the european medicines verification system eu hub & … · agenda fmd workshop - norway...
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THE EUROPEAN MEDICINES VERIFICATION SYSTEM
-EU HUB & NMVS
Fanny Trenteseaux (EMVO) & Kai Mjaanes (NOMVEC)
AGENDA
FMD WORKSHOP - NORWAY
24.10.2018
System Landscape
On-Boarding Partners & On-boardingProcess
System Functionalities
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SYSTEM LANDSCAPE
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3
STATUS ON-BOARDING
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127 154191 217 233 263
304345
593635 664
726794
927 952 9771015 1035
47 69 92 113151 174 211
265
478 498545
601668
804 827 841878 908
27 54 64 84 98 128 151 178224 239
279
373
477539
625667
713 725
4 10 10 13 21 4580 104
193 215262
1886 107
126165
222273
344389
464 486
0
200
400
600
800
1000
1200
Num
ber
OBPs On The Portal Signed Participation AgreementsLegitimacy check passed OBPs connected to the Hub (PRD)OBPs connected to the Hub (IQE)
24.10.2018
Data collected onOctober 15th 2018
NMVO ON-BOARDING - PROGRESS OVERVIEW
3 countries
Longer Implementation Period
1 countryConnected in IQE
26 countriesConnected in PRD
2 countries
Not Started Technical On-Boarding
In 9 Countries, first packs have been
verified by End-Users
Full functionality with coming releases 5
FLAT FEE
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AGENDA
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System Landscape
On-Boarding Partners & On-boardingProcess
System Functionalities
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THE DELEGATED REGULATION MANDATES RULES FOR ℞MEDICINES VERIFICATION
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
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ON-BOARDING PARTNER (OBP)
“Bouvy Pharma Belgium”= OBP (On-boarding Partner)
Affiliated Marketing
AuthorisationHolder
“Bouvy -ES”
Product ES1
Product ES2
Product ES3
Affiliated Marketing
AuthorisationHolder
“Bouvy -NL”
Product N
L1
Product N
L2
Affiliated Marketing
AuthorisationHolder
“Bouvy-AT”
Product A
T1
EMVO
EU Hub
24.10.2018
FMD WORKSHOP - NORWAY
o OBP means On-Boarding Partner. The OBP is the contracting partner of EMVO; it signs the Participation Agreement (PA).
o The OBP represents the Marketing Authorisation Holders (MAHs) on behalf of which it will upload data in the European Hub.
o The OBP has to be affiliated to the MAH(s) on behalf of which it will upload data in the European Hub.
o The MAH must be located in the European Economic Area.
o The OBP must have an Adhesion Letter signed by all MAHs it represents
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“Company A”(Manufacturing & Marketing Authorization Holder)
= On-boarding Partner (OBP)
Product AS1
Product AS2
Product AS3
EMVO
EU Hub
PA with EMVO
EXAMPLE 1
THE ROLE AMONG A CORPORATION
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“Company A” – European headquarter= OBP (On-boarding Partner)
Affiliated Manufacturing &
MarketingAuthorization Holder
“Company A -ES”
Product ES1
Product ES2
Product ES3
Affiliated Manufacturing &
MarketingAuthorization Holder“Company A -NL”
Product N
L1
Product N
L2
Affiliated Manufacturing &
MarketingAuthorization Holder
“Company A -AT”
Product A
T1
EMVO
EU Hub
PA with EMVO
EXAMPLE 2
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“Company B”= On-boarding Partner (OBP)
Affiliated MarketingAuthorisation Holder
“Company B-NL”
Product N
L1
Product N
L2
Product N
L3
Affiliated Marketing & Manufacturing
Authorisation Holder“Company B -AT”
Product A
T1
“Company A”= On-boarding Partner (OBP)
Affiliated Manufacturing &
Marketing Authorisation Holder “Company A -DE”
Product D
E1
Product D
E2
Product D
E3
Affiliated MarketingAuthorisation Holder
“Company A -FR”
Product FR1
Product FR2
Affiliated Manufacturing
Authorisation Holder“Company A -AT”
EMVO
FMD Workshop - Norway24.10.2018
EU Hub
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DEFINITION OBP AFFILIATE
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“Affiliate means, in relation to a Party, any other entity Controlling, Controlled or under common Control with the Party. "Control" and its derivatives mean either the holding, directly or indirectly, of 50 % or more than 50% ownership interest or the statutory or de facto authority to exercise a decisive influence on the appointment of the majority of directors or managers or the orientation of policy provided it is, at EMVO’s own absolute discretion, sufficiently proven.”*
* Current negotiations status at the OBP Focus Group
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ALL AFFILIATED MAHS HAVE TO BE LISTED IN THE OBPPORTAL
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“4.6.1.5. the OBP notifies EMVO about its OBP Affiliates (legal name, legal form, address of registered offices, if applicable national registration number in each market in which the OBP Affiliate operates) […]”
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5.1 MAH INFORMATION
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Note 1:• The OBP can maintain its MAH information. The portal offers the possibility for
the OBP to export the existing MAH list to update this in excel. After updating the excel sheet, the OBP can import the updated list.
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Note 2:• No product information required.
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LETTER OF ADHESION
“Bouvy Pharma Belgium”= OBP (On-boarding Partner)
Affiliated Marketing
AuthorisationHolder
“Bouvy -ES”
Product ES1
Product ES2
Product ES3
Affiliated Marketing
AuthorisationHolder
“Bouvy -NL”
Product N
L1
Product N
L2
Affiliated Marketing
AuthorisationHolder
“Bouvy-AT”
Product A
T1
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Addressed by the MAH to the OBP 2 types: for (i) EEA OBP and (ii)NON-EEA OBP Adhesion of the MAH to the Agreement
between the OBP and EMVO The MAH is jointly and severally liable with the
OBP vis-à-vis EMVO The MAH confirms it duly authorised the OBP
to upload its data onto the EU Hub on its behalf
Termination of the Agreement leads to termination of the adhesion
Additional conditions for non-EEA OBPs as set forth in Appendix 4 of the PA
Template to be shared by EMVO Signed letter to be sent to EMVO only upon
request!
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IN CASE OF “FRAUDULENT ATTEMPT”
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o The OBP is solely responsible for the uploading of data to the EMVS according to the Falsified Medicines Directive and Delegated Regulation;
o If the OBP uploads data of non-affiliated or non-existing MAHs, it commits a breach of the Agreement;
o In this case, EMVO is entitled to:o demand from the OBP to cure the breach within 30
days (if the breach is capable of cure);o terminate the Agreement immediately after expiry
of the 30 days if the breach remains uncured;o require that the OBP bears the financial impact of
such breach
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EMVO ON-BOARDING / NMVO CONTRACTING
EMV
O O
n-bo
ard
ing • Participation
Agreement
• One-time On-boarding Fee(table)
• Contractingpartner : OBP N
MV
O C
ontra
ctin
g • Contract in place
• Annual fee(flat fee model)
• Contractingpartner : MAH
SYSTEM COSTS
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ON-BOARDING PROCESS
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o Web-based OBP Portal
o On-boarding Partner (OBP)• Represents its affiliated MAHs and will upload data for them on the EU Hub• Either Parallel Distributor or Original Pack Manufacturer (If both, please advise the
Helpdesk).
o Step-by-step process• Contractual On-boarding Basic company information – SPOC and Authorised Representative Signature of a Participation Agreement Invoicing information Form MAH and product information
• Legitimacy Check Legitimacy Check outcome Counter-signed Participation Agreement Payment reception
• Technical On-boarding SDK ITE IQE Baseline test PRD
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ON-BOARDING PROCESS
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VALUABLE DOCUMENTATION
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o OBP On-boarding Guideline
o EMVS Master Data Guide
o Technical info-Pack
o NMVS Functionality Matrix
o Overview on connected NMVOs
o Coding requirements
o COM Q&A version 11
o NMVO’s Fee Models Overview
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AGENDA
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System Landscape
On-Boarding Partners & On-boardingProcess
System Functionalities
23
USE CASES/TRANSACTIONS OVERVIEW
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MASTER DATA
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COMMON MASTER DATA SPECIFIC MASTER DATA
+ MAH Name & address
+ Serialisation Flag
+ List of Wholesalers : (ID), Name & address
MASTER DATA
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TRANSMIT PRODUCT PACK DATA AND CHECK DATA -MANUFACTURER
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Nat
iona
l Sy
stem
EU H
ubM
anuf
actu
rer
Syst
emPh
ysic
al
Supp
lyC
hain
Produce and mark new
packs
Release Packing batch
Enter Product
Packs data
Transmit product
packs data
Buffer product
pack data
Send data receipt
confirmation
Receivedata receiptconfirmation
Executedata checks
Send data check
confirmation
Receivedata check confirmation
TRANSMIT PRODUCT PACK DATA AND CHECK DATA –PARALLEL DISTRIBUTOR (1/2)
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Nat
iona
l Sy
stem
EU H
ubM
anuf
actu
rer
Syst
emPh
ysic
al
Supp
lyC
hain
Unpackoriginal
Product repacked
Release repacked
Enter repacked
data
Enter original packs/
batch info
Transmit original
batch info
Receiveoriginal
batch info
Buffer product
packs data
Transmit product
packs data
Send data receipt
confirmation
Receive data receipt
confirmation
Execute data checks
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EU H
ubM
anuf
actu
rer
Syst
emPh
ysic
al
Supp
lyC
hain
Send data check
confirmation
Nat
iona
l Sy
stem
Receive data check
confirmation
Update « for repack »
buffer
Send buffer update
confirmation
Receive buffer update
confirmation
TRANSMIT PRODUCT PACK DATA AND CHECK DATA –PARALLEL DISTRIBUTOR (2/2)
PACK STATES
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Helpdesk: +372 611 90 44
Mail: [email protected]
Web-page: https://emvo-medicines.eu/
Problem? Feedback? Idea?
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