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F I MVO OBP WORK SHOP Pa ul Mills - E MVO AGE NDA I E MVS - - PowerPoint PPT Presentation

F I MVO OBP WORK SHOP Pa ul Mills - E MVO AGE NDA I E MVS Syste m Ove rvie w Onb o a rding Ma ste r Da ta Multi-Ma rke t Da ta I nte r-Ma rke t T ra nsa c tio ns 01/ 02/ 2018 F I MVO OBP WORK SHOP 2 AGE NDA I I Co nne c tio


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SLIDE 1

F I MVO OBP WORK SHOP

Pa ul Mills - E MVO

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SLIDE 2

F I MVO OBP WORK SHOP

AGE NDA I

2

E MVS Syste m Ove rvie w Onb o a rding Ma ste r Da ta Multi-Ma rke t Da ta I nte r-Ma rke t T ra nsa c tio ns

01/ 02/ 2018

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SLIDE 3

F I MVO OBP WORK SHOP

AGE NDA I I

3

Co nne c tio n T ype s NCA Re po rting 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

01/ 02/ 2018

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SLIDE 4

F I MVO OBP WORK SHOP 01/ 02/ 2018

SE SSI ON GUI DE L I NE S

4

  • 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 .

F I MVO OBP WORK SHOP

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SLIDE 5

F I MVO OBP WORK SHOP 01/ 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’ .

F I MVO OBP WORK SHOP

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SLIDE 6

F I MVO OBP WORK SHOP 01/ 02/ 2018

E MVS OVE RVI E W

6

  • 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)

F I MVO OBP WORK SHOP

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SLIDE 7

F I MVO OBP WORK SHOP 01/ 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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SLIDE 8

F I MVO OBP WORK SHOP 01/ 02/ 2018

ON-BOARDI NG – CURRE NT ST AT US

20 47 69 92 113 151 174 211 265 451 9 27 54 64 84 98 128 151 178 197 4 8

50 100 150 200 250 300 350 400 450 500 E a rlie r Ma y-17 Jun-17 Jul-17 Aug -17 Se p-17 Oc t-17 No v-17 De c -17 Ja n-18 Numb e r Sig ne d Pa rtic ipa tio n Ag re e me nts L e g itima c y c he c k pa sse d OBPs c o nne c te d to Hub V2 (PRD)

T a rg e t fig ure : 2291

OBPs in PRD: Bio g e n Inte rna tio na l Gmb H – Ba ye r AG – Amg e n E

uro pe BV – F . Ho ffma nn L a Ro c he L td – Ja nsse n Pha rma c e utic a NV – UXA fa rma – Na turla nd Ma g ya ro rsza g T e re lo e s K e re ske d e lmi K ft – Almus Pha rma c e utic a ls L imite d

8

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SLIDE 9

F I MVO OBP WORK SHOP 01/ 02/ 2018

WHAT I S AN “OBP”?

9

  • OBP me a ns On- Boa r

ding Pa r tne r. T

he OBP is the c o ntra c ting pa rty o f E MVO; it c o nc lude s the Pa rtic ipa tio n Ag re e me nt (PA).

  • T

he OBP r

e pr e se nts the Ma r ke ting Author iza tion Holde r s (MAH) o n b e ha lf o f whic h it will

uplo a d da ta fo r in the E uro pe a n Hub . It ha s the re fo re to b e le g a lly a utho rize d to c o nc lude c o ntra c ts o n b e ha lf o f a MAH/ a g ro up o f MAHs.

  • T

he OBP ha s to b e a ffilia te d (*) to the MAH(s) o n b e ha lf o f whic h it will uplo a d da ta in the E uro pe a n Hub .

  • T

he OBP sho uld b e lo c a te d in the E uro pe a n E c o no mic Are a .

  • T

he OBP c a n only uploa d pr

  • duc t da ta for

:

  • its a ffilia te d MAH’ s – the re spo nsib ility fo r uplo a d ve sts in the OBP who c a n

de le g a te to the MAH if wa nte d.

  • a ma nufa c ture r a s lo ng a s the ma rke ting a utho riza tio n o f the re la te d pro duc ts lie s

within the OBP c o rpo ra tio n. It’ s fo r the OBP to wo rk o ut ho w to inte rfa c e lo c a l QP’ s a nd RP’ s with the uplo a ding pro c e ss.

(*) Affilia te sha ll me a n, in re la tio n to a Pa rty, a ny o the r pe rso n a ffilia te d with suc h Pa rty within the me a ning o f Artic le 11 o f the Be lg ia n Co d e o f Co mpa nie s (it b e ing und e rsto o d , fo r the a vo id a nc e o f d o ub t, tha t the d e finitio n se t o ut in sa id Artic le 11 is a g re e d to a lso a pply to no n-Be lg ia n pe rso ns).

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SLIDE 10

F I MVO OBP WORK SHOP 01/ 02/ 2018

ON-BOARDI NG PROCE SS

10

1) Par tic ipation Re que st

  • Co lle c t info rma tio n
  • Initia l Co nta c t
  • Po rta l re g istra tio n

2) Contr ac tual Onboar ding

  • Co mpa ny Info rma tio n
  • Sing le Po int o f Co nta c t (SPOC)
  • Invo ic ing Info rma tio n
  • Pa rtic ipa tio n Ag re e me nt (PA)

3) L e gitimac y Che c k

  • L

e g itima c y c he c k o f

  • rg a niza tio ns

a nd pe rso n re spo nsib le

  • Multi-sta g e pro c e d ure
  • E

MVO re c e ive d Pa yme nt

4) T e c hnic al On- boar ding

  • Syste m Co nne c tio n
  • Syste m T

e sting

  • Syste m Ope ra tio n

Manage d and administe r e d by E MVO’s Co mme r c ial & Par tne r Manage me nt T e am Manage d by E MVO’s Ope r atio ns T e am

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SLIDE 11

F I MVO OBP WORK SHOP 01/ 02/ 2018

ON-BOARDI NG F E E

11

Early bird On-Boarding fee From the 15th January 2018 From the 15th June 2018 OBP with >12 MAHs €20.000 €30.000 €45.000 OBP with 6-12 MAHs €10.000 €15.000 €22.500 OBP with 3-5 MAHs €8.000 €12.000 €18.000 OBP with 2 MAHs €6.000 €9.000 €13.500 OBP with 1 MAH €3.000 €4.500 €6.750

+50% +50%

In o rd e r to suppo rt the On-b o a rd ing c o sts, E MVO will c ha rg e the OBP a One -T ime F e e . T he a pplic a b le On-b o a rd ing fe e tha t will b e invo ic e d to the OBP d e pe nd s o n the fo llo wing e le me nts:

  • T

he numb e r o f MAHs in E uro pe (E uro pe a n E c o no mic Are a a nd Switze rla nd ) the OBP re pre se nts

  • T

he timing whe n the OBP uplo a d s a va lid Pa rtic ipa tio n Ag re e me nt o n the OBP Po rta l.

NB: Ple a se no te tha t E MVO re se rve s its rig ht to po te ntia lly a pply a n a d d itio na l rise o f the On-b o a rd ing fe e in 2018.

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SLIDE 12

F I MVO OBP WORK SHOP 01/ 02/ 2018

HOW DOE S T HE ON-BOARDI NG WORK ?

12

On- boar ding Par tne r Por tal

(Suppo rt so ftwa re to g uide the OBPs thro ug h the re q uire me nts to c o nne c t to the E U Hub ) https:/ / e mvo -me dic ine s.e u/ pha rma c e utic a l-c o mpa nie s/ o b p-po rta l/ L inke d dire c tly fro m the E MVO We b site .

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SLIDE 13

F I MVO OBP WORK SHOP 01/ 02/ 2018

HOW T O SPE E D UP T HE PROCE SS RI GHT F ROM T HE ST ART ?

13

Co lle c t I nfo rma tio n:

1.

Visit E MVO Download Se c tion

2.

Visit E MVO Knowle dge Data Base

3.

Who will b e the On- Boar

ding Par tne r ?

4.

Wha t is my Co mpa ny Re g istra tio n numb e r a nd VAT numb e r?

5.

Who c a n a nd will b e the Author

ize d Re pr e se ntative?

6.

Who c a n a nd will b e the Single Point of Contac t?

7.

Ho w ma ny MAHs do e s the OBP re pre se nt?

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SLIDE 14

F I MVO OBP WORK SHOP 01/ 02/ 2018

HOW T O RE QUE ST T O PART I CI PAT E

14

  • 1. Via we b site – link
  • 2. F

ill in Use r + Co mpa ny de ta ils

  • 3. Yo u’ ll b e dire c te d to the c o nfirma tio n sc re e n
  • 4. Che c k yo ur e ma il to va lida te yo ur a c c o unt
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SLIDE 15

F I MVO OBP WORK SHOP 01/ 02/ 2018

HOW T O RE QUE ST T O PART I CI PAT E

15

  • 5. Yo ur c o mpa ny po rta l will b e c re a te d
  • 6. Yo ur c o mpa ny po rta l is c re a te d
  • 7. F
  • llo w the instruc tio ns in yo ur e ma il to lo g in to yo ur

Co mpa ny po rta l

  • 8. Yo ur Co mpa ny po rta l is re a dy to On b o a rd
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SLIDE 16

F I MVO OBP WORK SHOP 01/ 02/ 2018

T E CHNI CAL ON-BOARDI NG

16

T rig g e r ste p 4:

  • Ste p 3 c o mple te d

Status:

No t Sta rte d Co mple te d

Note :

I f yo u ma ke use o f a Ga te wa y Co nne c tio n, ste p 4.2.2 (I T E ) is o ptio na l

Ac c e ss sub -ste ps Ac c e ss sub -ste ps

Status:

No t sta rte d Co mple te d

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SLIDE 17

F I MVO OBP WORK SHOP 01/ 02/ 2018

4.1 T E CHNI CAL I NF O PACK

17

T he T e c hnic a l I nfo Pa c k c o nta ins the fo llo wing info rma tio n in the ir la st a va ila b le ve rsio ns:

1.

Do c ume nta tio n .NE T

  • .Ne t Ca llb a c k Se rvic e
  • .Ne t Hub 2.0 SDK
  • E

MVS0794 - E MVS OBPs .NE T SDK I nsta lla tio n Guide

2.

Do c ume nta tio n JAVA

  • E

MVS0787 - E MVS Ja va SDK I nsta lla tio n I nstruc tio ns F

  • r OBPs
  • E

MVS Ja va SDK _MAH_Hub _2

3.

On Bo a rding Ste ps

  • E

MVO_0077_OBP On-b o a rding Guide line

  • E

MVO_0086_OBP On-Bo a rding Pre se nta tio n

  • E

MVO_0117_Cre a ting CSR F ile s

  • E

MVS0714 - E MVS SDK fo r OBPs

  • E

MVS0789 - E MVS SDK Quic k Sta rt Guide F

  • r OBPs
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SLIDE 18

F I MVO OBP WORK SHOP 01/ 02/ 2018

E U HUB E NVI RONME NT S

18

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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SLIDE 19

F I MVO OBP WORK SHOP 01/ 02/ 2018

E MVS DAT A

19

  • 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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SLIDE 20

F I MVO OBP WORK SHOP 01/ 02/ 2018

E MVS DAT A CONT E NT

20

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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SLIDE 21

F I MVO OBP WORK SHOP 01/ 02/ 2018

E MVS DAT A

21

  • 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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SLIDE 22

F I MVO OBP WORK SHOP 01/ 02/ 2018

MUL T I

  • MARK

E T PRODUCT

22

  • 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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SLIDE 23

F I MVO OBP WORK SHOP 01/ 02/ 2018

MUL T I

  • MARK

E T PRODUCT

23

  • 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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SLIDE 24

F I MVO OBP WORK SHOP 01/ 02/ 2018

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

24

  • 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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SLIDE 25

F I MVO OBP WORK SHOP 01/ 02/ 2018

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

25

  • 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

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SLIDE 26

F I MVO OBP WORK SHOP 01/ 02/ 2018

DAT A T O BE SE NT

26

  • 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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SLIDE 27

F I MVO OBP WORK SHOP 01/ 02/ 2018

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

27

  • 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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SLIDE 28

F I MVO OBP WORK SHOP 01/ 02/ 2018

RE VE RSAL

28

  • 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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SLIDE 29

F I MVO OBP WORK SHOP 01/ 02/ 2018

OBP CONNE CT I ONS

29

  • 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 .

slide-30
SLIDE 30

F I MVO OBP WORK SHOP 01/ 02/ 2018

CONNE CT I ON T YPE S

30

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

slide-31
SLIDE 31

F I MVO OBP WORK SHOP 01/ 02/ 2018

NCA RE PORT I NG AND ACCE SS

31

  • Summa ry:
  • E

MVO a re wo rking to g e the r with the NCA WG 2 le a d b y Spa in

  • Ne a ring the e nd o f a le ng thy pro c e ss to de fine a nd a g re e a sta nda rd se t
  • f re po rts to b e pro vide d b y e a c h NMVS fo r the lo c a l ma rke t NCA.
  • T

he re po rts c o ve r a c c e ss a nd da ta fo r:

  • Supe rvisio n
  • I

nve stig a tio n

  • Re imb urse me nt
  • Pha rma c o vig ila nc e
  • So me re po rts re q uire da ta fro m the E

uro pe a n Hub – ho w this is pro vide d ha s to b e de c ide d.

  • Ho pe fully no t a ll re po rts will b e ma nda te d b y F

e b 2019 a s re so urc e s a t the I T pro vide rs will pro b a b ly no t a llo w this to o c c ur.

  • Re po rts will b e prio ritise d.
slide-32
SLIDE 32

F I MVO OBP WORK SHOP 01/ 02/ 2018

RE T ROSPE CT I VE DAT A UPL OADI NG

32

  • 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.

slide-33
SLIDE 33

F I MVO OBP WORK SHOP 01/ 02/ 2018

WHOL E SAL E – 3PL ’ S

33

  • 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 .

slide-34
SLIDE 34

F I MVO OBP WORK SHOP 01/ 02/ 2018

WHOL E SAL E – 3PL ’ S

34

  • 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 .