ISO/TS 20440:2023

TECHNICAL ISO/TS
SPECIFICATION 20440
Second edition
2023-03
Health informatics — Identification
of medicinal products —
Implementation guidelines for ISO
11239 data elements and structures
for the unique identification and
exchange of regulated information on
pharmaceutical dose forms, units of
presentation, routes of administration
and packaging
Informatique de santé — Identification des produits médicaux —
Guide de mise en œuvre des éléments de données et structures pour
l'identification unique et l'échange d'informations réglementées sur
les formes des doses pharmaceutiques, les unités de présentation, les
voies d'administration et les emballages de l'ISO 11239
Reference number
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Organization of controlled terms . 2
4.1 General . 2
4.2 Code-term pair and coded concept . 2
4.2.1 General . 2
4.2.2 Code-term pair . 2
4.2.3 Coded concept . 5
4.3 Versioning . 7
4.3.1 Versioning of the term . 7
4.3.2 Versioning of the terminology . 10
5 Terminologies .10
5.1 General . 10
5.2 Pharmaceutical dose form . 10
5.2.1 Pharmaceutical dose form overview . 10
5.2.2 Pharmaceutical dose form schema . 11
5.2.3 Pharmaceutical dose form example: Prolonged-release tablet . 17
5.2.4 Using pharmaceutical dose form attributes directly .22
5.3 Combined pharmaceutical dose form . 23
5.3.1 Combined pharmaceutical dose form overview .23
5.3.2 Combined pharmaceutical dose form schema . 24
5.3.3 Combined pharmaceutical dose form example: Powder and solvent for
solution for injection . 25
5.3.4 Other authorised combinations of terms — Combined terms and
combination packs . 26
5.4 Unit of presentation .28
5.4.1 Unit of presentation overview .28
5.4.2 Unit of presentation schema .28
5.4.3 Unit of presentation example: Tablet .29
5.5 Route of administration . 30
5.5.1 Route of administration overview .30
5.5.2 Route of administration schema .30
5.5.3 Route of administration example: Intravenous use . 31
5.6 Packaging . 31
5.6.1 Packaging overview . 31
5.6.2 Packaging schema . 31
5.6.3 Packaging example: Ampoule (Packaging category: Container) .33
5.6.4 Packaging example: Screw cap (Packaging category: Closure) .34
5.6.5 Packaging example: Oral syringe (Packaging category: Administration
device) . 36
5.6.6 Packaging concept summaries. 37
6 Mapping of regional terms .38
6.1 Differences in granularity between regional terminologies .38
6.2 Organization of regional terms in the database .40
6.2.1 General .40
6.2.2 Addition of regional terms to the database .40
6.2.3 Mapping regional terms to standardized coded concepts . 43
6.2.4 Versioning of mapped regional terms . 43
6.2.5 Mapped regional term example: Extended-release caplet .44
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health
informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
This second edition cancels and replaces the first edition (ISO/TS 20440:2016), which has been
technically revised.
The main changes are as follows:
— addition of a recommendation to label administrable dose forms as such, to distinguish them from
those pharmaceutical dose forms that are only manufactured dose forms;
— a section has been added describing how pharmaceutical dose form attributes can be used directly,
rather than simply serving to classify the pharmaceutical dose form;
— several examples have been updated to reflect terms and definitions that are in use.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at http://www.iso.org/members.html.
iv
Introduction
The terminologies described in ISO 11239 and in this document are essential for the implementation of
the IDMP standards as a whole.
Each region traditionally uses its own sets of terminologies to describe the concepts covered in
ISO 11239 within their regions; these terminologies are not harmonised with those of the other regions.
Therefore, harmonised controlled terminologies need to be provided to ensure that all regions can
refer to a given concept in the same manner. The purpose of this document is to describe how these
controlled vocabularies are constructed and illustrate their use for ISO 11239 implementation.
A number of the codes, terms and definitions used as examples in this document are taken from the
Standard Terms database of the European Directorate for the Quality of Medicines & HealthCare,
Council of Europe (EDQM), specifically those for UK English (EN-GB). The EDQM Standard Terms
database is not static and its content changes over time, so the examples provided in this document
might not remain current; furthermore, examples provided in language/region combinations other
than UK English are not necessarily taken from the EDQM Standard Terms database.
The EDQM Standard Terms database is an example of an implementation of ISO 11239, but reference to it
in this document does not imply that it is the standardized terminology to use for IDMP implementation.
v
TECHNICAL SPECIFICATION ISO/TS 20440:2023(E)
Health informatics — Identification of medicinal products
— Implementation guidelines for ISO 11239 data elements
and structures for the unique identification and exchange
of regulated information on pharmaceutical dose forms,
units of presentation, routes of administration and
packaging
1 Scope
This document describes data elements and structures for the unique identification and exchange of
regulated information on pharmaceutical dose forms, units of presentation, routes of administration
and packaging.
Based on the principles outlined in this document, harmonised controlled terminologies will be
developed according to an agreed maintenance process, allowing users to consult the terminologies
and locate the appropriate terms for the concepts that they wish to describe. Provisions to allow for
the mapping of existing regional terminologies to the harmonised controlled terminologies will also
be developed in order to facilitate the identification of the appropriate terms. The codes provided for
the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identify those
concepts.
This document is intended for use by:
— any organization that might be responsible for developing and maintaining such controlled
vocabularies;
— any regional authorities or software vendors who want to use the controlled vocabularies in their
own systems and need to understand how they are created;
— owners of databases who want to map their own terms to a standardized list of controlled
vocabularies;
— other users who want to understand the hierarchy of the controlled vocabularies in order to help
identify the most appropriate term to describe a particular concept.
This document does not specify a particular terminology for the implementation of ISO 11239.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11239, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated information on pharmaceutical dose forms, units of
presentation, routes of administration and packaging
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
4 Organization of controlled terms
4.1 General
This clause describes how each controlled term is built, describing the data types used to convey
the information and the versioning requirements for tracking their creation and evolution. Clause 5
describes the different types of terminologies and sub-vocabularies that use these data types, and any
relevant relationships between them.
Each field in Clause 4 is described under a separate subclause, consisting of the title of the field and a
table containing the following:
— "User Guidance", a description of the field;
— "Data Type", a description of the data type;
— "Conformance", a description of whether the field is mandatory, optional, or conditional;
— "Value Allowed", indicating the possible values for the field;
— "Business Rules", providing technical guidance for the field.
4.2 Code-term pair and coded concept
4.2.1 General
The code-term pair and the coded concept are the data types that are used to represent the information
that is required to describe each term in each terminology or sub-vocabulary, in each language/region
combination.
4.2.2 Code-term pair
4.2.2.1 Code-term pair overview
This is the underlying class for each term, and it is used to describe and define a term in a specific
language and for a specific region. It contains the core attributes for each concept, including the
identifier, the textual representation of the term (i.e. the controlled term itself), the definition, an
optional domain to indicate whether a term is restricted to veterinary use, an optional textual comment,
and the language and region codes.
Each controlled term or sub-term has a unique code-term pair for each language/region combination.
This combination of language and region allows for regional variants of a specific language to be catered
for; for example, where the spelling of a term or definition differs between UK English and US English, it
is possible to reflect this difference. Where terms and definitions already exist for a particular language
for a particular region, and the same language is used in a second region, it is a regional implementation
issue to decide whether terms and definitions need to be provided for the second region, or whether the
terms and definitions of the first region must be used.
When a new concept is required, a new coded concept shall be created, and at least one code-term pair
is required in order to hold the data to describe the concept. The language/region combination chosen
to represent the "value" shall always be created first to represent the concept, even when the request
originates from a different language/region combination. The maintenance organization shall provide
instructions on how to request a new term or a revision to an existing term.
4.2.2.2 Code-term pair: Code
User Guidance This field contains a unique, machine-readable identifier for the code-term pair.
In this document, the following format is used for the code:
— XXX-12345678-LL-RR
where
— XXX represents the class of term (see Table 1);
— 12345678 represents a unique 8-digit number; for sub-vocabularies, a
4-digit number is used;
— LL represents the language code;
— RR represents the region/country code.
Data Type String
Conformance Mandatory
Value Allowed Free text
Business Rule(s) Each code-term pair shall have one code.
The codes used in this document to represent the various classes of term in the examples that follow
are shown in Table 1.
Table 1 — Codes used to represent the class of term
Code Class
SOM State of matter
BDF Basic dose form
RCA Release characteristics
TRA Transformation
ISI Intended site
AME Administration method
PDF Pharmaceutical dose form
CDF Combined pharmaceutical dose form
UOP Unit of presentation
ROA Route of administration
PCA Packaging category
CON Container
CLO Closure
DEV Administration device
MAP Mapped term
4.2.2.3 Code-term pair: Term
User Guidance This field contains the textual term description for the code-term pair.
Data Type String
Conformance Mandatory
Value Allowed Free text
Business Rule(s) Each code-term pair shall have one term.
4.2.2.4 Code-term pair: Definition
User Guidance This field contains the textual definition for the code-term pair. The definition
is as comprehensive as possible, in order to guide the user to the most appropri-
ate term to describe a given concept. For example, it should be detailed enough
to distinguish between similar pharmaceutical dose forms, and may exception-
ally make direct reference to related terms in order to exclude them, although
such references may be considered more appropriate in the Comments section
instead.
Data Type String
Conformance Mandatory for the default code-term pair; optional for the translation code-
term pairs
Value Allowed Free text
Business Rule(s) Each code-term pair may have one definition. For each coded concept, the de-
fault code-term pair (e.g. EN-GB) shall have one definition. If a code-term pair
for a given language/region combination does not have a definition provided,
the definition in the code-term pair for the default language/region combina-
tion is adopted.
4.2.2.5 Code-term pair: Domain
User Guidance This field is used to identify whether a term is considered appropriate for both
human and veterinary use, or whether it is considered appropriate for veteri-
nary use only.
Data Type Concept Descriptor
Conformance Optional
Value Allowed "Human and veterinary"; "Veterinary only"
Business Rule(s) Each code-term pair may have one domain. Although veterinary medicines
are outside the scope of IDMP, certain regions use a single terminology system
to cover both medicines for human use and medicines for veterinary use; this
optional field is therefore included in order to allow veterinary-only terms to be
easily distinguished in such systems.
4.2.2.6 Code-term pair: Comment
User Guidance This optional field contains a textual comment for the code-term pair. It is used
to provide to the user additional information and guidance that would not be
strictly appropriate to appear as part of the definition.
Data Type String
Conformance Optional
Value Allowed Free text
Business Rule(s) Each code-term pair may have one comment.
4.2.2.7 Code-term pair: Language code
User Guidance This field contains the language in which the term, definition and comment are
described; in this document, the working language is English. The language
code used is in accordance with ISO 639-1.
Data Type Concept Descriptor
Conformance Mandatory
Value Allowed ISO 639-1 code, OID reference 1.0.639.1
Business Rule(s) Each code-term pair shall have one language code.
4.2.2.8 Code-term pair: Region code
User Guidance This field contains the region/country that uses this code-term pair, in the
language described above; it can be used to differentiate between regional
variants of that language; in this document, the default region is the United
Kingdom. The region code used is in accordance with ISO 3166-1. Alpha-2 (i.e.
2-letter) codes are used. The additional code EU is also allowed to represent the
European Union. It should be noted that the United Kingdom is represented in
ISO 3166-1 by the 2-letter code GB, as in the examples used in this document.
Data Type Concept Descriptor
Conformance Mandatory
Value Allowed ISO 3166-1 alpha-2 code, OID reference 1.0.3166.1.2.2.
Business Rule(s) Each code-term pair shall have one region code.
4.2.2.9 Code-term pair example
An example of a code-term pair for the concept "Tablet", a pharmaceutical dose form, is shown in
Table 2. Since the working language of this document is UK English, the language is English and the
region is the United Kingdom.
Table 2 — Example code-term pair for pharmaceutical dose form "Tablet" in UK English
Code PDF-10219000-EN-GB
Term Tablet
Solid single-dose uncoated preparation obtained by compressing uniform volumes of
particulate solids or by other means such as extrusion or moulding. Tablets include sin-
gle-layer tablets resulting from a single compression of particles and multi-layer tablets
Definition consisting of concentric or parallel layers obtained by successive compressions of particles
of different composition. Tablets are intended for oral use to release active substance(s) in
the gastrointestinal fluids by a rate depending essentially on the intrinsic properties of the
active substance(s) (conventional release).
languageCode EN
regionCode GB
4.2.3 Coded concept
4.2.3.1 Coded concept overview
This is the class that is used to represent the concept itself, and it is a collection of all of the code-term
pairs that define the same concept for each language/region combination. The code-term pairs for a
given concept can be considered as different translations of that concept; the coded concept groups
those various translations under a single, unique code. In order to represent the coded concept, one of
the code-term pairs is selected as the "value", while each other code-term pair is a "translation".
The use of a coded concept in another system allows for the identification of a concept without
specifying a particular language and region. The code-term pair selected as the "value" may be used
by default to represent the coded concept when a textual term is requested. The default code-term pair
in this document is English/United Kingdom. Where a language/region combination is specified by the
requesting system, the appropriate code-term pair for that combination can be used to represent the
coded concept.
As described in 4.2.2.1, when a new concept is required, a new coded concept shall be created, and at
least one code-term pair is required in order to hold the data to describe the concept. The language/
region combination chosen to represent the "value" shall always be created, even when the request
originates from a different language/region combination. The maintenance organization shall provide
instructions on how to request a new term, as well as how to request a revision to an existing term.
4.2.3.2 Coded concept: Code
User Guidance This field contains a unique, machine-readable identifier for the coded concept.
Data Type String
Conformance Mandatory
Value Allowed Free text
Business Rule(s) Each coded concept shall have one code.
4.2.3.3 Coded concept: Value
User Guidance This field contains the identifier of the code-term pair that has been chosen to
represent the coded concept. In this document this code-term pair is always
that of the English/United Kingdom combination.
Data Type String
Conformance Mandatory
Value Allowed Code-term pair identifier
Business Rule(s) Each coded concept shall have one value, which is considered to be its default
code-term pair. Whenever a new concept is created, the code-term pair with
the language/region combination that is chosen for the "value" shall always be
created first, even if the request is made for a different language/region combi-
nation.
4.2.3.4 Coded concept: Translation
User Guidance This repeatable field contains the identifier of the code-term pair that repre-
sents the concept using a language/region combination that is different from
that of the code-term pair used for the above coded concept value. In this docu-
ment, since the above value is always represented by English/United Kingdom,
these code-term pairs will represent combinations such as English/United
States, Japanese/Japan, French/France, etc.
Data Type String
Conformance Optional
Value Allowed Code-term pair identifier
Business Rule(s) Each coded concept may have zero to many translations.
4.2.3.5 Coded concept example
An example of a coded concept for the concept "Tablet" is shown in Table 3. Since the working language of
this document is UK English, the value is the code-term pair that has English as the language and United
Kingdom as the region (as shown in Table 2). In order to simplify the example, just two translations are
associated with it here: the code-term pair that has French as the language and France as the region,
and the code-term pair that has Japanese as the language and Japan as the region. As can be seen from
Table 3, only the code-term pair identifiers are required, since each one represents all of the necessary
information for each language/region combination, (such as for English and the United Kingdom as
shown in Table 2). The overall concept of "Tablet" (i.e. including all language/region combinations) has
its own identifier (code PDF-10219000 in this example).
Table 3 — Example coded concept for pharmaceutical dose form "Tablet", linking the code-term
pairs for the concept in English for the United Kingdom, French for France, and Japanese for
Japan
code PDF-10219000
value PDF-10219000-EN-GB
PDF-10219000-FR-FR
translation
PDF-10219000-JA-JP
4.3 Versioning
4.3.1 Versioning of the term
ISO/TR 14872 includes guidance on principles and procedures for versioning and change control.
Code-term pairs are used to populate a terminology database, and as such they can be considered as the
current representation of specific concepts for specific language/region combinations. They contain
the information that is considered to be the most important and relevant to the database user. However,
as controlled vocabularies can evolve over time, the situation arises whereby terms in a database need
to be revised, which means that code-term pairs therefore need to be revised.
In order to maintain a traceable history of a code-term pair, including any changes that are made to it,
each code-term pair is associated with versioning information. This is done with the use of versions.
Each time a code-term pair is created or modified, a version of that code-term pair is created.
A version acts as a record of a code-term pair at a specific point in time. It contains the elements of the
code-term pair at that point in time, as well as a timestamp, an identifier of the operator that made the
modification, and a description of the modification that took place. Also recorded in the version is the
status of the term; any change in status of a code-term pair will evoke the creation of a new version
of that code-term pair. Certain information, such as the identifier of the operator, may not be made
publicly available, but is nevertheless recorded.
These additional elements of versioning information are described in more detail below.
The coded concept can be considered as the container for all of the translations (i.e. code-term pairs)
for a given concept; it does not therefore require versioning information itself. The addition of a new
translation (i.e. a new code-term pair) does not therefore result in the creation of a new version of the
coded concept.
4.3.1.1 Versioning: Code
User Guidance This field contains the unique, machine-readable identifier for the version of the
code-term pair that is the subject of the versioning.
In this document, the following format is used for the code:
— XXX-12345678-LL-RR-V
where
— XXX-12345678-LL-RR represents the code-term pair;
— V represents the version number, the length of which is not limited to a
single digit.
Data Type String
Conformance Mandatory
Value Allowed The code is generated automatically from the code-term pair and the version
number.
Business Rule(s) Each version shall have one code.
4.3.1.2 Versioning: Creation date
User Guidance This field contains the time and date upon which the concept was first created.
The time stamp used is in accordance with ISO 8601.
Data Type Timestamp
Conformance Mandatory
Value Allowed Y Y Y Y-M M-DD h h: m m: s s
Business Rule(s) The creation date refers to the creation of the coded concept and the first
code-term pair for the default language/region. The time standard chosen to
measure the point in time (e.g. UTC, UTC+1) is used consistently throughout the
database.
4.3.1.3 Versioning: Created by
User Guidance This field contains an identification of the operator who created the concept,
such as their name or identifier.
Data Type String
Conformance Mandatory
Value Allowed Free text
Business Rule(s) This information is not made publicly available to all users, but is recorded in
the database and is accessible to the database administrator.
4.3.1.4 Versioning: Version date
User Guidance If a modification has been made to a term, then a new version of that term is
created, and this field contains the time and date upon which that version was
created. This also applies to the creation of the first version of the code-term
pair. The first version of the first code-term pair represents the creation of the
coded concept itself, and therefore has particular importance, which is why
it is considered appropriate always to indicate that date, even for subsequent
versions and for different translations. The time stamp used is in accordance
with ISO 8601.
Data Type Timestamp
Conformance Mandatory
Value Allowed Y Y Y Y-M M-DD h h: m m: s s
Business Rule(s) Each version of a code-term pair shall have one version date.
4.3.1.5 Versioning: Modification made
User Guidance If a modification has been made to a term, then a new version of that term is
created, and this field shall be used to add a description of or explanation for
the modification that was made. This also applies to the creation of the first
version of the code-term pair.
Data Type String
Conformance Mandatory
Value Allowed Free text, although a drop-down list of common modifications may be consid-
ered appropriate in order to help harmonise the entries.
Business Rule(s) Each version of a code-term pair shall have one entry for modification made.
4.3.1.6 Versioning: Modification by
User Guidance If a modification has been made to a term, then a new version of that term is
created, and this field contains an identification of the operator who made the
modification, such as their name or identifier. This also applies to the creation
of the first version of the code-term pair. The first version of the first code-term
pair represents the creation of the coded concept itself, and therefore has par-
ticular importance, which is why it is considered appropriate always to record
the creator, even for subsequent versions and for different translations.
Data Type String
Conformance Mandatory
Value Allowed Free text
Business Rule(s) This information is not made publicly available to all users, but is recorded in
the database and is accessible to the database administrator.
4.3.1.7 Versioning: Concept status
User Guidance This field contains the status of the term.
Data Type Concept descriptor
Conformance Mandatory
Value Allowed "Current"; "Deprecated"; "Rejected"; "Pending"
Business Rule(s) Each version of a code-term pair has a status, which allows the history of any
change in status of a term to be recorded. For example, if an existing, current
term (version 1) is to be deprecated, then a new version of the code-term pair is
created (version 2), with the status changed from "current" to "deprecated". It
is the intention that, for any given concept, the status is the same for all of the
translations; therefore, a mechanism should be implemented to ensure that the
status of each code-term pair of a coded concept is changed at the same time.
4.3.1.8 Versioning: Current concept
User Guidance If a term has been deprecated or rejected, and one or more other terms are
identified as a replacement, this repeatable field contains the identifier of the
replacement term.
Data Type String
Conformance Conditional
Value Allowed Coded concept identifier
Business Rule(s) This field is conditional on the status of a term being "deprecated" or "reject-
ed", and there being a replacement term identified.
4.3.1.9 Versioning: Version number
User Guidance This field contains an identifier for the particular version of the term being de-
scribed, in the form of a whole number. When a modification to a term is made,
a new version is created and identified through the version number, which
increases by a value of 1 from the previous version of the term. When a term is
first created this field has the value 1.
Data Type Integer
Conformance Mandatory
Value Allowed Positive integer greater than zero.
Business Rule(s) Each version shall have one version number.
4.3.2 Versioning of the terminology
The terminology is intended to be updated on a continuous basis, as new concepts and translations are
added. Therefore, it is not envisaged that there will be periodic updates of the terminology released
and identified with fixed version numbers. However, a snapshot of the database shall be recorded on
a regular basis, and thus there shall be periodic versions of the database available in case reversion to
a previous instance of the database is required (e.g. in case of corruption of the database due to some
unforeseen circumstances).
5 Terminologies
5.1 General
Each of the sets of terminologies described in this clause make use of the data types described in
Clause 4 to carry the information required to describe each individual concept.
The following subclauses describe each set of terminologies and provide examples to illustrate them.
All of the terms and definitions used are for illustration purposes only, and are not intended to reflect
the exact terms and definitions that will constitute the terminologies as such.
Each element in Clause 5 is described under a separate subclause, consisting of a title and a table
containing the following:
— "User Guidance", a description of the element;
— "Data Type", a description of the data type;
— "Conformance", a description of whether the element is mandatory, optional, or conditional;
— "Value Allowed", indicating the possible values for the element;
— "Business Rules", providing technical guidance for the element.
5.2 Pharmaceutical dose form
5.2.1 Pharmaceutical dose form overview
The pharmaceutical dose form is the physical manifestation of a product that contains the active
ingredient(s) and/or inactive ingredient(s) that are intended to be delivered to the patient.
A product can be described at two distinct stages: the stage at which it has been manufactured
(where it is referred to as the "manufactured item(s)"), and the stage at which it is administered to
the patient (where it is referred to as the "pharmaceutical product"). If a manufactured item must
undergo some form of transformation in order to produce the pharmaceutical product, this means
that the pharmaceutical dose form of a product will differ depending on whether it is describing the
manufactured item or the pharmaceutical product.
A medicinal product can therefore be described with two "types" of pharmaceutical dose form:
— the manufactured dose form (i.e. the pharmaceutical dose form of the manufactured item, as
produced by the manufacturer);
— the administrable dose form (i.e. the pharmaceutical dose form of the pharmaceutical product,
ready to be administered to the patient) (see Figure 1).
Figure 1 — Diagram illustrating the relationship between manufactured item and
manufactured dose form, and pharmaceutical product and administrable dose form, for a
medicinal product
NOTE The example in Figure 1 refers to a medicinal product consisting of a single manufactured item; for
further guidance on medicinal products consisting of two or more manufactured items that are intended to be
transformed into a single pharmaceutical product, see 5.3.
In cases where no transformation is required, and the manufactured item is the same as the
pharmaceutical product, the manufactured dose form and the administrable dose form are the same.
When a pharmaceutical dose form is described, no specific reference is necessarily made as to whether
it can be a manufactured dose form or an administrable dose form, although it can be deduced that,
while any pharmaceutical dose form can be a manufactured dose form, only a pharmaceutical dose
form that specifies no transformation can be an administrable dose form (this property may be used
by the maintenance organization to help identify whether a term can be considered as a manufactured
dose form only, or as either a manufactured dose form or an administrable dose form). The purpose of
using these terms is to simplify the language used:
— "manufactured dose form" = "pharmaceutical dose form of the manufactured item";
— "administrable dose form" = "pharmaceutical dose form of the pharmaceutical product".
However, it is recommended that the maintenance organization labels administrable dose forms as
such, in order to help distinguish them from those that are manufactured dose forms only. It is also
recommended that links be provided between terms in order to indicate the appropriate administrable
dose form for a given term. In particular, this would be useful for identifying the administrable dose
form(s) for each pharmaceutical dose form, combined pharmaceutical dose form, combined term and
combination pack.
5.2.2 Pharmaceutical dose form schema
5.2.2.1 Schema overview
The pharmaceutical dose form is organized according to its basic dose form, which in turn is organized
according to its state of matter. This is the simple, three-level hierarchy by which the pharmaceutical
dose forms are categorised.
In addition to this hierarchy, each pharmaceutical dose form has a number of characteristics attributed
to it, which can be used to help index the pharmaceutical dose form. These characteristics are:
release characteristics, transformation, intended site, and administration method; they allow for
pharmaceutical dose forms to be more easily identified, and for related pharmaceutical dose forms to
be identified together more easily and in a number of different ways (see Figure 2).
Figure 2 — Pharmaceutical dose form basic schema showing the principal hierarchy (solid
arrows)
...