reference medicinal product - TOPRA
reference medicinal product - TOPRA
reference medicinal product - TOPRA
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Legal Definition of a Generic<br />
Generic <strong>medicinal</strong> <strong>product</strong> (Art. 10.2b of 2001/83/EC)<br />
» Shall mean a <strong>medicinal</strong> <strong>product</strong> which has:<br />
» the same qualitative and quantitative composition in active<br />
substances<br />
» and the same pharmaceutical form as the <strong>reference</strong> <strong>medicinal</strong><br />
<strong>product</strong><br />
» and whose bioequivalence with the <strong>reference</strong> <strong>medicinal</strong> <strong>product</strong><br />
has been demonstrated by appropriate bioavailability studies<br />
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