This p ojec has ecei ed unding om he Eu opean Union’s Ho izon 2020
esea ch and inno a ion p og amme unde he G an Ag eemen No. 875299
P ojec ac onym: UNICOM
P ojec ull i le: Up-scaling he global uni ocal iden i ica ion o medicines
in he con ex o Digi al Single Ma ke s a egy
Call iden i ie : H2020-SC1-DTH-2019
Gap and equi emen s analysis o IDMP compa ible
applica ion o ms
D3.1: Gap and equi emen s analysis documen
Ve sion:
1.0
S a us:
Final d a
Dissemina ion Le el1:
PU
Due da e o deli e able:
30.11.2021
Ac ual submission da e:
30.11.2021
Wo k Package:
WP3: IDMP compa ible applica ion o ms
Lead pa ne o his deli e able:
AGES
Pa ne (s) con ibu ing:
AEMPS – ES, B A M – DE, CBG-MEB – NL, HPRA –
IE, MPA – SE, NoMA – NO
Deli e able ype2:
R
Main au ho (s):
AGES, Noel Diaman
AGES, Geo g Neuwi he
1 Dissemina ion le el: PU: Public; CO: Con iden ial, only o membe s o he conso ium (including he Commission Se ices);
EU-RES: Classi ied In o ma ion: RESTREINT UE (Commission Decision 2005/444/EC); EU-CON: Classi ied In o ma ion:
CONFIDENTIEL UE (Commission Decision 2005/444/EC); EU-SEC Classi ied In o ma ion: SECRET UE (Commission
Decision 2005/444/EC)
2 Type o he deli e able: R: Documen , epo ; DEM: Demons a o , pilo , p o o ype; DEC: Websi es, pa en illings, ideos,
e c.; OTHER; ETHICS: E hics equi emen ; ORDP: Open Resea ch Da a Pilo
UNICOM – D3.1: Gap and equi emen s analysis documen
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Re ision his o y
Ve sion
Da e Changes made Au ho (s)
0.1 13.10.2020 Concep , con en o e iew ND, GN
0.3 4.11.2020 Fi s d a ND
0.4 12.11.2020 In e nal e iew ND, GN
0.5 26.11.2020 Adap a ion ND
0.6 7.12.2020 In e nal e iew ND, GN
0.7 19.1.2021 Finalisa ion ND
0.8
26.01.2021
Finalisa ion Upda e
GN, ND
0.8.1 01.02.2021 Finalisa ion Upda e GN
0.8.2 13.02.2021 Finalisa ion Upda e GN
0.9 02.03.2021 Consul a ion e sion o e iew ND, GN
0.9.1 02.02.2021 Mino changes and sugges ions (in e nal e iew) Pelle Pe sson, SEMPA
0.9.2 23.03.2021 In eg a ed commen s om UNICOM pa ne s ND, GN
0.9.3 4.05.2021 In eg a ed commen s om EMA DADI and SPOR ND, GN
1.0 30.11.2021 Submi ed
S a emen o o iginali y
This deli e able con ains o iginal unpublished wo k excep whe e clea ly indica ed o he wise. Acknowledgemen o
p e iously published ma e ial and o he wo k o o he s has been made h ough app op ia e ci a ion, quo a ion o bo h.
UNICOM – D3.1: Gap and equi emen s analysis documen
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Deli e able abs ac
This documen is he summa y o he ou come o deli e able “3.1: Gap and equi emen s analysis
o p o iding he IDMP complian applica ion da ase ”. This deli e able was c ea ed wi hin ask “3.1
Pe o m a GAP-Analysis be ween he cu en applica ion da ase s and suppo ing ools and he
IDMP s anda ds”.
In his ask, he WP membe s e alua ed he gaps be ween he AS-IS “PDF based legacy
applica ion o ms” and he TO-BE “IDMP compa ible web o ms”. The ou come conside ed mul iple
pe spec i es:
• Da a s uc u e
• Use In e ace
• Da a con en
• Da a au ho ing p ocess
• Func ional and non- unc ional equi emen s
A de ailed equi emen s documen a ion can be ound in he AGES con luence wiki.
This deli e able is he inpu o he ollowing so wa e enginee ing p ocess, which will deli e he
echnical implemen a ion in an agile de elopmen me hodology.
Keywo ds: AGES, ISO IDMP, SPOR, REFACTORING, WEBFORM, eAF, PDF
This documen con ains ma e ial, which is he copy igh o he membe s o he UNICOM conso ium lis ed
abo e, and may no be ep oduced o copied wi hou hei pe mission.
The comme cial use o any in o ma ion con ained in his documen may equi e a license om he owne o
ha in o ma ion.
This documen e lec s only he iews o he au ho s, and he Eu opean Commission is no liable o any
use ha may be made o i s con en s. The in o ma ion in his documen is p o ided “as is”, wi hou wa an y
o any kind, and accep no liabili y o loss o damage su e ed by any pe son using his in o ma ion.
© 2019-2023. The pa icipan s o he UNICOM p ojec .
UNICOM – D3.1: Gap and equi emen s analysis documen
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TABLE OF CONTENTS
Re ision his o y ....................................................................................................................................... 2
Deli e able abs ac ................................................................................................................................. 3
Deli e able e iew ................................................................................................................................... 6
Lis o abb e ia ions ................................................................................................................................. 7
1 Execu i e summa y .......................................................................................................................... 9
2 Con en o he deli e able .............................................................................................................. 11
2.1 Con en s o he deli e able .................................................................................................... 11
2.1.1 Addi ional in o ma ion ........................................................................................................ 11
2.2 Au ho ship and esponsibili ies .............................................................................................. 11
3 Use expe ience ............................................................................................................................. 12
4 Con en o applica ion o ms........................................................................................................... 15
4.1 T ans o ma ion o con en ...................................................................................................... 15
4.1.1 Package ............................................................................................................................. 15
4.1.2 O ganisa ion and Con ac s ................................................................................................ 17
4.1.3 Manu ac u e s .................................................................................................................... 17
4.1.4 Ing edien ........................................................................................................................... 17
4.1.5 Manu ac u ed i em and Pha maceu ical p oduc ............................................................... 18
4.2 T ans o ma ions in he con en backbone ............................................................................. 19
4.3 Possible con en ex ensions de i ed om addi ional business cases ................................... 21
4.3.1 Po en ial ex ensions .......................................................................................................... 21
4.3.2 Technical app oaches o conside ex ensions .................................................................. 22
4.3.3 Indica ions .......................................................................................................................... 22
5 Da a au ho ing p ocess .................................................................................................................. 23
5.1 Gene al AS-IS p ocess .......................................................................................................... 23
5.2 Gene al TO-BE p ocess ........................................................................................................ 23
5.2.1 De ails Va ia ion Fo ms AS-IS ........................................................................................... 23
5.2.2 De ails Va ia ions Fo m TO-BE ......................................................................................... 24
5.2.3 De ails Ini ial Ma ke ing Au ho isa ion and Renewal Fo m TO-BE .................................... 25
5.2.4 Line Ex ensions ................................................................................................................. 25
5.3 U ilising RIM sys ems o c ea e applica ion da ase s ............................................................ 25
6 Requi emen s Analysis ................................................................................................................... 26
6.1 Documen unc ional equi emen s ........................................................................................ 26
6.2 Documen Business Rules o Va ia ion o m ........................................................................ 27
6.3 C ea e FHIR Resou ces ........................................................................................................ 27
6.3.1 Di e ences be ween EU IG, FHIR and eAF ...................................................................... 27
6.4 Se up equi emen s p ocesses ............................................................................................. 28
7 De elopmen .................................................................................................................................. 29
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7.1 O iginally planned a chi ec u e concep o a Powe Apps app oach .................................... 29
LIST OF FIGURES
Figu e 1: eAF PDF OMS selec ion ........................................................................................................ 13
Figu e 2: eAF AS-IS s uc u e o a package.......................................................................................... 16
Figu e 3: TO-BE FHIR s uc u e o a package ...................................................................................... 16
Figu e 4 IDMP Ing edien ep esen ed in FHIR #R5 ............................................................................. 18
Figu e 5: Composi ion compa ison eAF / IDMP .................................................................................... 19
Figu e 6: Use Case diag am (web o m) As an applican I wan o en e p ocedu al in o ma ion ........ 26
Figu e 7: O iginally planned Powe Apps A chi ec u e ........................................................................... 29
LIST OF TABLES
Table 1: MS Wo d based o ms ............................................................................................................. 12
Table 2: PDF based o ms..................................................................................................................... 12
Table 3: Web o m as da a en y ........................................................................................................... 14
Table 4: Compa ison FHIR / DES based backbones ............................................................................ 20
UNICOM – D3.1: Gap and equi emen s analysis documen
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Deli e able e iew
In e nal e iewe : UNICOM WP3
pa ne s Ex e nal e iewe : EMA
Answe Commen s Type* Answe Commen s Type*
Is he deli e able in acco dance wi h
he Desc ip ion o
Ac ion?
☒ Yes
☐ No
☐ M
☐ m
☐
a
☒ Yes
☐ No
☐ M
☐ m
☐
a
he in e na ional S a e
o he A ?
☒ Yes
☐ No
☐ M
☐ m
☐
a
☒ Yes
☐ No
☐ M
☐ m
☐
a
Is he quali y o he deli e able in a s a us
ha allows i o be sen
o Eu opean
Commission?
☒ Yes
☐ No
☐ M
☐ m
☐
a
☐ Yes
☒ No
☐ M
☐ m
☐
a
ha needs
imp o emen o he
w i ing by he o igina o
o he deli e able?
☐ Yes
☒ No
☐ M
☐ m
☐
a
☐ Yes
☒ No
☐ M
☐ m
☐
a
ha needs u he wo k
by he Pa ne s
esponsible o he
deli e able?
☐ Yes
☒ No
☐ M
☐ m
☐
a
☐ Yes
☒ No
☐ M
☐ m
☐
a
Is he s uc u e and con en s o he deli e able
s uc u ed, logical and
easy o unde s and?
☒ Yes
☐ No
☐ M
☐ m
☐
a
☒ Yes
☐ No
☐ M
☐ m
☐
a
sui able o mee i s
in ended scope?
☒ Yes
☐ No
☐ M
☐ m
☐
a
☒ Yes
☐ No
☐ M
☐ m
☐
a
Is in con o mance wi h
UNICOM deli e able
empla e?
☒ Yes
☐ No
☐ M
☐ m
☐ a
☒ Yes
☐ No
☐ M
☐ m
☐ a
* Type o commen s: M = Majo commen ; m = mino commen ; a = ad ice
UNICOM – D3.1: Gap and equi emen s analysis documen
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Lis o abb e ia ions
Abb e ia ion Comple e o m
ADO Azu e De Ops
AGES Aus ian Agency o Food and Heal h Sa e y
API Applica ion P og amming In e ace
CDM, LDM, PDM Concep ional, Logical, Physcial Da amodel
CMDx Coo dina ion G oup o Mu ual Recogni ion and Decen alised P ocedu es (human o e )
DADI Digi al Applica ion Da ase In eg a ion
DCP Decen alised P ocedu e
DES Da a Exchange S anda d (eAF PDF)
DoA Desc ip ion o he Ac ion
eAF Elec onic Applica ion Fo m
EC Eu opean Commission
eCTD Elec onic Common Technical Documen
ePI Elec onic P oduc In o ma ion
EMA Eu opean Medicines Agency
EMRN Eu opean Medicines Regula o y Ne wo k
FHIR Fas Heal hca e In e ope abili y Resou ces
IDMP ISO S anda d o he “Iden i ica ion o Medicinal P oduc s” (also ISO IDMP)
IRIS A secu e online pla o m o handling p oduc - ela ed scien i ic and egula o y p ocedu es
wi h EMA
EU IG EMA EU Implemen a ion Guide
ISO In e na ional O ganiza ion o S anda diza ion
MAA Ma ke ing Au ho isa ion Applica ion
MAH Ma ke ing Au ho isa ion Holde
MEA AGES Medicines & Medical De ices business segmen
(Ge man: Medizinma k au sich )
MG Managemen G oup (eAF-MG)
MP Medicinal P oduc
MRP Mu ual Recogni ion P ocedu e
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NCA Na ional Compe en Au ho i y
N A The EC g oup “No ice o applican s”
OMS O ganisa ion Managemen Se ices
PDF Po able Documen Fo ma (mos ly known om Adobe)
PHAROS Pha maceu ical O ganisa ion Sys em a AGES
PM P ojec Manage
PMS P oduc Managemen Se ices
POC P oo o Concep
RMS Re e ence Membe S a e
RMS Re e en ials Managemen Se ices
SMPC Summa y o P oduc Cha ac e is ics
SMS Subs ance Managemen Se ices
SPOR
EMA se ice deli e ing quali y da a managemen se ices o subs ances, p oduc s,
o ganisa ions and e e en ials (SPOR) o powe EU egula o y ac i i ies.
UX Use Expe ience (Op imising he use In e ace, sys em in e ac ion and gene al jou ney)
NeeS e e ina y Non eCTD elek onic Submission
WP Wo k package
XEVMPD Ex ended Eud aVigilance Medicinal P oduc Dic iona y
XML Ex ensible Ma kup Language
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1 Execu i e summa y
Applying o au ho isa ions o medicinal p oduc s and managing hei li e cycles is a egula ed p ocess
suppo ed by elec onic applica ion o ms and suppo ing elec onic ools. A he momen nei he he
s uc u e o applica ion o ms no he PDF based ools o ini ial au ho isa ions, a ia ions and enewals
a e suppo ing IDMP s anda ds. Thus, i is no possible o au oma e and eed egula o y p ocesses wi h
IDMP compa ible da a and easily e-use he da a in EU-wide eHeal h se ices. The change o mo e o
online IDMP compa ible o ms was igge ed by he egula o y ne wo k. This ini ia i e is now also
suppo ed by he EU commission ia he Ho izon 2020 p og amme.
I is an objec i e o UNICOM WP3 o p o ide basic wo k o o e come his cu en si ua ion by de eloping
IDMP compa ible online ools, which a e able o p o ide IDMP compa ible applica ion da ase s. The oll-
ou o he new ools will be o ganised by he Eu opean Regula o y Medicines Ne wo k (EMRN) and is
no in-scope o he UNICOM p ojec .
In mobilising ac i i y, he p ojec eam assessed he op imal app oach o deli e ing he solu ion, and
ensu ing ha he solu ion a chi ec u e and echnology choices p o ide a u u e p oo solu ion. This
included discussions wi h EMA in o ma ion echnology ep esen a i es o con i m alignmen wi h he
EMA echnology s a egy in o de o enable EMA o p o ide he long- e m suppo a angemen , hos ing
and main enance and con inued enhancemen o he IDMP compa ible applica ion o ms in a s able
ne wo k en i onmen .
The Agency ecommended o u ilise he pla o m “Powe Apps” which is al eady in use a he EMA o
o he ypes o applica ions (e.g. o o phan d ugs) in he IRIS sys em. The pla o m also p o ides a e-
usable in eg a ion wi h SPOR se ices and EMA’s use managemen . To e alua e he iabili y o “Powe
Apps” as a de elopmen pla o m, a p oo o concep (POC) was unde aken by EMA in July which
showed i s p omising esul s.
A e he ag eemen o he UNICOM pa ne s o ollow EMAs ecommenda ion o use “Powe Apps”,
EMA akes o e he esponsibili y o de eloping he echnical implemen a ion o he applica ion o ms
as pa o he DADI p ojec .
IDMP s anda ds desc ibe he unde lying concep s and seman ics, while FHIR is he necessa y
implemen a ion o exchange IDMP compa ible da a. The FHIR implemen a ion was also chosen by EMA
as a ounda ion echnology o es ablish da a in e ope abili y. Fo hese easons his documen conside s
IDMP, as well as FHIR opics.
This documen is he summa y o he ou come o deli e able “3.1: Gap and equi emen s analysis o
p o iding he IDMP complian applica ion da ase ”. This deli e able was c ea ed wi hin ask “3.1 Pe o m
a GAP-Analysis be ween he cu en applica ion da ase s and suppo ing ools and he IDMP s anda ds”.
In his ask, he WP membe s e alua ed he gaps be ween he AS-IS “PDF based legacy applica ion
o ms” and he TO-BE “IDMP compa ible Online Tools p o iding a PDF ep esen a ion and FHIR
message da a expo ”. The ou come o WP3’s wo k is he basis o he echnical implemen a ion in an
agile so wa e deli e y me hodology.
The au ho s ollowed he app oach o g oup he analysed gaps in o i e opics:
Chap e “Use expe ience”
The cu en applica ion o ms a e de i ed om a “pape wo ld”, which was ans o med in o PDF based
o ms. The e a e some imp o emen s being made in he la es e sions o he a ia ion o m on dynamic
da a en y, which will be u he enhanced. The new web based and IDMP/FHIR s uc u ed ool o
en e ing applica ion da a will he e o e be a signi ican nex ans o ma ion. This chap e desc ibes he
change o he use expe ience.
Chap e “Con en o applica ion o ms”
This chap e desc ibes gaps ela ed wi h he da a con en o applica ion o ms. Al hough he con en o
he applica ion o m will emain mos ly he same, he e a e some s uc u al changes necessa y o
comply wi h he IDMP model. These changes encompass mos ly in he con ex o “p oduc name”,
UNICOM – D3.1: Gap and equi emen s analysis documen
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Figu e 2: eAF AS-IS s uc u e o a package
In con as , he TO-BE s uc u e in FHIR depic s a scena io whe e a “packaged p oduc ” con ains a
packaged i em ha has a ype o package and a sel - e e ence o allow o con aine s in con aine . In
addi ion, he packaged i em con ains a e e ence o a numbe o manu ac u ed i ems. This allows o
needed hie a chies and linkage o manu ac u ed i ems and packaged p oduc s.
Figu e 3: TO-BE FHIR s uc u e o a package
Fu he mo e, he IDMP s anda ds clea ly de ine he seman ics on how o desc ibe a package da a in a
mo e de ined way han he cu en eAF, e.g. a he han ex
1. he package size is clea ly de ined as a numbe ,
2. ma e ial is a choice o con olled e ms om RMS
3. he manu ac u e is linked by a e e ence iden i ica ion
4. cha ac e is ics/p ope ies ha e sepa a e ields and don’ need o be all wi hin “desc ip ion”
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4.1.2 O ganisa ion and Con ac s
O ganisa ions and con ac s in he cu en eAF a e used in se e al sec ions e.g. o include a pe son o
a manu ac u e , MAH, esponsible pe sons o a ious obliga ions. The new ool will in oduce
imp o emen s.
The de ailed ep esen a ion o an “O ganisa ion” and i s loca ions” will be desc ibed only once p e e ably
based on manda o y selec ion om OMS. This will a oid adminis a i e e o when en e ing da a.
Con ac pe sons will be mainly s uc u ed in a “Con ac lis s and a ibu ed wi h hei ole a he han
sca e ed h oughou di e en sec ions o he o m. To enable a lis o di e en ypes o con ac s RMS
has c ea ed a con ac ype lis and FHIR a sec ion o medicinal p oduc con ac s.
4.1.3 Manu ac u e s
The lis o ields used o desc ibe a manu ac u e will be s anda dised, so ha all ypes o manu ac u e s
ha e a simila le el o in o ma ion.
The only di e ence will be ha some ha e a link o ano he esou ce in addi ion e.g.:
• subs ances – subs ance manu ac u e
• package – package manu ac u e
• de ice –de ice manu ac u e
The e will no longe be a di e en sec ion o each manu ac u e , bu one consolida ed sec ion
con aining all manu ac u e desc ibed by hei de ails and manu ac u ing ac i i ies (o “Ope a ion” as i
is named in FHIR).
4.1.4 Ing edien
The concep o “ing edien s” is de ined by he IDMP s anda ds. The lis o ing edien s can be compa ed
o “quali a i e and quan i a i e composi ion” in he cu en eAF.
IDMP s anda ds enable a mo e speci ic desc ip ion o he eAF con en :
• A mo e speci ic s eng h de ini ion o each ing edien , whe eas he cu en eAF has limi a ions.
• I allows bo h a “low” and a “high alue” o be speci ied, uppe and lowe ange, as well as a
compa a o o each alue, whe eas in he eAF he compa a o is used o depic only one o
hese op ions.
• Enables o speci y a e e ence s eng h and an ac i e moie y, whe eas he eAF allows o ei he
a base s eng h o an ac i e moie y.
• The e will now always be a p esen a ion s eng h and in addi ion, a concen a ion s eng h can
be speci ied as well
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Figu e 4 IDMP Ing edien ep esen ed in FHIR #R5
4.1.5 Manu ac u ed i em and Pha maceu ical p oduc
Pha maceu ical p oduc s a e adminis e ed o he pa ien in con as o he manu ac u ed i em, which is
he way i is p oduced and con ained in a package.
The cu en applica ion o ms a e no able o dis inguish hese wo elemen s (manu ac u ed i em and
pha maceu ical p oduc ) and usually only desc ibe he manu ac u ed i em, al hough he heade is called
“pha maceu ical p oduc ” (see eAF MAA sec ion 2.6).
ISO IDMP s anda ds in oduce a mo e de ailed concep o dis inguish be ween he “pha maceu ical
p oduc ” and “manu ac u ed i ems”. This equi ed spli could be conside ed as addi ional in o ma ion in
ela ion o he cu en N A o m, o as ano he way o ep esen ing cu en in o ma ion.
In case he p oduc is adminis e ed as i is manu ac u ed, he ing edien s (see chap e 4.1.1) will be
linked and eused and he con en is he same as o he manu ac u ed i em.
In o he cases he e will be indi idual composi ions de ined.
Wha is missing in IDMP s anda ds and he EU IG is a mo e e ined g ouping o ing edien s in o logical
pa s o depic e.g. capsule co e, capsule shell, p in ing ink as a composi ion g oup, as i is used in he
eAF oday.
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Figu e 5: Composi ion compa ison eAF / IDMP
4.2 T ans o ma ions in he con en backbone
The con en o he eAFs is s o ed in an elec onic da a o ma . This unde lying echnical s uc u e is
o ma ed in XML wi h a schema de ini ion ha is called “Da a Exchange S uc u e (DES)”. This
a chi ec u e allows egula o s o consume he da a con en in an au oma ised way. The ull eAF con en
can be p o ided o IT sys ems using a PDF na i e XML expo . Applican s can u ilise his echnique and
inpu da a in o he o m by popula ing he XML backbone wi h da a om applican s’ IT sys ems. The
syn ax o he XML alida es agains he DES ha is being published by he eAF main enance g oup on
an EMA websi e.
Bo h he da a o ma de ini ion DES and he esul ing XML expo ha e he disad an ages o con aining
a lo o PDF speci ic and unnecessa y elemen s, hey do no always e lec he o de o ields and ha e
no con inuous naming, - o s uc u e con en ion.
To o e come hese d awbacks he u u e ool will be based on a new unde lying da a s uc u e. The new
o ma will u ilise he concep o FHIR esou ces and esou ce bundles. The esou ce de ini ions a e
published and documen ed ex ensi ely online on he FHIR websi e8.
The new backbone design ollows he decision made by EMA o use FHIR as an exchange s anda d in
he EMRN. FHIR is being used o IDMP and SPOR implemen a ions9 and is he e o e he logical
consequence o he new applica ion o ms’ backbone.
8 See h p://build. hi .o g/ (d a e sion)
9 See SPOR API unde h ps://www.ema.eu opa.eu/en/documen s/ egula o y-p ocedu al-guideline/subs ances-p oduc s-
o ganisa ions- e e en ials-spo -spo -api- 2-speci ica ion_en.pd
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The nex able compa es he u u e FHIR based s uc u e wi h he legacy DES backbone:
FHIR based backbone DES based backbone
• In e na ional s anda d
suppo ed by a
wide communi y
• I is easy o p esen
in o ma ion in an
IDMP compa ible s uc u e
• FHIR has a esou ce ela ional concep
which allows o eusing iden ical
in o ma ion
• FHIR is used ac oss business domains
• Publicly a ailable FHIR se e s o
aining and es ing pu poses
• FHIR allows o ex ensions, bu hey a e
only known wi hin he speci ic business
domain
•
New da a elemen s o he s anda d
equi e ime consuming ballo s and can
be ejec ed
•
FHIR o esees key/ alue pai concep s
o a ibu es and lis s, bu ha ing
di e en lis s o he same ield can make
au oma ic da a ex ac ion complex
• A code able concep o a e e ence can
con ain di e en elemen s only known a
un ime making au oma ic da a
ex ac ion complex
• Lose coupling o da a s anda d and use
in e ace
• FHIR suppo s alida ion agains publicly
known schemas and p ojec speci ic
p o iles
•
• P op ie a y s anda d o applica ion
o ms, based on PDF speci ics
• Applicable only in Eu ope, no
communi y o ums o suppo
implemen e s
• No compa ible wi h IDMP s anda ds
• The s anda d doesn’ suppo ela ional
concep s10
• The use in e ace o he applica ion
o m needs o copy iden ical da a ac oss
sec ions
• DES con ains duplica e elemen s
because he PDF Use in e ace
equi es i
• No s andalone alida ion me hods a e
a ailable o IT sys ems, alida ion is
possible wi hin he PDF use in e ace
• DES is only used wi hin egula o y
ac i i ies wi hin au ho isa ion and
li ecycle managemen o medicinal
p oduc s
Table 4: Compa ison FHIR / DES based backbones
10 (e.g. Fo cen alized p oduc s, when se e al p oduc s a e popula ed in he o m, i is no possible o de e mine which
packages a e associa ed wi h each p oduc )
UNICOM – D3.1: Gap and equi emen s analysis documen
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4.3 Possible con en ex ensions de i ed om addi ional business cases
As desc ibed abo e he con en o eAFs is de ined by legal and egula o y needs unde he esponsibili y
o N A based a he Eu opean Commission. Con en ex ensions can only be made wi h N A ag eemen s.
Howe e , since he new ool is also in ended o suppo addi ional business cases he challenge is o
ind a way o bo h comply wi h his es ic ion and o make an ex ension echnically possible.
The cu en business cases a e he ollowing:
• Ini ial applica ions o ma ke ing au ho isa ions
• Va ia ions o ma ke ing au ho isa ions
• Renewal o ma ke ing au ho isa ions
Fu u e po en ial business cases migh ex end he cu en usage o he web o ms and unde lying da a
backbone:
• U ilise he da a con en o also popula e SPOR PMS, A icle 5711. and he Union P oduc
Da abases ( e e ina y domain) The SPOR Task o ce has published a s epwise app oach o
eplace he cu en XEVMP o ma by he eAF da a backbone12.
• Fu he Pos -Ma ke ing da a ela ed ac i i ies (e.g. a ailabili y epo ing, MAH ans e ,…)
Suppo ing “elec onic P oduc In o ma ion ePI”
I is ou o scope o UNICOM o ealise he suppo o u he business case bu he undamen al
a chi ec u al concep s will conside he u u e needs. The implemen a ion will be o ganised by sepa a e
p ojec s d i en by business needs and he EMRN s a egy.
4.3.1 Po en ial ex ensions
The ollowing business cases will igge ex ensions o he de ined eAF con ex
Po en ial ex ensions in he con ex o A icle 57(2) o Regula ion (EC) No. 726/2004
EMA plans o eplace he XEVMPR o ma wi h a FHIR based messaging. Addi ional da a elemen s o
he A . 57 (2) a e necessa y compa ed o he eAF ele an scope like
• Indica ions a e cu en ly no in scope o he elec onic applica ion o ms. A he momen
indica ions a e only con ained in SMPCs and na ional ex s. They a e also pa o he A . 57
da abase, in acco dance wi h A icle 57(2) o Regula ion (EC) No. 726/2004.
• Ma ke ing au ho isa ion holde 's con ac email add ess and elephone numbe o
pha maco igilance enqui ies.
Con ex o he implemen a ion o he Ve e ina y Medicinal P oduc Regula ion (EU)
2019)
Al hough he e e ina y domain is no di ec ly included in he UNICOM p ojec syne gies wi h he human
domain we e iden i ied and i possible, will be implemen ed. The e e ina y domain will also u ilise he
new ool wi h addi ional da a elemen s.
11 This da abase is de ined by A icle 57(2) o Regula ion (EU) 726/2004. See also h ps://www.ema.eu opa.eu/en/human-
egula o y/pos -au ho isa ion/da a-medicines-iso-idmp-s anda ds/da a-submission-au ho ised-medicines-a icle-57
12 h ps://www.ema.eu opa.eu/en/human- egula o y/ esea ch-de elopmen /da a-medicines-iso-idmp-s anda ds/spo -mas e -
da a/subs ance-p oduc -da a-managemen -se ices#eu-idmp-implemen a ion-guide--- e sion-2.0-sec ion
UNICOM – D3.1: Gap and equi emen s analysis documen
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4.3.2 Technical app oaches o conside ex ensions
This sec ion desc ibes how ex ensions a e made possible unde he condi ion ha he o icial eAF is
conse ed in i s cu en o ma .
Use expe ience
The use in e ace will enable he applican o en e addi ional da a needed o u he use cases. These
da a elemen s will be ma ked and special business ules will apply.
Technical backbone
The echnical da a s uc u e o he eAF message can e ol e in u u e eleases o include addi ional
FHIR esou ces needed o ca y in o ma ion o o he da a consume e.g. PMS o A .57.
eAF ep esen a ion used o submissions in egula o y submissions
The o icial eAF ep esen a ion in human eadable PDF used o submission in egula o y submissions
will only include da a con en as de ined by N A.
4.3.3 Indica ions
Indica ions a e cu en ly no in scope o he elec onic applica ion o ms. A he momen indica ions a e
only con ained in SMPCs and na ional ex s. They a e also pa o he A . 57 da abase, in acco dance
wi h A icle 57(2) o Regula ion (EC) No. 726/2004.
EU Implemen a ion Guide 2 Manda o y (a leas one language)
FHIR R5 Op ional
eAF con en No a ailable
Conclusion:
As his is o eseen as a majo change i is no pa o he i s implemen a ion o he new IDMP/FHIR-
based applica ion o ms.
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5 Da a au ho ing p ocess
5.1 Gene al AS-IS p ocess
Applica ion o ms a e cu en ly a ailable o download ia he EMAs websi e13. Applican s ha e o make
su e ha he la es e sions a e used A e en e ing applica ion da a in o he applica ion o m (eAF) he
au ho ing p ocess will be “ inalised” by adding a signa u e scan (pic u e) in o he PDF.
The applican has o include he eAF in he ele an dossie o submission, ei he inside eCTD module
1.2 (human) o inside he NeeS dossie ( e e ina y).
The ollowing sec ion desc ibes he AS-IS p ocess and he planned p ocess changes when en e ing
da a.
5.2 Gene al TO-BE p ocess
In he u u e scena io all applica ion o ms will be eplaced by online web o ms14.
These web o ms will only be accessible by a uni ied applica ion pla o m p o ided by EMA. This pla o m
equi es pe sonalised use c eden ials which can be acqui ed wi h EMAs iden i y managemen sys em.
The unde lying egis a ion and access p ocess is ha monised and in line wi h o he exis ing simila use
cases.
Once he use is logged in o he applica ion pla o m, hey can selec he app op ia e applica ion da ase
ype and c ea e new o con inue wi h exis ing da ase s.
The submission o he PDF ep esen a ion o he inalised da ase wi hin dossie s is he same as he
AS-IS p ocess.
5.2.1 De ails Va ia ion Fo ms AS-IS
The cu en a ia ion o m is spli in o ou pa s:
1. p ocedu al in o ma ion,
2. basic p oduc mas e da a
3. p oduc changes ( a ia ion classi ica ion and p oduc changes)
4. sec ion abou paedia ics and o phan
The in o ma ion gi en in he “p ocedu al in o ma ion” sec ion de ines he ype and classi ica ion o he
a ia ion and limi s he selec ions ha can be made in he “p oduc changes” sec ion.
The a ia ion classi ica ion de ines he scope o he changes and is based on he classi ica ion
guidance15.
The “basic p oduc mas e da a” sec ion con ains he main a ibu es o he conce ned p oduc s o he
a ia ion. Key alues a e used by da a impo ing ools a egula o le el o au oma ically iden i y
p oduc s, which a e ele an in his a ia ion. Addi ional a ibu es a e mainly used o plausibili y checks,
o ensu e ha he co ec p oduc s a e included in he a ia ion applica ion.
The “p oduc changes” sec ion allows o he inpu o he cu en p oduc mas e da a alues and he
inpu o he p oposed alue o a change (p esen and p oposed concep ). These alues a e ee ex
wi h one excep ion. I is possible o selec an o ganisa ion om SPOR OMS o e en add a g aphical
in o ma ion.
13 h p://esubmission.ema.eu opa.eu/ea /index.h ml
14 The esul is a FHIR message. The de ini ion will be published o enable c ea ion by IT sys ems (e.g. RIM om applican s).
15 h ps://ec.eu opa.eu/heal h/si es/heal h/ iles/ iles/be e eg/pha macos/classi ica ion_guideline_adop ed.pd
UNICOM – D3.1: Gap and equi emen s analysis documen
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In case o g oupings, he change is desc ibed once and is hen ele an o all p oduc s men ioned in
applica ion o m.
The las sec ion “abou paedia ics and o phan” is only a ailable o ype II o IB a ia ions.
5.2.2 De ails Va ia ions Fo m TO-BE
In he u u e he applican will be guided h ough he o m o:
• Fi s , selec he conce ned p oduc s. The sec ion “basic p oduc mas e da a” will no longe be
asking o manual inpu o p oduc da a, bu p omp o selec he conce ned p oduc s om he
p oduc managemen eposi o y, SPOR PMS, and au oma ically depic i s mas e da a.
The e may be es ic ions on who can selec which p oduc , so he login c eden ials would be
o wa ded o he SPOR sys em, and he p oduc lis may be limi ed acco dingly. The selec ion
o he p oduc s will also ha e an impac on he change sec ion.
• Second, speci y he changes by selec ing he a ia ion classi ica ion and hei espec i e
a ia ion ypes. This selec ion o he a ia ion classi ica ion will se he con ex o u he s eps
and will dynamically de ine ele an p oduc da a elemen s, which ha e o en e ed. The
selec ion o he a ia ion classi ica ion will limi he numbe o p oduc ields shown and display
only he ele an da a inpu and i s con ex
• Thi d, he sys em will be able o de i e he p ocedu e ype, he domain and he
g ouping/wo ksha ing in o ma ion based on he selec ed p oduc s and a ia ion classi ica ions
• Finally, he use will desc ibe he changes o he p oduc s o he ma ke ing au ho isa ion
This sec ion will no longe only ha e ee ex ields o p esen and p oposed da a, bu will euse
he o icial p oduc in o ma ion om SPOR PMS and display i i i is a ailable. This da a will be
changeable in a s uc u ed o ma o indica e he p oposed alue.
In summa y he ollowing will be implied:
• Ra he han ee ex he e will be s uc u ed da a inpu elemen s o ex , numbe s, da es, RMS
con olled e m lis selec choices and OMS/SMS/PMS based mas e da a.
• As PMS is a sys em ha is being de eloped s epwise, he e will be ee ex changes in he
a ia ion o m in he beginning, which will be eplaced wi h explici da a ields once hey become
a ailable in PMS.
• Legacy da a om SPOR PMS will show cu en da a in a ia ion o ms wi h all impu i ies ha
exis oday. I hese a e no cleaned be o e u ilised in a ia ion p ocess, hey could e y likely
be changed wi hin he a ia ion, changing mo e in o ma ion han ini ially in ended. This will be
a challenge wi h a ia ion classi ica ions and ees, bu will ul ima ely clean he legacy da a o
he A icle 57 EMA / MAH da abase, which is he sou ce o PMS.
• The e will be sepa a e da a inpu elemen s pe change o each selec ed p oduc . This is in
con as o ha ing one sha ed inpu elemen o all p oduc s pe selec ed a ia ion opic in he
cu en o m. Cu en ly he da a p opaga ion o each p oduc is done manually a he ecei ing
end, a egula o le el.
The u u e p ocess will shi his o he applican side, minimising e o s due o misunde s anding
and ensu ing ha he applica ion o m con ains all da a al eady p opaga ed co ec ly. This
means ha he ela ionship be ween he eques ed da a change and he p oduc is al eady
speci ied du ing inpu . Fo example, changing a package size o wo p oduc s will show all
packages o bo h p oduc s and he applican will upda e he ele an con en o bo h p oduc s.
The e may be sec ions whe e he change can be p opaga ed au oma ically bu in mos cases
UNICOM – D3.1: Gap and equi emen s analysis documen
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he applican has he du y, bu also he abili y o indica e he exac loca ion o he change o
e e y p oduc .
• A del a iew on he da a elemen s subjec o change and hei p esen in o ma ion will be
gene a ed o he egula o s o indica e wha has been upda ed o which p oduc s.
• The a ia ion o m con en can be used o main ain SPOR PMS con en wi h he MAH applican s
p o iding he applica ion da ase and NCAs alida ing and assessing he submi ed con en .
S a ing he a ia ion p ocedu e, p oduc s will be selec ed di ec ly om SPOR PMS and once
he applica ion o m is alida ed, his in o ma ion can be used o upda e all in o ma ion sys ems.
This would subs an ially imp o e da a quali y o EMA and he ne wo k.
• Finally, he ime i akes o ill in he o m will be subs an ially dec eased due o
o Seeing manda o y ields igh away wi h online alida ion on lea ing a ield
o 3 d pa y ools like au o comple e o o ms
o A gene ally leane s uc u e o en e da a
o Imp o ed pe o mance o open and manipula e he o ms
5.2.3 De ails Ini ial Ma ke ing Au ho isa ion and Renewal Fo m TO-BE
The MAA o m oday is a a he la ge PDF o m con aining se e al hund ed ields. Due o he change in
echnology o a web on end, he e a e some aspec s on alida ion and pe o mance, which will imp o e
he p oduc i i y o illing in he o m.
In he u u e, he MAA, enewal and he a ia ion o ms will sha e he sec ion desc ibing he medicinal
p oduc s (basic p oduc mas e da a).
The u u e MAA and enewal o ms will also bene i om selec ion om PMS o include e e ence
p oduc s
5.2.4 Line Ex ensions
Cu en ly he e is no plan o ewo k he p ocess o line ex ensions in he i s elease o he p ojec
al hough we a e discussing an imp o emen o he da a au ho ing p ocess. The sugges ion is o spli
he di e en ypes o line ex ensions in o wo g oups:
1. Line ex ensions ha change an exis ing p oduc (e.g. adding a ou e o adminis a ion)
2. Line ex ensions ha c ea e a new p oduc (e.g. adding a s eng h)
Ideally he i s g oup wha use he a ia ion o m o p o ide he sugges ed upda es o he p oduc and
he second g oup would use he MAA o m o speci y he de ails o he new p oduc .
5.3 U ilising RIM sys ems o c ea e applica ion da ase s
As some pha maceu ical companies ha e all he necessa y in o ma ion o an applica ion da ase in
hei espec i e IT-sys ems, he da a does no ha e o be manually d a ed in he new web o m.
Applican s will be able o euse da a om hei espec i e IT-Sys em o c ea e FHIR compa ible da a.
To p o ide applican s wi h he means o alida ing agains business ules and c ea ing he human
eadable PDF ep esen a ion a ool will be p o ided ha ollows he same alida ion ules as he online
web o m.
