1. EDQM anti-counterfeiting Traceability service for medicines

2. 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

3. 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

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

5. 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

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

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

8. 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

9. 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

10. 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

11. 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

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

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

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

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

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

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

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

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

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

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

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

23. 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

24. 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

25. General overview of eTACT ©2012 EDQM, Council of Europe, All rights reserved25 Phase 1: Concept development 2a: System development 2009-2010 Phase 2: Live demo 2010 – 2012 From 2013 2b: Workshops Phase 3: Service development

26. 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

27. 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

28. 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

29. 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

30. 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. 31©2012 EDQM, Council of Europe, All rights reserved To discuss  Technicalities  Project governance  Implementation strategy Aim of the workshops

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