Course Title: Pharmaceutical Supply Chain Integrity and Security
Chapter: Regulations in Europe
Lecture: The Delegated Act – Commission Delegated Regulation (EU) 2016/161 of October 2nd, 2015
The Directive 83/EC from 2001, as amended by the Falsified Medicines Directive, provides for measures to prevent falsified medicinal products from entering legitimate supply chain. The Delegated Act details the rules for safety features on the packaging of medicinal products for human use, ensuring their identification and authenticity.
The Commission assessed the benefits, cost and cost-effectiveness of different policy options and incorporated core elements of their assessment in this regulation. Unified rules within the Union have to be implemented uniformly by all member states to be effective.
The core principle set out in this regulation is end-to-end verification of all medicinal products bearing the safety features, and additional verification of high-risk products by wholesalers. This means that product identity and authenticity will be verified at the beginning of the supply chain, and at the end, when the products are supplied to the public.