1. LEY N.o 29459 - LEY DE LOS PRODUCTOS FARMACÉUTICOS, DISPOSITIVOS MÉDICOS Y PRODUCTOS SANITARIOS.
- Author
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Dongo, Víctor
- Subjects
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DRUG laws , *MEDICAL equipment , *HEALTH products , *MEDICAL supplies , *CLINICAL drug trials , *PHARMACEUTICAL policy , *PHARMACEUTICAL industry - Abstract
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]
- Published
- 2009