There is intense pressure in the pharmaceutical parallel import sector: Parallel importers process large quantities of already serialized pharmaceuticals daily through complex repackaging processes. Every package must be inspected, processed, reserialized, and made available for the target market in accordance with the requirements of the EU Falsified Medicines Directive. At the same time, demands for efficiency, traceability, and compliance are increasing.
Many solutions for parallel import focus either on processing existing serial numbers or on managing new serialization data. The partnership between medAspis and tracekey combines both areas into a coordinated process and reduces the manual effort required at the interfaces between operational processing and compliance.
The requirements for the parallel import of pharmaceuticals are constantly increasing. Changing serialization regulations and rising compliance requirements are adding to the complexity throughout the entire value chain. At the same time, processes must remain cost-effective, scalable, and audit-ready.
High Scan Volumes
Thousands of packages must be inspected and processed in the receiving area without compromising productivity.
Regulatory Requirements
New serial numbers must be generated, managed, and reported to the relevant systems in compliance with regulations.
Lack of Process Integration
Many solutions cover only individual process steps, creating additional interfaces and requiring manual effort.
Time-Sensitive Processes
There must be no unnecessary delays between verification, repackaging, and reintroduction to the market.
The partnership between medAspis and tracekey was developed specifically to meet the needs of parallel importers.
Instead of using different systems to handle individual process steps, medAspis and tracekey offer a comprehensive solution tailored to the needs of parallel importers. With Lean FMD and the Speed Scanner, medAspis ensures the rapid capture, verification, and deactivation of existing serial numbers. Building on this, mytracekey PHARMA generates and manages the new serial numbers, exchanges them with business partners as needed, and supports the compliant distribution of repackaged products to the respective target market. This creates an integrated workflow that links physical goods processes with digital serialization.
Efficient Processing of Large Volumes: Even large quantities of packages can be processed efficiently, without manual data transfers between systems and without slowing down existing processes.
Less Manual Effort: Automated processes reduce the effort required for verification, serialization, and data management.
Audit Readiness and Compliance: Seamless traceability of all relevant serialization events.
Less Effort Required for Integration: The solutions from medAspis and tracekey have been specifically designed to work together, allowing data to be used throughout the parallel import process without any manual intermediate steps.
Combine fast scanning processes with user-friendly serialization to lay the foundation for compliance, efficiency, and scalability in parallel imports.
This joint solution is designed specifically for parallel importers, parallel distributors, and repackaging companies that process pharmaceuticals for various target markets. Pharmaceutical wholesalers, logistics service providers, and companies with high scanning and serialization volumes can also benefit from the combination of Lean FMD and mytracekey PHARMA.
No. Lean FMD was designed to integrate with existing warehouse, ERP, and WMS processes. At the same time, mytracekey PHARMA offers a user-friendly, cloud-based platform to support existing serialization processes as seamlessly as possible.
The solution supports parallel importers from the time goods are received through to the subsequent distribution of a product. It facilitates the verification and deactivation of existing serial numbers, repackaging processes, and the creation, management, and use of new serial numbers for new target markets.