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Wien, 05.07.2017

All-Hands-MeetingVerifikation von Arzneimitteln in Österreich

06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 2

PROJEKTAUFTRAG

Rahmenbedingun-gen, Beteiligte

Projektplan

Artikelstamm

Onboarding

ERMITTLUNG DES STATUS QUO

Prozessbeteiligte

Distributionsmatrix

Geschäftsprozesse

AUSBLICK

Software SupplierMeeting

Sonstige Themen

Agenda

FUNKTIONWEISE DES NMVSTransaktionstypen

Systemkonfiguration

Integrationsszenarien


PROJEKTAUFTRAG


Projektplan

Artikelstamm

Onboarding


Prozessbeteiligte

Distributionsmatrix

Geschäftsprozesse

AUSBLICK


Sonstige Themen

Agenda


Systemkonfiguration


* Inhalte der Infoveranstaltung 05.07.17mit nachfolgend eigener Agenda


EINLEITUNG

Gesetz

Grundidee

Beteiligte

Arvato

PROJEKTAUFTRAG

Herausforderungen

Massnahmen

Erfahrungen

ARTIKELSTAMM

Data Matrix Code

PZN vs. PPN / NTIN

Agenda

AUSBLICK

Onboarding

Nächste Schritte

PROJEKTPLAN

5-Phasen-Modell

Early birds


Schrittweise zu noch mehr Arzneimittelsicherheit


Der Countdown läuft …

Sources: https://emvo-medicines.eu/downloads/ and www.securpharm.de

[30.06.17]

Unique Identifier

Anti-Tampering Device (ATD)

Point of dispense verification

Databases

Legislation

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

http://www.securpharm.de/


Die Grundidee“Point of dispense medicines verification”

Source: https://emvo-medicines.eu/about-emvo/european-medicines-verification-system/


Kernprozesse und beteiligte Stakeholder

EU-Hub NMVS

Upload1. Products2. Packs

EU legis-lation

Autho-rities

Verification Verification + Dispense

Software Supplier

Upload1. Products2. Packs


BertelsmannInternational führender Media und Service Konzern

Umsatz

Mitarbeiter

> 17 Mrd. Euro

> 117.000

57 Fernseh-, 31 Radiosender > 10.000 produzierte

Stunden pro Jahr 105 Mrd. Online-Video

Views

250 Verlage weltweit 800 Mio. verkaufte Bücher 584 New York Times

Bestseller in 2015

> 500 Medienaktivitäten, Magazine, digitale Angebote

> 130 Auszeichnungen für Journalisten und Autoren

Nr. 4 im weltweiten Musikrechtemanagement (11 Märkte)

> 70.000 Songwriter & Künstler unter Vertrag

Zahlreiche Hightech-Kunden Breites Service-Portfolio mit

Präsenz in 39 Ländern Nr. 1 im Fashion

E-Commerce EU

Nr. 1 Druckerei in Europa 1,6 Millionen Tonnen

gedrucktes Papier pro Jahr > 20 Standorte weltweit

> 28 Millionen Kurse pro Jahr (Relias)

Absolventen in 168 Ländern (Udacity)

6.600 Studenten (HotChalk)

Globales Fonds-Netzwerk > 100 Beteiligungen in

Start-Ups 30 neue Investitionen in

2015


ArvatoInternational vernetzter Outsourcing-Dienstleister

>3.2Milliarden Euro durch bearbeitete

Forderungen

700Millionen

ausgelieferte

Sendungen

pro Jahr

Supply Chain Management

FinanceCustomerRelationship Mgmt.SOLUTIONS

IT

300Millionen

Kundeninteraktionen

pro Jahr

>80Millionen

ausgelieferte Handys

pro Jahr

in China

100Mio. abgerechnete

Werbe-Klicks

in 180 Währungen

pro Tag

40Millionen

betreute Konsumenten

in Customer Loyalty

Systemen

>10Millionen

ausgelieferte E-Books

Umsatz

Mitarbeiter

> 4,8 Mrd. Euro

> 70.000

innovativ – agil – flexibel – international


ArvatoThink global – act local

Kitchener

USA:BerryvilleDallasDullesDuncan, SCHorshamLouisville, KY Mountain ViewNew YorkPleasant Prairie, WIRenoValencia, CAWeaverville, NC

Bogota)

Buenos Aires

Singapore

Bangkok

Port Elizabeth

CasablancaMarrakesh

Beijing

Shanghai

Hong Kong

Guangzhou

Hangzhou

Xiamen

Shenzhen

Lisbon Porto

Spain:8 locations

Dublin

Changchun

Belgium:AntwerpBrusselsZaventem

Netherlands:AbcoudeHilversumVenloVenray

Poland:PlewiskaSzczecinPoznan Blonie WarsawGadki

UK:Beverley/ WillerbyBirminghamEast RidingHigh WycombeLiverpoolLondon

France:19 locations

Manila

New Delhi

GurgaonSwitzerland:AdligenswilBaarPrattelnRotkreuzSchlieren

Bergamo Athens

Turkey:Ankara DiyarbakirIstanbul Izmir

Nordic countries

TallinnYaroslavl

Vienna

Budapest

Czech Republic:Brno, PragueMlada BoleslawStochov

Sydney

São Paulo)

Guarulhos)

HortolândiaManaus

Germany: 57 locationsMexico DF

Monterrey Juarez

Vancouver

Lima


Arvato SystemsDaten & Fakten

New York

GüterslohToronto

Birmingham

San Francisco

Kuala Lumpur

Shanghai

Amsterdam

Zürich

Beijing

Nanjing

GuangszhouGreenville

Los Angeles

Hauptsitz

Standort

UMSATZ

€ 418 MMITARBEITER

> 3.000STANDORTE

> 25

Weitere Standorte in Deutschland:z. B. Baden-Baden, Berlin, Bielefeld, Bremen, Dortmund, Düsseldorf, Hamburg, Köln, Leipzig, München, Ratingen, Rostock, Walldorf


Arvato‘s Footprint in Serialization

NATIONAL VERIFICATION SYSTEMS

Selected BluePrint Provider by EMVO

Expertise by pilot project securPharm since 2012

COMPANY SOLUTION

Pharmaceutical

Manufacturer

European

Hub

Sites

CMOs

Manage Serialization Processeson company level (MAH)

Connect to all relevant markets


EINLEITUNG

Gesetz

Grundidee

Beteiligte

Arvato

PROJEKTAUFTRAG

Herausforderungen

Massnahmen

Erfahrungen

ARTIKELSTAMM

Data Matrix Code

PZN vs. PPN / NTIN

Agenda

AUSBLICK

Onboarding

Nächste Schritte

PROJEKTPLAN

5-Phasen-Modell

Early birds


We have to master one central challenge

Organize Cooperation !

• The stakeholders must learn to act together in a new context.

• New overarching processes must be established.

• Stakeholders are depending on each other, i.e. delays and errors will propagate and accumulate downstream.


NMVS StakeholdersMany stakeholders are involved …

• Organisators

• NMVO

• EMVO

• Software providers

• Solidsoft Reply (EMVS/EU Hub)

• Arvato

• Pharmacy/hospital/wholesalerSW providers/IT departments

• Authorities

• Vertriebsunternehmen

• Marketing authorization holders

• Contract manufacturers

• Parallel distributors

• Primary distributors

• Wholesalers

• Public pharmacies

• Hospital pharmacies

• Secondary distributors

• Army

• Prisons

• Airlines

• Nursing homes

• Drug treatment centers

• NGOs

• ...


A complex web of stakeholders must learn to cooperate smoothly

Officines,hôpitaux

Officines,hôpitaux

Officines,hôpitaux

ExploitantsExploitantsExploitants Arvato

Pharmacies

MAHs

EMVO, EU Hub

Parallel Distributors

Wholesalers

NMVO

Authorities

Arvato uses the EU Hub to download product/pack data;Arvato implements changes of

the URSMAHs use the EU Hub

to upload their product/pack data

Authorities define their needs concerning the data to provided

NMVO defines specific requirements (e.g. needs of the authorities)

Wholesalers use the NMVS Parallel distributors

use the NMVS

Parallel distributors receive medicaments from the

wholesalers

Pharmacies receive medicaments from the

wholesalers

Pharmacies receive medicaments from the

MAHs

MAHs use the NMVS (data analysis)

Software Suppliers

Pharmacies use the software products of the software

suppliers

Software suppliers depend on Arvato to adapt/connect

their software products

Authorities

Authorities approve new serialized medicaments

ExploitantsExploitantsCMOs

Stakeholder A

Stakeholder B

Legend

Stakeholder B depends on stakeholder A

The CMOs have to prepare their production for

serialization.

Wholesalers receive medicaments from the MAHs

EMVO, EU Hub

Par. distributors use the EU Hub

Pharmacies use the NMVS


What exactly needs to be done? (1)

• All MAHs must

• Introduce serialization for their products (package design, regulatory approval, production preparation, production start)

• Synchronize with their manufacturers (CMOs)

• Synchronize with their wholesalers

• Connect with the EU-Hub and start uploading product data and pack data

• Adapt their IT systems to handle serialized products (incl. EU Hub interface)

• Manage detected falsifications including false positives

• All wholesalers / parallel distributors must

• Synchronize with their MAHs

• Adapt their IT systems to handle serialized products (incl. NMVS interface)

• Manage both serialized and non-serialized products for a transition time

• Wait for serialized products to be delivered by all their MAHs




• All pharmacies must

• Align with their software suppliers

• Introduce upgraded IT systems for scanning of serialized products

• Onboard to the NMVS system (certificates, access rights, etc.)

• Train their employees

• Adapt their daily business processes

• Wait for serialized packs to propagate through the supply chain


• All software suppliers must

• Understand the NMVS web service interface and specify the required changes to their software products

• Plan and reserve implementation capacities

• Implement and test the specified changes to their software products

• Coordinate the rollout of their new software product releases to the pharmacies



• The EU Hub will for the first time have to ...

• ... handle transactions from multiple countries

• ... handle multi-market products/transactions

• ... handle inter-market transactions

• AMVO will have to ...

• ... keep an overview of all the stakeholders involved and their respective progress in the project

• ... align with the Austrian authorities

• ... manage detected falsifications including false positives

• General aspects

• The NMVS must be formally validated by the AMVO and approved by EMVO

• Further URS changes by EMVO are likely to occur in the future and will have to be considered


• Große Herausforderungen für MAHs

• Implementierung der Serialisierungslösungen in die Produktionslinien und die IT Systeme

• Anbindung an den EU-Hub und Test der Uploading-Prozesse

• Hoher Zeitbedarf für

• Klärung organisatorischer Sachverhalte der Stakeholder-Gruppen

• Warenflüsse

• Bsp. Praxistest securPharm

• Klärung von Geschäftsprozessen

Erfahrungen

MAH PatientPharmacyWholesalerManufacturer

140 Tage


Business Processes(1) Example: What happens when a Multi-Market Pack is dispensed?

European Hub(EMVO)

Dispense pack XYZ/1234

(2) Norwegian NMVS informs EU Hub about dispense of the multi-market pack

National Repository

National Repository

Dispense packXYZ/1234

Dispense packXYZ/1234

(4) EU Hub informs NMVS‘s in Finland and Sweden about the dispense of the multi-market pack somewhere else

National Repository

Dispense pack XYZ/1234

DispenseProduct XYZ

Serial Nr 1234

Database entries:

...XYZ = Multi market product....XYZ/1234 => „Supplied“

(1) Norwegian NMVS sets pack status to „supplied“ and detects that XYZ is a multi-market product.

(0) Product XYZ is available in Norway, Finland, Sweden

(3) EU Hub looks up in which other countries the multi-market pack would be dispenseable

Database entries:

...XYZ = Multi market product....XYZ dispenseable in Norway, Sweden, Finland ....

(5) Finnish and Swedish NMVS‘s set pack status to „supplied“.

Database entries:


Database entries:



Business Processes (2) Example: What is an Inter-Market Transaction?

European Hub(EMVO)

Dispense pack ABC/5678

(2) Norwegian NMVS reports dispense to EU Hub to check if product/pack is known elsewhere

Database entries:

...ABC/5678 is dispenseableABC/5678 => „Supplied“ ....

National RepositoryDispense packABC/5678

(4) EU Hub forwards dispense information to German NMVS

Report backABC/5678

(5) German NMVS reports back that pack was found and that its status has been set to „Supplied“

Report backABC/5678 (6) EU Hub reports back that pack

was found in another NMVS

(3) EU Hub looks up in which other countries the product ABC is known Database entries:

...Product ABCdispenseable in Germany....

Dispense pack ABC/5678

DispenseProduct ABC

Serial Nr 5678

(0) Pack ABC/5678 has been imported from Germany to cover a drug shortage.

(1) Norwegian NMVS cannot find product ABC in its database National Repository

Database entries:

....Product ABC unknown....

(7) NMVS reports back that an Inter-Market Transaction was executed


Business Processes (3) Process Illustration: Repackaging by Parallel Distributor

(5) Parallel Distributor uploads A-package data („checked out“) and B-package data with new batch-id(s) and serial numbers incl. reference tooriginal A-batches to EU Hub

MAHNational Repository

(NMVS)

European Hub

(3) Finnish Wholesalersells some packages of

product A to Swedish Parallel Distributor

National Repository(NMVS)

(4) Parallel Distributor re-packages A-packs into product

B-packs with new serial numbers.1)

Par. Distr.

(7) EU Hub sends B-package data with new

serial numbers to NMVS Sweden

Wholesaler

(8) EU Hub sends status updates for repacked A-packs

(„checked out“), i.e. serial numbers, to

Finnish NMVS

(1) Finnish MAHuploads packagedata for product A to EU-Hub

(6) EU Hub saves relationship between A-batches and B-batches in case a later recall of an A-batch should occur.

1) Important remarks:a) Both A-packs and B-packs may belong to several different batches but a 1:n relationship between A-batches and B-batches needs to be maintained.b) It is possible that only a part of an A-batch is sold to the Parallel Distributor, so other parts may remain in the original country, e.g. Finland.c) A cascading process is possible, i.e. the Parallel Distributor in Sweden might resell some packs of product B to a Parallel Distributor in Norway that repacks them into product C.

(2) EU-Hub

uploads packagedata for product A to Finnish NMVS


EINLEITUNG

Gesetz

Grundidee

Beteiligte

Arvato

PROJEKTAUFTRAG

Herausforderungen

Massnahmen

Erfahrungen

ARTIKELSTAMM

Data Matrix Code

PZN vs. PPN / NTIN

Agenda

AUSBLICK

Onboarding

Nächste Schritte

PROJEKTPLAN

5-Phasen-Modell

Early birds


Time PlanningHigh Level Perspective

There are roughly 19 months left until medicine verification becomes mandatory in Europe

This is our plan to finish the project within the available time frame:

What are the results of each phase?Let‘s go through the five phases shown.

Phase 1

Initialization

Phase 2Ramp-up stage A

Onboarding ofearly-bird MAHs

Phase 3Ramp-up stage B

Onboarding of early-bird pharmacies/wholesalers

Onboarding of MAHs

Phase 4Ramp-up stage C

Onboarding of remainingpharmacies/wholesalers and MAHs

Phase 5

Production

Feb 9, 2019July 2017 … End of 2017… … Beginning of 2018 …


Planning, Detail ViewPhase 1: Initialization


Onboarding of early-bird MAHs

Results of Phase 1:

Organization A final requirements analysis for the Austrian NMVS has been made The major project decisions have been taken The planning is complete The software suppliers have registered themselves in the software supplier portal The description of the NMVS web service interface has been made available

to the software suppliers of pharmacies and wholesalers

New functionalities The first MAHs are preparing the production of serialized medicines The first MAHs are able to upload product/pack data to the EU Hub A connection between the NMVS and the EU Hub has been established The EU Hub can upload product/pack data to the NMVS

Phase 5

Production

Feb 9,2019



Onboarding of MAHs


Onboarding of pharmacies/wholesalers and MAHs

Phase 1

Initialization


Planning, Detail ViewPhase 2: Ramp-up Stage A

MAH

EU Hub(EMVS)

Parallel Distributor

National Blueprint System(NMVS Austria)

Data upload(products, packs)

During phase 2, the highlighted information flows will be tested:



Planning, Detail ViewPhase 2: Ramp-up Stage A

Phase 1

Initialization

Results of Phase 2:

Usage The first serialized packs have been manufactured and put into the supply chain. Product/pack data have been transferred to the NMVS, i.e. the information flow between MAHs and the

NMVS via the EU Hub has been tested.

Organization

A small group of pharmacies and wholesalers („early birds“) has been chosen to test theverification/dispensing of medicines in Phase 3

New functionalities

The first pharmacy software suppliers have already connected their software productswith the NMVS web services interface

A web app will be provided as fall-back scenario for Phase 3 (if the software suppliers are not fast enough)

Phase 5

Production

Feb 9,2019



Onboarding of MAHs






Planning, Detail ViewPhase 3: Ramp-up Stage B

Officine, hôpital

MAH

European Hub(EMVS)



During Phase 3, additional data flows will be tested:

Wholesaler

Verification,dispense

Requests and pack status changesRequests and pack status changes for multi-market products

Web app Web appWholesaler software

Pharmacy software

„early birds“

Pharmacy




Planning, Detail ViewPhase 3: Ramp-up Stage B



Results of Phase 3:

Usage The first serialized medicines have arrived at the pharmacies/wholesalers. The first software suppliers have connected their pharmacy/wholesaler software with the NMVS web services. The early-bird pharmacies/wholesalers have verified/dispensed the first serialized medicines,

i.e. the information flow between the MAHs and the NMVS has been tested end-to-end. The web app is no longer available.

Organization

The onboarding of the major part of the pharmacies and wholesalers has been prepared.

New functionalities

The NMVS web services are fully functional, including multi-market transactions.

Phase 1

Initialization

Phase 5

Production

Feb 9,2019





Onboarding of MAHs


Planning, Detail ViewPhase 4: Ramp-up Stage C

OfficineOfficineGrossiste

MAH

European Hub(EMVS)



During Phase 4, the functionality of the various pharmacy and wholesaler software systems will be tested:

Wholesaler Pharmacy

Verification,dispense,

lock, sample,undo dispense ...

Wholesaler software

Pharmacy software



Requests and pack status changes for multi-market products

Requests and pack status changes


Planning, Detail ViewPhase 4: Ramp-up Stage C



Onboarding of MAHs

Results of Phase 4:

New functionalities All software suppliers have connected their systems with the NMVS web services. The new pharmacy/wholesaler software systems have been installed at almost all pharmacies and wholesalers.

Organisation The software suppliers have trained their users at pharmacies and wholesalers.

Utilization The new software version have already been used at the pharmacies and wholesalers. The vast majority of medicine packs on the Austrian market is now serialized.



Phase 1

Initialization

Phase 5

Production

Feb 9,2019


Onboarding of remaining pharmacies/wholesalers and MAHs


Planning, Detail ViewPhase 5: Production


Onboarding of remaining pharmacies/wholesalers and MAHs



Onboarding of MAHs

Results until Feb 9, 2019:

New functionalities The new pharmacy/wholesaler software systems have been installed at all pharmacies and wholesalers

Utilization The verification of medicines has become a routine at the pharmacies and wholesalers. Almost all medicine packs on the Austrian market are now serialized.



Phase 1

Initialization

Phase 5

Production

Feb 9,2019


EINLEITUNG

Gesetz

Grundidee

Beteiligte

Arvato

PROJEKTAUFTRAG

Herausforderungen

Massnahmen

Erfahrungen

ARTIKELSTAMM

Data Matrix Code

PZN vs. PPN / NTIN

Agenda

AUSBLICK

Onboarding

Nächste Schritte

PROJEKTPLAN

5-Phasen-Modell

Early birds


National Trade Item Numbers (NTINs)

NTINs (National Trade Item Numbers which are special cases of GTINs, Global Trade Item Numbers, issued by GS1) will bethe encoding scheme to be used by Austrian manufacturers to generate globally unique product codes.

NTIN (National Trade Item Number) 1)

0 90 8888 123456 9

PZNGS1 prefixfor „ARGE Pharma“

Country prefix

Check digit

1) See also [EFPIA-EUPACKCOD]

http://argepharma.fcio.at/DE/argepharma.fcio.at/Kodierung%20von%20Arzneimitteln/Kodierung+von+Arzneimitteln.aspx

http://argepharma.fcio.at/DE/argepharma.fcio.at/Kodierung von Arzneimitteln/Kodierung+von+Arzneimitteln.aspx


Structure of a Package Data Matrix Code based on GTIN/NTINAccording to EFPIA European Pack Coding Guidelines1)

01012345678901281719120121123456789A123456789B<GS>10ABATCHCODE12345

Serial Number Field

Application Id 21„Serial Number“

Serial number (variable length, max. 20 chars)

Group separator (0x1D)

Batch/Lot Number Field

1) See also [GS1-GENSPEC], [GS1-GTINALLOC] 2) This represents what is sent by the scanner after reading. The string encoded in the 2D data matrix has a slightly different structure

Application Id 10„Batch/Lot Number“

(variable length, max. 20 chars)

No group separator character

because of last fieldBatch/lot number

Application Id 17„Expiration

Date“

Expiration Date Field

Product Number Field

Expiration Date

YYMMDD or YYMM00

„2019-12-01“

Application Id 01„GTIN“

(Product Number)

GTIN 13 digits +

1 check digit

GTIN (01) 01234567890128SERIAL (21) 123456789A123456789BLOT (10) ABATCHCODE12345EXPIRY 2019-12-01

This is how the example data above would be encoded as a 2D code and printed on a package in human readable form:

Example2) :

09088881234569


Sicherheitsmerkmale

Unique Identifier

Anti-Tampering Device (ATD)

Legislation

• Informationen bzgl. Codierregeln

• AMVO … folgt …

• EMVO Knowledge Databasehttps://emvo-medicines.eu/faq/

• European Commissionhttps://ec.europa.eu/health/human-use/falsified_medicines_en

• securPharmhttp://www.securpharm.de/pharma/codierregeln.html

• Informationen bzgl. der Vorrichtungen gegen Manipulation

• DIN EN 16679:2015-03Verpackung - Merkmale zur Überprüfung von Manipulationen an Arzneimittelverpackungen

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

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

https://ec.europa.eu/health/human-use/falsified_medicines_en

http://www.securpharm.de/pharma/codierregeln.html


EU Hub Product Data Model

Extract from EMVO User Requirement Specification (URS)

European Hub(EMVO)

MAH

Product Master DataBatch DataPack Data

Product related notifications(e.g. recall of repacked

medicament if MAH is a Parallel Distributor)

A part of the product

master data is to be

provided per market

Product master data

(especially market

specific data) may

change over time.

Only GTIN format and PPN format are possible


EINLEITUNG

Gesetz

Grundidee

Beteiligte

Arvato

PROJEKTAUFTRAG

Herausforderungen

Massnahmen

Erfahrungen

ARTIKELSTAMM

Data Matrix Code

PZN vs. PPN / NTIN

Agenda

AUSBLICK

Onboarding

Nächste Schritte

PROJEKTPLAN

5-Phasen-Modell

Early birds


OnboardingIm Rahmen diverser Onboarding-Prozesse werden (vertragliche) Regelungen getroffen

EU-Hub NMVS

EU legis-lation

Software Supplier

5

1 2 3

4

Autho-rities

6

7

https://emvo-medicines.eu/eu-hub-on-boarding/

https://it.arvato.com/en/services/nmvs-portal-en.html

8 9

Vertriebs-unternehmen


Ausblick

OnboardingTests

Anpassung derProduktionsprozesse

Early birds

Anbindung an den EU-Hub

Einbindung der IT-Dienstleister

Abstimmung mitPartnern in der Prozesskette

Anpassung der IT-Systeme


PROJEKTAUFTRAG


Projektplan

Artikelstamm

Onboarding


Prozessbeteiligte

Distributionsmatrix

Geschäftsprozesse

AUSBLICK


Sonstige Themen

Agenda


Systemkonfiguration



• Mitglieder

• ÖAK – Österreichische Apothekerkammer• Die Österreichische Apothekerkammer ist die gesetzliche Berufsvertretung der mehr als 5.400 Apothekerinnen und Apotheker,

die sowohl in öffentlichen Apotheken als auch in Krankenhäusern tätig sind.

• OeGV - Österreichischer Generikaverband• Der Österreichische Generikaverband ist ein Zusammenschluss von Generika-Produzenten, die sich zur optimalen Versorgung

der österreichischen Patientinnen und Patienten mit hochwertigen, preiswerten Arzneimitteln bekennen. Die [11] Mitgliedsunternehmen sorgen für Wertschöpfung und rund 15.000 Arbeitsplätze. 90 Prozent der rund 300 Millionen in Österreich produzierten Packungen werden exportiert.

• PHAGO - Verband der österreichischen Arzneimittelvollgrosshändler• PHAGO ist eine freiwillige Interessenvertretung des österreichischen Arzneimittelvollgroßhandels [6 Mitgliedsunternehmen].

Dessen wichtigste Aufgabe ist die Sicherstellung der Arzneimittelversorgung für Österreich. Als Rückgrat der Arzneimittel-versorgung kümmert sich der Großhandel daher um die Planung, Abwicklung und Auslieferung von 20 Millionen Arzneimitteln, die jedes Monat von der Industrie in die Apotheke gebracht werden müssen. Der Großhandel lagert über 50.000 Artikel von mehr als 2.000 Lieferanten. Damit bündelt er das gesamte Arzneimittel-Sortiment, um jederzeit für Patienten liefern zu können.

• Pharmig – Verband der pharmazeutischen Industrie Österreichs• Die Pharmig ist die freiwillige, parteipolitisch unabhängige Interessenvertretung der österreichischen pharmazeutischen

Industrie und vertritt diese mit einer Stimme auf nationaler und internationaler Ebene. In der Pharmig haben sich rund 120 Unternehmen mit ca. 18.000 Mitarbeitern zusammengeschlossen, die den Arzneimittelmarkt zu gut 95 Prozent abdecken und einen Exportüberschuss von über 700 Millionen Euro erwirtschaften.

Austrian Medicines Verification Organisation (AMVO)


• Systemnutzer

§ 7.1. Die Nutzer des AMVS werden an das Gesamtsystem während der Vertragslaufzeit angebunden und setzen sich nach derzeitigem Stand aus den einzelnen Nutzergruppen (a) bis (h) wie folgt zusammen:

• Packungen

155 Mio Packungen pro Jahr

Anzahl Systemnutzer und Packungen

# Anzahl Stakeholder

(a) NMVO

(b) 1.360 Apotheken

(c) 50 Krankenhausapotheken

(d) 870 Hausapotheken

(e) 170 Großhändler

(f) 270 Zulassungsinhaber/Vertriebsunternehmen

(g) 20 Hersteller/Vertriebsunternehmen

(h) österreichische Aufsichtsbehörden

2.740

Software Supplier

Anzahl Stakeholder

Software Supplier / IT-Dienstleister

Marketing Authorisation Holders (MAH)

Contract Manufacturing Organization (CMO)

Depositeur


Dispensing Doctor

…

ErgänzungMapping

• Der Bedarf, Stammdaten bzgl. der Firmen und zugehöriger Personen zu erfassen, ergibt sich im Rahmen der Onboarding-Prozesse u.a. wie folgt:

• Treffen vertraglicher Regelungen

• Anlage von Usern im System

• Herstellen von Eindeutigkeiten (insbesondere MAH-ID)

• Vorbereitung der Abrechnung

• Beispiele/Entwurf• Personen

• Anrede

• Vorname

• Nachname

• E-Mail

• Telefonnummer

• Rolle


SystemnutzerErmittlung der Stammdaten

Software Supplier

• Firmen

• ID (z.B. MAH-ID)

• Stakeholder typ (z.B. Grosshandel, Apotheke, IT-Dienstleister)

• Area of activity (z.B. Krankenhaus (bzgl. Apotheke), Apotheke (bzgl. IT-Dienstleister))

• Name

• Strasse

• Hausnummer

• Land

• Postleitzahl

• Stadt

• Internet

• Pilotpartner j/n

• Software name

• Software version

• Konzentrator

• Partner (Auftraggeber/Lieferant)


Warenflüsse transparent machenDistributionsmatrix

.

.

.

1 2 3

1

2

3

Wer liefert wem Ware ?

Wer bucht wann die Abgabe des Arzneimittels ?

Wie viele Stakeholder dieses Typs gibt es ?


Warenflüsse transparent machenDistributionsmatrix


PROJEKTAUFTRAG


Projektplan

Artikelstamm

Onboarding

ERMITTLUNG DES STATUS QUOProzessbeteiligte

Distributionsmatrix

Geschäftsprozesse

AUSBLICK


Sonstige Themen

Agenda


Systemkonfiguration



Transaction typesAuthorisation

Transaction Type Pharmacy 1) Wholesaler 1)

Verification X X

Dispense X X

Destroy X X

Export X

Sample, for authorities/sample archives X X

Free sample, for healthcare professionals X

Lock X

Stolen X

1) X = Transaction authorized

Source: EMVO, URS EMVO_0015 European Medicines Verification System: Requirements Specification Part II, version 2016-10-20


Transaction groups

• G100 - Distributor Transactions

• G200 - MAH Transactions

• G300 - Reports

• G400 - Administration

• G500 - EU Hub Transactions

• G600 - Stakeholder Onboarding Support

• G700 - Onboarding software suppliers

Example

Transaction typesOverview transaction groups


Permission mapping


(1) Single Pack transactions

• Submit Single Pack TransactionSingle pack transactions, e.g. Verify Single Pack, Dispense Single Pack, Destroy Single Pack

• Undo Single Pack TransactionReverse single pack transactions, e.g. Undo Dispense

(2) Bulk transactions

• Submit Bulk TransactionsBulk transactions are lists of transactions with the same product, batch id and transaction type. They are generated by wholesalers to handle large quantities of packs, e.g. Bulk Verify Packs, Bulk Export Packs.

• Request Bulk Transactions ResultBulk transactions are processed asynchronously. These web services are used to fetch the results of previously submitted bulk transactions.

(3) Offline Bulk transactions

• Submit Offline Bulk Transactions (“Offline Recap”)Offline bulk transactions contain transactions with heterogeneous products and transaction types. They are generated by pharmacies when the local transaction buffer is emptied after an offline period.

• Request Offline Bulk Transactions Result (“Offline Recap”)Offline bulk transactions are processed asynchronously. These web services are used to fetch the results of previously submitted offline bulk transactions.

Transaction typesSingle vs. bulk, online vs. offline


System Architecture Overview Example for decentralized integration scenario

Disp. DoctorDisp. Doctor

MAHMAH

Pharmacy

MAH

Hospital

European Hub(EMVS)

Local pharmacy software installation, bundles communication with all dispensestations, >= 30 different pharmacy software vendors, ca. 22,500 pharmacies

Product/pack data upload

Legend

Verification dispense,etc.

Disp. Doctor

Pharmacy

Pharmacy

Pharmacy

Hospital

Hospital

National Repository(NMVS)

Local hospital software installation, bundles communication with all dispensestations, ca. 3,000 hospitals, very heterogenuous

Wholesaler

Wholesaler

Local wholesaler/par. distr. software installation, bundles communication with all local stations for verification etc.

Dispense(Web app)

Par. Distr.Par. Distr.

(MAH)

Par. Distr.(Wholesaler)

Legend

Digital certificate, issued by arvato

Digital certificate, issued by EMVO

Pharmacy

Product/ pack data

upload

Multicountryrequests


„User groups“ and „Users“NMVS terms explained

NMVO admin

User Group (client)„Pharmacies“

User Group (client)„Wholesalers“

User Group (client)„Hospital pharmacies“

An NMVO administrator creates user groups(„clients“ with „users“) and grants them usage rights

PharmacieGilmar, Namur

Apotheek Strobbe Els,

Gent

...

St-Nikolaus Hospital,

Eupen

...

AZ Damiaan,Oostende

...

Wholesaler B

Agency 1

Agency 2

Wholesaler AConcentrator

CHU de LiègeConcentrator

H 1

H 2

...

„Users“


PROJEKTAUFTRAG


Projektplan

Artikelstamm

Onboarding

ERMITTLUNG DES STATUS QUOProzessbeteiligte

Distributionsmatrix

Geschäftsprozesse

AUSBLICK


Sonstige Themen

Agenda


Systemkonfiguration



Share Knowledge Enable for StartSupport

Implementation Assist

Testing/Validation

get support in case of technical problems

FAQ is available

quality assurance with complete test set for all relevant use-cases

short registration process

Hand out first documentation about the National Verification System

Hand out technical information (WSDL)

create a User Account and hand out client certificates

get access to the generic NMVS Integration environment

Onboarding Procedure for Software SuppliersOur Onboarding Approach


Onboarding Procedure for Software SuppliersThree steps

(1) Software Supplier registers with the software supplier portal(SharePoint) and applies for access.

(2) NMVO checks the request and approves portal access.Each software supplier gets one portal user only.

(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 SuppliersShare Knowledge


Share Knowledge

short registration process

Hand out first documentation about the National Verification System

Hand out technical information (WSDL)

(1)Register yourself!

(2)Approve access request

(3)Get access to the central SharePoint!

Read the manuals!

Use the Software Developer Kit (SDK)!https://share.arvato-systems.de/customer/NMVS


https://it.arvato.com/de/services/it---commerce---nmvs-portal.html

Registration Portal

Software Supplier Portal

https://share.arvato-systems.de/customer/NMVS


https://it.arvato.com/de/services/it---commerce---nmvs-portal.html


Onboarding Procedure for Software SuppliersOverview Supplier Portal


Dokument“ID-004 Software Supplier Onboarding”



Onboarding Procedure for Software SuppliersSoftware Developer Kit

Arvato will provide the following resources as part of a “Starter package”:

Interface documentation (Technical / XSD, Use-Cases and API usage)

Test environment incl. test accounts

Code samples (c#, java) – also as libraries

Reference implementation (c#, java) of client stubs and offline functionality

Comprehensive testing plans – cover functional and non-functional tests

SOAP-UI Mock Testing Project

Approval of client software on integration environment

General information

Detailed roadmap regarding future developments and interface releases


PraxistestSample Product

Recommended ConceptWe prepare real pack as a sample product which can be used to explain the concept and do tests in rollout andrun phase

Tasks Declare Name and Ownership incl. Costs Product Registration in the country and at EMVO/NMVO Create the Design/Layout Approve Design Order printed Pack Create Serials Serialize Products Upload to the Hub Distribute in the Market

Quelle: vfa-securPharm Informationsveranstaltung 04.11.13


EU Hub Product Data Model

Extract from EMVO User Requirement Specification (URS)

European Hub(EMVO)

MAH

Product Master DataBatch DataPack Data

Product related notifications(e.g. recall of repacked

medicament if MAH is a Parallel Distributor)

A part of the product

master data is to be

provided per market

Product master data

(especially market

specific data) may

change over time.

Only GTIN format and PPN format are possible


Ausblick

Deployments

Testing

Schulung

Releaseplan

AbnahmenReporting

Audits

Support

Onboarding Distributoren


Danke für Ihre Aufmerksamkeit !

Diskussion und Fragen


Ihr Kontakt

Thomas Günther

Senior Account Manager

Phone: +49 5241 80 45802

Mobile: +49 171 860 36 20

E-Mail: [email protected]

Arvato Systems

https://it.arvato.com

Peter Koop

Vice PresidentHealthcare Solutions

Phone: +49 5241 80 89 392

Mobile: +49 160 366 95 08

E-Mail: [email protected]

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