Propuesta de procedimiento operativo estándar para inscripción simplificada del registro sanitario para medicamentos aprobados en países de alta vigilancia sanitaria
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Date
2021
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Universidad Nacional de Trujillo
Abstract
El presente informe tuvo como objetivo elaborar un procedimiento operativo estándar para inscripción simplificada de registro sanitario para medicamentos aprobados en países de alta vigilancia sanitaria, según normativa vigente. Se realizó una revisión de las normas vigentes y se redactó un procedimiento operativo estándar a implementar denominado POE- FRAPE-001 inscripción simplificada de registro sanitario de medicamentos aprobados en países de alta vigilancia sanitaria, y tres formatos a utilizar en el proceso, FOR- FRAPE-001 formato consideraciones para el expediente de inscripción simplificada de registro sanitario de medicamentos aprobados en países de alta vigilancia sanitaria; FOR- FRAPE-002 Lista de verificación para la revisión del expediente de inscripción simplificada de registro sanitario de medicamentos aprobados en países de alta vigilancia sanitaria; y FOR- FRAPE-003 Formato de seguimiento al expediente. El procedimiento operativo estándar pretende optimizar el proceso que se lleva a cabo cuando se requiere solicitar la inscripción de productos nuevos para ser comercializados por una droguería, reduciendo los errores operativos, haciendo un uso eficiente del tiempo de trabajo, lo que permitirá al área de asuntos regulatorios obtener registros sanitarios que cumplan con la normativa vigente según Decreto Supremo Nº 016-2011-SA- Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y productos Sanitarios y modificatorias , y lo correspondiente en el TUPA 204 que fue modificado el 03 de agosto del 2019. Se elaboró la propuesta de un procedimiento operativo estándar de registro sanitario para medicamentos aprobados en países de alta vigilancia
ABSTRACT The objective of this report was to develop a standard operating procedure for the simplified registration of the health registry for approved drugs in countries with high health surveillance, according to current regulations. A review of the current regulations was carried out and a standard operating procedure to be implemented called POE-FRAPE-001 simplified registration of the sanitary registry of approved drugs in countries with high sanitary surveillance was drawn up, and three formats to be used in the process, FOR-FRAPE -001 format considerations for the simplified registration file of the sanitary registry of approved drugs in countries with high sanitary surveillance; FOR-FRAPE-002 Checklist for the review of the simplified registration file of the sanitary registry of approved drugs in countries with high sanitary surveillance; and FOR-FRAPE- 003 File follow-up format. The standard operating procedure aims to optimize the process that is carried out when it is required to request the registration of new products to be marketed by a drugstore, reducing operational errors, making efficient use of work time, which will allow the business area regulatory obtain health records that comply with current regulations according to Supreme Decree No. 016-2011-SA- Regulations for the registration, control and health surveillance of pharmaceutical products, medical devices and health products and amendments, and the corresponding in the TUPA 204 that was modified on August 3, 2019. The proposal of a standard operating procedure for sanitary registration for drugs approved in high surveillance countries was prepared
ABSTRACT The objective of this report was to develop a standard operating procedure for the simplified registration of the health registry for approved drugs in countries with high health surveillance, according to current regulations. A review of the current regulations was carried out and a standard operating procedure to be implemented called POE-FRAPE-001 simplified registration of the sanitary registry of approved drugs in countries with high sanitary surveillance was drawn up, and three formats to be used in the process, FOR-FRAPE -001 format considerations for the simplified registration file of the sanitary registry of approved drugs in countries with high sanitary surveillance; FOR-FRAPE-002 Checklist for the review of the simplified registration file of the sanitary registry of approved drugs in countries with high sanitary surveillance; and FOR-FRAPE- 003 File follow-up format. The standard operating procedure aims to optimize the process that is carried out when it is required to request the registration of new products to be marketed by a drugstore, reducing operational errors, making efficient use of work time, which will allow the business area regulatory obtain health records that comply with current regulations according to Supreme Decree No. 016-2011-SA- Regulations for the registration, control and health surveillance of pharmaceutical products, medical devices and health products and amendments, and the corresponding in the TUPA 204 that was modified on August 3, 2019. The proposal of a standard operating procedure for sanitary registration for drugs approved in high surveillance countries was prepared
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Keywords
Medicamento aprobado. Registro sanitario. Procedimiento operativo estándar