{"id":4532,"date":"2024-08-27T15:18:18","date_gmt":"2024-08-27T20:18:18","guid":{"rendered":"https:\/\/scrconsultings.com\/?p=4532"},"modified":"2026-01-27T12:09:06","modified_gmt":"2026-01-27T17:09:06","slug":"import-requirements-peru-bolivia-chile-documents","status":"publish","type":"post","link":"https:\/\/scrconsultings.com\/es\/import-requirements-peru-bolivia-chile-documents\/","title":{"rendered":"Requisitos para la Importaci\u00f3n de Productos Farmac\u00e9uticos, Dispositivos M\u00e9dicos y Productos Sanitarios en Per\u00fa, Bolivia y Chile"},"content":{"rendered":"<h4><strong><span style=\"color: #05316b;\">1. Per\u00fa:<\/span><\/strong><\/h4>\n<p>Estos son los documentos requeridos para importar los siguientes productos:<\/p>\n<p class=\"translation-block\"><strong>Medicamentos<\/strong><br>\n\n-Registro Sanitario o Certificado de Registro y Ficha Resumen (VUCE)<br>\n-Certificado de An\u00e1lisis (lote)<br>\n-Certificado GMP o equivalente<br>\n-Certificado Oficial de Importaci\u00f3n (COI) y Autorizaci\u00f3n RD para Entrada (para psicotr\u00f3picos y narc\u00f3ticos)<\/p>\n<p class=\"translation-block\"><strong>Biol\u00f3gicos y derivados de plasma humanos<\/strong><br>\n\n-Registro Sanitario o Certificado de Registro y Ficha Resumen (VUCE)<br>\n-Certificado de An\u00e1lisis (lote)<br>\n-Certificado GMP o equivalente<br>\n-Certificado Oficial de Importaci\u00f3n (COI) y Autorizaci\u00f3n RD para Entrada (para psicotr\u00f3picos y narc\u00f3ticos)<br>\n-Certificado Negativo para VIH, Hepatitis B y C (para derivados de plasma humano)<\/p>\n<p class=\"translation-block\"><strong>Suplementos diet\u00e9ticos y edulcorantes<\/strong><br>\n\n-Registro Sanitario o Certificado de Registro y Ficha Resumen (VUCE)<br>\n-Certificado de An\u00e1lisis (lote)<br>\n-Certificado GMP o equivalente<br>\nGal\u00e9nicos<br>\n\n-Registro Sanitario o Certificado de Registro y Ficha Resumen (VUCE)<br>\n-Certificado de An\u00e1lisis (lote)<br>\n-Certificado GMP o equivalente<\/p>\n<p class=\"translation-block\"><strong>Productos naturales<\/strong><br>\n\n-Registro Sanitario o Certificado de Registro y Ficha Resumen (VUCE)<br>\n-Certificado de An\u00e1lisis (lote)<\/p>\n<p class=\"translation-block\"><strong>Dispositivos m\u00e9dicos<\/strong><br>\n\n-Registro Sanitario o Certificado de Registro y Ficha Resumen (VUCE)<br>\n-Certificado de An\u00e1lisis (lote)<br>\n-Certificado GMP o equivalente o ISO 13485<br>\n-Autorizaci\u00f3n IPEN (solo para equipos de tecnolog\u00eda controlada que emiten radiaci\u00f3n ionizante)<\/p>\n<h4><span style=\"color: #05316b;\"><strong>2. Bolivia:<\/strong><\/span><\/h4>\n<p class=\"translation-block\">En Bolivia, el Despacho Aduanero implica el conjunto de procedimientos y formalidades aduaneras necesarias para la aplicaci\u00f3n de mercanc\u00edas. Este r\u00e9gimen aduanero, establecido por ley, ser\u00e1 documentado, p\u00fablico, simplificado y oportuno, de acuerdo con los principios de buena fe, transparencia y facilitaci\u00f3n del comercio.<\/p>\n<p class=\"translation-block\">Es responsabilidad nacional de AGEMED regular, controlar, supervisar, regularizar y velar por todos los aspectos relacionados con el Sistema Nacional de Vigilancia y Control de Medicamentos, siendo la emisi\u00f3n del Certificado de Autorizaci\u00f3n de Despacho Aduanero realizada por esta entidad.<\/p>\n<p class=\"translation-block\">El Certificado de Autorizaci\u00f3n de Despacho Aduanero (CADA) es un elemento fundamental para acceder a medicamentos legalmente reconocidos. Por lo tanto, es exclusivamente responsabilidad del solicitante verificar la exactitud de la informaci\u00f3n declarada y la documentaci\u00f3n presentada a AGEMED en cumplimiento con el marco normativo vigente.<\/p>\n<p>Para las empresas legalmente establecidas con AGEMED, los requisitos necesarios son los siguientes:<\/p>\n<p>It includes import authorizations for products intended for manufacturing, promotion,<br \/>\nregistration samples, quality control standards, market research, or general commercialization.<\/p>\n<p class=\"translation-block\">a. Formulario 011 \u2013 Certificado de Autorizaci\u00f3n de Despacho Aduanero debidamente completado.<br>\n\nb. Factura comercial o nota de venta de acuerdo con las normas de origen.<br>\n\nc. Lista de empaque o nota espec\u00edfica de la empresa importadora cuando la factura no incluya el n\u00famero de lote y la fecha de caducidad de todos los productos.\n<br>\nd. Certificado de control de calidad para cada lote a importar (hojas t\u00e9cnicas, documentos del sistema de gesti\u00f3n de calidad o informes de calidad no son aplicables; se refiere a documentos de informe de calidad, declaraci\u00f3n del proveedor o fabricante, certificado de calidad o conformidad) para medicamentos o su equivalente para materias primas, dispositivos m\u00e9dicos, reactivos de diagn\u00f3stico, cosm\u00e9ticos, productos de higiene del hogar y absorbentes, incluyendo productos de referencia.\n<br>\ne. Hoja t\u00e9cnica con la descripci\u00f3n del nombre, imagen y codificaci\u00f3n si aplica para equipos biom\u00e9dicos, accesorios y repuestos.\n<br>\nf. Para vacunas, cuando sea aplicable, el Certificado de Liberaci\u00f3n del Lote actual.\n<br>\ng. Para la importaci\u00f3n de Medicamentos Legalmente Reconocidos, la empresa debe tener Representaci\u00f3n Legal v\u00e1lida en el momento de la revisi\u00f3n, previamente presentada en original y legalizada o apostillada en el \u00c1rea de Licencias del Departamento de Vigilancia y Control de AGEMED.\n<br>\nh. Cuando sea aplicable, se debe incluir una Resoluci\u00f3n Administrativa de Licencia de Importaci\u00f3n previa para sustancias controladas (psicotr\u00f3picos\/narc\u00f3ticos\/precursores), ya sea que se trate de materias primas, est\u00e1ndares de referencia, muestras m\u00e9dicas, productos terminados o a granel, muestras para registro. El tipo de producto debe declarar el nombre comercial seg\u00fan la factura, el nombre gen\u00e9rico (solo el nombre gen\u00e9rico de la sustancia controlada indicando si es base, sal, \u00e9ter o \u00e9ster).<br>\n\ni. Cuando sea aplicable, se debe considerar que, en el caso de sustancias controladas, se debe proporcionar una previsi\u00f3n anual; una previsi\u00f3n suplementaria puede ser solicitada antes de solicitar el CADA.<br>\n\nj. Pago por el servicio del \u201cCertificado para Despacho Aduanero de Medicamentos Legalmente Reconocidos\u201d o \u201cCertificado para Despacho Aduanero de Materias Primas\u201d de acuerdo con las tarifas del R.M. 0265.<\/p>\n<h4><span style=\"color: #05316b;\"><strong>3. Chile:<\/strong><\/span><\/h4>\n<p class=\"translation-block\">Los documentos requeridos para importar productos farmac\u00e9uticos y sus materias primas, incluyendo narc\u00f3ticos y psicotr\u00f3picos, dispositivos m\u00e9dicos, cosm\u00e9ticos y sus materias primas; suplementos diet\u00e9ticos y pesticidas para uso sanitario y dom\u00e9stico en Chile siguen el siguiente proceso:<\/p>\n<p class=\"translation-block\">El ISP (Instituto de Salud P\u00fablica de Chile), en acuerdo con la Subsecretar\u00eda de Salud P\u00fablica en representaci\u00f3n de las Autoridades Regionales de Salud (Seremis de Salud), es el organismo encargado de emitir el Certificado de Destino Aduanero (CDA) para productos sujetos a control sanitario en todo el territorio nacional, de acuerdo con la Ley 18.164\/82 del Ministerio de Hacienda.\n\nPor otro lado, el Servicio Nacional de Aduanas autoriza la Declaraci\u00f3n de Entrada de mercanc\u00edas al pa\u00eds (DIN). En este contexto, el ISP es el organismo t\u00e9cnico responsable de evaluar y autorizar el uso, consumo, distribuci\u00f3n, transferencia o disposici\u00f3n de bienes sujetos a regulaci\u00f3n sanitaria que ingresan al pa\u00eds mediante la emisi\u00f3n de una Resoluci\u00f3n de Autorizaci\u00f3n de Uso y Disposici\u00f3n.<\/p>\n<p class=\"translation-block\"><strong>Para obtener el CDA::<\/strong><br>\n\n\u2013 Registro Sanitario (Resoluci\u00f3n del ISP solo para productos que requieran registro)<br> \u2013 Certificado de An\u00e1lisis del pa\u00eds de origen<br> \u2013 Certificado GMP \u2013 Autorizaci\u00f3n Sanitaria del almac\u00e9n de almacenamiento<br> \u2013 Gu\u00eda de transporte (a\u00e9rea o mar\u00edtima) <br>\u2013 Factura Comercial \u2013 Lista de Empaque<br> \u2013 Certificado de Importaci\u00f3n Oficial (solo para productos narc\u00f3ticos\/psicotr\u00f3picos)<br> \u2013 Autorizaci\u00f3n de Exportaci\u00f3n del pa\u00eds de origen (solo para productos narc\u00f3ticos\/psicotr\u00f3picos)<\/p>\n<p class=\"translation-block\"><strong>Para obtener la Resoluci\u00f3n de Autorizaci\u00f3n de Uso y Disposici\u00f3n::<\/strong><br>\n\n\u2013 Registro Sanitario (Resoluci\u00f3n del ISP solo para productos que requieran registro)<br> \u2013 Certificado de An\u00e1lisis del pa\u00eds de origen<br> \u2013 Certificado GMP<br> \u2013 Autorizaci\u00f3n Sanitaria del almac\u00e9n de almacenamiento <br>\u2013 Gu\u00eda de transporte (a\u00e9rea o mar\u00edtima)<br> \u2013 Factura Comercial<br> \u2013 Lista de Empaque<br> \u2013 Declaraci\u00f3n de Entrada Aduanera (DIN)<br> \u2013 Certificado de Importaci\u00f3n Oficial (solo para productos narc\u00f3ticos\/psicotr\u00f3picos) <br>\u2013 Autorizaci\u00f3n de Exportaci\u00f3n del pa\u00eds de origen (solo para productos narc\u00f3ticos\/psicotr\u00f3picos) <br>\u2013 Gu\u00eda de despacho nacional (solo para productos narc\u00f3ticos\/psicotr\u00f3picos)<\/p>","protected":false},"excerpt":{"rendered":"<p>1. Per\u00fa: These are the documents required to import the following products: Medicines &#8211; Health Registration or Certificate of Registration and Summary Sheet (VUCE) &#8211; Certificate of Analysis (batch) &#8211; GMP Certificate or equivalent &#8211; Official Import Certificate (COI) and RD Authorization for Entry (For psychotropics and narcotics) Biologicals and human plasma derivatives &#8211; Health [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":4606,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46,83,79,82],"tags":[],"class_list":["post-4532","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-health-products","category-medical-devices","category-pharmaceutical-products"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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