Elaboración del dossier y secuencia de procesos para la obtención del registro sanitario de una especialidad farmacéutica mediante la VUCE
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Date
2022
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Publisher
Universidad Nacional de Trujillo
Abstract
Este informe de prácticas pre profesionales tiene como objetivo, documentar las actividades realizadas y desempeño en el área de Asuntos Regulatorios dentro de una droguería en la ciudad de Lima, dedicada a importar y comercializar medicamentos genéricos, productos biológicos, agentes de diagnóstico y dispositivos médicos de clase I, II y III. El área en mención se encarga de realizar todos los tramites de Registro Sanitarios, como inscripción, reinscripción, cambios mayores y menores, consultas técnicas y otros; frente a la autoridad regulatoria del país, la DIRECCIÓN GENERAL DE MEDICAMENTOS INSUMOS Y DROGAS (DIGEMID), siguiente la normativa vigente. En el periodo de duración de las prácticas, se evaluó con indicadores de desempeño; como el conocimiento de las normativas D.S. 016-2011 y sus modificatorias, La Ley General de Salud 26842, La Ley 29459 “Ley de productos farmacéuticos, dispositivos médicos y productos sanitarios”, y otras normativas actuales; así como la proactividad y capacidad de adquirir conocimientos prácticos respecto a la inscripción de registro sanitario, como algunos ejemplos. En tal sentido, en el presente informe, se elaboró un dossier para la inscripción de un Registro Sanitario del producto “Enalapril 10mg Tableta” mediante la Ventanilla Única de Comercio Exterior – VUCE, siguiendo los requerimientos de la normativa actual; y también, se evidenció la secuencia de procesos para la importación y comercialización de una especialidad farmacéutica.
ABSTRACT The objective of this pre-professional internship report is to document the activities and performance in the area of Regulatory Affairs in a drugstore in the city of Lima, dedicated to import and commercialize generic drugs, biological products, diagnostic agents and class I, II and III medical devices. The area in question is responsible for carrying out all the procedures of Health Registration, such as registration, re-registration, major and minor changes, technical consultations and others; before the regulatory authority of the country, the DIRECCIÓN GENERAL DE MEDICAMENTOS INSUMOS Y DROGAS (DIGEMID), following the current regulations. For the duration of the internship, I was evaluated with performance indicators, such as knowledge of the regulations D.S. 016-2011 and its amendments, the General Health Law 26842, Law 29459 "Law of pharmaceuticals, medical devices and medical devices," and other current regulations, as well as proactivity and ability to acquire practical knowledge regarding the registration of health registration, as some examples. In this sense, in this report, a dossier is prepared for the registration of a Sanitary Registration of the product "Enalapril 10mg Tablet" through the Foreign Trade Single Window - VUCE, following the requirements of the current regulations; and also, the sequence of processes for the importation and commercialization of a pharmaceutical specialty is evidenced
ABSTRACT The objective of this pre-professional internship report is to document the activities and performance in the area of Regulatory Affairs in a drugstore in the city of Lima, dedicated to import and commercialize generic drugs, biological products, diagnostic agents and class I, II and III medical devices. The area in question is responsible for carrying out all the procedures of Health Registration, such as registration, re-registration, major and minor changes, technical consultations and others; before the regulatory authority of the country, the DIRECCIÓN GENERAL DE MEDICAMENTOS INSUMOS Y DROGAS (DIGEMID), following the current regulations. For the duration of the internship, I was evaluated with performance indicators, such as knowledge of the regulations D.S. 016-2011 and its amendments, the General Health Law 26842, Law 29459 "Law of pharmaceuticals, medical devices and medical devices," and other current regulations, as well as proactivity and ability to acquire practical knowledge regarding the registration of health registration, as some examples. In this sense, in this report, a dossier is prepared for the registration of a Sanitary Registration of the product "Enalapril 10mg Tablet" through the Foreign Trade Single Window - VUCE, following the requirements of the current regulations; and also, the sequence of processes for the importation and commercialization of a pharmaceutical specialty is evidenced
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Keywords
Registro Sanitario, DIGEMID, VUCE, Asuntos regulatorios.