Elaboración de un dossier de una especialidad farmacéutica de uso odontológico para la obtención del registro sanitario
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Date
2022
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Journal ISSN
Volume Title
Publisher
Universidad Nacional de Trujillo
Abstract
En el presente informe de prácticas pre-profesionales tiene como objetivos elaborar un flujograma del proceso de elaboración de un dossier y la elaboración del dossier de una especialidad farmacéutica de uso odontológico en el área de asuntos regulatorios de un laboratorio farmacéutico nacional, es un estudio tipo descriptivo que tiene como finalidad proporcionar conocimientos para la inscripción de una especialidad farmacéutica y lograr la obtención del registro sanitario. Se reviso cada requisito aplicable para la inscripción de una especialidad farmacéutica categoría 1, tomando en cuenta los criterios de evaluación de la Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) y la normativa aplicable a cada requisito, finalmente el dossier se somete mediante Ventanilla Única de Comercio Exterior (VUCE). Se concluyó que, se describió el proceso de elaboración de un dossier encontrando similitud en las especialidades farmacéuticas, diferenciándose en los requisitos por categorías y el tiempo de resolución del dossier en función de su complejidad y la elaboración de un dossier de una especialidad farmacéutica de uso odontológico
ABSTRACT In the present report of pre-professional practices it has as objectives to elaborate a flowchart of the process of elaboration of a dossier and the elaboration of the dossier of a pharmaceutical specialty of odontological use in the area of regulatory affairs of a national pharmaceutical laboratory, it is a study type descriptive whose purpose is to provide knowledge for the registration of a pharmaceutical specialty and obtain the health registration. Each applicable requirement for the registration of a category 1 pharmaceutical specialty was reviewed, taking into account the evaluation criteria of the General Directorate of Medicines, Supplies and Drugs (DIGEMID) and the regulations applicable to each requirement, finally the dossier is submitted through the Window Single Foreign Trade (VUCE). It was concluded that the process of preparing a dossier was described, finding similarities in the pharmaceutical specialties, differing in the requirements by categories and the resolution time of the dossier based on its complexity and the preparation of a dossier of a pharmaceutical specialty for dental use.
ABSTRACT In the present report of pre-professional practices it has as objectives to elaborate a flowchart of the process of elaboration of a dossier and the elaboration of the dossier of a pharmaceutical specialty of odontological use in the area of regulatory affairs of a national pharmaceutical laboratory, it is a study type descriptive whose purpose is to provide knowledge for the registration of a pharmaceutical specialty and obtain the health registration. Each applicable requirement for the registration of a category 1 pharmaceutical specialty was reviewed, taking into account the evaluation criteria of the General Directorate of Medicines, Supplies and Drugs (DIGEMID) and the regulations applicable to each requirement, finally the dossier is submitted through the Window Single Foreign Trade (VUCE). It was concluded that the process of preparing a dossier was described, finding similarities in the pharmaceutical specialties, differing in the requirements by categories and the resolution time of the dossier based on its complexity and the preparation of a dossier of a pharmaceutical specialty for dental use.
Description
Keywords
Dossier, Especialidad farmacéutica, Asuntos regulatorios, Registro sanitario.