5. Worldwide Inititives Technology Overview

Transcription

1 Key Prject Results (ABSTRACT) KR1 The mdel EFPIA supprts fr Prduct Verificatin at the Pint f Dispense wrks in practice KR2 Effective identificatin f fake packs as well as expired packs and recalled prducts KR3 system availability and perfrmance allw pharmacists t wrk at nrmal pace and withut significant additinal effrt KR8 The presence f mre than ne cde n the pack causes cnfusin fr the user and will jepardise user acceptance KR9 The necessary data segregatin and data security can be technically ensured KR10 Pharmacists are highly interested t get expiry date and batch number in machine readable frm 90% f pharmacist find the system easy t use 85% find the system generally fast 99% transactin cmpleted within 1 sec. 75% users desn t feel extra effrt using in daily wrks Layut prblems Basic Training required Semplificatin required: t use a single CODE, will avid false reading & Rewrks 58 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev Wrldwide Inititives Technlgy Overview 59 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev. 1.0 Prduct Identificatin means a readable graphic/electrnic sequence f character (cde) which can be Individually recgnize and cllected Human reading is: Expensive Imprecise Time Cnsuming Subject t the Human Nt adequate fr industrial use Refers t the methds f autmatically identifying bjects, cllecting data abut them, and entering that data directly int cmputer systems - with/withut human invlvement Technlgies typically cnsidered as part f AIDC include Barcde, Radi Frequency Identificatin (RF-ID), Bimetrics, MAG-Stripes, Optical Caratcter Recgnitin (OCR), Smart Cards, and vice recgnitin AIDC is als cmmnly referred t as Autmatic Identificatin, Aut-ID, and "Autmatic Data Capture. 60 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev

2 ISO/IEC ISO/IEC ISO/IEC ISO/IEC Buens Aires ETIF Internatinal and ANVISA Annexes Traceability Requirements G. Rssi 2010 rev Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev. 1.0 Hand Held Industrial 63 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev

3 Features ACTVIVE RFID Passive RFID Tag Pwer Surce Internal TAG Tag Battery YES NO Availability f Pwer Required Signal Strength t TAG Cntinuus Lw Energy Transferred Using RF frm reader Only in field frm READER High Range Mre than 50 mt 3 TO 5 Mt, usually less Multi Tag Reading 1000 TAGS recgnised (at high speed) Few hundreds TAGs within 3 mt Data Strage 128 KB R/W 128B R/W 64 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev. 1.0 Barcde & Printed Simblgy RF - ID Optical Technlgy Barcde Label and Barcde Reader Passive CODE and printed nce Ecnmic Supprt (Label) Barcde Rader and 2D Reader are standard prduct (even prtable) Barcde reader has standard PC Cnnectin (Keybard emulatin, Serial, USB) Multiple reading Reading Accuracy Easy t Prduce n demand / n line Print nly nce Need Physycal/direct Cntact Less flexible in Time Radi Frequency TECHNOLOGY Use a Chip (TAG) and a Reader (Antenna) Different sequence f data can be recrded int the chip memry TAGs culd be R/W, Passive r Active Mre Expensive Supprt (Label) Dedicated Device Multiple Reading Reading Accuracy Integratin with ther sensrs TAGs culd be mdified Desn t need Physycal/Direct Cntact Mre flexible in time (re-use f label/supprt) 65 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev. 1.0 Batch Wireless Fixed Statin Bill f Lading Material Tracking 66 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev

4 6. Wrldwide Initiatives Track&Trace Slutins 67 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev. 1.0 A Unique Identificatin Number will trace medicines thrught alla the Supply Chain in REAL TIME This is the mst cmplex scenari, cause f requires the active invlvment f each steps/lcatin with a unique centralized Database Cul be implemented tgether with e-pedigree Manufacturer Whlesaler A Whlesaler B Pharmacy Shipment JHKL Shipment JHKL Shipment JHKL Shipment JHKL DB 68 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev

5 EFPIA system architecture 70 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev

6 73 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev. 1.0 Track&Trace system were intrduced in the pharmaceutical and animal health envirnment t bviusly cver: Track a single unit f prduct frm the manufacturer t the pharmacy (r pint f dispensing), thrugh the entire supply chain Trace a single unit f prduct backwards, starting frm the end custmer t the manufacturer 74 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev. 1.0 Traceability since tday: At batch level Linear barcde including prduct cde read autmatically with a barcde reader at pharmacy level (best case/nt in all cuntries) Batch number and expiry date written in clear n the secndary and primary packaging Traceability Tmrrw: At unit f sales level (i.e. at bx level) Prduct cde, batch number expiry date included in the cde in rder t be read autmatically and avid dispensing errrs Deliver the right prduct t the patient Autmatic detectin f expired prducts Serializatin (1 randmized number per bx) wuld allw t prevent cunterfeits and fight reimbursement fraud 75 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev

7 7. Wrldwide Mandatry Requirements The Brasilian Reslutin 76 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev. 1.0 On January , t curb the grwing cunterfeit market, Brazil passed a law (Nº ) mandating the drug manufacturers and distributrs t act n the specific serializatin and track and trace requirements f electrnic identificatin and data capture This three year plan is by far the mst aggressive deadline laid ut by the Brazilian gvernment. The fllwing is the pertinent text f the law It is created the Natinal System f Medicatins Cntrl, invlving the prductin, marketing, distributin and medical, dntlgical and veterinary prescriptin, as well as the ther types f actins prvided fr in the sanitary cntrls Every medicatin prduced, distributed r sld within the natinal territry will be cntrlled by means f the Natinal System f Medicatins Cntrl 77 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev. 1.0 The cntrl is equally applicable t medical, dntlgical and veterinary prescriptins The cntrl will be made by means f an identificatin system exclusive fr the prducts, service prviders and users, with the adptin f capture technlgies, strage and electrnic data transmissin The prducts and their distributrs will receive specific identificatin based n data capture system by electrnic means Other cmpnents related t the prductin, distributin, imprt, exprt, marketing, prescriptin and use f medicatins can be included by the federal sanitary vigilance agency The prper federal sanitary vigilance agency will implement and crdinate the Natinal System f Medicatins Cntrl 78 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev

8 Brazil Reslucin n 59 Nvember, 2009 Chain = Prductin, Imprt, Distributin, Transprtatin, strage, Dispensatin Capture Technlgy: strage & Data Electrnic Transmissin 2D Data Matrix is defined as Data capture technlgy it must Cntain Unique Medicine Identifier (UMI) crrespnding t each unit cmmercialized All the transactin shall be registered and be available t the supervisin bdies f the Natinal System f health Surveillance Secndary packaging f all medicines shall cntain ID and safety Methds t make pssible the Prduct traceability frm Manufacturing t Dispensatin 79 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev. 1.0 Prducer UMI: Registratin Nr. (ANVISA) Lt Number Manufacturer Date Validity Term CNPJ f the Cmpany receiving the Medicine Transactin Date Distributr Database Requirements: UMI CPNJ f the Sender CPNJ f the Receiver Transactin date Authririty Database Retailer Database Requirements: UMI CPNJ f the Sender Transactin date 80 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev. 1.0 Brazilian Requirements Registratin number Lt Number Manifacture Date Validity Term CNPJ (Receiver) Transactin Date EFPIA Standards Manufacturer Prduct Cde (GTIN/EAN 14 r psedu GTIN 14 digits UNIQUE Serial Number (randmized) up t 20 Alpha Numeric Char. Expiry Date Batch Number 6 Digits (yymmdd) up t 20 Alpha Numeric Char. 81 Buens Aires ETIF Internatinal and ANVISA Traceability Requirements G. Rssi 2010 rev