Bibliographic Details
| Title: |
LEY N.o 29459 - LEY DE LOS PRODUCTOS FARMACÉUTICOS, DISPOSITIVOS MÉDICOS Y PRODUCTOS SANITARIOS. |
| Alternate Title: |
LAW No 29459 OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND SANITARY PRODUCTS. |
| Authors: |
Dongo, Víctor1 vdongoz@yahoo.es |
| Source: |
Revista Peruana de Medicina Experimental y Salud Pública. 2009, Vol. 26 Issue 4, p517-529. 13p. 1 Chart, 6 Graphs. |
| Subjects: |
DRUG laws, MEDICAL equipment, HEALTH products, MEDICAL supplies, CLINICAL drug trials, PHARMACEUTICAL policy, PHARMACEUTICAL industry |
| Geographic Terms: |
PERU |
| Abstract (English): |
The Law of Pharmaceutical Products, Medical devices and Sanitary products No. 29459, published in November, 2009, guides the regulations of these products, substituting Chapter III of the General Law of Health No. 26842. Through this law, the most questioned aspects of the Law No. 26842 have been modified, establishing requisites to apply for the sanitary registry of pharmaceutical products that are necessary to guarantee their efficacy, security and quality, also including the required terms for their evaluation and the cost of the health registration fee must be according to all what implies to give the registry, including control activities and health surveillance. It also resets the requirement of the operating health approval, prior to the initiation of the activities, and having had a previous inspection to verify the accomplishment of the actual legal devices. The law also incorporates three specific chapters about access, rational use of pharmaceutical products, medical devices and health products, as well as a chapter on research. [ABSTRACT FROM AUTHOR] |
| Abstract (Spanish): |
La Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios No. 29459, publicada en noviembre de 2009, orienta la regulación de estos productos sustituyendo al Capítulo III de la Ley General de Salud No. 26842. A través de esta Ley se ha modificado los aspectos más cuestionados en la Ley No. 26842, al establecer requisitos para solicitar el registro sanitario de productos farmacéuticos que son necesarios para garantizar su eficacia, seguridad y calidad, incluyendo también los plazos necesarios para su evaluación y que el costo de la tasa por registro sanitario sea en función de lo que implique otorgar dicho registro, lo cual incluye también las actividades de control y vigilancia sanitaria. Así mismo, restablece la exigencia de la autorización sanitaria de funcionamiento, previa al inicio de las actividades, previa inspección para verificar el cumplimiento de los dispositivos legales vigentes. La Ley incorpora también tres capítulos específicos sobre acceso, uso racional de productos farmacéuticos, dispositivos médicos y productos sanitarios, así como un capítulo de investigación. [ABSTRACT FROM AUTHOR] |
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Copyright of Revista Peruana de Medicina Experimental y Salud Pública is the property of Instituto Nacional de Salud (Peru) and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| Database: |
MedicLatina |
