Post-registration clinical trial of a medicinal product for medical use
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Главная Documents Vocabulary Post-registration clinical trial of a medicinal product for medical use
Post-registration clinical trial of a medicinal product for medical use

Post-registration clinical trial of a medicinal product for medical use is a clinical trial of a medicinal product for medical use conducted by the manufacturer of the medicinal product which is put in civil circulation after the state registration, for the purpose of additional collection of data on its safety and efficacy, extension of indications of such medicinal product, as well as for the purpose of revealing adverse reactions of the medicinal product on the patients

Source: Russian Federation Law №61-FZ March 24, 2010 "On Circulation of Medicines"

 
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