Falsified Medicines Directive: Are You Ready for Smart Compliance?

Falsified Medicines Directive: Are You Ready for Smart Compliance?

Compliance with EU's FMD is a top priority of pharmaceutical manufacturers and wholesalers in Europe. By February 9, 2019, companies selling pharmaceutical products in most countries of the EEA must have their drug serialization systems up and running in full compliance with the new FMD requirements on drug serialization and traceability. Most companies have started their compliance efforts, but many are some distance away from full compliance and are struggling to meet the soon-approaching deadline — especially smaller manufacturers and contract manufacturing organizations."Serialization initiatives can be rather resource intensive, but the benefits can go well beyond compliance. Addressing drug serialization and traceability projects with the right set of digital technologies can enable life science companies to achieve "smart compliance" and to extract long-term business value from regulatory-driven technology investments." — Senior Research Analyst Nino Giguashvili, IDC Health Insights Europe

Please Note: Extended description available upon request.

Executive Snapshot
Situation Overview
Drug Serialization in Europe: The Time to Act Is Now
EU's Falsified Medicines Directive
ISO IDMP on the Horizon
The Final Countdown to FMD
Innovation Through Serialization: From Basic Compliance to STAR(S)2
Standardize: Mastering the Data
Track: Enabling End-to-End Traceability with IoT
Analyze and React: Making Actions Data-Driven with Advanced Analytics
Share Securely: Empowering Data Exchange and Collaboration with Cloud, Guarded by Future-Proof Security Tools
Advice for the Technology Buyer
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