Tiêu chuẩn iso ts 20440 2016

Table 1 — Co es used to represent the clas of term SOM State of mat er BDF Basic dose form RCA R ele se characteristic ISI Inten ed site AME Administration method PDF P armaceutical dose

Health informatics — Identification

In ormatique de santé — Identification de s produits médica x —

G uide de mise en oeuvre de s élément de do n es et structure s p ur

l’identification u ique et l’éch n e d’inf rmations ré lementées sur

le s frme s de s dose s p armac utiques, le s u ités de prés entation, le s

v ies d’administration et le s emb la e s de l’ISO 1 2 9

Refer ence n mb r

ISO/TS 2 4 0:2 16(E)

Fir t edition

2 16-06-0

COPYRIGHT PROTECTED DOCUMENT

© ISO 2016, P blshed in Sw itz rlan

A ll rig hts r eserved Unles otherw ise spe ified, nopar of this p blc tion ma y be r epr od c d or utilz d otherw ise in an form

or b an me ns, ele tr onic or me hanic l, inclu in p oto opying , or postin on the internet or an intranet , w ithout prior

written permis ion Permis ion c n be req esed from either ISO at the ad r es below or ISO’s member bod y in the c u try of

F reword i v

Introduction v

1 Sc ope 1

2 Or ganisation of c ontrol ed ter ms 1

2.1 General 1

2.2 Code-te m p ir an coded conc pt 2

2.2.1 General 2

2.2.2 C de-te m p ir 2

2.2.3 C ded conc pt 5

2.3 Ve sioning 6

2.3.1 Ve sioning of the te m 6

2.3.2 Ve sioning of the te minolog y 9

3 Terminolog ies 9

3.1 General 9

3.2 Pharmac utical dose form 1

3.2.1 P armac utical dose form o e view 1

3.2.2 P armac utical dose form schema 1

3.2.3 P armac utical dose form example: Pr olong ed-r elease ta let 1

3.3 Combined pharmac utical form 2

3.3.1 C mbined pharmac utical dose form o e view 2

3.3.2 C mbined pharmac utical dose form schema 2

3.3.3 C mbined pharmac utical dose form example: Powde an solvent or solution for inje tion 2

3.3.4 Othe authorised combinations of te ms — C mbined te ms an combination packs 2

3.4 Unit of pr esentation 2

3.4.1 Unit of pr esentation o e view 2

3.4.2 Unit of pr esentation schema 2

3.4.3 Unit of pr esentation example: Ta let 2

3.5 Route of adminis ration 2

3.5.1 Route of adminis ration o e view 2

3.5.2 Route of adminis ration schema 2

3.5.3 Route of adminis ration example: Intra venous use 2

3.6 Packag ing 3

3.6.1 Packag ing o e view 3

3.6.2 Packag ing schema 3

3.6.3 Packag ing example: A mp ule (Packag ing categ ory: C ntaine ) 3

3.6.4 Packag ing example: S rew ca (Packag ing categ ory:Closur e) 3

3.6.5 Packag ing example: Or al syring e (Packag ing categ ory: Adminis ration devic ) 34 3.6.6 Packag ing conc pt summaries 3

4 Mapping of reg io al ter ms 36 4.1 Difer enc s in g ran larity betwe n reg ional te minolog ies 3

4.2 Or ganisation of r eg ional te ms in the datab se 3

4.2.1 General 3

4.2.2 A ddition of r eg ional te ms to the data ase 3

4.2.3 Ma ping r eg ional te ms to c ntral coded conc pt 41

4.2.4 Ve sioning of ma ped r eg ional te ms 41

4.2.5 Ma ped reg ional te m example: Ex ten ed-release ca let 41

Biblog raphy 43

ISO (he Int ernational Org nization for Stan ardization) is a worldwidefede ation of national s an ards

b dies (ISO membe b dies) The work of pr p ring Int ernational Stan ards is normaly car ied out

through ISO t ech ical committ ees Each membe b dy int er st ed in a subje t for w hich a t ech ical

committ ee has be n es a lshed has the right t o be r pr sent ed on that committ ee Int ernational

org nizations, g ove nmental an non-g ove nmental, in laison with ISO, also take part in the work

ISO cola orat es closely with the Int ernational Ele trot ech ical C mmis ion (IEC) on al matt ers of

ele trot ech ical s an ardization

The proc d r s used t o develo this document an those int en ed for it furthe maint enanc ar

desc ibed in the ISO/IEC Dir ctives, Part 1 In p rticular the dife ent a pro al c it eria ne ded for the

dife ent ty es of ISO document should be not ed This document was draft ed in ac ordanc with the

edit orial rules of the ISO/IEC Dir ctives, Part 2 ( e www.iso.org dir ctives)

A tt ention is drawn t o the p s ibi ity that some of the element of this document ma be the subje t of

p t ent right ISO shal not be held r sponsible for identifying any or al such p t ent right Detais of

any p t ent right identified d ring the develo ment of the document wi be in the Introd ction an / r

on the ISO ls of p t ent de larations r c ived ( e www.iso.org p t ent )

Any trade name used in this document is information given for the convenienc of use s an does not

cons itut e an en orsement

F or an ex lanation on the meaning of ISO spe ific t erms an ex r s ions r lat ed t o conformity

as es ment, as wel as information a out ISO’ s adhe enc t o the WTO principles in the Te h ical

Bar ie s t o Trade (TBT), se thefolowing URL:F or word — Sup lementary information

The committ ee r sp nsible for thisdocument is ISO/TC2 5, Health inormatic s

The t erminolo ies desc ibed in EN /ISO 1 2 9:2 1 (he eaft er r fe r d t o as ISO 1 2 9) an in this

Te hnical Spe ification ar es ential for the implementation of the IDMP s an ards as a w hole

Each r gion traditionaly uses it own set of t erminolo ies t o desc ibe the conc pt co e ed in

ISO 1 2 9within their r gions;these t erminolo iesar not harmonised with those of theothe r gions

The efor , harmonised controled t erminolo ies ne d t o be pro ided t o ensur that al r gions can r fe

t o a given conc pt in the same manne The purpose of this Te hnical Spe if ication is t o desc ibe how

these controled v ca ularies ar cons ruct ed an i lus rat e their use for ISO 1 2 9 implementation

Health informatics — Identification ofmedicinal pr oducts

This Te h ical Spe if ication desc ibes data element an s ructur s for the uniq e identif ication an

ex chang e of r gulat ed information on pharmac utical dose forms, u it of pr sentation, rout es of

adminis ration an p cka ing

Based on the principles outlned in this Te h ical Spe if ication, harmonised controled t erminolo ies

wi be develo ed ac ording t o an a r ed maint enanc proc s , al owing use s t o consult the

t erminolo ies an locat e the a pro riat e t erms for the conc pt that they wish t o desc ibe Pro isions

t o alow for the ma ping of exis ing r gional t erminolo ies t o the harmonised control ed t erminolo ies

wi also be develo ed in orde t o faci itat e the identification of the a pro riat e t erms The codes

pro ided for the t erms can then be used in the r lev nt f ields in the Ph ID, PCID and MPID in orde t o

identify thoseconc pt

This Te hnical Spe if ication is int en ed for use b :

— any org nisation that might be r sp nsible for develo ing an maintaining such controled

voca ularies;

— any r gional a uthorities or sof war ven ors w ho wish t o use the control ed v ca ularies in their

own sy st ems an ne d t o u de s an how they ar c eat ed;

— owne s of data ases w ho wish t o ma their own t erms t o a c ntral l s of controled v ca ularies;

— othe use s w ho wish t o u de s an the hie ar hy of the controled v ca ularies in orde t o help

identify the mos a pro riat e t erm t o desc ibe a particular conc pt

The t erminolo y t o be a pled in the cont ext of this Te h ical Spe if ication an set out in ISO 1 2 9 is

un e develo ment Al codes, t erms an def initions used as ex mples in this Te h ical Spe if ication

ar pro ided for i us ration purp ses only, an ar not int ended t o r pr sent thef inal t erminolo y

2 Or ganisation ofcontrol ed terms

2.1 General

This Clause desc ibes how each controled t erm is buit, desc ibing the data ty es used t o convey

the information an the ve sioning r q ir ment for tracking their c eation an evolution Clause 3

desc ibes the dife ent ty es of t erminolo ies an sub-voca ularies that use these data ty es, and any

r lev nt r lationships betwe n them

Each f ield in Clause 2 is desc ibed u de a sep rat e subclause, consis ing of the title of the field an a

ta le containing the folowing:

— “Use Guidanc ” , a desc iption of the f ield;

— “Data Ty e” , a desc iption of the data ty e;

— “Conformanc ” , a desc iption of w hethe the field is man at ory, o tional, or conditional;

— “Value Alowed” , in icating the p s ible v lues for the f ield;

— “ Busines R ules” , pro iding t echnical guidanc for the field

2.2 Code-term pair and c oded c onc ept

2.2.1 General

The code-t erm p ir an the coded conc pt ar the data ty es that ar used t o r pr sent he information

that is r q ir d t o desc ibe each t erm in each t erminolo y or sub-v ca ulary, in each languag e /r gion

combination

2.2.2 C de-term pair

2.2.2.1 Co e-term pair o er view

This is the un e lying clas for each t erm, an is used t o desc ibe and def ine a t erm in a spe ific languag e

an for a spe if ic r gion It contains the cor at ribut es for each conc pt, inclu ing the identif ie , the

t extual r pr sentation of the t erm ( i.e the control ed t erm it elf), the definition, an o tional domain t o

in icat e w hethe a t erm isr s rict ed t o vet erinary use, an o tional t extual comment, an the languag e

an r gion codes

Each controled t erm or sub-t erm has a uniq e code-t erm p ir for each languag e /r gion combination

This combination of languag e an r gion alow s for r gional v riant of a spe ific languag e t o be cat er d

for; for ex mple, w he e the spel ng of a t erm or def inition dife s betwe n UK E gl sh an US E glsh, it

is pos ible t o r fle t this dife enc Whe e t erms an definitions alr ady exis for a p rticular languag e

for a particular r gion, and the same languag e is used in a se ond r gion, it is a r gional implementation

is uet o de ide w hethe t erms an definitions ne d t o be pro ided for the se on r gion, or w hethe the

t erms an def initions of thef irs r gion shal be used

When a new conc pt is r q ir d, a new coded conc pt mus be c eat ed, an at leas one code-t erm pair

is r q ir d in orde t o hold the data t o desc ibe the conc pt The languag e /r gion combination chosen

t o r pr sent the “v lue” shal alway s be c eat ed f irs t o r pr sent the conc pt, even w hen the r q es

originat es from a dife ent languag e /r gion combination The maint enanc org nisation shal pro ide

ins ructions on how t o r q es a new t erm or a r vision t o an exis ing t erm

2.2.2.2 Co e-term pair : Co e

User Guidance This f ield contains a u iq e, machine-re da le identif ier for the code-t erm pair In this

Tech ical Specif ication, the folowing format is used for the code:

— XX -1 3456 8-L -RR

where

— XXX represents the clas of term (se Ta le 1);

— 1 3456 8 represents a u iq e 8-digit n mb r; for sub-voca ularies,

a 4-digit n mb r is used;

— L represents the langua e code;

— RR represents the re ion/cou try code

Data T pe String < T>

Value Alowed Fre t ext

Busines R ule(s ) Each code-t erm pair shal have one code

The codes used in this Te h ical Spe if ication t o r pr sent the v rious clas es of t erm in the ex mples

that folow ar shown in Ta le 1

Table 1 — Co es used to represent the clas of term

SOM State of mat er

BDF Basic dose form

RCA R ele se characteristic

ISI Inten ed site

AME Administration method

PDF P armaceutical dose form

CDF Combined p armaceuticaldose form

UOP Unit of presentation

ROA R out e of administration

P A Packa ing cate ory

DEV Administration device

2.2.2.3 Co e-ter m pair: Term

User Guidance This f ield contains the te tual t erm des ription for the code-term pair

Data T pe String < T>

Busines R ule(s) Each code-term pair shal have one term

2.2.2.4 Co e-ter m pair: Definitio

User Guidance This f ield contains the t extual def inition for the code-term pair The def inition is as

com-prehensive as pos ible, in order t o guide the user t o the most ap ropriat e t erm t o des rib

a given concept F or e ample, it should b detailed enough t o distinguish b tween similar

p armaceutical dose forms, an may ex ceptionaly make direct reference t o relat ed t erms

in order to ex clu e them, although such references may b considered more ap ropriat e

in the Comments section inst ead

Data T pe String < T>

Conformance Man atory for the default code-term pair; optional for the translation code-term pair

Busines R ule(s) Each code-term pair may have one def inition For e ch coded concept, the default

code-t erm pair (e.g EN-GB)shal have one def inition If a code-t erm pair for a given langua e /

re ion combination do s not have a def inition provided, the def inition in the code-term

pair for the default langua e /re ion combination is adopted

2.2.2.5 Co e-term pair : Domain

User Guidance This f ield is used to identify whether a term is considered ap ropriat e for b th h man

an veterinary use, or whether it is considered ap ropriate for vet erinary use only

Data T pe Concept Des riptor <CD>

Value Alowed ”Human an vet erinary”; “Vet erinary only”

Busines R ule(s ) Each code-t erm pair may have one domain Although vet erinary medicines are outside the

s ope of IDMP, certain re ions use a single terminolo y sy stem to cover b th medicines

for h man use an medicines for veterinary use; this optional f ield is therefore inclu ed

in order t o al ow vet erinary-only terms t o b e sily distinguished in such systems

2.2.2.6 Co e-term pair : Comment

User Guidance This optional f ield contains a t extual comment for the code-t erm pair It is used t o provide

to the user ad itional information an guidance that would not b strictly ap ropriate

to ap e r as part of the def inition

Data T pe String < T>

Value Alowed Fre t ext

Busines R ule(s ) Each code-t erm pair may have one comment

2.2.2.7 Co e-term pair : Lang uag e c ode

User Guidance This field contains the languag e in w hich the t erm, definition an comment are des rib d;

in this Tech ical Specif ication, the working langua e is E glish T e languag e code used

is in line with ISO 63 -1

Data T pe Concept Des riptor <CD>

Value Alowed ISO 63 -1 code, OID reference 1.0.63 1

Busines R ule(s ) Each code-t erm pair shal have one langua e code

2.2.2.8 Co e-term pair : Reg io c ode

User Guidance This f ield contains the re ion/cou try that uses this code-term pair, in the languag e

de-s rib d a ove; it can b used to diferentiat e b tween re ional variants of that languag e;

in this Tech ical Specif ication, the default re ion is the United Kingdom T e re ion code

used is in line with ISO 3 6 -1 Alp a-2 (i.e 2-let er) codes are used T e ad itional code

EU is also alowed to represent the E rope n Union It should b noted that the United

Kingdom is represent ed in ISO 3 6 -1 by the 2-let er code GB, as in the e amples used

in this Tech ical Specif ication

Data T pe Concept Des riptor <CD>

Value Alowed ISO 3 6 -1 alp a-2 code, OID reference 1.0.3 6 1.2.2

Busines R ule(s ) Each code-t erm pair shal have one re ion code

2.2.2.9 Co e-term pair example

An ex mple of a code-t erm p ir for the conc pt “Ta let” , a pharmac utical dose form, is shown in

Ta le 2 Sinc theworking languag e of this Te h ical Spe if ication isUK Englsh, the languag e is E glsh

an ther gion is the Unit ed King dom

Table 2 — Example co e-term pair for pharmaceutical d se form “Tablet in UK E gl sh

Definition

S lid single-dose u co t ed preparation o tained by compres ing u iform volumes of par

-ticulate solids or by other me ns such as e trusion or moulding Ta lets inclu e single-layer

ta lets resulting from a single compres ion of particles an multilayer ta lets consisting of

concentric or paralel layer o tained by suc es ive compres ions of particles of diferent

composition Ta lets are int en ed for oral use to rele se active substance(s) in the g

stro-intestinal fluids by a rate depen ing es entialy on the intrinsic properties of the activ e

substance(s) (conventional rele se)

2.2.3 C ded c onc ept

2.2.3.1 Co ed c onc ept o erview

This is the clas that is used t o r pr sent the conc pt it elf, an is a cole tion of al of the code-t erm

p irs that define the same conc pt for each languag e / region combination The code-t erm p irs for a

given conc pt can be conside ed as dife ent translations of that conc pt ; the coded conc pt groups

those v rious translations un e a single, u iq e code In orde t o r pr sent the coded conc pt, one of

the code-t erm pairs is sele t ed as the“v lue” , w hie each othe code-t erm pair is a “ ranslation”

The use of a coded conc pt in anothe sy st em alow s for the identification of a conc pt without

spe ifying a p rticular languag e an r gion The code-t erm pair sele t ed as the “v lue” ma be used

b default t o r pr sent the coded conc pt w hen a t extual t erm isr q est ed The default code-t erm pair

in this Te h ical Spe ification is Englsh/Unit ed King dom Whe e a languag e /r gion combination is

spe if ied b the r q es ing sy st em, the a pro riat e code-t erm pair for that combination can be used t o

r pr sent the coded conc pt

As desc ibed in 2.2.2.1, w hen a new conc pt is r q ir d, a new coded conc pt mus be c eat ed, an at leas

one code-t erm p ir is r q ir d in orde t o hold the data t o desc ibe the conc pt The languag e / region

combination chosen t o r pr sent the “v alue” mus alway s be c eat ed, even w hen the r q es originat es

from a dife ent languag e / region combination The maint enanc org nisation shal pro ide ins ructions

on how t o r q es a new t erm, as wel as how t o r q es a r vision t o an exis ing t erm

2.2.3.2 Co ed c onc ept: C de

User Guidance This f ield contains a u iq e, machine-re da le identif ier for the coded concept

Data T pe String < T>

Busines R ule(s) Each coded concept shal have one code

2.2.3.3 Co ed c onc ept: Value

User Guidance This f ield contains the identif ier of the code-term pair that has b en chosen t o represent

the coded concept In this Tech ical Specif ication this code-term pair is always that of

the E glish/Unit ed Kingdom combination

Data T pe String < T>

Value Alowed Code-term pair identif ier

Busines R ule(s ) Each coded concept shal have one value, which is considered to b its default code-term

pair Whenever a new concept is c e ted, the code-t erm pair with the langua e /re ion

combination that is chosen for the “v alue” shal alway sb c e t ed f ir t, even if the req est

is made for a diferent langua e /re ion combination

2.2.3.4 Co ed c onc ept: Translation

User Guidance This repe ta le f ield contains the identif ier of the code-term pair that represents the

concept using langua e /re ion combination that is diferent rom that of the code-t erm

pair used for the a ove coded concept v alue In this Tech ical Specification, since the a ove

value is always represented by E glish/United Kingdom, these code-t erm pair wil

rep-resent combinations such as E glish/United States, Japanese /Japan, French/France, etc

Data T pe String < T>

Value Alowed Code-term pair identif ier

Busines R ule(s ) Each coded concept may have zero to man translations

2.2.3.5 Co ed c onc ept example

An ex mple of a coded conc pt for theconc pt “Ta let” is shown in Ta le 3 Sinc the working languag e

of this Te h ical Spe if ication is UK Englsh, the v lue is the code-t erm p ir that has E gl sh as the

languag e an Unit ed King dom asthe r gion (as shown in Ta le 2) In orde t o simpl fy the ex mple, jus

two translations ar as ociat ed with it he e: the code-t erm pair that has Fr nch as the languag e an

Franc as the r gion, an the code-t erm p ir that has Ja anese as the languag e an Ja an as the r gion

As can be se n from Ta le 3, only the code-t erm p ir identif ie s ar r q ir d, sinc each one r pr sent

al of the ne es ary information for each languag e /r gion combination, ( uch as for E glsh and the

Unit ed King dom as shown in Ta le 2) The o e al conc pt of “Ta let” ( i.e inclu ing al languag e /r gion

combinations) has it own identifie (code PDF-1 2 9 0 in this ex mple)

T able 3— Example coded co cept for p armaceut ical dose form “T ablet”, lnk ing the co e-term

pair for t he co cept in Engl sh for the United King dom, French for France, and Ja panese for Japan

2.3.1 Ver sio ing of the term

ISO/TR 148 2 inclu es guidanc on principles an proc d r s for ve sioning an chang e control

Code-t erm p irs ar used t o p pulat e a t erminolo y data ase, an as such they can be conside ed as the

cur ent r pr sentation ofspe ific conc pt for spe ific languag e / region combinations They contain

the information that is conside ed t o be the mos important an r lev nt t o the data ase use Howeve ,

as control ed v ca ularies can ev lve o e time, the situation arises w he eb t erms in a data ase ne d

t o be r vised, w hich means that code-t erm p irs the efor ne d t o be r vised

In orde t o maintain a trac a le hist ory of a code-t erm p ir, inclu ing any chang es that ar made t o it,

each code-t erm p ir is as ociat ed with ve sioning information This is done with the use of ve sions

Each time a code-t erm p ir is c eat ed or modified, a ve sion of that code-t erm p ir isc eat ed

A ve sion act as a r cord of a code-t erm p ir at a spe if ic p int in time It contains the element ofthe

code-t erm p ir at that p int in time, as wel as a times amp, an identif ie of theo e at or that made the

modif ication, and a desc iption of the modification that t ook plac Also r corded in the ve sion is the

s atus of the t erm; any chang e in s atus of a code-t erm p ir wi evoke the c eation of a new ve sion

of that code-t erm p ir Ce tain information, such as the identifie ofthe o e at or, ma not be made

publcly a ai a le, but is neve theles r corded

These ad itional element of ve sioning information ar desc ibed in mor detai below

The coded conc pt can be conside ed as the containe for al of the translations ( i.e code-t erm p irs)

for a given conc pt ; it does not the efor r q ir ve sioning information it elf The ad ition of a new

translation ( i.e a new code-t erm pair) does not the efor r sult in the c eation of a new ve sion of the

coded conc pt

2.3.1.1 Ver sio ing : C de

User Guidance This f ield contains the u iq e, machine-re da le identif ier for the ver ion of the

code-t erm pair that is the subject of the ver ioning

In this Tech ical Specif ication, the fol owing format is used for the code:

— XX -1 3456 8-L -RR-V

where

— XX -1 3456 8-L -RR represents the code-term pair;

— V represents the ver ion n mber, the length of which is not lmited to

a single digit

Data T pe String < T>

Value Alowed The code is g nerated aut omaticaly from the code-term pair an the ver ion n mb r

Busines R ule(s) Each ver ion shal have one code

2.3.1.2 Ver sio ing : Creatio date

User Guidance This f ield contains the time an date u on which the concept was f ir t c e t ed T e time

stamp used is in line with ISO 860

Data T pe Timestamp <TS

Value Alowed YY Y-MM-DD h :mm:s

Busines R ule(s) The c e tion date refer t o the c e tion of the coded concept an the f ir t code-term pair

for the default langua e /re ion T e time stan ard chosen to me sure the point in time

(e.g UT , UT + )is used consistently throughout the data ase

2.3.1.3 Ver sio ing : Created b

User Guidance This f ield contains an identif ication of the operator who c e ted the concept, such as

their name or identif ier

Data T pe String < T>

Busines R ule(s) This information is not made p blicly availa le t o al user , but is recorded in the data ase

an is ac es ible t o the data ase administrator

2.3.1.4 Ver sio ing : Ver ion date

User Guidance If a modif ication has b en made t o a term, then a new ver ion of that t erm is c e ted,

an this f ield contains the time an date u on which that ver ion was c e ted T is also

ap lies to the c e tion of the f ir t ver ion of the code-term pair The f ir t ver ion of the

f ir t code-t erm pair represents the c e tion of the coded concept itself, an therefore has

particular importance, which is wh it is considered ap ropriat e always t o in icate that

dat e, even for subseq ent ver ions an for diferent translations The time stamp used

is in line with ISO 860

Data T pe Timestamp <TS

Value Alowed YY Y-MM-DD h :mm:s

Busines R ule(s ) Each ver ion of a code-t erm pair shal have one ver ion date

2.3.1.5 Ver sio ing : Mo ificatio made

User Guidance If a modif ication has b en made t o a term, then a new ver ion of that t erm is c e ted,

an this f ield shal b used to ad a des ription of or e planation for the modif ication

that was made This also ap lies to the c e tion of the f ir t ver ion of the code-t erm pair

Data T pe String < T>

Value Alowed Fre t ext, although a drop-down list of common modif ications may b considered ap

ro-priate in order t o help harmonise the entries

Busines R ule(s ) Each ver ion of a code-t erm pair shal have one entry for modif ication made

2.3.1.6 Ver sio ing : Mo ificatio b

User Guidance If a modif ication has b en made t o a term, then a new ver ion of that t erm is c e ted,

an this field contains an identification of the operator who made the modification,

such as their name or identif ier T is also ap lies to the c e tion of the f ir t ver ion of

the code-term pair T e f ir t ver ion of the f ir t code-term pair represents the c e tion

of the coded concept itself, an therefore has particular importance, which is wh it is

considered ap ropriate always to record the c e tor, even for subseq ent ver ions an

for diferent ranslations

Data T pe String < T>

Value Alowed Fre t ext

Busines R ule(s ) This information is not made p blicly av aila le t o al user , but is recorded in the data ase

an is ac es ible to the data ase administrator

2.3.1.7 Ver sio ing : C nc ept status

User Guidance This f ield contains the status of the term

Data T pe Concept des ript or <CD>

Value Alowed ”C r ent” ; “Deprecated “R ejected “Pen ing”

Busines R ule(s) Each ver ion of a code-term pair has a status, which alows the hist ory of an chang e in

status of a t erm t o b recorded F or e ample, if an e isting, cur ent term (ver ion 1) is

t o b deprecated, then a new ver ion of the code-term pair is c e ted (ver ion 2), with

the status chang d from “ ur ent to “deprecated” It is the intention that, for an given

concept, the status is the same for al of the translations; therefore, a mechanism should

b implement ed to ensure that the status of e ch code-term pair of a coded concept is

chang d at he same time

2.3.1.8 Ver sio ing : C r r ent c onc ept

User Guidance If a t erm has b en deprecat ed or rejected, an one or more other t erms are identif ied

as a replacement, this repe ta le f ield contains the identif ier of the replacement term

Data T pe String < T>

Value Alowed Coded concept identif ier

Busines R ule(s) This f ield is con itional on the status of a t erm b ing “deprecat ed” or “ reject ed” , an there

b ing a replacement erm identif ied

2.3.1.9 Ver sio ing : Ver sion number

User Guidance This f ield contains an identif ier for the particular ver ion of the t erm b ing des rib d,

in the form of a whole n mb r When a modif ication t o a t erm is made, a new ver ion is

c e ted an identif ied through the ver ion n mb r, which inc e ses by a value of 1from

the previous ver ion of the t erm When a term is f ir t c e ted this f ield has the value 1

Data T pe Inte er <INT>

Value Alowed Positive inte er gre ter than zero

Busines R ule(s) Each ver ion shal have one ver ion n mb r

2.3.2 Ver sio in of the ter minolog y

The t erminolo y is int en ed t o be updat ed on a contin ous b sis, as new conc pt an translations ar

ad ed The efor it is not envisag ed that the e wi be pe iodic updat es of the t erminolo y r leased

an identif ied with fix ed ve sion n mbe s Howeve , a sna shot of the data ase shal be r corded on

a r gular b sis, an th s the e shal be pe iodic ve sions of the data ase a ai a le in case r version t o

a pr vious ins anc of the data ase is r q ir d (e.g in case of cor uption of the data ase d e t o some

unfor se n cir ums anc s)

3 Terminolog ies

3.1 General

Each of the set of t erminolo ies desc ibed in this Clause make use of the data ty es desc ibed in

Clause 2t o car y the information r q ir d t o desc ibe each in ivid al conc pt

The folowing subcla uses desc ibe each set of t erminolo ies an pro ide ex mples t o i lus rat e them

Al of the t erms an definitions used ar for i lus ration purp ses only, an ar not int en ed t o r fle t

the ex ct t ermsan definitions that wi l cons itut e the t erminolo ies as such

Each element in Clause 3 is desc ibed u de a sep rat e subclause, consis ing of a title an a ta le

containing the folowing:

— “Use Guidanc ” , a desc iption of the elemen

— “Data Ty e” , a desc iption of the data ty e;

— “Conformanc ” , a desc iption of w hethe the element is man at ory, o tional, or con itional;

— “Value Alowed” , in icating the p s ible v lues for the elemen

— “Busines R ules” , pro iding t echnical guidanc for the element

3.2 Pharmac eutical dose form

3.2.1 Phar mac eutical dose for m o er view

The pharmac utical dose form is the phy sical manifes ation of a prod ct that contains the active

ingr dient (s)an / r inactive ingr dient (s) that ar int en ed t o be del ve ed t o the p tient

A prod ct can be desc ibed at two dis inct s ag es: the s ag e at w hich it has be n man factur d

(w he e it is r fe r d t o as the “ man factur d it em( ) ), an the s ag e at w hich it is administ er d t o

the p tient (w he e it is r fe r d t o as the “ pharmac utical prod ct” If a man factur d it em has t o

un e g o some form of trans ormation in orde t o prod c the pharmac utical prod ct, this means

that the pharmac utical dose form of a prod ct wi l dife depen ing on w hethe it is desc ibing the

man factur d it em or the pharmac utical prod ct

A medicinal prod ct can the efor be desc ibed with two “ y es”of pharmac utical dose form:

— the man factur d dose form ( i.e the pharmac utical dose form of the man factur d it em, as

prod c d b the man factur r);

— the adminis ra le dose form ( i.e the pharmac utical dose form of the pharmac utical prod ct,

r ady t o be administ er d t o the patient)( e Figur 1)

Figure 1 — Dia ram i lustrating the relatio ship betwe n manufactured item an

man factured dose form, and pharmaceutical product and administrable dose form, for a

medicinal prod ct

In cases w he e no trans ormation is r q ir d, and the man factur d it em is the same as the

pharmac utical prod ct, the man factur d dose form an the adminis ra le dose form ar the same

When a pharmac utical dose form is desc ibed, the e is no spe if ic r fe enc made t o w hethe it can

be a man factur d dose form or an adminis ra le dose form, although it can be ded c d that, w hi e

any pharmac utical dose form can be a man factur d dose form, only a pharmac utical dose form

that spe if ies no trans ormation can be an adminis ra le dose form ( his pro e ty ma be used b the

maint enanc org nisation t o help identify w hethe a t erm can be conside ed as a man factur d dose

form only, or aseithe a man factur d dose form or an adminis ra le dose form) The purpose of using

these t erms is t o simpl fy the languag e used:

— “ man factur d dose form” = “ pharmac utical dose form of the man factur d it em” ;

— “adminis ra le dose form” = “ pharmac utical dose form of the pharmac utical prod ct”

3.2.2 Pharmac eutical dose form s hema

3.2.2.1 Schema o er view

The pharmac utical dose form is org nised ac ording t o it b sic dose form, w hich in turn is org nised

ac ording t o it s at e of matt er This is the simple, thr e-level hie ar hy b w hich the pharmac utical

dose forms ar cat eg orised

In ad ition t o this hie ar hy, each pharmac utical dose form has a n mbe of charact eris icsat ribut ed

t o it, w hich can be used t o help index the pharmac utical dose form These charact eris ics ar :

r lease charact eris ics, trans ormation, int en ed sit e, and adminis ration method; they alow for

pharmac utical dose forms t o be mor easi y identified, an for r lat ed pharmac utical dose forms t o

be identif ied t og ethe mor easiy and in a n mbe of dife ent wa s ( e Figur 2)

Figure 2 — Pharmaceutical d se form basic s hema showing the principal hierar hy (sold

ar ow s) and characteristic (dotted ar ow s)

This same schema is shown in the form of a u if ied model ng languag e (UML) clas dia ram in

Figur 3, with the ad itional information of the v lue for each clas ( in each case a coded conc pt) an

the r lationship betwe n the clas es The r lationships ar shown using the c ow’ s fe t format, w hich is

ex lained in the leg en of the f igur

Figure 3— Pharmaceutical dose form s hema with c ow’s fe t entity-relatio ship notatio

These r lationships r fle t the folowing conditions

— A s at e of matt er ma ha e one or mor ( i.e 0 t o many, o tional) b sic dose forms as ociat ed t o it ;

w hie it is p s ible that a given s at e of matt er ma ha e no b sic dose forms as ociat ed t o it, this is

unl kely in practic , bearing in min the ve y lmit ed n mbe of s at es of matt er

— Each b sic dose form shal be as ociat ed with one s at e of matt er

— A b sic dose form ma ha e one or mor ( i.e 0 t o many, o tional) pharmac utical dose forms

as ociat ed t o it ; w hie it is p s ible that a given b sic dose form ma ha e no pharmac utical dose

forms as ociat ed t o it, this is only lkely t o oc ur w hen a new b sic dose form conc pt has be n

c eat ed an the ear as yet no r lat ed pharmac utical dose forms in the t erminolo y

— Each pharmac utical dose form shal be as ociat ed with one b sic dose form

— Each pharmac utical dose form shal be as ociat ed with one or mor ( i.e 1 t o many, man at ory) of

each of the folowing: R elease charact eris ics, Trans ormation, Int ended sit e, an A dminis ration

method;w he e the e is, for ex mple, no trans ormation r q ir d, an a pro riat e n l v lue shal be

a ai a le for sele tion

— Each r lease charact eris ic, trans ormation, adminis ration method and int en ed sit e ma

be as ociat ed with one or mor ( i.e 0 t o many, o tional) pharmac utical dose forms; a given

charact eris ic ma be as ociat ed with no pharmac utical dose forms, for ex mple w hen the

charact eris ic is f irs c eat ed, befor the c eation of any pharmac utical dose form that r q ir s it

These charact eris ics ar princip l y used for in exing purp ses, an wi not alway s ne d t o be

r fle t ed in the pharmac utical dose form t erm it elf, but in some cases they wi F or ex mple, a

solution that is int en ed t o be ins i led int o the eye in the form of dro s might be caled “ Eye dro s,

solution” , a t erm in w hich the b sic dose form ( olution), int en ed sit e (ocular, i.e the eye) an

adminis ration method ( ins i ation, i.e in the form of dro s) al a pear In contras , a solution that

is int en ed t o be taken oraly b swalowing might be cal ed “Oral solution” , a t erm in w hich the b sic

dose form ( olution) and int ended sit e (oral) a pear, but the adminis ration method ( walowing) does

not, sinc it is conside ed un e es ary It is s i used t o charact erise an in ex the t erm, but it is not

ne es ary for it t o be spe if ical y s at ed as p rt of the t erm Only w he e at ribut es ar conside ed t o

be important in dis inguishing betwe n pharmac utical dose form t erms wi they be r pr sent ed

in the t erm Information on the b sic principles that g ove n these sort of de isions w hen c eating a

pharmac utical dose form t erm (e.g edit orial rules) shal be pro ided b the maint enanc org nisation

in the form of a use guide

3.2.2.2 State of mat er

User Guidance The state of mat er clas is the highest-level grou ing cat eg ry that can b used to

clas-sify p armaceutical dose forms, al owing them to b identif ied ac ording t o whether

they are a solid, semisolid, liq id or g s, or whether the state of mat er is u cle r For

e ample, al solid p armaceutical dose forms, whether they are ta lets, capsules,

gran-ules, powder , etc can b clas if ied t og ther u der a single cate ory of state of mat er

The state of mat er clas is the parent of the b sic dose form clas Each state of mat er

can have b tween zero an man b sic dose forms as ociat ed with it

The re son that a state of mat er may have zero b sic dose forms as ociated with it

is that a state of mat er must b c e t ed b fore an b sic dose form can b as ociated

with it This situation usualy e ists for a short period of time only, since it is e pect ed

that a state of matt er wil b c e t ed only when it is ne ded in order t o cate orise an

anticipated new b sic dose form Because of the limited pos ible stat es of mat er, this

is only likely to oc ur d ring the initial pop lation of the data ase

Data T pe String < T>

Value Alowed Coded concept identif ier

Busines R ule(s) The state of mat er of a man factured dose form is that of the man factured item, an

not of the eventual p armaceutical prod ct ; e.g the stat e of matt er for the p

arma-ceutical dose form “Powder for solution for injection” is “S lid”, since it is the man

-factured it em ( he powder)that is des rib d, an not the p armaceutical prod ct ( he

solution)

The state of mat er clas is a sub-voca ulary that is used solely in this s hema; the

identif ier of the coded concepts used for this clas are not inten ed to b used outside

of this s hema

3.2.2.3 Basic dose form

User Guidance The b sic dose form clas is the secon -highest grou ing cat eg ry that can b used

to clas ify p armaceutical dose forms, an is itself clas if ied ac ording to the stat e of

mat er.T e b sic dose form alows p armaceutical dose forms to b clas if ied ac

ord-ing t o the g neral ty e of form that hey tak e, without g ing into specif ic charact

eris-tic For e ample, al ta lets,whether they are inten ed for oral use, va inaluse,etc

whether they are inten ed to b swalowed, chewed, insert ed, etc whether they are

inten ed t o b administered as they are, dis olved, disper ed, et c can b clas if ied

to ether u der a single cate ory of b sic dose form

The b sic dose form clas is the child of the stat e of matt er clas an the parent of the

p armaceutical dose form clas Each b sic dose form is as ociat ed with one state of

mat er, an can have b tween zero an man p armaceutical dose forms as ociated

with it

The re son that a b sic dose form may have zero p armaceutical dose forms as oci

ated with it is that a b sic dose form must b c e ted b fore an p armaceuticaldose

form can b as ociat ed with it T is situation usual y e ists for a short period of time

only, since it is e pected that a b sic dose form wil b c e ted only when it is ne ded

in order t o cat eg rise an anticipat ed new p armaceutical dose form

Data T pe String < T>

Value Alowed Coded concept identif ier

Busines R ule(s ) The b sic dose form of a man factured dose form is that of the man factured item, an

not of the eventual p armaceutical prod ct For e ample, the b sic dose form for the

p armaceutical dose form “Powder for solution for injection” is “Powder”, since it is the

man factured it em ( he powder)that is des rib d, an not he p armaceutical prod ct

( he solution)

The b sic dose form clas is a sub-voca ulary that is used solely in this s hema; the

identif ier of the coded concepts used for this clas are not inten ed t o b used outside

of this s hema

3.2.2.4 Phar mac eutical dose for m

User Guidance The p armaceutical dose form clas represents the p ysical manifestation of a prod ct

that contains the active ingredients) an / r inactive ingredients that are int en ed t o

b delivered to the patient

The p armaceutical dose form clas is the child of the b sic dose form clas Each

p armaceutical dose form is as ociat ed with one b sic dose form It also has one t o

man as ociations with e ch of the four characteristic clas es: rele se characteristic ,

transformation, int en ed site, an administration method

Data T pe String < T>

Value Alowed Coded concept identif ier

Busines R ule(s ) This is the central clas in the s hema, an it is the identifier of the coded concepts used

for this clas that are used elsew here t o represent the p armaceutical dose form T ese

are the only identifier in the s hema that are int en ed t o b used outside of the s hema

3.2.2.5 Rele se character istic

User Guidance The rele se characteristic clas is used t o des rib how the active substance(s) are

lib rated from a medicinal prod ct, an al ows a distinction t o b made b tween

con-ventional rele se (i.e b sed on the intrinsic properties of the active ingredient (s))an

a rang of non-conventional ty es of rele se (where the p armaceuticalprod ct has

b en formulated in such a way as to rele se the active ingredients at a diferent ime or

rat e) Non-conventional rele se is most req ently encou tered with solid oral medici

nal prod cts, where the time or d ration of a sorption of the active substance(s)from

the g stroint estinal tract can b manip lated by a n mb r of diferent ormulation

t ech iq es, although this is not the only pos ible ty e of p armaceutical dose form for

which rele se characteristic can b varied

The rele se characteristic clas is not a child of the p armaceutical dose form, but

is as ociated with it o provide characterizing information that can b in ex ed T is

al ows p armaceutical dose forms to b cat eg rised ac ording to the rele se charac

-t eris-tic However, it is pos ible for a rele se characteristic t o e ist but not b used to

des rib an p armaceutical dose form; therefore, e ch rele se characteristic can b

as ociated with zero t o man p armaceutical dose forms

Since e ch p armaceutical dose form is as ociated with at le st one rele se character

-istic, an ap ropriat e term is req ired for those forms that have conventional rele se

characteristic For e ample, the E glish/Unit ed King dom t erm may b “Conventional

rele se”

Data T pe String < T>

Value Alowed Coded concept identif ier

Busines R ule(s) The rele se characteristic clas is a sub-voca ulary that is used solely in this s hema;

the identif ier of the coded concepts used for this clas are not inten ed to b used

outside of this s hema

3.2.2.6 Transfor mation

User Guidance The transformation clas is used t o des rib whether a p armaceutical dose form of

a medicinal prod ct is inten ed to u derg one or more specif ied transformations in

order t o ren er it suita le for administration to the patient Such transformations are

req ired where the medicinal prod ct as man factured an packa ed ( he “ man

-factured it em”)is diferent from the prod ct that is administered to the patient the

“ pharmaceutical prod ct ) For e ample, a man factured it em in the form of a powder

ne ds to b dis olved in a given solvent t o c e t e a p armaceutical prod ct in the form

of a solution; the p armaceutical dose form of the man factured item would have a

transformation at ribute to in icat e this (e.g.“dis olution”)

The transformation clas is not a child of the p armaceuticaldose form, but is as

ociat-ed with it o provide characterizing information that can b in ex ed T is alows p ar

-maceutical dose forms t o b cat eg rised ac ording to the transformation However, it

is pos ible for a transformation to e ist but not b used to des rib an p armaceutical

dose form; therefore, e ch transformation can b as ociated with zero to man p ar

-maceutical dose forms

Since e ch p armaceutical dose form is as ociated with at le st one transformation,

an ap ropriate term is req ired for those forms that are not inten ed to u derg a

transformation For e ample, the E glish/Unit ed Kingdom t erm may b “No transfor

-mation”

Data T pe String < T>

Value Alowed Coded concept identif ier

Busines R ule(s) The transformation clas is a sub-voca ulary that is used solely in this s hema; the

identif ier of the coded concepts used for this clas are not inten ed to b used outside

of this s hema

3.2.2.7 Intended site

User Guidance The int en ed sit e clas is used t o des rib the g eneral b d sit e at w hich a p armaceuti

cal dose form is int en ed t o b administ ered, alb it in a high-level, g eneralised man er

It is not eq iv alent t o a precise rout e or sit e of administration, w hich is specified

else-where in the medicinal prod ct’ s documentation; in e d the authorised rout e of

admin-istration is a separat e t erminolo y that serves a diferent p rpose, as des rib d in 3.5

The inten ed sit e clas is not a child of the p armaceutical dose form, but is as ociated

with it to provide characterizing information that can b in ex ed T is al ows p ar

-maceutical dose forms t o b cate orised ac ording t o the inten ed sit e.However, it is

pos ible for an int en ed site t o e ist but not b used to des rib an p armaceutical

dose form; therefore, e ch int en ed sit e can b as ociated with zero to man p

arma-ceutical dose forms

Since e ch p armaceutical dose form is as ociat ed with at le st one int en ed site, an

ap ropriat e t erm is req ired for those forms for which there is no specif ic int en ed

site For e ample, the E glish/Unit ed King dom term may b “Un nown/Mis elane us”

Data T pe String < T>

Value Alowed Coded concept identif ier

Busines R ule(s ) The inten ed sit e clas is a sub-voca ulary that is used solely in this s hema; the

iden-tif ier of the coded concepts used for this clas are not int en ed t o b used outside of

this s hema

3.2.2.8 Administratio metho

User Guidance The administration method clas is used to des rib the way that a p armaceutical

dose form is inten ed to b administered t o the patient, alb it in a high-level,g

neral-ised man er It is not eq ivalent o a precise method of administration, which might b

specif ied elsewhere in a medicinal prod ct’ s documentation

The administration method clas is not a child of the p armaceutical dose form, but

is as ociat ed with it t o provide characterizing information that can b in ex ed T is

al ows p armaceutical dose forms t o b cate orised ac ording t o the administration

method However, it is pos ible for an administration method to e ist but not b used

to des rib an p armaceutical dose form; therefore, e ch administration method can

b as ociat ed with zero t o man p armaceutical dose forms

Since e ch p armaceutical dose form is as ociat ed with at le st one administration

method, an ap ropriat e term is req ired for those forms for which there is no specif ic

administration method For e ample, the E glish/Unit ed Kingdom t erm may b “Not

specif ied”

Data T pe String < T>

Value Alowed Coded concept identif ier

Busines R ule(s ) The administration method clas is a sub-voca ulary that is used solely in this s hema;

the identif ier of the coded concepts used for this clas are not inten ed t o b used

outside of this s hema

3.2.3 Phar mac eutical dose for m example: Prolo g ed-rele se tablet

3.2.3.1 Example o erview

This Cla use gives an ex mple of how a pharmac utical dose form conc pt, that of a prolong ed-r lease

ta let, is cons ruct ed using code-t erm p irs an coded conc pt for each of the cat eg ories an

charact eris ics shown in Figur 2, for the languag e /r gion combinations of E glsh/Unit ed King dom,

Fr nch/ ranc and Ja anese /Ja an F or each cat eg ory or charact eris ic, the code-t erm p irs for

the languag e / region combinations ar used t o c eat e a coded conc pt t o r pr sent that cat eg ory or

charact eris ic, w hich in turn ar used t o help charact erise the pharmac utical doseform

3.2.3.2 State of mat er c ode-ter m pair

Table 4 — Example co e-term pair for the state of matter categ ory “Sold”

definition solid categ ory state of mat er

cat ég rie solide pour l’état de

la matière

The codes for s at e of matt er code-t erm p irs shown in Ta le 4 ar used t o buid the s at e of matt er

coded conc pt, as shown in 3.2.3.3

3.2.3.3 State of mat er c oded c onc ept

Table 5 — Example co ed co cept for the state of matter categ ory “Sold”

The code for s at e of matt er coded conc pt shown in Ta le 5 is used t o charact erise the pharmac utical

dose form, as shown in 3.2.3.1

3.2.3.4 Basic dose form c ode-ter m pair s

Table 6 — Example co e-term pair for the basic dose form categ ory “Tablet

definition

cate ory of solid p

arma-ceutical dose forms that are

usualy compres ed volumes

of particulate solids (but

may b o tained by other

me ns ), formed into a shape

that is ap ropriate for their

inten ed use

caté orie des formes p ar

-maceutiq es solides q i sont

g néralement des volumes

compres és des particules

solides (mais q i peuvent

être o t en es par d’autres

The codes for b sic dose form code-t erm pairs shown in Ta le 6 ar used t o buid the b sic dose form

coded conc pt, as shown in 3.2.3.5

3.2.3.5 Basic dose form c oded c onc ept

Table 7 — Example co ed co cept for the basic dose form categ ory “Tablet

The code for b sic dose form coded conc pt hown in Ta le 7 is used t o charact erise the pharmac utical

dose form, as shown in 3.2.3.1

3.2.3.6 Rele se character istic c ode-ter m pair

Table 8 — Example co e-term pair for the rele se characteristic “Prolong ed rele se”

definition

a slower rele se of the active

substance(s) compared t o that

w hich is se n with a con

en-tional-rele se p armaceutical

dose form, achieved by a

spe-cial formulation design an /

or man facturing method

u e lib ration plus lent e de

la(des) substance(s)active(s)

par rap ort à ce q i est v

avec u e forme p

armaceu-tiq e à lib ration

conven-tion el e, ré lisé par u e

formulation ou méthode de

fa rication special

The codes for r lease charact eris ics code-t erm p irs shown in Ta le 8 ar used t o bui d the r lease

charact eris ics coded conc pt, as shown in 3.2.3.7

3.2.3.7 Rele se character istic c oded c onc ept

Table 9 — Example co ed co cept for the rele se characteristic “Prolo g ed rele se”

The code for r lease charact eris ics coded conc pt shown in Ta le 9 is used t o charact erise the

pharmac utical dose form, as shown in 3.2.3.1

3.2.3.8 Transformation c ode-ter m pair s

Table 1 — Example code-term pair for the transformatio characteristic “No transformation”

definition

no transformation of the

man-ufactured item is req ired

aucu e transformation de l’ar

-ticle fa riq é est néces aire

The codes for trans ormation code-t erm pairs shown in Ta le 1 ar used t o buid the trans ormation

coded conc pt, as shown in 3.2.3 9

3.2.3.9 Transfor mation c oded c onc ept

Table 1 — Example coded co cept for the transformatio characteristic “No transformation”

The code for trans ormation coded conc pt shown in Ta le 1 is used t o charact erise the pharmac utical

dose form, as shown in 3.2.3.1

3.2.3.10 Intended site c ode-ter m pair s

Table 12 — Example code-term pair for the inten ed site characteristic “Oral”

definition

the item is inten ed to b

taken int o the b d through

the mouth

l’ article est destiné à être pris

dans le corps par la b uche

The codesfor int en ed sit e code-t erm p irs shown in Ta le 1 ar used t o buid theint en ed sit e coded

conc pt, as shown in 3.2.3.1

3.2.3.11 Intended site c oded c onc ept

Table 13— E ample coded co cept for the inten ed site characteristic “Oral”

The code for int en ed sit e coded conc pt shown in Ta le 1 is used t o charact erise the pharmac utical

dose form, as shown in 3.2.3.1

3.2.3.12 Administratio metho c ode-ter m pair

Table 1 — Example co e-term pair for the administratio meth d characteristic

“Swalowing”