Ecuador: Norma técnica de importación de medicamentos

Last Updated: 17 March 2017
Article by Expertise Advisor Abogados

Informamos que la Dirección Ejecutiva de la Agencia Nacional de Regulación, Control y Vigilancia Sanitaria – ARCSA, mediante resolución No. ARCSA-DE-011-2016-GGG publicada en el Registro Oficial 760 de 23 de mayo de 2016, resolvió expedir la Normativa Técnica Sanitaria para autorizar la importación de medicamentos, productos biológicos, dispositivos médicos de uso humano, reactivos bioquímicos y de diagnóstico en caso de emergencia sanitaria, para tratamiento especializados no disponibles en el país, para tratamientos de enfermedades catastróficas, raras o huérfanas o para fines de investigación clínica humana. A continuación un resumen de los puntos más importantes de la mencionada normativa.

Motivos de importación:

La Agencia Nacional de Regulación, Control y Vigilancia Sanitaria - ARCSA autorizará la importación de los productos descritos en la normativa técnica sanitaria, por las siguientes causas:

  1. Por estado de emergencia sanitaria declarada por acto de poder público;
  2. Para personas que requieran tratamientos especializados no disponibles en el país debidamente justificadas;
  3. Para personas que sufran de enfermedades catastróficas, raras o huérfanas, debidamente justificadas;
  4. Para fines de investigación clínica humana, cuyo protocolo haya sido aprobado con antelación por la ARCSA

Sin perjuicio de aquello, los medicamentos de uso y consumo humano que contengan en su formulación sustancias sujetas a fiscalización, deberán cumplir con lo establecido en la Ley Orgánica de Prevención Integral del fenómeno socio económico de las Drogas y de Regulación y Control del Uso de Sustancias Catalogadas sujetas a fiscalización.

La autorización para la importación tendrá una vigencia de 90 días, contados a partir de su


En caso de que el solicitante sea (i) el paciente, (ii) quien lo represente legalmente, (iii) el Director Médico o Responsable Técnico del establecimiento de salud responsable de la atención del mismo; o, (iv) el responsable del establecimiento de salud perteneciente al Sistema Nacional de Salud, según corresponda, deberá́ presentar una solicitud a la ARCSA, a la cual se adjuntarán los siguientes requisitos:

  1. Detalle de/los producto/s a importar, emitida por el Médico Tratante, o Director Médico del establecimiento de salud que brinda la asistencia al/los paciente/s;
  2. Informe clínico suscrito por el Médico Tratante o Director Médico del establecimiento de salud que brinda la asistencia al/los paciente/s, con el justificativo médico sobre la necesidad de/los paciente/s de recibir dicho tratamiento con los productos a importar.
  3. Copia del Registro Sanitario del producto, o su equivalente, emitido por la autoridad competente del país del cual se realizará la importación del mismo, cuando corresponda;
  4. Consentimiento informado suscrito por el paciente o su representante legal, y el Médico Tratante o Director Médico del establecimiento de salud que brinda la asistencia al/los paciente/s, cuando corresponda;
  5. Copia de la factura, proforma o documento equivalente emitido por el establecimiento proveedor del producto en el extranjero, en donde se detalle el/los producto/s que se van a importar.

En caso de que la emergencia sanitaria sea declarada por acto de poder público, la instancia del Ministerio de Salud Pública que así́ lo requiera, deberá́ presentar:

  1. Detalle del/os producto/s a importar, emitida y aprobada por el responsable del establecimiento de salud perteneciente al Sistema Nacional de Salud

Condiciones y prohibiciones:

  • Los productos a los que se refiere la presente normativa técnica sanitaria serán importados en las cantidades específicas de acuerdo a lo autorizado por la ARCSA.
  • Se prohíbe la importación de los productos objetos de esta resolución, en caso de identificarse alertas sanitarias relacionadas con los mismos.

Originally published 24 de mayo de 2016

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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