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 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 F I MVO OBP WORK SHOP 3

SE SSI ON GUI DE L I NE S o 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 . o 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 . o 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 . 01/ 02/ 2018 F F I I MVO OBP WORK MVO OBP WORK SHOP SHOP 4

E MVS OVE RVI E W o E MVS is a DI ST RI BUT E D I T syste m. o 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’ . 01/ 02/ 2018 F F I I MVO OBP WORK MVO OBP WORK SHOP SHOP 5

E MVS OVE RVI E W o 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 o 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 o 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) 01/ 02/ 2018 F F I I MVO OBP WORK MVO OBP WORK SHOP SHOP 6

E MVS OVE RVI E W National Blueprint National National System System System National Blueprint National National Blueprint National System System System System European Parallel Hub Distributor Pharmaceutical Manufacturer National System National System Pharmacy Wholesaler 01/ 02/ 2018 F I MVO OBP WORK SHOP 7

ON-BOARDI NG – CURRE NT ST AT US 500 451 450 T a rg e t fig ure : 2291 400 350 Numb e r 300 265 250 211 197 200 174 151 150 178 113 151 92 128 100 69 98 47 84 50 20 64 54 8 4 27 0 9 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 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 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) 01/ 02/ 2018 F I MVO OBP WORK SHOP 8

WHAT I S AN “OBP”? o OBP me a ns On- Boa 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 ding Pa r the Pa rtic ipa tio n Ag re e me nt (PA). o T he OBP r s (MAH) o n b e ha lf o f whic h it will e pr e se nts the Ma r ke ting Author iza tion Holde r 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. o 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 . o 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 . o T he OBP c a n only uploa d pr oduc 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). 01/ 02/ 2018 F I MVO OBP WORK SHOP 9

ON-BOARDI NG PROCE SS • Co lle c t info rma tio n • Initia l Co nta c t • Po rta l re g istra tio n 1) Par tic ipation Manage d and Re que st administe r e d by • Co mpa ny Info rma tio n E MVO’s • Sing le Po int o f Co nta c t (SPOC) Co mme r c ial & • Invo ic ing Info rma tio n 2) Contr ac tual Par tne r • Pa rtic ipa tio n Ag re e me nt (PA) Onboar ding Manage me nt T e am • L e g itima c y c he c k o f o rg a niza tio ns a nd pe rso n re spo nsib le 3) L e gitimac y • Multi-sta g e pro c e d ure Che c k • E MVO re c e ive d Pa yme nt Manage d by • Syste m Co nne c tio n E MVO’s • Syste m T e sting 4) T e c hnic al On- Ope r atio ns boar ding • Syste m Ope ra tio n T e am 01/ 02/ 2018 F I MVO OBP WORK SHOP 10

ON-BOARDI NG F E E 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: o 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 o 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. Early bird From the 15 th From the 15 th On-Boarding June 2018 January 2018 fee +50% +50% 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 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. 01/ 02/ 2018 F I MVO OBP WORK SHOP 11

HOW DOE S T HE ON-BOARDI NG WORK ? 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 . 01/ 02/ 2018 F I MVO OBP WORK SHOP 12

HOW T O SPE E D UP T HE PROCE SS RI GHT F ROM T HE ST ART ? Co lle c t I nfo rma tio n: Visit E MVO Download Se c tion 1. Visit E MVO Knowle dge Data Base 2. Who will b e the On- Boar ding Par tne r ? 3. Wha t is my Co mpa ny Re g istra tio n numb e r a nd VAT numb e r? 4. Who c a n a nd will b e the Author e se ntative ? ize d Re pr 5. Who c a n a nd will b e the Single Point of Contac t ? 6. Ho w ma ny MAHs do e s the OBP re pre se nt? 7. 01/ 02/ 2018 F I MVO OBP WORK SHOP 13

HOW T O RE QUE ST T O PART I CI PAT E 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 01/ 02/ 2018 F I MVO OBP WORK SHOP 14

HOW T O RE QUE ST T O PART I CI PAT E 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 o llo w the instruc tio ns in yo ur e ma il to lo g in to yo ur 8. Yo ur Co mpa ny po rta l is re a dy to On b o a rd Co mpa ny po rta l 01/ 02/ 2018 F I MVO OBP WORK SHOP 15

T E CHNI CAL ON-BOARDI NG T rig g e r ste p 4: • Ste p 3 c o 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 Status: No t Sta rte d Co mple te d Status: No t sta rte d Co mple te d Ac c e ss sub -ste ps Ac c e ss sub -ste ps 01/ 02/ 2018 F I MVO OBP WORK SHOP 16