Module 3 2019

Regulatory Dossier

➢ Where is this information contained: S.1 General Information S.1.1 Nomenclature S.1.2 Structure S.1.3 General Properties

S.3 Characterization S.3.1 Elucidation of Structure and other Characteristics S.3.2 Impurities

Nomenclature and Characterisationof the Active Ingredient

The Organisation for Professionals in Regulatory Affairs