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NEW RULES –
PHARMA SERIALIZATION - EFFICIENCY
BEYOND FMD COMPLIANCE
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FMD SERIALISATION OBJECTIVE
- PREVENTING COUNTERFEIT OR UNAUTHORISED PRESCRIPTION
MEDICINE ENTERING THE SUPPLY CHAIN
SerialisationUnique identification of
each saleable pack
AuthenticationConfirms that pack data
agrees with database
Enables the pack to be
confirmed as dispensed
Improving Patient
Safety
Reducing Fraud
Maintains the legitimacy of the Pharma supply chain
Manufacturers
Depositaries
Wholesale
Distributors
PharmaciesHealth
Establishments
PHARMA SUPPLY CHAIN ORGANIZATION
Pre-Wholesaler
EUROPEAN MEDICINES
VERIFICATION SYSTEM
NMVS
Marketing Authorisation Holder(s)
without
Parallel Distribution activity
System owner = OBP
System owner = EMVO
System owner = OBP
Marketing Authorisation Holder(s)
with
Parallel Distribution activity
System owner
= NMVO
National Blueprint Interface
Interface
Pharmacy System Hospital System
System owner = Pharmacist System owner = Wholesaler
OBP: On-boarding Partner
NMVS: National Medicines Verification System
NMVO: National medicines verification Organisation
EMVO
Inte
rfac
e
Inte
rfac
e
Other dispensing
System
System owner = Dispenser
Interface Interface
Inte
rfac
e
Wholesaler /
Distributor SystemSystem owner = Dispenser
Article 23
Locations
Commissioning Verification / Decommission Decommissioning
Pharmaceutical
ManufacturerDistributorWholesaler Pharmacist
+
Patient
Product
Flow
Product
FlowProduct
Flow
Product
Flow
Unique
Serialisation with
Random Numbers
Upload
Number
Medicines
Verification
SystemAuthentication Number
Risk Based
Verification
Product Code
Batch
Expiry
S/N
Verification
upon Dispense to Patient✓Required by
Delegated Regulation
POINT OF DISPENSE VERIFICATION AND AUTHENTICATION
Commissioning
Pharmaceutical
ManufacturerWholesalerWholesaler Pharmacist
+
Patient
Product
Flow
Product
FlowProduct
Flow
Product
Flow
Unique
Serialisation with
Random Numbers
Upload
Number
Medicines
Verification
System
Verification / Decommission
Risk Based
Verification
Product Code
Batch
Expiry
S/N
Decommissioning
Authentication Number
Verification
upon Dispense to Patient✓Required by
Delegated Regulation
POINT OF DISPENSE VERIFICATION AND AUTHENTICATION
Commissioning
Pharmaceutical
ManufacturerWholesalerWholesaler Pharmacist
+
Patient
Product
Flow
Product
FlowProduct
Flow
Product
Flow
Unique
Serialisation with
Random Numbers
Upload
Number
Medicines
Verification
System
Verification / Decommission
Risk Based
Verification
Product Code
Batch
Expiry
S/N
Decommissioning
Authentication Number
Verification
upon Dispense to Patient✓ Required by
Delegated Regulation
POINT OF DISPENSE VERIFICATION AND AUTHENTICATION
STAKEHOLDER RESPONSIBILITIES
Task/Transaction Pharmacy Wholesaler
Verification
Dispense
Destroy
Export
Sample (for authorities)
Free sample (for
healthcare professionals)
Lock
Stolen
Recommission
TOP TIPS
o Execution devices with applications that allow for 2D
data matrix decoding
o Serialization software with national hub connectivity
for live and batch data transfer
o No requirement to rework existing business systems
to handle individual serial numbers
o Phased integration of existing systems with the
serialization system allows for compliance and future
proofing
o Back office reporting and data archiving will allow
generation of business metrics and reports
Execution of operations
Management of operations
and data access
Communications
Store events and reporting
EDGE TECHNOLOGIES
Warehousing
FALSIFIED MEDICINES DIRECTIVE (FMD) COMPLIANCE
What is needed…
Compliance
Efficiency
Agility
Scalability
Integration of new constraints…
in existing process’s
with existing lead times
and legacy solutions
EDGE TECHNOLOGIES
HH Terminals Voice PTL ImageID RFID Printing
Receiving Put Away Replenishment Picking Shipping Inventory
Processes
Scanning
Mobile Operation Work Station Table Reading Conveyor
EDGE
TECHNOLOGIE
S
Manual Scanning
Verify
DecommissionDispense
Destroy
Export
Sample
Free sample
Lock
Stolen
Recommission(Click to display
the video)
MOBILE
TERMINAL
Verify
DecommissionDispense
Destroy
Export
Sample
Free sample
Lock
Stolen
Recommission
DESKTOP
STATION
MULTI-BARCODE
SCANNING TABLE
Multi barcode
capture
Visual assistance
MULTI-BARCODE
SCANNING
STATION
Full tray, multi barcode
capture
Visual notifications
Wrong item
highlighted for instant
correction
Verify
Decommission
Dispense
Destroy
Export
Recommission
CONVEYOR
STATIONIDStation HMI
(Panel PC)
Light/Acoustic alarm
Controller HMI
Control Button
Panel
Rejector
Reading station
Conveyor
Waste bin
Control Cabinet
COLLABORATIVE INFORMATION HUB
Information
HubTrack & Trace Hub
• Industry Partners
• CMO’S
• CPO’S
• Quality/Safety Team
• Commercial Team
• Supply Chain Team
EDGE APP’SPackaging
APP’s
Sensors
Country Falsified
Medicine Directives
COMMUNICATE (WITH NMVS & OTHER IT SYSTEMS)
STORE & SHARE DATA
REPORT
Track & Trace Repository
PROCESS
APPLICATION
ZetesMedea HHT
• Verification + Decommissioning +
Recommissioning
ZetesOlympus• Back office reporting
• NMVO communication
ZETESOLYMPUSWEB CONSOLE – FMD OPERATIONS LOGS
ZETESOLYMPUSWEB CONSOLE – EXAMPLE OF REPORTING ON DECOMMISSIONING FOR DESTRUCTION REASON
ZETESOLYMPUSWEB CONSOLE – EXAMPLE OF REPORTING ON DECOMMISSIONING FOR DESTRUCTION REASON
EDGE
TECHNOLOGIES
Warehouse
SUPPLY CHAIN
EVENTS &
TRACKING
REPOSITORYCorporate
ERP
NATIONAL
SYSTEM
IMPACT FOR WHOLESALERS
Order Picking
Pack / Ship
Receiving• Authentication
• Aggregation
De-Aggregation
• Deactivate
Decommissioning
WMS
TMS
EUROPEAN
HUB
NMVO
EMVO
Europe
Government
PHARMA REFERENCE
