Rubrik: Fachthemen
(Treffer aus pharmind, Nr. 05, Seite 612 (2018))
Voglmaier M
Compliance with the EU FMD Directive / Challenges for data management · Voglmaier M · TraceLink Europe, Uxbridge, United Kingdom
Over 50 countries will have introduced serialisation legislation in the fight against counterfeiting, a problem which costs the industry billions every year, and more importantly, compromises patient safety. The complexity of introducing a serialisation solution has, to date, been largely underestimated by the entire supply chain – evidenced by the FDA’s decision to delay active enforcement in the US due to a lack of readiness. In the EU, many manufacturers and packaging organisations have simply been too slow to begin serialisation programmes that will ensure compliance ahead of the 2019 deadline. In a preview of the TraceLink’s 2017 Global Drug Supply, ...