TraceWay Track&Trace system is a hardware-software complex that provides solutions for pharmaceutical market participants in introducing medications labeling and tracking. It is optimized for the serialization, aggregation, medications tracking and uploading the necessary reports to the federal government information system MMMP (monitoring the movement of medicinal products) in full compliance with decrees of the Government of the Russian Federation. TraceWay has a certificate of state registration meeting the international standards GS1, GMP, GAMP 5, GSP, GDP.
Specification documents regulating medications mandatory labeling
RF Government Regulation:
- Decree No. 62 “On conducting experiment on labeling with control (identification) marks and tracking certain types of medications for medical use”.
- Federal Law N 425-FZ (Federal Law) “On amendments to the Federal Law “On Circulation of Medicines”.
- Decree No. 1556 “Regulation on the MMMP system”.
- Order No. 2828-r “On the tracking medications for medical use system operator”.
- No. 1557 “On the aspects of the MMMP system implementation”.
- No. 1558 “On approval of the Rules for posting publicly available information contained in the system”.
- Federal Law No. 61 “On the Circulation of Medicines”.
- Federal Law No. 475 “On amendments to the Federal Law “On the Circulation of Medicines”.
TraceWay Track&Trace system pharmaceutical market architecture
Pharmaceutical market TraceWay TTS Solutions
- TraceWay Track&Trace system software component
- Serialization TraceWay equipment:
- Aggregation TraceWay equipment
- Warehouse accounting TraceWay equipment:
- Complex operations TraceWay equipment