[PPT] - F I MVO E ND USE R AND I SV WORK SHOP Pa ul Mills - E MVO PowerPoint Presentation

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F I MVO E ND USE R AND I SV WORK SHOP

Pa ul Mills - E MVO

SLIDE 2

F I MVO OBP WORK SHOP

AGE NDA I

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E MVS Syste m Ove rvie w Wha t the Hub do e s (a nd ho w) Ma ste r Da ta Multi-Ma rke t Da ta I nte r-Ma rke t T ra nsa c tio ns

02/ 02/ 2018

SLIDE 3

F I MVO OBP WORK SHOP

AGE NDA I I

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Co nne c tio n T ype s Re tro spe c tive Uplo a ding o f Da ta Who le sa le rs a nd 3PL ’ s Wra p-up Q&A

02/ 02/ 2018

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

SE SSI ON GUI DE L I NE S

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Que stio ns while I

ta lk a re g re a t – he lps with the flo w

I

mig ht a sk to de la y a re spo nse if it’ s c o ming up in a la te r slide .

Ha ppy if yo u wa nt to a sk a b o ut thing s no t dire c tly c o ve re d –

ma ke use o f ha ving me he re .

Ple a se re me mb e r tha t we a re a ll le a rning .
T

he re is a spe c ific a tio n fo r E MVS (the infa mo us URS)

Re a lity sa ys tha t a syste m o f this size a nd sc o pe is unlike ly to b e 100%

de sc rib e d a s we ne e d in the URS – so we a da pt whe n ne e de d.

I

’ m he re to le a rn a s muc h a s yo u a re .

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

E MVS OVE RVI E W

5

E

MVS is a DI ST RI BUT E D I T syste m.

At its he a rt is the E

uro pe a n Hub

All On-Bo a rding Pa rtne rs (OBP’ s) (e .g . MAH’ s o r MF

R’ s) fo r o rig ina l pa c ks a nd Pa ra lle l Distrib utio n c o nne c t to the Hub .

T

he Hub distrib ute s da ta re c e ive d fro m OBP’ s to the Na tio na l Me dic ine s Ve rific a tio n Syste m’ s (NMVS).

T

he Hub ma na g e s ‘ Ale rts’ re c e ive d fro m NMVS’ s a nd se nds the m to the re le va nt OBP.

T

he Hub ma na g e s pa ra lle l tra de re c o nc ilia tio n.

T

he Hub ha ndle s Multi-Ma rke t Pa c k (MMP) da ta a nd the ma rke t sync hro nisa tio n o f de c o mmissio ning . I t a lso ha ndle s c ro ss-b o rde r ve rific a tio n/ de c o mmissio ning kno wn a s I nte r-Ma rke t T ra nsa c tio ns (I MT )

T

he Hub sa ve s e a c h OBP ha ving to c o nne c t to e a c h tra ding ma rke t individua lly – it’ s a ‘ sing le po int o f c o nne c tio n’ .

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

E MVS OVE RVI E W

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Surro unding the Hub a re NMVS’ s – o ne pe r ma rke t.
T

he NMVS’ s a re the syste ms tha t Who le sa le , Pe rso ns Autho rise d to Supply (PAT S) a nd Ho spita ls c o nne c t to .

T

he NMVS unde rta ke s the ve rific a tio n a nd de c o mmissio ning a c tivitie s (the Hub do e sn’ t ho ld the pa c k da ta ).

F
r MMP’ s – e a c h NMVS info rms the Hub o f the tra nsa c tio n a nd the Hub

sync hro nise s the o the r NMVS’ s whe re the sa me da ta is he ld.

F
r o ut o f ma rke t e nq uire s, the NMVS a sks the Hub to find the ma rke t fro m

whic h a de c o mmissio n o r ve rific a tio n e nq uiry c a n b e sa tisfie d.

T

he NMVS a lso c re a te s mo st o f the re po rts re q uire d fo r the lo c a l NCA (so me ma y b e g e ne ra te d b y the Hub upo n re q ue st)

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

E MVS OVE RVI E W

7

National System Pharmacy Wholesaler Pharmaceutical Manufacturer Parallel Distributor National System National System

European Hub

National System National System National System National Blueprint System National Blueprint System National Blueprint System

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

WHAT DOE S T HE HUB DO?

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Prima rily it a c ts a s a sing le po int o f c o nne c tio n fo r a ll OBP’ s.
I

t the n ro ute s da ta a nd re q ue sts fro m the OBP to re le va nt ma rke ts a nd

rc he stra te s re spo nse s a nd a le rts.
T

he Hub unde rta ke s the re spo nsib ility fo r pa ra lle l distrib utio n b a tc h le ve l re c o nc ilia tio n.

I

t a c ts a s the trig g e r po int fo r b a tc h re c a lls o r pro duc t withdra wa ls.

T

he Hub a lso pro vide s the me c ha nism fo r a llo wing o ut o f ma rke t pa c ks to b e sc a nne d a nd de c o mmissio ne d (I nte r-Ma rke t T ra nsa c tio ns)

T

he inte rfa c e s a re a ll se c ure d we b se rvic e s

E

MVO pro vide s a we b -b a se d Ga te wa y syste m tha t a llo ws e a sy a c c e ss fo r OBP’ s during ra mp-up o r fo r c o ntinue d use b y sma lle r OBP’ s lo ng e r te rm

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

WHAT DOE S T HE HUB DO WI T H DAT A?

9

T

he Hub :

Sto re s ma ste r da ta fo r a ll OBP’ s fo r a ll ma rke ts whe re the pro duc t wa s inte nde d fo r sa le .
It sto re s the b a tc h he a de r da ta fo r a ll b a tc he s o r a ll pro duc t
It do e s no t sto re the se ria l numb e rs no r the ir sta te .
It c re a te s a nd ma na g e s “re -pa c k b uffe rs” whic h a re sto re s to ma na g e the re c o nc ilia tio n
f pa ra lle l distrib utio n a c tivitie s.
Inb o und b uffe r fo r pro d uc t c o d e a nd b a tc h ID d e c o mmissio n (a nd a ll the se ria l ID’ s) plus the to ta l

d o se c o unt d e c o mmissio ne d .

Outb o und b uffe r fo r the pro d uc t c o d e a nd b a tc h ID c re a te d , linke d to the inb o und b uffe r plus the

se ria l ID’ s c re a te d a nd the to ta l d o se s re pa c ke d .

Sto re s a udit tra ils fo r e ve ry a c tivity inc luding a no n-re pudia tio n lo g fo r inb o und me ssa g e s.
Sto re s the re q uire d ma pping da ta fo r Inte r-Ma rke t T

ra nsa c tio ns a nd sto re s a n a udit tra il fo r a ll I MT a c tivitie s.

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

E MVS AND HUB CONNE CT I VI T Y

10

Pharmacy Wholesaler Pharmaceutical Manufacturer Parallel Distributor

European Hub

NMVS

EMVO Gateway

Se c ure we b se rvic e s Se c ure we b se rvic e s Se c ure we b se rvic e s Se c ure we b se rvic e s

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

E U HUB E NVI RONME NT S

11

IQE e nvir

nme nt
Inte g ra te d Qua lity

Enviro nme nt

Use d fo r Qua lity-

& Ce rtific a tio n te sting b y multiple OBP’ s

Va lida te d

e nviro nme nt

PRD e nvir

nme nt
Pro duc tive

E nviro nme nt

Va lida te d

e nviro nme nt

IT E IQE PRD

IT E e nvir

nme nt
Inte g ra te d T

e st

Enviro nme nt

Use d a s sa ndb o x

b y multiple OBP’ s

I

nte g ra tio n te sting

f OBP’ s

c o nne c tio n

IQE : Inte g ra tio n Qua lity E

nviro nme nt

IQE : Inte g ra tio n Qua lity E

nviro nme nt

PRD: Pro d uc tive E

nviro nme nt

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

E MVS DAT A

12

Ma ste r Da ta
T

he ‘ stuff’ tha t de sc rib e s the pro duc t/ SK U a nd tha t de fine s whic h ma rke ts it will b e so ld.

Ba tc h Da ta
T

he b a tc h he a de r (Ba tc h I D a nd E xpiry) a nd MF R de ta ils a nd the se ria l I D’ s.

Pa ra lle l Distrib utio n
T

re a te d a s a n OBP e xc e pt

Ba tc h da ta c re a te s re c o nc ilia tio n sto re s in the Hub ho lding the

de c o mmissio ne d se ria l I D’ s, the pro duc t a nd b a tc h c o de s a nd the numb e r o f do se s de c o mmissio ne d

Ne wly c o mmissio ne d pro duc t/ pa c ks a re the n linke d to the sto re s.

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

E MVS DAT A CONT E NT

13

N.B. the mo de l a b o ve do e s no t c urre ntly inc lude the AT C c o de a me ndme nt c urre ntly unde r disc ussio n no r a ny po te ntia l a me ndme nt fo r na tio na l SK U na ming .

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

E MVS DAT A

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Co ntra c te d Who le sa le rs
Se e Artic le 33 (h).
T

he se a re the who le sa le rs (mo st like ly 3PL ’ s) with who m yo u ha ve a writte n c o ntra c t to sto re a nd distrib ute (no te no thing is sa id a b o ut se lling !)

L

ike ly to b e a ve ry sho rt list fo r mo st pro duc ts

T

his isn’ t a list o f a ll the sta ke ho lde rs tha t ha ndle / se ll yo ur pro duc t.

A re a so na b le so urc e o f g uida nc e re g a rding Ma ste r Da ta c a n

b e fo und o n the E MVO we b site .

https:/ / e mvo -me dic ine s.e u/ ne w/ wp-

c o nte nt/ uplo a ds/ E MVO_0122_E MVS-Ma ste r-Da ta -Guide .pdf

Do c ume nt due fo r re visio n to inc lude I

DMP (SPOR) ma pping info rma tio n a nd E MVO Ga te wa y e le me nt na me ma pping .

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

MUL T I

MARK

E T PRODUCT

15

E

MVS suppo rts OBP’ s se nding da ta to multiple ma rke ts in o ne sing le tra nsa c tio n.

T

he NMVS a nd Hub ma inta in the sync hro nisa tio n o f pa c ks spre a d a c ro ss the se ma rke ts

T

he Hub a llo ws fo r b a tc h re c a ll to b e ta rg e te d b y ma rke t (o r multiple ma rke ts) fo r MMP’ s

T

he Hub ha ndle s pro duc t withdra wa l fo r MMP’ s in o ne sing le me ssa g e (simila r to b a tc h re c a ll).

All re spo nse s fro m multiple ma rke ts a re re po rte d to the OBP in

a ma nne r tha t is e a sy to de c iphe r.

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

MUL T I

MARK

E T PRODUCT

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L

e t’ s ste p thro ug h a thre e ma rke t MMP pro c e ss

Assume the OBP ha s lo a de d the da ta a nd the Hub ha s se nt it to a ll thre e

ma rke ts.

A pa c k is de c o mmissio ne d in Ma rke t A suc c e ssfully
Ma rke t A se nds a no tific a tio n to the Hub tha t pa c k xyz o f pro duc t a b c ,

b a tc h 123 ha s b e e n de c o mmissio ne d to a sta te S.

T

he Hub c he c ks the ma ste r da ta fo r pro duc t a b c , b a tc h 123 a nd de te rmine s the ma rke ts o f inte nde d sa le .

T

he Hub se nds a de c o mmissio n re q ue st to the NMVS’ s in ma rke ts B a nd C (no t A b e c a use it kno ws tha t wa s the so urc e )

Ma rke ts B a nd C se t the pa c k sta te fo r pa c k xyz o f pro duc t a b c , b a tc h

123 to S a nd c o nfirm the suc c e ssful upda te to the Hub

Hub c o nfirms the upda te to the NMVS in ma rke t A

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

I NT E R-MARK E T T RANSACT I ONS

17

T

he se a re tra nsa c tio ns tha t a re initia te d whe n a pa c k is sc a nne d in a ma rke t whe re it wa s no t de stine d to b e so ld b y the OBP/ MAH.

Re a so ns this mig ht ha ppe n inc lude :
Co mpa ssio na te use (spe c ia l lic e nc e ) pa c ks.
Pa c ks tha t a re le g a lly use d o n a ma rke t b ut so urc e d fro m a no the r (e .g .

L uxe mb o urg use s pa c ks fro m BE , F R a nd DE in o rig ina l c o nditio n.

Pa c ks tha t re a lly sho uldn’ t b e the re !
Ho w do e s it wo rk?

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

I NT E R-MARK E T T RANSACT I ONS

18

I

MT Da ta F lo w (Ve rific a tio n Sho wn)

National System (Initiating) Actor European Hub National System (Fulfilling) Verify Pack Request Intermarket Pack Verification Intermarket Pack Verification Verify Pack Response Product Not Found OR Batch and Pack Not Found Intermarket Pack Verification Response Intermarket Pack Verification Response

SLIDE 19

F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

DAT A T O BE SE NT

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F

ro m the initia ting NMVS to the Hub a nd Hub to the fulfilme nt NMVS we ne e d da ta to b e se nt:

Pro duc t Co de & Pro duc t Co de Sc he me (ma nda to ry)
Pro duc t Ba tc h Numb e r (ma nda to ry)
Pa c k Se ria l Numb e r (ma nda to ry)
Ba tc h E

xpiry Da te (o ptio na l)

T

he Ne w Pa c k Sta te (ma nda to ry)

T

he Orig ina ting L

c a tio n Co de (ma nda to ry)

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

I NT E R-MARK E T VE RI F I CAT I ON T RANSACT I ON

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SLIDE 21

F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

I NT E R-MARK E T ST AT E CHANGE T RANSACT I ON

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

I NT E R-MARK E T T RANSACT I ON I N PRACT I CE

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No w le t’ s sc a n a pa c k the NMVS do e sn’ t kno w
Use r sc a ns a me dic ina l pa c k.
De ta ils fro m the sc a n a re tra nsfe rre d to the NMVS (na tio na l me dic ine s

ve rific a tio n syste m).

T

he NMVS “lo o ks-up” the pa c k sta tus using the da ta tra nsfe rre d.

T

he NMVS fa ils to find the pro duc t -> I nte r-ma rke t T ra nsa c tio n

T

he NMVS finds the pro duc t b ut no t the b a tc h -> I nte r-ma rke t T ra nsa c tio n

T

he NMVS finds the pro duc t & b a tc h b ut no t the pa c k -> the NMVS re je c ts the tra nsa c tio n, re spo nds to the use r a nd ra ise s a n a le rt.

Re g a rdle ss o f the o utc o me , the NMVS write s a n a udit lo g fo r the

tra nsa c tio n.

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

I MT OUT L I NE

23

I

nte r-Ma rke t T ra nsa c tio n

F

irstly – no t simply a q ue ry – this inc lude s a ll tra nsa c tio n type s e .g . ve rific a tio n a nd de c o mmissio n/ re ve rsio n.

I

nte r-Ma rke t T ra nsa c tio n is sta rte d b y a n NMVS.

Da ta fro m the sc a nne d c o de , the tra nsa c tio n so ug ht, the Clie nt I

D a nd Ma rke t I D a re se nt to the Hub .

T

he Hub c he c ks the pro duc t ma ste r to find the pro duc t c o de

I

f no t fo und – re turns a n e rro r “pro duc t no t fo und” to the NMVS.

T

he Hub c he c ks the pro duc t ma ste r to find the b a tc h c o de

I

f no t fo und – re turns a n e rro r “b a tc h no t fo und” to the NMVS.

Assuming the Pro duc t Co de a nd Ba tc h Co de c o mb ina tio n is fo und, the

Hub fo rwa rds the re q ue st to a ma rke t indic a te d a s a “ma rke t o f inte nde d sa le ”.

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

I MT OUT L I NE (CONT

I NUE D)

24

T

he “ma rke t o f inte nde d sa le ” NMVS re c e ive s the tra nsa c tio n a nd lo o ks up the pa c k sta tus.

T

he pa c k sta tus (o r a n e rro r) is re turne d to the Hub .

T

he NMVS ma ke s a n a udit lo g re c o rd sta mping the tra nsa c tio n with the de ta ils a nd the o rig ina l c lie nt I D a nd o rig ina l ma rke t I D a nd the da te / time .

Why sta mp with the se – b e c a use the NMVS tha t physic a lly unde rta ke s

the tra nsa c tio n re q ue ste d is in c o ntro l o f a ny po te ntia l re ve rsa l o pe ra tio n so ne e ds to lo g who a nd whe re a nd whe n.

T

he Hub will re c e ive the re spo nse a nd fo rwa rd it b a c k to the

rig ina l NMVS whe re the sc a n o c c urre d whic h in turn will

info rm the use r.

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

I MT RE VE RSAL

25

T

he sa me pro c e ss a s the o rig ina l tra nsa c tio n b ut:

T

he NMVS fo r the “ma rke t o f inte nde d sa le ” will no w c he c k tha t the c rite ria de fine d in De le g a te d Re g ula tio n Artic le 13 spe c ific a lly:

Re ve rse d within 10 da ys fo llo wing the o rig ina l de c o mmissio n
Pa c k ha s no t e xpire d o r b e e n pla c e d unde r re c a ll, withdra wn, de stro ye d o r

sto le n a nd;

T

he re ve rsa l is pe rfo rme d b y a pe rso n within the sa me pre mise s a s the pe rso n who o rig ina lly de c o mmissio ne d the pa c k (uniq ue ide ntifie r)

As suc h it is vita l tha t the NMVS whic h unde rto o k the o rig ina l

de c o mmissio n kno ws who unde rto o k the o rig ina l de c o mmissio n (i.e . the Clie nt I D a nd Ma rke t I D c o mb ina tio n) a nd whe n the y did it.

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

OBP CONNE CT I ONS

26

Whe n o nb o a rding OBP’ s ha ve the c ho ic e o f dire c t

c o nne c tio ns o r g a te wa y c o nne c tio ns,

Dire c t
T

he se a re c o nne c tio ns ma de dire c tly fro m a n in-ho use / o n-pre mise syste m like a n E RP o r sto c k ma na g e me nt syste m. e .g . SAP AT T P.

T

he se c o nne c tio ns re ly o n the pro vide r c o nfig uring the syste m to wo rk fo r the c lie nt a nd no t using a c o mmo n c o nne c tio n pro visio n.

Ga te wa y
He re the syste m supplie r is pro viding a c o mmo n se rvic e to ma ny OBP’ s

a nd in g e ne ra l, the se syste ms a re no t o n-pre mise b ut c lo ud-b a se d.

E

xa mple s wo uld inc lude the E MVO Ga te wa y, T ra c e link e tc .

T

he ke y is tha t the c o nne c tio n use d to the Hub is ‘ c o mmo n’ to a ll OBP’ s using the syste m supplie rs pro duc t a nd thus, E MVO ha ve a hig he r e xpe c ta tio n tha t the c o nne c tio n is re lia b le a nd unc ha ng e d fro m la st use .

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

CONNE CT I ON T YPE S

27

OBP C OBP B OBP A

OBP A Hub Conne c tion 1

Ga te wa y Pro vide r X Ga te wa y Pro vide r Y OBP’ s Syste m a OBP’ s Syste m b OBP’ s Syste m c

OBP B Hub Conne c tion OBP C Hub Conne c tion

E U Hub

OBP A Hub Conne c tion 2 OBP A Gate way Conne c tion OBP C Gate way Conne c tion OBP B Gate way Conne c tion

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

RE T ROSPE CT I VE DAT A UPL OADI NG

28

Only impo rta nt fo r multi-ma rke t pro duc t o r if se ria lise d pro duc t

is pla c e d o n a ma rke t b e fo re the NMVS is live a nd pro duc tive .

T

he ide a he re is to uplo a d da ta fo r se ria lise d pro duc t a s the sa le s ma rke t(s) c o me o nline po te ntia lly a fte r physic a l pro duc t ha s b e e n shippe d a nd c o nsume d.

As a n OBP yo u do this to :
Ma ke the se ria lise d pro duc t da ta a va ila b le in the NMVS whe re yo u se ll.
T
a vo id b e ing de lug e d with fa lse ne g a tive a le rts (whic h will ha ppe n if

the pro duc t da ta do e sn’ t e xist – the E MVS will c o nside r yo ur pa c ks a s po te ntia lly fa lsifie d.

Re tro spe c tive ly uplo a de d da ta will, b y de finitio n, ha ve pa c k

sta tus indic a tio ns tha t a re wro ng – b e c a use sto c k will ha ve b e e n use d b e fo re b e ing de c o mmissio ne d.

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

WHOL E SAL E – 3PL ’ S

29

Who le sa le rs a nd 3PL

’ s c o nne c t to the NMVS a nd no t the Hub a t le a st tha t’ s ho w the URS e nvisa g e d it.

T his mo de l is the o ne e nvisa g e d b y the E MVO URS T ra nsa c tio ns a re a ttrib ute d to the 3PL .

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F I MVO E ND USE R AND I SV WORK SHOP 02/ 02/ 2018

WHOL E SAL E – 3PL ’ S

30

Alte rna tive c o nne c tio n stra te g ie s inc lude :

T his mo de l is lo w c o st to de plo y b ut ma y b e mo re c o stly fo r the 3PL to o pe ra te . T his o ne do e s ma rk tra nsa c tio n a s unde rta ke n b y the OBP Using this mo de l, tra nsa c tio ns a re a ttrib ute d to the OBP no t the 3PL .