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Nov 2018 - IDC Perspective - Doc # EMEA44354218

Falsified Medicines Directive: Are You Ready for Smart Compliance?

By: Nino GiguashviliSenior Research Analyst, Silvia PiaiSenior Research Manager, EMEA

Abstract

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


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