Elaboración de dossier para su reinscripción de soluciones oftálmicas en un laboratorio farmacéutico nacional
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El presente informe de prácticas pre profesionales tuvo como objetivo elaborar un dossier para la reinscripción de soluciones oftálmicas en un laboratorio farmacéutico nacional en el área de asuntos regulatorios. La metodología de trabajo se basó en la revisión y análisis de la normativa vigente Ley 29459, Ley de los productos farmacéuticos, dispositivos médicos y productos sanitarios; así también, DS. N° 016- 2011-SA, Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos Dispositivos Médicos y Productos Sanitarios. Se obtuvo como resultados la clasificación de los requisitos de acuerdo con el tipo de categoría (I, II, III) para solicitar el registro sanitario de los productos farmacéuticos, los cuales son necesarios para garantizar su eficacia, seguridad y calidad; y la elaboración de ocho dosieres de productos para su reinscripción de acuerdo con el tipo de categoría (I, II y III). Se concluye que, se elaboraron ocho dosieres para la reinscripción de soluciones oftálmicas en un laboratorio farmacéutico nacional de acuerdo a la normatividad vigente y se informó la elaboración de los dosieres al jefe de asuntos regulatorios, los cuales fueron conformes, cumpliendo con los requisitos de acuerdo a la normativa vigente.
ABSTRACT This report of pre-professional practices has as purpose develop dossier for the re- registration of ophthalmic solutions in a national pharmaceutical laboratory in the area of regulatory affairs. The work methodology was based on the review and analysis of current regulations Law 29459, Law on pharmaceutical products, medical devices and health products; so too, DS. N° 016-2011-SA, Regulation for the Registration, Control and Health Surveillance of Pharmaceutical Products, Medical Devices and Health Products. The results were the classification of the requirements according to the type of category (I, II, III) to request the sanitary registration of pharmaceutical products, which are necessary to guarantee their efficacy, safety and quality; and the preparation of eight dossiers of products for re-registration according to the type of category (I, II and III). It is concluded that, Eight dossiers were prepared for the re-registration of ophthalmic solutions in a national pharmaceutical laboratory in accordance with current regulations and the preparation of the dossiers was reported to the head of regulatory affairs, which were in accordance, complying with the requirements according to current regulations.
ABSTRACT This report of pre-professional practices has as purpose develop dossier for the re- registration of ophthalmic solutions in a national pharmaceutical laboratory in the area of regulatory affairs. The work methodology was based on the review and analysis of current regulations Law 29459, Law on pharmaceutical products, medical devices and health products; so too, DS. N° 016-2011-SA, Regulation for the Registration, Control and Health Surveillance of Pharmaceutical Products, Medical Devices and Health Products. The results were the classification of the requirements according to the type of category (I, II, III) to request the sanitary registration of pharmaceutical products, which are necessary to guarantee their efficacy, safety and quality; and the preparation of eight dossiers of products for re-registration according to the type of category (I, II and III). It is concluded that, Eight dossiers were prepared for the re-registration of ophthalmic solutions in a national pharmaceutical laboratory in accordance with current regulations and the preparation of the dossiers was reported to the head of regulatory affairs, which were in accordance, complying with the requirements according to current regulations.
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Keywords
Registro sanitario, dossier, asuntos regulatorios