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

▶

Nov 29, 2023 340 likes •397 views

E-verifikation Anita Finne Grahnn, LIF E- verification Pharmaceutical Pharmacist Wholesaler Patient Wholesaler Manufacturer Product Flow Unique Verification Serialisation with upon Dispense Random Numbers Voluntary to Patient

SLIDE 1

E-verifikation

Anita Finne Grahnén, LIF

SLIDE 2

E- verification

The key stakeholders all support the Point-of-Dispensing verification concept

Verification upon Dispense to Patient Patient Pharmaceutical Manufacturer Unique Serialisation with Random Numbers 2D Data Matrix Code

n 2nd Pack

Upload Number Medicines Verification Repository Pharmacist Wholesaler Product Flow Wholesaler Voluntary Verification

Product # Batch Expiry S/N

Authenticate Number

SLIDE 3

Process - European Hub

National Blueprint System n Wholesaler Pharmacy National System n Parallel Distributor Wholesaler Pharmaceutical Manufacturer European Hub National System 1 Pharmacy National Blueprint System 1 Pharmacy Wholesaler Wholesaler Pharmacy

Manufacturer: data upload + voluntary verification Parallel Distributor: mandatory verification + data upload Periodic cross-region update Pharmacy mandatory verification Wholesaler voluntary verification

SLIDE 4

ESM

European Stakeholder Model

Each pack has its own identity

 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

SLIDE 5

Tillgång till data

Varje intressent äger sina ”egna” data
Behörighetsstrukturen måste vara strikt
Tillsynsmyndigheten (Läkemedelsverket) får tillgång till