Spring Intro 2023

16/02/2023

GENERICS

The Organisation for Professionals in Regulatory Affairs

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What Is A Generic?

What Is A Generic product? Article 10(2)(b), Directive 2001/83/EC: “generic medicinal product” shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product , and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies

• Same active substance • Same quantity of active substance • Same pharmaceutical form • Bioequivalent

…as the reference product

The Organisation for Professionals in Regulatory Affairs

8