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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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 3
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
* Inhalte der Infoveranstaltung 05.07.17mit nachfolgend eigener Agenda
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 4
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 5
Schrittweise zu noch mehr Arzneimittelsicherheit
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 6
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 7
Die Grundidee“Point of dispense medicines verification”
Source: https://emvo-medicines.eu/about-emvo/european-medicines-verification-system/
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 8
Kernprozesse und beteiligte Stakeholder
EU-Hub NMVS
Upload1. Products2. Packs
EU legis-lation
Autho-rities
Verification Verification + Dispense
Software Supplier
Upload1. Products2. Packs
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 9
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 10
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 11
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 12
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 13
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 14
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 15
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.
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 16
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
• ...
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 17
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 18
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
• Manage detected falsifications including false positives
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 19
What exactly needs to be done? (2)
• 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
• Manage detected falsifications including false positives
• 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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 20
What exactly needs to be done? (3)
• 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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 21
• 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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 22
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:
...XYZ = Multi market product....XYZ/1234 => „Supplied“
Database entries:
...XYZ = Multi market product....XYZ/1234 => „Supplied“
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 23
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 24
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 25
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 26
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 …
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 27
Planning, Detail ViewPhase 1: Initialization
Phase 2Ramp-up stage A
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
Phase 3Ramp-up stage B
Onboarding of early-bird pharmacies/wholesalers
Onboarding of MAHs
Phase 4Ramp-up stage C
Onboarding of pharmacies/wholesalers and MAHs
Phase 1
Initialization
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 28
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:
Data upload(products, packs)
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 29
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
Phase 3Ramp-up stage B
Onboarding of early-bird pharmacies/wholesalers
Onboarding of MAHs
Phase 4Ramp-up stage C
Onboarding of pharmacies/wholesalers and MAHs
Phase 2Ramp-up stage A
Onboarding ofearly-bird MAHs
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 30
Planning, Detail ViewPhase 3: Ramp-up Stage B
Officine, hôpital
MAH
European Hub(EMVS)
Parallel Distributor
National Blueprint System(NMVS Austria)
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
Data upload(products, packs)
Data upload(products, packs)
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 31
Planning, Detail ViewPhase 3: Ramp-up Stage B
Phase 2Ramp-up stage A
Onboarding ofearly-bird MAHs
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
Phase 4Ramp-up stage C
Onboarding of pharmacies/wholesalers and MAHs
Phase 3Ramp-up stage B
Onboarding of early-bird pharmacies/wholesalers
Onboarding of MAHs
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 32
Planning, Detail ViewPhase 4: Ramp-up Stage C
OfficineOfficineGrossiste
MAH
European Hub(EMVS)
Parallel Distributor
National Blueprint System(NMVS Austria)
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
Data upload(products, packs)
Data upload(products, packs)
Requests and pack status changes for multi-market products
Requests and pack status changes
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 33
Planning, Detail ViewPhase 4: Ramp-up Stage C
Phase 3Ramp-up stage B
Onboarding of early-bird pharmacies/wholesalers
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 2Ramp-up stage A
Onboarding ofearly-bird MAHs
Phase 1
Initialization
Phase 5
Production
Feb 9,2019
Phase 4Ramp-up stage C
Onboarding of remaining pharmacies/wholesalers and MAHs
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 34
Planning, Detail ViewPhase 5: Production
Phase 4Ramp-up stage C
Onboarding of remaining pharmacies/wholesalers and MAHs
Phase 3Ramp-up stage B
Onboarding of early-bird pharmacies/wholesalers
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 2Ramp-up stage A
Onboarding ofearly-bird MAHs
Phase 1
Initialization
Phase 5
Production
Feb 9,2019
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 35
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 36
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 37
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 38
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/
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 39
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 40
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 41
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 42
Ausblick
OnboardingTests
Anpassung derProduktionsprozesse
Early birds
Anbindung an den EU-Hub
Einbindung der IT-Dienstleister
Abstimmung mitPartnern in der Prozesskette
Anpassung der IT-Systeme
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 43
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 44
• 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)
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 45
• 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
Parallel Distributor
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
• Telefonnummer
• Rolle
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 46
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)
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 47
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 ?
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 48
Warenflüsse transparent machenDistributionsmatrix
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 49
PROJEKTAUFTRAG
Rahmenbedingun-gen, Beteiligte
Projektplan
Artikelstamm
Onboarding
ERMITTLUNG DES STATUS QUOProzessbeteiligte
Distributionsmatrix
Geschäftsprozesse
AUSBLICK
Software SupplierMeeting
Sonstige Themen
Agenda
FUNKTIONWEISE DES NMVSTransaktionstypen
Systemkonfiguration
Integrationsszenarien
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 50
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 51
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 52
Permission mapping
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 53
(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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 54
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 55
„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“
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 56
PROJEKTAUFTRAG
Rahmenbedingun-gen, Beteiligte
Projektplan
Artikelstamm
Onboarding
ERMITTLUNG DES STATUS QUOProzessbeteiligte
Distributionsmatrix
Geschäftsprozesse
AUSBLICK
Software SupplierMeeting
Sonstige Themen
Agenda
FUNKTIONWEISE DES NMVSTransaktionstypen
Systemkonfiguration
Integrationsszenarien
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 57
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 58
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 59
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/en/services/nmvs-portal-en.html
https://it.arvato.com/de/services/it---commerce---nmvs-portal.html
Registration Portal
Software Supplier Portal
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 60
Onboarding Procedure for Software SuppliersOverview Supplier Portal
https://share.arvato-systems.de/customer/NMVS
Dokument“ID-004 Software Supplier Onboarding”
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 61
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 62
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 63
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
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 64
Ausblick
Deployments
Testing
Schulung
Releaseplan
AbnahmenReporting
Audits
Support
Onboarding Distributoren
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 65
Danke für Ihre Aufmerksamkeit !
Diskussion und Fragen
06.07.2017 | Thomas Günther | Arvato Systems | All-Hands-Meeting AMVS 05.07.17 66
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]