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\">Caracter\u00edsticas distintas de certos medicamentos listados<\/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\">Obra de arte de rotulagem<\/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\">N\u00famero do C\u00f3digo Nacional de Medicamentos (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\">Consulte <\/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\">o C\u00f3digo de Regulamenta\u00e7\u00f5es Federais<\/span><\/a><span data-contrast=\"auto\"> para obter mais detalhes.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;O que \u00e9 um arquivo mestre?&#8221; tab_id=&#8221;what-is-a-master-file&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Um <\/span><a href=\"https:\/\/www.registrarcorp.com\/master-files\/\"><span data-contrast=\"none\">Arquivo Mestre<\/span><\/a><span data-contrast=\"auto\"> \u00e9 um envio seguro e confidencial de dados de produtos propriet\u00e1rios para uma ag\u00eancia regulat\u00f3ria, como a Ag\u00eancia de Administra\u00e7\u00e3o de Alimentos e Medicamentos dos EUA (FDA) ou a Associa\u00e7\u00e3o Nacional de Produtos M\u00e9dicos (NMPA) na China.<\/span>[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743716164337{background-color: #003873 !important;}&#8221; el_class=&#8221;p-resp-section p-resp-section&#8211;smaller blue-gradient-section&#8211;color-bars&#8221;][vc_row content_placement=&#8221;middle&#8221; el_class=&#8221;text-neutral-000&#8243;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;m-width-desktop-1100 mx-auto order-last order-md-first&#8221;][vc_column_text css=&#8221;.vc_custom_1743775092024{margin-bottom: 64px !important;}&#8221; el_class=&#8221;rc-heading-m-resp mb-mobile-32&#8243;]\n<h2>Alcan\u00e7ar um medicamento melhor <br class=\"d-none d-xl-block\" \/>conformidade com facilidade<\/h2>\n[\/vc_column_text][vc_btn title=&#8221;Comece j\u00e1&#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%2Fpt-br%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;53743&#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;] Ader\u00eancia ao medicamento foi feita \u2028r\u00e1pido e f\u00e1cil [\/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;]A conformidade com a FDA dos EUA n\u00e3o deixa espa\u00e7o para erros. 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