Drug Serialisation in Portugal: Traceable Quality System for GUR Companies
Eight companies one solution
The new regulatory environment of the European Union drawn by the Falsified Medicines Directive 2011/62/EU has redefined the concepts of patient safety and integrity by increasing the transparency of the supply chain. Above all, it harmonised the product safety requirements across all member states. To handle the complexities of serialisation effectively and to exchange implementation-specific knowledge and experience, eight Portuguese pharmaceutical companies united their efforts. BASI, Bial, Bluepharma, Edol, Medinfar, Sidefarma, Sofarimex and Tecnimede formed the Global User Requirements (GUR) working group at the end of 2015. GUR members focused on outlining the major project requirements, as well as on finding the right serialisation solution to be installed in all the production lines of the group.