12.45 Medicines Verification in a Pharma Company Tuula Avonius, Portfolio Manager, Orion Pharma Eeva Melama, Serialisation Project Manager, Orion Pharma 13.15 FiMVO demos - Mika Weckström, Development Manager, Receptum - Jukka Nurmi, Product Manager, Pharmadata - FiMVO process presentation 13.45 Q&A session 14.00 End of the workshop

9.30 Medicines Verification System – General update Maija Gohlke-Kokkonen, General Manager, FiMVO 9.45 Project Status and Testing update Tero Vesa, Project Manager, FiMVO Tim Strässer, Project Manager, arvato Systems GmbH 10.45 News from the European Hub Paul Mills, Operations Department, EMVO - Hub operations - Master Data - 3PLs 12.00 Lunch

Welcome!

Project Status and Testing update

MAHs registered in Arvato NMVS’s

Number of serialized packs in Arvato NMVS’s

Overall number of pharmacies to be connected

Number of NMVS test cases

Number of Arvato countries where rollout planning has been completed

Time remaining until go live (Feb 9, 2019)

Number Finnish IT company users in the Arvato SWS Portal

2,300

1/14

Number of MAH’s where onboarding to EU-HUB has started

158

Number of NMVS web services ready to be rolled out

408 / 99,580

51.27 Mio. 52 / 74

30 372 days

450/ >2000

Key Performance Indicators

11.2017 Receptum

pilot readiness

General Project Plan

Apr-Aug 2017 Sep-Nov 2017 Nov 2017-May 2018 Jun-Oct 2018 Nov 2018-Feb 2019

Testing Deployment Specification and design

9.2.2019 Production mandatory

(by legislation)

1.11.2018 Production readiness

Feb 2019

1.4.2018 Marela technical

readiness

Pre-production Production

July 2017 Specs from Arvato

Next 11.9.2017

January 2018 FiMVS 1.0

April 2018 FiMVS 1.1

- Translations - Multi-market packs

May 2018 FiMVS PRD

environment ready

6.2018 Oriola ready

1.11.2018 Hospital pharmacies

installed

1.2.2018 Receptum pharmacies

installed

1.9.2017 PharmaData

technical readiness

December 2017 EMVO EU Hub 2

Release 1.3

1.8.2018 Abilita ready 5.2018

Tamro ready

4.2018 OneClinic technical readiness

Q2/2018 Magnum

Medical testing

November 2018 FiMVS 1.2

- Intermarket query - All features

August 2018 Certificates

August 2018 EMVO EU Hub 2 Summer release

Testing process and schedule

15.2.-30.4.2018 May - October 2018 Nov 2018-Feb 2019

Testing in IQE

Deployment and monitoring in PRD

9.2.2019 Production mandatory

Feb 2019

Pre-production Production

January 2018 FiMVS 1.0

April 2018 FiMVS 1.1

November 2018 FiMVS 1.2

August 2018 Certificates

Software vendor certifications in IQE: First release and major changes after that will be certified

Testing continues in IQE if required

Key target dates Event Target start date

IQE environment available Dec 2017

Commence onboarding test participants: - MAHs and pharmacies - Wholesalers - Hospital pharmacies

15 Feb 2018

1 Apr 2018 1 May 2018

Test participants commence verifying and dispensing

15 Feb 2018

IQE Target start date PRD Target start date

Manufacturers upload product pack data

15 Feb 2018 Monitoring of transactions in PRD

1 May 2018

End of IQE testing (please note FiMVO can also conduct IQE testing after this on a case by case basis)

30 April 2018

End of monitoring on PRD

30 September 2018

Certificate requests/ injections

End User 1 System

PRD

End User 1 System

PRD

Country 1 End User SW

PRD

End User 1 System

PRD

End User 1 System

PRD

Country 1 End User SW

PRD

End User 1 System

PRD

End User 1 System

PRD

Country 1 End User SW

PRD

EU Hub IQE

OBP n IQE

NMVS Certificate M‘ment System

„IQE“

OBP 1 IQE

End User 1 System

IQE

End User 1 System

IQE

Country 2 End User SW

IQE

...

End User 1 System

IQE

End User 1 System

IQE

Country 1 End User SW

IQE

End User 1 System

IQE

End User 1 System

IQE

Country p End User SW

IQE ...

MAH 1.1 MAH 1.2 MAH 1.m

...

... MAH n.1 MAH n.2 MAH n.k

EU Hub PRD

NMVS Country 2

PRD

OBP r PRD

NMVS Country 1

PRD

OBP 1 PRD

End User 1 System

PRD

End User 1 System

PRD

Country 2 End User SW

PRD

NMVS Country p

PRD

...

...

End User 1 System

PRD

End User 1 System

PRD

Country 1 End User SW

PRD

End User 1 System

PRD

End User 1 System

PRD

Country p End User SW

PRD ...

MAH 1.1 MAH 1.2 MAH 1.s

...

... MAH r.1 MAH r.2 MAH r.t

NMVS Certificate M‘ment System

„PRD“

Country 2 NMVS

IQE

Country 1 NMVS

IQE

Country p NMVS

IQE

... Software Supplier NMVS Sandbox

Software Supplier Portal

(Registration, Info)

NMVO Sharepoint

End User 1 System

IQE

End User 1 System

IQE

SW Supplier End User SW

DEV

...

Software Suppliers from all countries

...

NMVOs from all countries

User creation requests

Test data

generation & result requests

SW Supplier

Approvals

NMVS Certificate

M‘ment System „IQE“

Software Suppliers IQE PRD

Certificate requests/injections

End user GUI

access

Product & pack data upload Product & pack data upload

Product & pack data upload

Product & pack data upload

End user GUI

access

End user GUI

access

End user GUI

access

End user GUI

access

Certificate requests/injections

Product & pack data upload Product & pack data upload

End user GUI

access Test transactions

Externally Accessible NMVS Instances

(1) Software Supplier registers with the NMVS Software Supplier portal and applies for access.

(2) NMVO checks the request and approves access to the NMVS Software Supplier Portal.

(3) Software Supplier ... • downloads documentation (handbooks, WSDLs, XML) • checks for news & updates • submits questions and service requests • downloads certificates for the NMVS Integration Environment • downloads test sets to ...

• ... test against the NMVS Integration Environment • ... qualify its software for the NMVS Production Environment

Onboarding Procedure for Software Suppliers

(4) NMVO exports end user data including onboarding/logon data from the NMVS.

(5) Based on the exported end user data, the NMVO orders a service provider to send onboarding/login data to the end users, e.g. via mail and e-mail. For security reasons, two independent communication channels are needed.

(6) With their access data, end users log on to the NMVS portal. They now can download certificates and connect with the NMVS via Web Service and/or Web GUI.

@

Onboarding Procedure for End users 1)

1) Any entity a) obliged to verify medicines and b) distributing medicines to patients or other entities, e.g. a pharmacy

Arvato SWS Sandbox

NMVO

Stakeholder (SW-Supplier)

Information, that Arvato registration portal is ready to use

Registration @ Arvato SWS Portal

Send email confirmation request

Approve account

Create user account and send out credentials

Enable own software to work with NMVS

Create client certificate

Test own software against SWS Sandbox

Approve software version

Arvato SWS Portal

Confirm email address

Grant user access to Portal

Onboarding Procedure for Software Suppliers (Flow Chart)

How does the registration process work in detail? After you have registered and been approved by the NMVO, you will receive three e-mails. 1. E-mail 1 informs you that you have now access to the Software Supplier Portal.

Just use the credentials you have defined during the registration process (i.e. your e-mail address and the password you have chosen).

2. E-mail 2 provides additional user credentials for the NMVS Certificate Management System and the Generic NMVS Integration Environment. You will use these credentials to access the NMVS Certificate Management System and to authenticate yourself towards the Generic NMVS Integration Environment (together with the digital certificate downloaded in step 3).

3. E-mail 3 provides a TAN which is required to download your individual digital certificate from the NMVS Certificate Management System. Important: Do not forget to note the passphrase which will be displayed when downloading the certificate. You will need the passphrase to activate the certificate.

Onboarding Procedure for Software Suppliers

1. Execute pack transactions for certain transaction types. A list of the transactions will be provided to you by FiMVO.

2. Apply undo transactions for the transaction types executed in point 1.

1) Verify Pack is available in all states (not shown everywhere) 2) Undo destroy/stolen is not possible. 3) Not possible if batch has expired/has been recalled or if the product has been withdrawn 4) Independent of the batch/product status

Test cases – IQE Part I - Single Pack Transactions

1. Execute homogenous bulk transactions for certain transaction types. A list of the transactions will be provided to you by FiMVO (wholesalers only).

2. Apply undo transactions for the transaction types executed in point 1 (wholesalers only).

3. Send a report request to FiMVS to obtain results of the submitted homogenous bulk transactions (wholesalers only).

4. Submit mixed bulk transactions with various single pack transactions, including undos, based on the list provided by FiMVO (pharmacies only).

Test cases – IQE Part II - Bulk transactions

5. Send a report request to FiMVS to obtain results of the submitted mixed bulk transactions (pharmacies only).

6. Check that transactions have been successfully executed and error conditions properly reported if

a. the entire bulk transaction fails b. some of the submitted single pack transactions fail c. the bulk request result is still pending.

7. Check that the mixed bulk transactions are submitted properly after an offline period.

Test cases – Part II (cont.) - Bulk transactions

• End users: – Private pharmacies:

• FiMVO will create the test pharmacies manually, about 6-10 pharmacies, in IQE • The rest, about 800, will be created with an csv-file • IT-companies will then on-board all pharmacies

– Hospital pharmacies: • FiMVO will create the test pharmacies manually • The rest will be created with a csv-file • IT-companies or service providers will then on-board all pharmacies

– Wholesalers: • FiMVO will create those manually • IT-company or company itself will then on-board

End user on-boarding

• February 2018 – Formal approval from EMVO to start testing in IQE – Private pharmacy software vendors are ready to start testing and certification in IQE – Test pharmacies and wholesalers can connect to FiMVS in IQE

• April 2018 – Second official FiMVS release (core 1.1) from Arvato, includes multi-market feature – Hospital pharmacy software vendors are ready to start testing and certification in IQE

• May 2018 – PRD will be ready, MAHs, pharmacies and wholesalers can start to use that, no testing anymore

• Summer 2018 – Hospital pharmacy installation program is on and all private pharmacies are already installed – Finnish certificates will be implemented

• November 2018 – Third official FiMVS release (core 1.2) from Arvato, includes intermarket transaction/query and reports – FiMVS is in preproduction phase, all users installed

• February 2019 – FiMVS is in production on 9.2.2019

Important project schedule points, summary