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European Prescription Drug Tracking


The recent focus has been on regulations relating to the 2011 European Falsified Medicines Directive (FMD), referred to as DIRECTIVE 2011/62/EU, which amends EU Directive 2001/83/EC relating to the prevention of entry of falsified medicinal products into the legal supply chain in Europe.

The specific details for the implementation are being defined now and the law is scheduled to become effective in 2017.

The requirements for encoding packages and for tracking product information have been widely discussed and are integrated into business strategy and requirements for our clients. Several organizations, including EDQM and European Federation of Pharmaceutical Industries and Associations (EFPIA) are preparing guidance to comply with the 2011 European Falsified Medicines Directive (FMD).

There are several very specific requirements for manufacturers and wholesalers that will be defined based on your company procedures and business systems.

Projects have delivered (1) strategy, (2) project roadmap and plans, (3) User Requirement Specification (URS) for (a) enterprise serialization, (b) packaging systems, (c) warehouse/shipping (referred to as EDGE), and (d) regulatory reporting such as e-pedigree, (4) contract manufacturer and logistics provider requirements and governance, (5) compliance with global regulatory requirements, (6) functional and design specifications, (8) business system and packaging designs and architectures, (9) pilot planning and scenarios, (10) GAMP based validation, and (11) vendor selection.

Projects have included solutions involving serialization, track and trace, electronic pedigree (e-Pedigree), country traceability reporting (i.e., Turkish Ministry of Health, China, etc.), radio frequency identification (RFID), barcoding and scanning, GS1 electronic product code information services (EPCIS), supply chain, warehousing and Electronic Data Interchange (EDI). Pharma Logic Solutions is a longstanding Solution Provider for GS1 US Healthcare.

Strategy, business and user requirements, designs and implementations have included solutions from SAP (ECC, SCM, Aii, OER, Aie), JD Edwards, Oracle (OPSM, OPM), Manhattan Associates, MAPICS, Acsis (ProducTrak), Axway, rfXcel, Frequentz, Systech, Optel Vision (TrackSafe, Line Master, PharmaProof), Cognex, Mettler Toledo, Seidenader (Körber Medipak), Antares Vision (Xyntek), Laetus, ROC-IT Solutions, TAKE Solutions, Uhlmann, Nosco, Werum PAS-X, Tracelink, Videojet and others.

Contact us to discuss your needs and contrast the Pharma Logic Solutions solutions against previous providers to see why our approach is the ideal solution. 


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Updated: Saturday July 20, 2024.