F I MVO OBP WORK SHOP
Pa ul Mills - E MVO
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
Pa ul Mills - E MVO
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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 .
he re is a spe c ific a tio n fo r E MVS (the infa mo us URS)
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.
’ m he re to le a rn a s muc h a s yo u a re .
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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 .
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).
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.
he Hub ma na g e s pa ra lle l tra de re c o nc ilia tio n.
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 )
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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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 .
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 ).
sync hro nise s the o the r NMVS’ s whe re the sa me da ta is he ld.
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.
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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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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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)
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
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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).
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.
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 .
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 .
he OBP c a n only uploa d pr
:
de le g a te to the MAH if wa nte d.
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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1) Par tic ipation Re que st
2) Contr ac tual Onboar ding
3) L e gitimac y Che c k
e g itima c y c he c k o f
a nd pe rso n re spo nsib le
MVO re c e ive d Pa yme nt
4) T e c hnic al On- boar ding
e sting
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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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:
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
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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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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1.
2.
3.
ding Par tne r ?
4.
5.
ize d Re pr e se ntative?
6.
7.
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ill in Use r + Co mpa ny de ta ils
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Co mpa ny po rta l
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T rig g e r ste p 4:
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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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
MVS0794 - E MVS OBPs .NE T SDK I nsta lla tio n Guide
2.
Do c ume nta tio n JAVA
MVS0787 - E MVS Ja va SDK I nsta lla tio n I nstruc tio ns F
MVS Ja va SDK _MAH_Hub _2
3.
On Bo a rding Ste ps
MVO_0077_OBP On-b o a rding Guide line
MVO_0086_OBP On-Bo a rding Pre se nta tio n
MVO_0117_Cre a ting CSR F ile s
MVS0714 - E MVS SDK fo r OBPs
MVS0789 - E MVS SDK Quic k Sta rt Guide F
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IQE e nvir
Enviro nme nt
& Ce rtific a tio n te sting b y multiple OBP’ s
e nviro nme nt
PRD e nvir
E nviro nme nt
e nviro nme nt
IT E IQE PRD
IT E e nvir
e st
Enviro nme nt
b y multiple OBP’ s
nte g ra tio n te sting
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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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.
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.
re a te d a s a n OBP e xc e pt
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
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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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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 !)
ike ly to b e a ve ry sho rt list fo r mo st pro duc ts
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.
c o nte nt/ uplo a ds/ E MVO_0122_E MVS-Ma ste r-Da ta -Guide .pdf
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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ma rke ts.
b a tc h 123 ha s b e e n de c o mmissio ne d to a sta te S.
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 .
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 )
123 to S a nd c o nfirm the suc c e ssful upda te to the Hub
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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.
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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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xpiry Da te (o ptio na l)
he Ne w Pa c k Sta te (ma nda to ry)
he Orig ina ting L
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ve rific a tio n syste m).
he NMVS “lo o ks-up” the pa c k sta tus using the da ta tra nsfe rre d.
he NMVS fa ils to find the pro duc t -> I nte r-ma rke t T ra nsa c tio n
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
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.
tra nsa c tio n.
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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:
sto le n a nd;
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)
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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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.
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.
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.
xa mple s wo uld inc lude the E MVO Ga te wa y, T ra c e link e tc .
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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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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MVO a re wo rking to g e the r with the NCA WG 2 le a d b y Spa in
he re po rts c o ve r a c c e ss a nd da ta fo r:
nve stig a tio n
uro pe a n Hub – ho w this is pro vide d ha s to b e de c ide d.
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.
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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.
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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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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 .