E-verifikation Anita Finne Grahnn, LIF E- verification - PowerPoint PPT Presentation

E-verifikation Anita Finne Grahnén, LIF

E- verification Pharmaceutical Pharmacist Wholesaler Patient Wholesaler Manufacturer Product Flow Unique Verification Serialisation with upon Dispense Random Numbers Voluntary to Patient Verification 2D Data Matrix Code on 2 nd Pack Product # Medicines Batch Expiry Verification Upload Number Authenticate Number S/N Repository The key stakeholders all support the Point-of-Dispensing verification concept

Process - European Hub European Hub Parallel Pharmaceutical Distributor Manufacturer National National National Blueprint Blueprint System 1 System 1 System n National System n Pharmacy Wholesaler Pharmacy Wholesaler Pharmacy Wholesaler Wholesaler Pharmacy Parallel Distributor: mandatory verification + data upload Pharmacy mandatory verification Wholesaler voluntary verification Manufacturer: data upload + voluntary verification Periodic cross-region update

ESM Each pack has its own identity European Stakeholder Model  The ESM uses a Data-Matrix code , developed to internationally recognised standards  Four key data elements: • Manufacturer Product Code • Randomised unique serial number • Expiry date • Batch number  Example: Product #: (01)09876543210982 Batch: (10)A1C2E3G4I5 Expiry: (17)140531 S/N: (21)12345AZRQF1234567890 4

Tillgång till data  Varje intressent äger sina ”egna” data  Behörighetsstrukturen måste vara strikt  Tillsynsmyndigheten (Läkemedelsverket) får tillgång till de data de behöver för utredning 5