Information session 2016-10-27 The implementation project team Solidsoft Reply Ltd e-verification of Pharmaceuticals - what will it mean for Pharmacies and Wholesalers?
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Information session 2016-10-27The implementation project teamSolidsoft Reply Ltd
e-verification of Pharmaceuticals- what will it mean for Pharmacies and Wholesalers?
Introduction� Formal implementation project established March 2015
� Steering group and two working groups; technical and governance
� Participants from LIF, FGL, LH, SvAF and LDF in all groups
� Two major milestones reached in June 2016:o The mandatory governance organisation, e-VIS was formedo The system provider, Solidsoft Reply, was selected
� Sweden is well placed to meet the legal requirements:o Experience from the Swedish Pilot 2009-2010o Advanced infrastructure and collaborative climate
2
Implementation of Falsified Medicines Directive (FMD) required to Feb 2019
� Objective Protection of patients from counterfeited medicines in the legal distribution chain
� Content Pan-European system to verify the authenticity of medicinal products
3
2011
9Feb2019CompleteImplementation
9Feb2016PublicationofDelegatedActs
July2011PublicationofFMD
36Mon.
20192016
Non-compliance puts sales at risk
The Delegated Regulation mandates rules for medicines verification
4
Serialization by manufacturerRisk based verification by WholesalersVerification and check-out at
point of dispense
Safety features:Code (‘unique identifier’)
+Tamper evidence
System set up and governed by manufacturers and marketing auth. holders in consultation with other stakeholders. Oversight by competent authorities
Product #: 09876543210982S/N: 12345AZRQF1234567890Batch: A1C2E3G4I5Expiry: 140531
e-VIS (e-verifikation i Sverige)
� Association
� Statutes� Membership by constituency� Two categories; Full membership and associated
membership� Full membership is required for voting/veto and a seat
on the Board� Veto rights for the industry regarding key decisions
about the National system they are mandated to set up, run and pay for
5
e-VIS
� We have 5 constituencies participating in the project
� Only 4 are members of e-VIS (all have Full Membership)
� The Pharmacy Association has chosen to remain outside e-VIS due to principal reasons
� e-VIS Board will make all the formal decisions, but…
� A ”consultation group” (includes the Pharmacy Association) will discuss all information and intended decisions
6
Government contactsCompetent authority – Medical Products Agency
� Have been kept informed over the past few years
� Formal consultation with MPA in June� A few adjustments to e-VIS statutes to allow for their
participation should they decide so
� Legal review of the Delegated Regulation and possible need for further adjustments of the Swedish law is ongoing with both MPA and Ministry � Verification/decommissioning for hospitals needs to be
clarified – the ambition is to avoid this burden/cost on health care personnel if at all possible – Key for setting up the system
� Decommissioning of Vaccines is a big concern – there are some 4000+ places where vaccines are given….
7
EMVSNationalBlueprintSystem
AnOverviewforPharmaciesAndWholesalers
CharlesYoung
EMVSOverview
DistributionofproductandpackdatatomarketsVerificationatthepointofdispenseAdditionalVerificationinthesupplychainProductandpackdatauploadfromMAHsandPDsRepackingMulti-marketpacksNotifications,alertsandreportsVerification,anddecommissioningbypharmaciesandwholesalersSupplytopublic(dispense)bypharmacies
EuropeanMedicinesVerificationSystem
EMVSComponents
PharmacySystem
WholesalerSystem
ManufacturerSystem
ParallelDistributer
System
Owner = Manufacturer
Owner = EMVO
Owner = Parallel Distributer
Owner = Pharmacy Owner = Wholesaler
Owner = NMVO
WebAccess
DataFlow(NormalOperation)
WebAccess
Manufacturer
ManufacturerSystem
Parallel
ParallelDistributer
System
Interface
PharmacySystem
WholesalerSystem
Interface
Interface
NationalSystemCapabilitiesForPharmaciesandWholesalers/Distributors
NationalBlueprintSystemScopePreciselymeetstheDelegatedRegulationrequirements
Integratedon-boardingportalforPharmaciesandWholesalers
Web-basedemergencyVerificationPortal
NMVOAdministrationandReportingPortal
NCAPortal
MeetsEMVO’sRequirementsUseCases PrimaryStakeholder(s)
• MasterDataUpload• ProductPackDataUpload• RecallBatch• Withdraw Product• RequestReport
ManufacturingAuthorisationHolder(MAH)
• VerifySingle/BulkofPack(s) Pharmacist,Wholesaler,MAH
• DispensePack• Re-IntroduceDispensedPack
Pharmacist(Wholesaler)
• DecommissionSingle/BulkofPack(s)• UndoDecommissionSingle/Bulkof
Pack(s)
Pharmacist,Wholesaler,MAH
• ExportBulkofPacksfromEU• UndoExportBulkofPacksfromEU
WholesalerMAH
EachManufacturer/PDprovidesmanyProducts
EachProductisproducedinmanyBatches
EachBatchcontainsmanySerialisedItems
EachSerialisedItemhasmanyEventsrecorded
EachProductislicencedtobesoldinoneormultipleMarkets
DataManufacturer /
ParallelDistributer
Product
Batch
Serialised Item
Event
Target Market
Market
ProductCodeScheme: ProductCodeCodingscheme(GTINorPPN)
ProductCode: Theproductcode
SerialNumber: Serialnumberofthepack.
BatchNumber: Thebatch(orlot)numberforthesetofproductpacksbeingcreatedorupdated.
ExpiryDate: Thebatchexpirydate.
VerifyPack- Request
/product/gtin/05060141900022/pack/96392630670?batch=DemoPack&expiry=2021-03-31
ClientCredentials
• Organisation• Location• Equipment
AccessToken
Status: Packstatus
Reason: Coderelatingtothereasonwhyitsunavailable
VerifyPack- Response
• Available• Decommissioned• Expired• Not Found
• Stolen• Intended for Destruction• Sample (NCA)• Free Sample• Supplied• Checked-Out• Locked• Withdrawn• Active• Exported• Recalled
{"Status":"Decommissioned","Reason":"Supplied"
}
NationalSystemFeatures
FullymanagedserviceoperationCloudHosted
Fulloperatedandmonitored
Maintained
WebsiteAccesscoveringallusecasesFullDisasterRecoverySelf-serviceOn-BoardingTechnicalHelpDeskSDKincluding:FullTechnicalDocumentation
Workingcodesample(includingstore&forward)
ClassLibraries&othercodeartefacts
Verification/decommissioning points in the Pharmacy/WS processes
21
2011
Tillverkare
Grossist
Öppenvårdsapotek
Rekvisition
Riskbaserad
Avaktivering
Produktflöde
Leverans till professionella kunder
Inleverans Avaktivering
Leverans till professionella kunder**
Recept Privatkund
Tillverkning på sjukhus
Inleverans Avaktivering
Vacciner (etc.?)
Beställningar
Frivillig verifieringspunkt
Krav på avaktivering
EDI*
Elektronisk beställning men även telefon, fax och mail
Sjukhem, tandläkare, veterinärer, vårdcentraler, äldreboenden, etc.*
**
Rekvisition Leverans till sjukhus
Dosrecept Privatkund
Sjukhusapotek
Inleverans Avaktivering
Dosapotek
Inleverans Avaktivering (Utlämningsställe)
Rekvisition Leverans till sjukhus
Extemporeapotek
Inleverans AvaktiveringRecept Leverans till apotek
Ok produkt
Varning
?
Flödesschema e-verifiering: inklusive verifiering & avaktivering1.0
Steg 2. Avaktivering
Databas för e-verifikation
Bild visar vart i receptexpeditionsprocessen avaktivering skerSteg 1. Verifiering
Åsa Brümmer, 5 okt 2016
Leveransaviseras
Leveransankommer
lagerLagring
E-verifieringochkontrollförsegling
Godsmottag.-kontroller
IndragningLeveransspärrIN:Avsändarekontrolleras
a) FrånMAHellerpartsomharavtalmedMAH
b) FrånPartihandelutanavtalmedMAH(skerejidagvadgällerOriola/Tamro)
Retur,seegetflöde
Leveranstillapotek
Leveranstillvaccinationscentraler
Leveranstillslutenvård
LeveranstillPartihandel
Leveranstillannanenl.art23
Normalflöde (Visarkontaktpunktermedsystemet,antingenenbartE-verifieringavkodellerävenändringavkodensstatus)
?
?
Alltid enligt regelverkRiskbaserat eller enl. uppdrag
Förpackningtilldestruktion(verifering/avaktivering)
Åsa Brümmer, 5 okt 2016
Returaviseras
Returankommer
lager
E-verifieringochkontrollförsegling
Returhantering-kontroller
IN:Avsändarekontrolleras
a) Frånapotekb) Frånpartihandel
c) Frånslutenvårdd) Frånvaccinations-centralere) Frånannan,art23
Lagring
Returflöde
N
JReturbedömssomkurantochsäljbar
Alltid enligt regelverk
Förpackningtilldestruktion(verifering/avaktivering)
Coffee break
☕😊
25
Pilot
HighLevelProjectPlan
8 Months 11Months 9 Months
28 Months
NationalLandscapeFactsandFiguresLocalImplementationProcessVariationsNationalregistryforknownfactsPharmacies
Wholesalers
ITSystemSuppliersIntroduction
Variations
InputfromNMVO
SoftwareDevelopmentKitDocumentationandGuidanceCodeExamples(Java,C#)Workingexampleofstore&forwardToolsandlibraries
DevelopmentPortalDevelopmenthub
Willevolvetocapture‘lessonslearned’,
bestpractice,etc.
SignNDAforaccess
HelpdeskTechnicalsupport
IntegrationStrategy
ImplementationApproach
Set-upCreateSystemEnvironments
AgreeScenarioProcesses/publishguidelines/Training
IdentifyPilotParticipants(inviteonly)
WorkwithISV’stoenableintegration
EngagewithMAHs/ParallelDistributers
PilotRegisterparticipants
StartOn-boardingparticipants
ProveUseCases/Scenarios
Review/AmendProcesses
Ramp-upOpensystemtoallstakeholders
Environments
Integrated Test EnvironmentSandbox for interface / connectivity testing
ITE
IQE
Prod
Integrated Quality EnvironmentSelf certification
Production Environment
On-boardingProcess
Step1:Identify&Contact
•Identify•Create/UploadKnownFacts•MakeInitialContact
Step2:ContractualOnboarding
• SignNon-DisclosureAgreement• SignParticipationAgreement
Step3Technical
Onboarding
• SystemConnection(ITE)• SystemTesting(IQE)• SystemOperation(Prod)
Managedandadministeredbythe
NMVO
Auto-managed by the Solidsoft
Reply On-boarding Portal
EmailissentfromNMVOinvitingPharmacy/Wholesalertoparticipate(containslinktoregistrationpage)Pharmacycompletesform(includesknownfacts– e.g.IDnumber)NMVOapprovesregistration(dependingondatamatches)Pharmacy/Wholesalerreceiveemailprovidingaccesstoon-boardingwebsiteFromwebsitePharmacy/Wholesalernowgeneratesapplicationcredentials
RegistrationProcess
What is the “Pilot”? A limited, well controlled implementation of the total system
EU Hub
SMVS
PhWS
EMVO
E-ViS
§
§§
§
MAH
What is endpoint and what happens then?Ramp up to full implementation
35
EU Hub
SMVS
PhWS
EMVO
E-ViS
§
§§
§
All PharmaciesAll
Whole-salers
MAH
§
All MAH
Swedish MAH (eqv)
Processes/Guidelines/SOP:s
36
MasterData
Upload
ProductPackDataUpload
RecallBatch
RequestReport
VerifyPack.
DispensePack
UndoDecommis-sion Pack
ExportPackfromEU
Decom-missionPack
Undo ExportPackfromEU
Use caseExecuted by
Pharmacy Wholesaler Wholesaler
Manuf.,PD Manuf.,PD Manuf.,PD Manuf.,PD,Wholesaler,Ph.
Manuf.,PD,Wholesaler,Ph.
X X X
X X XX
Exception
Use cases,statusandexceptions
RecalledAvailableRepacked (PD)
Manuf.,PD,Wholesaler,Ph.
Manuf.,PD,Wholesaler,Ph.
Re-Intro-duce Disp-ensed Pack
Pharmacy
XAvailableDispensed ExportedDecommissioned AvailableAvailable
X
XX
Nostatuschange
Use cases &exceptions tobedescribed ininstructions/StandardOperatingProcedures
Use case example,”Dispense Pack”
DispensePack
Pharmacy
X
Dispensed
SwedishBluePrint system
Normalcase
DispensePack
Pharmacy
X
NostatuschangeSwedishBluePrint system
Exception• Packalready dispensed• Productexported• Productonrecall• Etc.
Proceduralmeasures
Technical systemreaction
Inform systemadministra-tors (Exception Level 3to4)Inform also relevantstake-holder (Exception Level 5)
Tobedescribed ininstructions/StandardOperatingProcedures
Inform Pharmacy,(Exception Level 2to5)Inform Pharmacyonly (Exc.Level 2)
Prerequisites to start the Pilot
� A number of Pharmacies and Distributors are ready:� IT systems adapted and connected to Swedish system
� Personnel trained
� Serialised packs available in a sufficient number� MAH with high volume products on the Swedish market
have serialised these and uploaded to the EU Hub
� SOPs/instructions for events affecting more than one actor have been developed to a final draft� In particular exceptions occurring when verifying or
decommissioning packs
39
Actions needed� Assess the impact this will have on your systems
and processes
� Decide if you want to be part of the first wave, i.e. participate in the pilot� Build your interface, get access to the SMVS and make
necessary changes to your software
� Provide input to the governance; processes, SOP:s, training etc
� Plan for the full implementation to be ready well ahead of Feb 2019
40
Implementation timelines – no time to loose!
41
2011
9Feb2019Mandatoryverificationofallpackagesinscope
9Feb2016PublicationofDelegatedActs
July2011PublicationofFMD
36Mon.
20192016
• Connect appr 2500 manufacturers to the EU Hub• Establish National Systems for 32 countries • Connect many thousand Pharmacies and Wholesalers• Serialise all pharmaceutical packages in scope (10.5 bn)
2017 2018
Questions?
ThankYou
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