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UPDATES AND MUST-KNOWS ABOUT THE EU-HUB ON-BOARDING PROCESS

Fanny TrenteseauxCommercial & Partner Management

Department

CONTENT

2

FMD Implementation in Europe

EMVO’s On-boarding Process

Status quo in the 32 Member States

EU HUB ON-BOARDING PROCESS

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CONTENT

3





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THE COUNTDOWN IS RUNNING

4EU HUB ON-BOARDING PROCESS

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FMD LEGISLATION AND DELEGATED ACT

July 2011Publication of FMD

2011

9 Feb 2019 Mandatory verification of

all packs in scope

9 Feb 2016Publication of

Delegated Regulation

36

Mon.

20192016 2017 2018

• Connect approx. 2,500 companies to the EMVS

• Establish National Systems in 32 countries

• Connect many thousand Pharmacies and Wholesalers

• Serialise all affected pharmaceutical packs (10.5 bn)

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EMVO MEMBERS


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SYSTEM LANDSCAPE


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EMVO ON-BOARDING / NMVO CONTRACTING


EM

VO

On

-bo

ard

ing • Participation

Agreement

• One-time On-boarding Fee(table)

• Contractingpartner : OBP N

MV

O C

on

tra

ctin

g • Contract in place

• Annual fee(flat fee model)

• Contractingpartner : MAH

SYSTEM COSTS


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ON-BOARDING PARTNER (OBP) PER COUNTRY


Additional non-european countries:

1 OBP

4 OBPs

1

0 20 40 60 80 100 120 140 160 180 200

OBPs per Country

Austria Belgium Bulgaria Croatia Cyprus

Czech Republic Denmark Estonia Finland France

Germany Greece Hungary Iceland Ireland

Italy Latvia Liechtenstein Lithuania Luxembourg

Malta Netherlands Norway Poland Portugal

Romania Slovakia Slovenia Spain Sweden

Switzerland United Kingdom

3

13

8

14

31

3

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STATUS CONTRACTUAL ON-BOARDING


80

127

154

191

217233

263

293

20

47

69

92

113

151

174

199

0

50

100

150

200

250

300

350

Earlier May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Nov-17

Nu

mb

er

OBPs On The Portal Signed Participation Agreements

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CONTENT

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WHAT IS AN “OBP”?

o OBP means On-Boarding Partner. The OBP is the contracting party of EMVO; itconcludes the Participation Agreement (PA).

o The OBP represents the Marketing Authorization Holders (MAH) it will uploaddata for in the European Hub. It has therefore to be legally authorized toconclude contracts on behalf of a MAH/a group of MAHs.

o The OBP has to be affiliated (*) to a MAH/a group of MAHs

o The OBP should be located in the European Economic Area.

o The OBP can only upload product data for affiliated manufacturers as long themarketing authorization of such products lie within the OBP corporation.

(*) Affiliate shall mean, in relation to a Party, any other person affiliated with suchParty within the meaning of Article 11 of the Belgian Code of Companies (itbeing understood, for the avoidance of doubt, that the definition set out in saidArticle 11 is agreed to also apply to non-Belgian persons).

14

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CONNECTION TYPES


OBP COBP BOBP A

OB

P A

Hu

b C

on

ne

ctio

n 1

Gateway

Provider X

Gateway

Provider Y

OBP’s System

aOBP’s

System b

OBP’s

System c

OB

P B

Hu

b

Co

nn

ec

tio

n

OB

P C

Hu

b

Co

nn

ec

tio

n

EU Hub

OB

P A

Hu

b

Co

nn

ec

tio

n 2

OB

P A

G

ate

wa

y

Co

nn

ec

tio

n

OB

P C

G

ate

wa

y

Co

nn

ec

tio

n

OB

P B

G

ate

wa

y

Co

nn

ec

tio

n

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WHAT IS AN OBP GATEWAY PROVIDER?


o A third-party contractor engaged by the OBP, who assists the OBP entirely or partially with the development, the implementation, the provision, the use, and/or the operational phase related to the OBP interface to the EU Hub via a Gateway Connection,

o Every OBP Gateway Provider has to be promoted by at least one OBP in the On-boarding Process,

o EMVO has then to validate and approve the proposed Gateway Providers, if all requirements are fulfilled.

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HOW TO SPEED UP THE PROCESS RIGHT FROM THE START?


Collect Information:

1. Visit EMVO Download Section https://emvo-medicines.eu/downloads/

2. Consult our training videos:

• OBP Check-list for contractual On-boarding

• The On-boarding Partner Portal

1. Visit EMVO Knowledge Data Base https://emvo-medicines.eu/faq/

• Who will be the On-Boarding Partner?

• What is my Company Registration number and VAT number?

• Who can and will be the Authorized Representative?

• Who can and will be the Single Point of Contact?

• How many MAHs does the OBP represent?

• And many more…

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https://emvo-medicines.eu/downloads/

HOW DOES THE ON-BOARDING WORK?


https://emvo-medicines.eu/home/obp/obp-portal/

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https://emvo-medicines.eu/home/obp/obp-portal/

ON-BOARDING PARTNER PORTAL


Step 2: Participation Agreement + Detailed information

Step 3: Approvals

Step 1: Provide Initial Information

Step 4: Technical On Boarding

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STEP 1: PROVIDE INITIAL INFORMATION


Estimated time to complete

To add or modify the requested information

Trigger step 1:Successful Request to

Participate

Status: Not StartedIn ProgressComplete

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1.1 COMPANY INFORMATION


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FRENQUENTLY COMMITTED ERRORS


o Company name

make sure to provide the full official name of your company

o Company identification numbers : VAT and Company registration number

make sure not to get confused between the OBP company, the parent company, and the MAHs information.

make sure to include the full sequence of digits, no typo, and the initial country identification in front, if necessary

o Country name / Country of registration

make sure to provide the Country name, not the county

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1.2 AUTHORISED REPRESENTATIVE


Note :

The Authorised Representative (AR) is the person authorised to sign on behalf of the company. The AR will sign the Non-

Disclosure Agreement and the Participation Agreement.

Action:A prefilled NDA will be

generated

Mandatory in order toproceed with the further

steps

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Copy of proof of the Authorised Representative

Purpose: check the authorisation of your named AuthorisedRepresentative to sign on behalf of the company

an official register – a notary certificate – a CEO Letter

the AR expressly named together with his/her autorisation and/or his/her position among the senior management

validity of the document with respect to a potential expiration date


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Step 3: Approvals



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STEP 2: DETAILED INFORMATION AND PARTICIPATION AGREEMENT


Download General Info Pack

Status: Not StartedAwaiting ApprovalApprovedRejected

Status: Not StartedCompleted

Status: Not Started

CompletedA sample of the PA is available on our website in its download section.

View and Download prefilled ParticipationAgreement (PA)

Trigger step 2:Successful Initial Information and

Authorise Representative copy of proof

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2.2 SINGLE POINT OF CONTACT


Note 1:

• The SPOC details will be listed in the Participation

Agreement.

• By signing the PA, the Authorised Representative will

confirm the SPOC appointement.

• The SPOC will be the responsible for providing all the

required information in the OBP Portal. And will be the onlyperson allowed to confirm the information provided.

IMPORTANT NOTE : CREDENTIALS

The first SPOC listed will receive credentials via e-mail. From that moment, the initial Registration Requester’scredentials will be revoked. The second SPOC will notreceive credentials.If the SPOC is the same person as the RegistrationRequester, the credentials will stay unchanged.

Explained in the tooltips and

our online documentation

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OBP CONTRACT WITH EMVO

29

▪ Contractual framework for participation in the On-boarding project, e.g.

• Use of the EMVO Gateway

• Interface development

• Connect to the HUB

• SDK

▪ Includes a Non-Disclosure Agreement covering the provision of Confidential

Information by EMVO, e.g on

• European Hub

• EMVO Gateway

▪ Purpose: Execution of Technical On-Boarding

The Participation Agreement (PA)


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ON-BOARDING FEE


One-Time Fee per OBP

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Contracts

Consistency between the named Authorised Representative in step 1.2. and the person that actually signed the contracts

no ammendments

TWO hardcopies have to be sent to EMVO

both hardcopies have to be signed by the relevant person

both hardcopies have to be original versions (not scanned)


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2.5 INVOICING INFORMATION


Mandatoryfields In Number of MAHs the OBP has to chose from a

drop-down menu the total number of MAHs it willupload data for in the European Hub.

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2.7 MAH AND PRODUCT INFORMATION


Note 1:

• New item allows the OBP to add a new MAH into the list.

• Edit allows the OBP to copy paste an excelsheet with all its MAHs listed, using the exact

same name and location of the columns as

shown in that section.

Note 2:

For the purpose of the Legitimacy Check theOBP has to provide a minimum of one MAH and

a minimum of one corresponding product

information.

In the end, the OBP will have to fill-in the wholelist of MAHs for which it will upload data in the

European Hub.

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2.7 MAH AND PRODUCT INFORMATION


Note:

Product information;

• The Marketing Authorisation Number is the licensed number related to the number of the

product that the MAH received when

applying for Marketing Authorisation

• The Marketing Authorisation Name; togetherwith the name, please mention the strength

and the pack size of the product in order to

allow EMVO to identify the exact product

presentation linked to the Marketing

Autorisation Number.

• The Marketing Authorisation Registration refers to the country covered by the marketing

authorization and may be centralized.

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Marketing Authorisation information

The information from your application for marketing authorisation to the relevant national entity.

Number: unique MA code for each product (! Typo, additional letters, slash, dots and hyphen, etc.)

Name: depends on product form, strength, pack size,… please be precise!

Registration: depends on the country targeted by the MA


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2.8 CONFIRM ALL INPUTTED INFORMATION


By clicking on the Confirm button the SPOC confirms the accuracy

of the information provided on the portal.

This triggers the Legitimacy Check.

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Step 3: Approvals



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STEP 3: APPROVALS


Status: Not StartedPassedFailed

Trigger step 3:Step 2 completed and

confirm button pressed.

Status: Not StartedAwaiting hardcopySent back on xx:xx:xxxx

Status:

No StatusAwaiting payment

Payment received

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LEGITIMACY CHECK


o Triggered when the SPOC confirms the accuracy of the information provided on the portal

o Around 50 parameters checked

o Direct and indirect checks are conducted

o Outsourced: conducted totally independently from EMVO –ensuring efficiency, accuracy and objectivity

o The check is conducted by actual people – ensuring a solution-oriented and reflexive approach

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Step 3: Approvals



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EU HUB ENVIRONMENTS


IQE environment• Integrated Quality

Environment • Used for Quality-

& Certification testing by multiple OBP’s

• Validated environment

PRD environment• Productive

Environment• Validated

environment

ITE IQE PRD

ITE environment• Integrated Test

Environment• Used as sandbox

by multiple OBP’s • Integration testing

of OBP’sconnection IQE: Integration Quality Environment

IQE: Integration Quality Environment

PRD: Productive Environment

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STEP 4: TECHNICAL ON-BOARDING


Trigger step 4:• Step 3 completed

Status:

Not StartedCompleted

Note: If you make use of a

Gateway

Connection, step

4.2.2 (ITE) is optional

Access sub-steps

Access sub-steps

Status:

Not startedCompleted

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CONTENT

43





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44

STATUS IN THE 32 MEMBER STATES


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EXECUTIVE SUMMARY COUNTRY READINESS

45

15

14

22

0

31

11

810

16

24

6

27

13

28

4

3

26

19

17

8

12

30

9

32

2529

22

7

11

5

23

2

1

Early Adopter

Main Stream

Late Follower

Non EU Countries


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ORGANISATIONAL CHART


General Management

Andreas Walter

Commercial & Partner

Management Tobias Beer

Fanny Trenteseaux

Léa Auriol (Intern)

André Geraldes

Kirsi Kulmakorpi

(Intern)

NN (Legal

Counsel)

Jannik Jäger (Intern)

Operations

Koen Van

Gompel

Paul Mills (External

Consultant)

Willem Theunissen

(External Consultant)

Office Management

Marisa Jimenez Sanchez

Quality Assurance Stephan

Theunissen

Markus Gerigk (External

Consultant)

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)

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Tel. Helpdesk+372 611 90 44

[email protected]

www.emvo.medicines.eu

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