The deadlines for compliance with the Drug Supply Chain Security Act (DSCSA) in the United States are getting closer every day. US hospital and retail pharmacies are racing to meet new serialization, verification, and 2D barcode requirements before November 2020, followed by a mandate for full supply chain digitalization in 2023.
At the same time, many pharmacies across Europe are struggling to achieve compliance with the European Union’s Falsified Medicines Directive (FMD), which became law in February 2019. For companies lagging on EU FMD compliance—or those that invested in solutions which failed to deliver promised results—the time to refocus on compliance efforts is now.
TraceLink is a global compliance partner that enables retail and hospital pharmacies in the US and EU to improve operational efficiency, add business value, and achieve compliance with their region’s unique supply chain serialization and product verification requirements.
Benefits for US pharmacies:
- Meet all DSCSA serialization and verification requirements, from lot-level traceability to full supply chain digitalization.
- Easily connect with trade partners and eliminate point to point integration risk.
- Manage transaction histories, information, and statements for both serialized and non-serialized items.
- Support for a broad set of use cases such as drop shipments, loan/borrow, and 340B programs.
Benefits for EU pharmacies:
- Tested, approved, and secure integrations to all EU National Medicine Verification Systems.
- Seamless, secure connections to the EU hub for document processing and compliance reporting.
- Unmatched expertise with a proven track record of helping more than 350 companies achieve EU FMD compliance.
Achieve compliance and streamline operations with TraceLink’s healthcare solution, including:
Electronically connect to and exchange data with direct trade partners, consolidate multiple sources of compliance data, and ensure enterprise connectivity with all suppliers.
This EPCIS repository enables pharmacies to manage events associated with serialization data, store information connected to every drug received, establish a digitalization platform, and enable analytics.
Product Information Manager
Receive real-time product master data updates, instantly receive authentication responses, and ensure recalled products are quickly identified.
Capture product receipt and all serialized data and populate a serialized data repository. TraceLink’s mobile scanning integrates fully with other TraceLink applications and existing scanning solutions.
Analytics and Reporting
Report on stored data, reduce costs through improved inventory analysis, and provide end-to-end visibility to the entire enterprise.