Electronic Product Information
A Direct and Secure Channel for Pharmaceutical Information
Medicine’s product leaflets inform patients about the safe usage of a medicine and assist healthcare professionals in prescribing them. Moving from paper to digital product information bringsmultiple benefits:
- Anti-Counterfeit: unlicensed products cannot have digitally verified e-leaflet
- Health outcomes: more targeted medication instructions for different patient groups
- Environment: no production of paper leaflets
- Financial: no production costs and recalls due to wrong or outdated information
From a regulatory perspective, the European Commission and the European Medicines Agency (EMA) have identified areas where medical product information could be improved to meet the needs of patients and healthcare professionals. These wide-ranging actions include the objective to enhance readability and develop an electronic format for the leaflet.
Spherity works with Pharma companies on a future-proof electronic Product Information System for commercial medicines (ePI) as well as on digital identity for clinical drugs and kits used in clinical trials (ePI-CT).
Equipping each manufacturer, regulator and medicine box in a value chain with our Cloud Identity Wallet allowed us to realize a trusted electronic product information solution. That solution increases patients safety by improved instructions and reduces time-to-market and process costs for involved manufacturers, regulators and healthcare professionals.
- Mobile application to display content of e-leaflet and verify signatures to prove data provenance
- Real-time revocation of content and expiration warning via mobile application
- Cyber-physical link with 2D matrix code to prove product authenticity
“Based on our successful collaboration with Spherity, the industry agreed to further investigate the usage of W3C Decentralized Identifiers and Verifiable Credentials technology to electronically verify Authorized Trading Partners in the saleable returns verification process in an industry-wide pilot.”
Dr. Oliver Nuernberg
Chief Product Owner, SAP Life Sciences