Cadena de procesos para la obtención del registro sanitario de un medicamento en Ecuador
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Date
2021
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Journal ISSN
Volume Title
Publisher
Universidad Nacional de Trujillo
Abstract
En el presente informe se describe el proceso por el que pasó el dossier del producto farmacéutico anticonceptivo Postpil, desde la orden de trabajo emitida por la empresa DKT INTERNATIONAL a RAFINT hasta la aprobación del registro sanitario por parte de la autoridad regulatoria de ecuador ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria) y la emisión del respectivo certificado de Registro Sanitario. El proceso de revisión, organización y trabajo grupal realizados por RAFINT se realizaron de tal modo que el dossier cumpla con el Acuerdo ministerial 586 Reglamento de registro sanitario para medicamentos en general
ABSTRACT This report describes the process that the dossier of the Postpil contraceptive pharmaceutical product went through, from the work order issued by DKT INTERNATIONAL to RAFINT until the approval of the sanitary registration by the regulatory authority of Ecuador ARCSA (National Agency for Regulation, Control, and Sanitary Surveillance) and the issuance of the respective Sanitary Registration certificate. The review process, organization and group work performed by RAFINT were conducted in such a way that the dossier complies with Ministerial Agreement 586 Regulation of sanitary registration for medicines in general
ABSTRACT This report describes the process that the dossier of the Postpil contraceptive pharmaceutical product went through, from the work order issued by DKT INTERNATIONAL to RAFINT until the approval of the sanitary registration by the regulatory authority of Ecuador ARCSA (National Agency for Regulation, Control, and Sanitary Surveillance) and the issuance of the respective Sanitary Registration certificate. The review process, organization and group work performed by RAFINT were conducted in such a way that the dossier complies with Ministerial Agreement 586 Regulation of sanitary registration for medicines in general
Description
Keywords
Registro sanitario, Anticonceptivo