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A medicinal product not defined within the description of an IMP and may be considered a background, challenge, concomitant, endpoint, escape, or rescue medication dosed for preventive, diagnosis, or therapeutic reasons. The medicinal product can be provided by the study sponsor or the clinical site.
Publication Source: ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIPs)
Publication Date: 2013
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