Elaboración de dossier para la obtención de Registro Sanitario de una Especialidad Farmacéutica de categoría 1
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El presente informe de prácticas pre profesionales tuvo la finalidad de elaborar un dossier para obtener el registro sanitario de una especialidad farmacéutica de categoría 1, el cual es presentado ante nuestra autoridad regulatoria que es la Dirección General de Medicamentos, Insumos y Drogas (DIGEMID), mediante la Ventanilla Única de Comercio Exterior (VUCE), que es una página virtual, en la cual el usuario puede realizar todo tipo de trámites y pagos que sean requeridos. El obtener el Registro Sanitario implica que tanto el laboratorio como la droguería tiene la autorización para fabricación, importación y comercialización de un producto farmacéutico, el cual debe cumplir con 3 principios de la regulación: eficacia, seguridad y calidad. Se concluyó que se realizó la elaboración del dossier en el cual se presentaron ciertos requisitos como: especificaciones técnicas y metodología analítica del Ingrediente Farmacéutico Activo (IFA), Producto Terminado (PT) y Excipientes, especificaciones técnicas del material de envase, estudios de estabilidad entre otros requisitos necesarios para obtener el registro sanitario.
ABSTRACT The purpose of this report on pre-professional practices was to prepare a dossier to obtain the sanitary registration of a category 1 pharmaceutical specialty, which is presented to our regulatory authority, which is the General Directorate of Medicines, Supplies and Drugs (DIGEMID). through the Foreign Trade Single Window (VUCE), which is a virtual page, in which the user can carry out all kinds of procedures and payments that are required. Obtaining the Sanitary Registry implies that both the laboratory and the drugstore have the authorization to manufacture, import and commercialize a pharmaceutical product, which must comply with 3 principles of the regulation: efficacy, safety and quality. It was concluded that the preparation of the dossier was carried out in which certain requirements were presented, such as: technical specifications and analytical methodology of the Active Pharmaceutical Ingredient (API), Finished Product (TP) and Excipients, technical specifications of the packaging material, stability studies between other requirements necessary to obtain the sanitary registration.
ABSTRACT The purpose of this report on pre-professional practices was to prepare a dossier to obtain the sanitary registration of a category 1 pharmaceutical specialty, which is presented to our regulatory authority, which is the General Directorate of Medicines, Supplies and Drugs (DIGEMID). through the Foreign Trade Single Window (VUCE), which is a virtual page, in which the user can carry out all kinds of procedures and payments that are required. Obtaining the Sanitary Registry implies that both the laboratory and the drugstore have the authorization to manufacture, import and commercialize a pharmaceutical product, which must comply with 3 principles of the regulation: efficacy, safety and quality. It was concluded that the preparation of the dossier was carried out in which certain requirements were presented, such as: technical specifications and analytical methodology of the Active Pharmaceutical Ingredient (API), Finished Product (TP) and Excipients, technical specifications of the packaging material, stability studies between other requirements necessary to obtain the sanitary registration.
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Keywords
Registro sanitario, Especificaciones técnicas, Producto farmacéutico