CRED Managing Variations Effectively

EU Falsified Medicines Legislation: implementation of safety features • Falsified medicines Directive 2011/62/EU on prevention of the entry into the legal supply chain of falsified medicinal products • Delegated Act on Safety features (2016/161) lays down the technical specifications of the unique identifier ; the modalities for the verification of the safety features; “White and Black lists”: medicines exempted or included.

Unique identifier (UI)

Anti-tampering device (ATD)