Elementor #4160
For a generic pharmaceutical company, the Summary of Product Characteristics (SmPC) is not a creative writing exercise. It is a regulatory compliance task governed by the Principle of Concordance. The “Mirror Effect” is the industry standard approach: your generic SmPC must act as a mirror of the Reference Medicinal Product (the princeps) for all clinical and pharmacological data, while accurately reflecting the specific quality attributes of your own formulation. This guide breaks down the SmPC section by section, identifying what to copy, what to adapt, and where the data originates within your Common Technical Document (CTD). Part 1: The Philosophy of the Mirror Why copy the Reference Product? Your generic marketing authorization is based on Article 10(1) of Directive 2001/83/EC. You are not proving safety and efficacy from scratch; you are proving