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

F I MVO E ND USE R AND I SV WORK SHOP Pa ul Mills - E MVO

AGE NDA I 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 F I MVO OBP WORK SHOP 2

AGE NDA I I 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 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 . 02/ 02/ 2018 F I MVO E ND USE R AND I SV WORK 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’ . 02/ 02/ 2018 F I MVO E ND USE R AND I SV WORK 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) 02/ 02/ 2018 F I MVO E ND USE R AND I SV WORK 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 02/ 02/ 2018 F I MVO E ND USE R AND I SV WORK SHOP 7

WHAT DOE S T HE HUB DO? o 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. o 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 o rc he stra te s re spo nse s a nd a le rts. o 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. o 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. o 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) o T he inte rfa c e s a re a ll se c ure d we b se rvic e s o 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 02/ 02/ 2018 F I MVO E ND USE R AND I SV WORK SHOP 8

WHAT DOE S T HE HUB DO WI T H DAT A? o 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 • o 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. 02/ 02/ 2018 F I MVO E ND USE R AND I SV WORK SHOP 9

E MVS AND HUB CONNE CT I VI T Y NMVS Se c ure Pharmacy Wholesaler we b se rvic e s Se c ure we b se rvic e s European Se c ure we b se rvic e s Parallel Hub Distributor Pharmaceutical Manufacturer Se c ure we b se rvic e s EMVO Gateway 02/ 02/ 2018 F I MVO E ND USE R AND I SV WORK SHOP 10

E U HUB E NVI RONME NT S E IT IQE PRD IT E e nvir onme nt IQE e nvir onme nt PRD e nvir onme nt • I nte g ra te d T e st • I nte g ra te d Q ua lity • Pro duc tive E nviro nme nt E nviro nme nt E nviro nme nt • Use d a s sa ndb o x • Use d fo r Qua lity- • Va lida te d b y multiple OBP’ s & Ce rtific a tio n e nviro nme nt • I nte g ra tio n te sting te sting b y multiple o f OBP’ s OBP’ s c o nne c tio n • Va lida te d IQE : Inte g ra tio n Qua lity E nviro nme nt : Inte g ra tio n Qua lity E nviro nme nt IQE e nviro nme nt PRD: Pro d uc tive E nviro nme nt 02/ 02/ 2018 F I MVO E ND USE R AND I SV WORK SHOP 11

E MVS DAT A o 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. o 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. o 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. 02/ 02/ 2018 F I MVO E ND USE R AND I SV WORK SHOP 12

E MVS DAT A CONT E NT 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 . 02/ 02/ 2018 F I MVO E ND USE R AND I SV WORK SHOP 13

E MVS DAT A o 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. o 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 . 02/ 02/ 2018 F I MVO E ND USE R AND I SV WORK SHOP 14

MUL T I -MARK E T PRODUCT o 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. o 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 o 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 o 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). o 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. 02/ 02/ 2018 F I MVO E ND USE R AND I SV WORK SHOP 15