{"id":41339,"date":"2016-08-30T19:40:03","date_gmt":"2016-08-30T23:40:03","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-drugs\/"},"modified":"2020-02-21T16:50:39","modified_gmt":"2020-02-21T16:50:39","slug":"fda-drugs","status":"publish","type":"page","link":"https:\/\/legacy.registrarcorp.com\/pt\/fda-drugs\/","title":{"rendered":"Medicamentos"},"content":{"rendered":"
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Medicamentos<\/h1>\n
\n

Registre-se com a Food and Drug Administration (FDA) dos EUA<\/strong><\/h2>\n[\/vc_column_text][vc_row_inner el_class=”row-content-center”][vc_column_inner]
Iniciar<\/span><\/div>
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Registro
\ne Listagem<\/h2>\n[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]Propriet\u00e1rios ou Operadores de todos os Estabelecimentos nos EUA ou fora que est\u00e3o envolvidos na fabrica\u00e7\u00e3o, prepara\u00e7\u00e3o, propaga\u00e7\u00e3o, composi\u00e7\u00e3o ou processamento de medicamentos s\u00e3o requeridos \u00e0 se registrar e submeter listagem para cada medicamento que ser\u00e1 distribuido comercialmente nos Estados Unidos.[\/vc_column_text][vc_column_text el_class=”side-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/a>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=”side-by-side mobile-reverse”][vc_column width=”1\/2″ el_class=”side-left align-left” css=”.vc_custom_1581877147665{background-color: #3b4254 !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-text-block font-white”]A FDA requer que r\u00f3tulos de medicamentos sejam indicados com um expans\u00edvel Markup de Idioma (XML) em formato estruturado no r\u00f3tulo do produto (SPL). A Registrar Corp pode te ajudar a modificar a sua rotulagem de medicamentos para conformar com os regulamentos da FDA. A Registrar Corp fornece gr\u00e1ficos revisados e prontos para impress\u00e3o ou editados, e um relat\u00f3rio que detalha os regulamentos, guias de conformidade, cartas de alerta, alertas de importa\u00e7\u00e3o, e outros documentos com orienta\u00e7\u00f5es da FDA.[\/vc_column_text][vc_column_text el_class=”side-links font-white”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left hasImage” css=”.vc_custom_1581877157753{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/drug-label-scaled.jpg?id=41281) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

Revis\u00e3o de Rotulagem
\ne Ingredientes<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=”side-by-side”][vc_column width=”1\/2″ el_class=”side-left align-right hasImage” css=”.vc_custom_1581877512373{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/03\/fda-drug-master.jpg?id=40102) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column_text el_class=”side-title-block”]\n

Arquivos principais
\nde Medicamento<\/h2>\n[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ el_class=”side-right align-left”][vc_column_text el_class=”side-text-block”]Um\u00a0Drug Master File\u00a0arquivo principal de medicamento \u00e9 uma submiss\u00e3o \u00e0 FDA que pode ser usado para suportar pr\u00e9-autoriza\u00e7\u00f5es de comercializa\u00e7\u00e3o para fornecer informa\u00e7\u00f5es confidenciais detalhadas sobre empresas, processos, ou artigos utilizados na fabrica\u00e7\u00e3o, processamento, embalamento, e armazenagem de um ou mais medicamentos. O time de especialistas regulat\u00f3rios da Registrar Corp fornece orienta\u00e7\u00f5es para elementos cruciais, formatos, e particularidades de submiss\u00f5es de Arquivos Principais de Medicamentos.[\/vc_column_text][vc_column_text el_class=”side-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/a>[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_section css=”.vc_custom_1574176315943{background-color: #ececec !important;}”][vc_row equal_height=”yes” el_class=”grid-tiles”][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581964367690{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/adverse-event-scaled.jpg?id=41239) !important;}” el_class=”grid-tile-title hasImage”]\n

Contato de Eventos Adversos para Medicamentos Sem Prescri\u00e7\u00e3o<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]A FDA dos EUA exige que os r\u00f3tulos de medicamentos vendidos sem receita comercial que n\u00e3o tenham um aplicativo aprovado ostentem um endere\u00e7o ou n\u00famero de telefone nos Estados Unidos para receber relat\u00f3rios dos consumidores sobre eventos adversos graves. A Registrar Corp pode servir como seu contato nos EUA para o encaminhamento oportuno de relat\u00f3rios de consumidores para sua empresa, conforme exigido pela FDA.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581964401554{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2018\/08\/drug-labels-new-product.jpg?id=40003) !important;}” el_class=”grid-tile-title hasImage”]\n

Regulamentos para Instala\u00e7\u00f5es terceirizadas<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Farm\u00e1cias de composi\u00e7\u00e3o que se registram na FDA como Outsourcing Facilities podem se qualificar para isen\u00e7\u00e3o de certos requisitos de aprova\u00e7\u00e3o e rotulagem da FDA. Os Especialistas em Regulamenta\u00e7\u00e3o da Registrar Corp podem registrar farm\u00e1cias como Instala\u00e7\u00f5es de Terceiriza\u00e7\u00e3o, al\u00e9m de ajud\u00e1-las a cumprir os regulamentos da FDA, incluindo o envio de relat\u00f3rios anuais sobre medicamentos.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581964438662{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2019\/10\/VoluntaryMalfunctionSummary.jpg?id=39819) !important;}” el_class=”grid-tile-title hasImage”]\n

Auto-identifica\u00e7\u00e3o para Instala\u00e7\u00f5es de Medicamentos gen\u00e9ricos<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Os operadores de instala\u00e7\u00f5es que produzem medicamentos gen\u00e9ricos e APIs de medicamentos gen\u00e9ricos devem enviar informa\u00e7\u00f5es de \u201cauto-identifica\u00e7\u00e3o\u201d \u00e0 FDA entre 1 de maio e 1 de junho de cada ano.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-offset-0 vc_col-lg-4 vc_col-md-offset-0 vc_col-md-6 vc_col-sm-offset-0 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581964468332{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/01\/container-yard.png?id=39392) !important;}” el_class=”grid-tile-title hasImage”]\n

Relat\u00f3rio 3PL \/ WDD na FDA<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]As Empresas Parceiras de Logistica (3PL) e os Distribuidores Atacadistas de Medicamentos (WDD) devem se reportar \u00e0 FDA entre o 1ro de janeiro e o 31 de mar\u00e7o de cada ano.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581964503738{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/detention-scaled.jpg?id=41099) !important;}” el_class=”grid-tile-title hasImage”]\n

Assist\u00eancia com Deten\u00e7\u00f5es<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Empresas enviando produtos para os Estados Unidos podem encontrar seus envios sujeitos \u00e0 Deten\u00e7\u00e3o sem Avalia\u00e7\u00e3o F\u00edsica (DWPE) pela FDA. Produtos sujeitos \u00e0 DWPE s\u00e3o retidos no porto de entrada enquanto a FDA realiza fiscaliza\u00e7\u00e3o adicional, testes e an\u00e1lises. Atrasos devido a DWPE podem prolongar a apreens\u00e3o para entregar os produtos dentro do prazo.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/a>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ offset=”vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1582215273310{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/color-additive.jpg?id=41658) !important;}” el_class=”grid-tile-title hasImage”]\n

Requerimentos para Aditivos de Cor<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Um aditivo de cor de f\u00e1rmaco \u00e9 qualquer corante, pigmento ou outra subst\u00e2ncia que possa dar cor a um medicamento. Aditivos de cor de medicamentos s\u00e3o regulados pela FDA.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/a>[\/vc_column_text][\/vc_column][vc_column offset=”vc_col-lg-offset-4 vc_col-lg-4 vc_col-md-6 vc_col-xs-12″][vc_column_text css=”.vc_custom_1581964590435{background-image: url(https:\/\/regstaging.wpengine.com\/wp-content\/uploads\/2020\/02\/export-certs-scaled.jpg?id=41085) !important;}” el_class=”grid-tile-title hasImage”]\n

Certificados de exporta\u00e7\u00e3o para Governos estrangeiros<\/h2>\n[\/vc_column_text][vc_column_text el_class=”grid-tile-block”]Empresas que exportam produtos dos Estados Unidos s\u00e3o frequentemente solicitadas por clientes estrangeiros ou governos estrangeiros a fornecer e \u201cCertificado de Exporta\u00e7\u00e3o\u201d para produtos regulados pela FDA. Um Certificado de Exporta\u00e7\u00e3o \u00e9 um documento preparado pela FDA contendo informa\u00e7\u00f5es sobre regulamenta\u00e7\u00f5es de produtos ou status comercial.[\/vc_column_text][vc_column_text el_class=”grid-tile-links”]Iniciar<\/a><\/p>\n

Pre\u00e7os<\/a>[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_row][vc_column]

<\/i><\/i><\/div><\/div><\/div>
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