1. European Medicines Verification Organisation (EMVO)
What is EMVO and how does EU Hub function?
Tobias Beer
(Head of Commercial & Partner Management)
dd/mm/yyyy

2. e-verifisering av legemiddelpakninger
Agenda
European Medicines Verification System
How to get connected?
Technical On-boarding
Master Data-flow and Multi-country packs
31/03/2017
e-verifisering av legemiddelpakninger

3. EMVS’ System Landscape
European Hub
Ensures interoperability between national systems
Secures cross-border trade and handling of multicountry packs
Provides cost savings for connecting manufacturers
Supports establishment of standard interfaces
31/03/2017
e-verifisering av legemiddelpakninger

4. EMVO’s stakeholder
EAHP - European Association of Hospital Pharmacists (in discussion)
31/03/2017
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5. EMVO Board of Directors Commercial & Partner Management
Organisational chart
EMVO Board of Directors
President: Hugh Pullen (EFPIA)
Vice-President: Sonia Ruiz Morán (PGEU)
Treasurer: Richard Freudenberg (EAEPC)
Monika Derecque-Pois (GIRP)
Adrian van den Hoven (Medicines for Europe)
General Manager
Andreas Walter
Christoph Krähenbühl
Commercial & Partner Management
Tobias Beer
Operations
Paul Mills
Office Manager
Marisa Jimenez Sanchez
Quality Assurance
Stephan Theunissen
Markus Gerigk
Fanny Trenteseaux NN
Willem Theunissen
31/03/2017
e-verifisering av legemiddelpakninger

6. e-verifisering av legemiddelpakninger
Blueprint Approach
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7. Elements of Blueprint Approach
Full Stakeholder participation in NMVO Governance
Implementation of national systems based on compliance with EMVO URS
Technical operation by an IT Blueprint Provider
Support by EMVO during deployment process
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8. e-verifisering av legemiddelpakninger
Blueprint Tendency
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9. e-verifisering av legemiddelpakninger
Overview 15 14 2 20 31 1 18 10 16 24 6 27 13 28 4 3 26 19 17 8 12 30 9 32 25 29 22 7 11 5 23 21
Blueprint candidate Small Country Blueprint Blueprint open Standalone system No Information Non EU Countries
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10. e-verifisering av legemiddelpakninger
On-boarding
31/03/2017
e-verifisering av legemiddelpakninger

11. e-verifisering av legemiddelpakninger
OBP Portal I
Prerequisite to on-board > MAHs/Parallel Distributors
User-friendly web-based portal
Decrease EMVO‘s response time
Starting point/ trigger for legitimacy check
31/03/2017
e-verifisering av legemiddelpakninger

12. e-verifisering av legemiddelpakninger
OBP Portal II
31/03/2017
e-verifisering av legemiddelpakninger

13. On-Boarding Process Initial Contact Portal registration
Non-Disclosure Agreement (NDA)
1) Participation Request
2) Legitimacy Check
Legitimacy check of organizations and person responsible
Multi-stage procedure
Managed and administered by EMVO’s Commercial & Partner Management
Team
3) Contractual/ Commercial On-boarding
Participation Agreement (PA)
On-boarding Fee payment
4) Technical On-boarding
System Connection
System Testing
System Operation
Managed by EMVO’s Operations Team
27 March 2017
vfa – Info-Veranstaltung

14. Step 1: Provide Initial Information
To add or modify the requested information
Status:
Not Started
In Progress
Complete
Trigger step 1:
Successful Request to Participate
Estimated time to complete
Training videos are available
31/03/2017
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15. e-verifisering av legemiddelpakninger
On-Boarding Fee
One-Time Fee per OBP
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16. Technical On-boarding
Starts when Participation Agreement is signed by EMVO
OBP will connect his client sequentially to:
the ITE environment to develop an interface
the IQE environment to certify his interface
The PRD environment to use his interface
OBP can choose to connect via
a Direct connection (data send from client straight to EU Hub)
a Gateway connection (Data sent first to a Gateway Provider. The Gateway Provider sends it through to the EU Hub

17. e-verifisering av legemiddelpakninger
Connection Types
EU Hub
OBP A Hub Connection 1
OBP A Hub Connection 2
OBP B Hub Connection
OBP C Hub Connection
Gateway
Provider X
Gateway
Provider Y
OBP A Gateway Connection
OBP B Gateway Connection
OBP C Gateway Connection
OBP A
OBP B
OBP C
OBP’s System a
OBP’s System b
OBP’s System c
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18. Master data guideline available in mid April
Master Data – Data Flow
OBP
Master data guideline available in mid April

19. Batch Data – Data Flow
OBP

20. Pack Data – Data Flow
OBP
Batch and Pack Data move together in one single transaction.
They’re shown on separate diagrams for clarity only.

21. Multi-market packs (Master Data – Product Code Mapping)
The master data easily manages shared (multi-market) packs.
Example – A Dual Market Product – Norway and Germany

22. Master Data What Each Market Receives
Data Received by Norway
Data Received by Germany

23. Look-up process Client (Pharmacy/Wholesaler) Application reads:
D<GS> d32
Database gives ≡ Vnr “ ”

24. e-verifisering av legemiddelpakninger
Contact details NMVOs
31/03/2017
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25. e-verifisering av legemiddelpakninger
Contact details NMVOs
31/03/2017
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26. e-verifisering av legemiddelpakninger
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27. e-verifisering av legemiddelpakninger
THANK YOU
for your
ATTENTION!
31/03/2017
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28. e-verifisering av legemiddelpakninger
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29. Master Data Distribution
Because the master data contains ‘market specific’ elements, a single look- up process from the printed GTIN provides the NHRN to consuming systems (pharmacies' system and wholesaler system)
This is in the printed code
GS1 Format
Data Element AI
Data
PC (GTIN) 01 SN 21
ABCDZZ99T
LOT 10
NOT4SALE1234ABCDWXYZ
EXP 17
190209
< This is the NHRN
For this
specific market
This is in the data provided by the European Hub

30. e-verifisering av legemiddelpakninger
What is an “OBP”?
OBP means On-Boarding Partner and is the contracting party of EMVO and concludes the non-disclosure agreement (NDA) and participation agreement (PA).
The OBP is legally authorized to sign on behalf of a MAH/a group of MAHs.
The OBP has to be affiliated (*) to a MAH/a group of MAHs
(*) Affiliate shall mean, in relation to a Party, any other person affiliated with such Party within the meaning of Article 11 of the Belgian Code of Companies (it being understood, for the avoidance of doubt, that the definition set out in said Article 11 is agreed to also apply to non-Belgian persons).
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31. Relationship OBP* and EMVO
Corporation/Group
Affiliated entity “Marketing Authorisation Holder A”
Affiliated entity “Marketing Authorisation Holder B”
“Affiliated entity Marketing Authorisation Holder C”
OBP*
EMVO
Participation Agreement
Affiliated entity “Producer 1”
OBP’s System
EU Hub
Sends Data to the HUB
Affiliated entity “Producer 2”
Affiliated entity “Sales Rep. 1”
Affiliated entity “Sales Rep. 2”
*On-Boarding Partner
*Confirmation letter
Contract Manufacturing Organisation
31/03/2017
e-verifisering av legemiddelpakninger

32. Relationship OBP* and EMVO
Corporation/Group
Affiliated entity “Marketing Authorisation Holder A”
Affiliated entity “Marketing Authorisation Holder B”
“Affiliated entity Marketing Authorisation Holder C”
OBP*
EMVO
Participation Agreement
Affiliated entity “Producer 1”
OBP’s System
EU Hub
Sends Data to the HUB
Affiliated entity “Producer 2”
Affiliated entity “Sales Rep. 1”
Affiliated entity “Sales Rep. 2”
*On-Boarding Partner
*Confirmation letter
Contract Manufacturing Organisation
31/03/2017
e-verifisering av legemiddelpakninger

33. e-verifisering av legemiddelpakninger
DISCLAIMER
31/03/2017
e-verifisering av legemiddelpakninger