EDQM anti-counterfeiting Traceability service for medicines

The eTACT project 1.Introduction  What is the background to the project?  EDQM proposal  Progress of the project  Benefits 2.Demo  Introduction  Live demo session ©2012 EDQM, Council of Europe, All rights reserved2

The eTACT project 1.Introduction  What is the background to the project?  EDQM proposal  Progress of the project  Benefits 2.Demo  Introduction  Live demo session ©2012 EDQM, Council of Europe, All rights reserved3

The Council of Europe ©2012 EDQM, Council of Europe, All rights reserved4 Core values: human rights pluralist democracy rule of law

European Directorate for the Quality of Medicines & HealthCare (EDQM) Council of Europe Directorate Convention on the Elaboration of a European Pharmacopoeia (1964) ©2012 EDQM, Council of Europe, All rights reserved5

CoE/EDQM anti-counterfeiting strategy ©2012 EDQM, Council of Europe, All rights reserved6 Inspection Testing MedicrimeCustoms

What is mass serialisation? Unique identifier  human readable  machine readable Distinguishes items from each other ©2012 EDQM, Council of Europe, All rights reserved7

Current situation: Point-of-Dispense verification ©2012 EDQM, Council of Europe, All rights reserved8 Verification at dispensing point Retail pharmacy Generation of item code Manufacture Distribution

Falsified Medicines Directive (FMD) Directive 2011/62 Safety features  Identifier that is readable by wholesale distributors and pharmacists  Tamper-proof device (outside scope of eTACT) ©2012 EDQM, Council of Europe, All rights reserved9

The eTACT project 1.Introduction  What is the background to the project?  EDQM proposal  Progress of the project  Benefits 2.Demo  Introduction  Live demo session ©2012 EDQM, Council of Europe, All rights reserved10

EDQM Traceability service - eTACT ©2012 EDQM, Council of Europe, All rights reserved11 Generation of UMI = Unique Medicine Identifier Verification of UMI Pharmacy Internet Mail-order Distribution Manufacture Verification of UMI Patients

Public governance  EDQM  Authorities  Confidentiality of data ©2012 EDQM, Council of Europe, All rights reserved12

Current situation: product coding ©2012 EDQM, Council of Europe, All rights reserved13 Mostly 1D barcode coding for product number only

Proposal for future coding ©2012 EDQM, Council of Europe, All rights reserved14 GTIN: product number

Proposal for future coding ©2012 EDQM, Council of Europe, All rights reserved15 Serial: randomised number

Proposal for future coding ©2012 EDQM, Council of Europe, All rights reserved16 Batch No.

Proposal for future coding ©2012 EDQM, Council of Europe, All rights reserved17 Expiry date: yymmdd

Proposal for future coding ©2012 EDQM, Council of Europe, All rights reserved18 NHRN: National Health Reimbursement Number (National Product Code if different from GTIN)

Unique Medicine Identifier (UMI) ©2012 EDQM, Council of Europe, All rights reserved19 All combine into a Unique Medicine Identifier = UMI

Manufacturers uploading UMIs ©2012 EDQM, Council of Europe, All rights reserved20 Queries from authenticated stakeholders and patients

Manufacturers not uploading UMIs ©2012 EDQM, Council of Europe, All rights reserved21 Queries from authenticated stakeholders and patients

Manufacturers not uploading UMIs ©2012 EDQM, Council of Europe, All rights reserved22 Queries from authenticated stakeholders and patients

Scope ©2012 EDQM, Council of Europe, All rights reserved23 Any pharmaceutical products Actors:  Any registered business stakeholders  Authorities  Patients 36 member states of the European Pharmacopoeia and beyond Secondary packaging

The eTACT project 1.Introduction  What is the background to the project?  EDQM proposal  Progress of the project  Benefits 2.Demo  Introduction  Live demo session ©2012 EDQM, Council of Europe, All rights reserved24

General overview of eTACT ©2012 EDQM, Council of Europe, All rights reserved25 Phase 1: Concept development 2a: System development Phase 2: Live demo 2010 – 2012 From b: Workshops Phase 3: Service development

The eTACT project 1.Introduction  What is the background to the project?  EDQM proposal  Progress of the project  Benefits 2.Demo  Introduction  Live demo session ©2012 EDQM, Council of Europe, All rights reserved26

Benefits Creates a harmonised approach  Inter-operable and flexible Protects confidentiality of data  Public governance Allows patients to verify their medicines ©2012 EDQM, Council of Europe, All rights reserved27

The eTACT project 1.Introduction  What is the background to the project?  EDQM proposal  Progress of the project  Benefits 2.Demo  Introduction  Live demo session ©2012 EDQM, Council of Europe, All rights reserved28

The eTACT project 1.Introduction  What is the background to the project?  EDQM proposal  Progress of the project  Benefits 2.Demo  Introduction  Live demo session ©2012 EDQM, Council of Europe, All rights reserved29

Aim of the workshops To show you the demo system simulating a supply chain Real Enterprise Resource Planning (ERP) and Point-of-Sales (PoS) Emulators Business intelligence tools ©2012 EDQM, Council of Europe, All rights reserved30

31©2012 EDQM, Council of Europe, All rights reserved To discuss  Technicalities  Project governance  Implementation strategy Aim of the workshops

32©2012 EDQM, Council of Europe, All rights reserved