Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)

This document is intended to provide specific levels of information relevant to the identification
of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and
relationships between data elements that are required for the exchange of regulated information, in
order to uniquely identify pharmaceutical products. This identification is to be applied throughout
the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In
addition, this document is essential to ensure that pharmaceutical product information is assembled
in a structured format with transmission between a diverse set of stakeholders for both regulatory
and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and
compatibility for both the sender and the recipient.
This document is not intended to be a scientific classification for pharmaceutical products. Rather, it is
a formal association of particular data elements categorised in prescribed combinations and uniquely
identified when levelling degrees of information are incomplete. This allows for Medicinal Products to
be unequivocally identified on a global level.
References to other normative IDMP and messaging standards for pharmaceutical product information
are included in Clause 2, to be applied in the context of this document.
Medicinal products for veterinary use are out of scope of this document.

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation und zum Austausch von pharmazeutischen Produktkennzeichen (ISO 11616:2017)

Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les produits pharmaceutiques (ISO 11616:2017)

ISO 11616:2017 vise à fournir des niveaux d'informations spécifiques pertinents pour l'identification d'un médicament ou d'un groupe de médicaments. Elle définit les éléments de données, les structures et les relations entre des éléments de données nécessaires à l'échange d'informations réglementées visant à identifier de façon unique des produits pharmaceutiques. Cette identification est destinée à être appliquée tout au long du cycle de vie du produit afin de soutenir sur le plan mondial les activités réglementaires, de pharmacovigilance et autres. De plus, le présent document est essentiel pour garantir que les informations sur un produit pharmaceutique sont rassemblées dans un format structuré pouvant être transmis entre différentes parties prenantes, à des fins aussi bien réglementaires que cliniques (par exemple, ordonnances électroniques, aide à la décision clinique). Cela permet d'assurer l'interopérabilité et la compatibilité entre émetteur et destinataire.
ISO 11616:2017 n'est pas destiné à constituer une classification scientifique des produits pharmaceutiques. Il s'agit plutôt d'une association formelle d'éléments de données en particulier, catégorisés en combinaisons spécifiées et identifiés de manière unique lorsque les informations d'un niveau parmi une hiérarchie de niveaux sont insuffisantes. Cela permet l'identification des médicaments sans ambiguïté au niveau mondial.
Des références à d'autres normes IDMP et de messagerie relatives aux informations sur les produits pharmaceutiques sont incluses dans l'Article 2, pour application dans le contexte du présent document.
Les médicaments à usage vétérinaire ne relèvent pas du domaine d'application du présent document.

Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih izdelkih (ISO 11616:2017)

Namen tega dokumenta je zagotoviti specifične ravni informacij v zvezi z identifikacijo medicinskega izdelka ali skupine medicinskih izdelkov. Določa podatkovne elemente, strukture in odnose med podatkovnimi elementi, ki so potrebni za izmenjavo predpisanih informacij, da se enotno identificirajo farmacevtski izdelki. Ta identifikacija se mora uporabljati skozi celoten življenjski cikel izdelka, da se podpirajo farmakovigilanca, regulativne dejavnosti in druge dejavnosti na globalni ravni. Poleg tega je ta dokument bistvenega pomena za zagotavljanje zbiranja informacij o farmacevtskih izdelkih v strukturirani obliki s prenosom med raznolikimi interesnimi skupinami v zakonodajne in klinične namene (npr. e-predpisovanje, podpora za klinično odločanje). To zagotavlja interoperabilnost in usklajenost za pošiljatelja in prejemnika.
Namen tega dokumenta ni znanstvena klasifikacija farmacevtskih izdelkov. To je
uradna zbirka posebnih podatkovnih elementov, ki so kategorizirani v predpisanih kombinacijah in enoznačno prepoznavni, kadar so ravni informacij nepopolne. To omogoča nedvoumno identifikacijo medicinskih izdelkov na globalni ravni.
Sklici na druge normativne standarde za identifikacijo medicinskih izdelkov in sporočanje informacij o farmacevtskih izdelkih so vključeni v točki 2 in namenjeni uporabi v okviru tega dokumenta.
Medicinski izdelki za uporabo v veterini niso del področja uporabe tega dokumenta.

General Information

Status
Published
Public Enquiry End Date
30-Dec-2016
Publication Date
06-Mar-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
22-Dec-2017
Due Date
26-Feb-2018
Completion Date
07-Mar-2018

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SLOVENSKI STANDARD
SIST EN ISO 11616:2018
01-april-2018
1DGRPHãþD
SIST EN ISO 11616:2013

Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za

enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih izdelkih

(ISO 11616:2017)

Health informatics - Identification of medicinal products - Data elements and structures

for the Unique Identification and Exchange of regulated Pharmaceutical Product
Information (ISO 11616:2017)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation und zum Austausch von pharmazeutischen
Produktkennzeichen (ISO 11616:2017)
Informatique de santé - Identification des médicaments - Éléments de données et

structures pour l'identification unique et l'échange d'informations réglementées sur les

produits pharmaceutiques (ISO 11616:2017)
Ta slovenski standard je istoveten z: EN ISO 11616:2017
ICS:
11.120.10 Zdravila Medicaments
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11616:2018 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11616:2018
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SIST EN ISO 11616:2018
EN ISO 11616
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2017
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 11616:2012
English Version
Health informatics - Identification of medicinal products -
Data elements and structures for the Unique Identification
and Exchange of regulated Pharmaceutical Product
Information (ISO 11616:2017)

Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von

- Éléments de données et structures pour Arzneimitteln - Datenelemente und -strukturen zur

l'identification unique et l'échange d'informations Identifikation und zum Austausch von

réglementées sur les produits pharmaceutiques (ISO pharmazeutischen Produktkennzeichen (ISO

11616:2017) 11616:2017)
This European Standard was approved by CEN on 17 November 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11616:2017 E

worldwide for CEN national Members.
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SIST EN ISO 11616:2018
EN ISO 11616:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 11616:2018
EN ISO 11616:2017 (E)
European foreword

This document (EN ISO 11616:2017) has been prepared by Technical Committee ISO/TC 215 "Health

informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the

secretariat of which is held by NEN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by June 2018, and conflicting national standards shall be

withdrawn at the latest by June 2018.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 11616:2012.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 11616:2017 has been approved by CEN as EN ISO 11616:2017 without any modification.

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SIST EN ISO 11616:2018
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SIST EN ISO 11616:2018
INTERNATIONAL ISO
STANDARD 11616
Second edition
2017-10
Health informatics — Identification
of medicinal products — Data
elements and structures for unique
identification and exchange of
regulated pharmaceutical product
information
Informatique de santé — Identification des médicaments — Éléments
de données et structures pour l'identification unique et l'échange
d'informations réglementées sur les produits pharmaceutiques
Reference number
ISO 11616:2017(E)
ISO 2017
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SIST EN ISO 11616:2018
ISO 11616:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 11616:2018
ISO 11616:2017(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms, definitions and abbreviated terms ................................................................................................................................ 2

4 Conformance terminology and context as it relates to the ISO IDMP standards and

corresponding IDMP technical specifications ....................................................................................................................... 9

5 Requirements .......................................................................................................................................................................................................... 9

5.1 Elements required for the unique identification of pharmaceutical products ................................ 9

5.2 Exchange of pharmaceutical product information ...............................................................................................10

6 Description of the information modelling principles and practices ...........................................................10

6.1 General considerations .................................................................................................................................................................10

6.2 Conceptual overview diagrams .............................................................................................................................................11

6.3 High-level diagrams .........................................................................................................................................................................11

6.4 Detailed description diagrams ...............................................................................................................................................12

6.4.1 General...................................................................................................................................................................................12

6.4.2 Relationships between classes .........................................................................................................................13

6.4.3 Attributes of classes ...................................................................................................................................................14

6.4.4 Generalised classes and patterns ...................................................................................................................14

6.4.5 Translation and language ......................................................................................................................................14

7 Identifying characteristics for the identification of pharmaceutical products ................................14

7.1 Pharmaceutical product identification strata and levels .................................................................................14

7.1.1 General...................................................................................................................................................................................14

7.1.2 PhPID specified substance ...................................................................................................................................15

7.1.3 Pharmaceutical product specified substance identification (PhPID SpSub) ............16

7.2 Cardinality ................................................................................................................................................................................................17

7.3 Representation of strength concentration ...................................................................................................................17

7.4 Pharmaceutical product identifier (PhPID) ................................................................................................................18

7.5 Pharmaceutical product substance stratum elements (PhPID_SUB_Lx) ...........................................18

7.5.1 Construct of the pharmaceutical product substance stratum ...............................................18

7.5.2 Substance set....................................................................................................................................................................18

7.5.3 Administrable dose form .......................................................................................................................................19

7.5.4 Unit of presentation ...................................................................................................................................................19

7.5.5 Medical device .................................................................................................................................................................19

7.6 Pharmaceutical product specified substance stratum elements (PhPID_SpSUB_Lx) .............19

7.6.1 Construct of the pharmaceutical product specified substance stratum .......................19

7.6.2 Specified substance set ...........................................................................................................................................20

7.6.3 Administrable dose form .......................................................................................................................................20

7.6.4 Unit of presentation ...................................................................................................................................................20

7.6.5 Medical device .................................................................................................................................................................20

7.7 Identifying characteristics to express strength .......................................................................................................20

7.7.1 Expressing strength ...................................................................................................................................................20

7.7.2 Attributes for representation of strength in PhPID stratum elements ..........................21

7.7.3 Representation of strength for a patch ......................................................................................................23

8 Relationship between MPID/PCID and PhPID ....................................................................................................................23

8.1 Concepts required for the unique identification of a Medicinal Product and the

association with PhPIDs ..............................................................................................................................................................23

8.2 Pharmaceutical product identification criteria .......................................................................................................25

8.2.1 General considerations ............................................................................................................................................25

8.2.2 Multiple products packaged as a kit and administered as separate

Medicinal Products .....................................................................................................................................................25

© ISO 2017 – All rights reserved iii
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SIST EN ISO 11616:2018
ISO 11616:2017(E)
8.2.3 Multiple products packaged as a kit for reconstitution and administered

as one Medicinal Product .....................................................................................................................................26

8.2.4 Components of kits which are not packaged together (e.g.

radiopharmaceutical kits) ....................................................................................................................................26

8.2.5 Different representations of strength in two or more regions for

identical products ........................................................................................................................................................26

8.2.6 Representation of PhPID for a patch ...........................................................................................................27

9 Relationship between IMPID/IPCID and PhPID ................................................................................................................27

10 Conceptual model .............................................................................................................................................................................................29

Bibliography .............................................................................................................................................................................................................................30

iv © ISO 2017 – All rights reserved
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SIST EN ISO 11616:2018
ISO 11616:2017(E)
Foreword

ISO (the International Organization for Standardisation) 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

organisations, 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 standardisation.

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 on 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 the following

URL: www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 215, Health informatics.

This second edition cancels and replaces the first edition (ISO 11616:2012), which has been technically

revised.
© ISO 2017 – All rights reserved v
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SIST EN ISO 11616:2018
ISO 11616:2017(E)
Introduction

This document was developed in response to a worldwide demand for internationally harmonised

specifications for Medicinal Products. It is part of a set of five ISO Standards and four ISO Technical

Specifications which together provide the basis for the unique Identification of Medicinal Products (IDMP).

These sets of standards and technical specifications comprise:
— ISO 11615;
— ISO/TS 20443;
— ISO 11616;
— ISO/TS 20451;
— ISO 11238;
— ISO/TS 19844;
— ISO 11239;
— ISO/TS 20440;
— ISO 11240.

The purpose of this document is to present data elements, structures and their relationships in order

to uniquely identify and exchange regulated pharmaceutical product information. This document

provides an accurate and consistent mechanism to fully represent the relationship of pharmaceutical

product identifier(s) (PhPID) with the following:
— Medicinal Product Identifier(s) (MPIDs);
— Package Component Identifier(s) (PCIDs);
— Investigational Medicinal Product Identifier(s) (IMPIDs);
— Investigational Package Component Identifier(s) (IPCIDs).

These standards and technical specifications for the identification of Medicinal Products support the

activities of medicines regulatory agencies worldwide by region. These include a variety of regulatory

activities related to development, registration and life cycle management of Medicinal Products, as well

as pharmacovigilance and risk management.

To meet the primary objectives of the regulation of medicines and pharmacovigilance, it is necessary

to reliably exchange Medicinal Product information in a robust and consistent manner. The IDMP

standards therefore support, at a minimum, the following interactions:
— regulatory medicines authority to regulatory medicines authority;
— pharmaceutical company to regulatory medicines authority;
— sponsor of a clinical trial to regulatory medicines authority;
— regulatory medicines authority to other stakeholders (as applicable);
— regulatory medicines authority to worldwide-maintained data sources.

The necessary messaging specifications are included as an integral part of the IDMP standards to secure

the interactions above. This is critical to describing and protecting the integrity of the interactions

listed above for the submission of regulated Medicinal Product information in the context of unique

product identification and acknowledgement of receipt (which includes the validation of transmitted

information).
vi © ISO 2017 – All rights reserved
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SIST EN ISO 11616:2018
ISO 11616:2017(E)

Unique identifiers produced in conformance with the IDMP standards are aimed at supporting

applications where it is necessary to reliably identify and trace the use of Medicinal Products.

There are many terms in use to describe basic concepts in the regulatory, pharmaceutical and

healthcare standards development domain for different purposes and in different contexts. The terms

and definitions given in this document are to be applied for the concepts which are required to uniquely

identify, characterise and exchange regulated Medicinal Products and associated information.

The terms and definitions adopted in this document are intended to facilitate the interpretation and

application of legal and regulatory requirements but they are without prejudice to any legally binding

document. In case of doubt or potential conflict, the terms and definitions contained in legally binding

documents prevail.

This document has been developed in conjunction with the Common Product Model (CPM) and

Structured Product Labelling (SPL) in HL7.
© ISO 2017 – All rights reserved vii
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SIST EN ISO 11616:2018
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SIST EN ISO 11616:2018
INTERNATIONAL STANDARD ISO 11616:2017(E)
Health informatics — Identification of medicinal products
— Data elements and structures for unique identification
and exchange of regulated pharmaceutical product
information
1 Scope

This document is intended to provide specific levels of information relevant to the identification

of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and

relationships between data elements that are required for the exchange of regulated information, in

order to uniquely identify pharmaceutical products. This identification is to be applied throughout

the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In

addition, this document is essential to ensure that pharmaceutical product information is assembled

in a structured format with transmission between a diverse set of stakeholders for both regulatory

and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and

compatibility for both the sender and the recipient.

This document is not intended to be a scientific classification for pharmaceutical products. Rather, it is

a formal association of particular data elements categorised in prescribed combinations and uniquely

identified when levelling degrees of information are incomplete. This allows for Medicinal Products to

be unequivocally identified on a global level.

References to other normative IDMP and messaging standards for pharmaceutical product information

are included in Clause 2, to be applied in the context of this document.
Medicinal products for veterinary use are out of scope of this document.
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 3166-1, Codes for the representation of names of countries and their subdivisions — Part 1: Country codes

ISO 11238, Health informatics — Identification of Medicinal Products — Data elements and structures for

the unique identification and exchange of regulated information on substances

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

ISO 11240, Health informatics — Identification of Medicinal Products — Data elements and structures for

the unique identification and exchange of units of measurement

ISO 11615:2017, Health informatics — Identification of Medicinal Products — Data elements and structures

for the unique identification and exchange of regulated Medicinal Product information

ISO/TS 19844, Health informatics — Identification of Medicinal Products — Implementation guidelines

for data elements and structures for the unique identification and exchange of regulated information on

substances
© ISO 2017 – All rights reserved 1
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SIST EN ISO 11616:2018
ISO 11616:2017(E)

ISO/TS 20440, Health informatics — Identification of Medicinal Products — Implementation guide 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

ISO/TS 20443, Health informatics — Identification of Medicinal Products — Implementation guidelines for

ISO 11615 data elements and structures for the unique identification and exchange of regulated Medicinal

Product information

ISO/TS 20451, Health informatics — Identification of Medicinal Products — Implementation guidelines

for ISO 11616 data elements and structures for the unique identification and exchange of regulated

pharmaceutical product information
HL7 Version 3 Standard, Common Clinical Product Model
HL7 Version 3 Standard, Common Product Model CMETS
HL7 Version 3 Standard, Regulated Product Submission
HL7 Version 3 Standard, Structured Product Labelling
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardisation at the following addresses:

— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1.1
adjuvant

component that potentiates the immune response to an antigen and/or modulates it towards the

desired immune response
3.1.2
administrable dose form

pharmaceutical dose form (3.1.7) for administration to the patient, after any necessary transformation

of the manufactured items (3.1.17) and their corresponding manufactured dose forms (3.1.16) has been

carried out

Note 1 to entry: The administrable dose form is identical to the manufactured dose form in cases where

no transformation of the manufactured item is necessary [i.e. where the manufactured item is equal to the

pharmaceutical product (3.1.24)].

Note 2 to entry: Administered dose form and pharmaceutical administrable dose form are synonyms of

administrable dose form.
3.1.3
clinical trial

any investigation in human subjects intended to discover or verify the clinical, pharmacological

and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse

reactions to an investigational Medicinal Product(s) (3.1.12), and/or to study absorption, distribution,

metabolism and excretion of investigational Medicinal Product(s) with the object of ascertaining its

safety and/or efficacy
Note 1 to entry: The terms clinical trial and clinical study are synonymous.
2 © ISO 2017 – All rights reserved
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SIST EN ISO 11616:2018
ISO 11616:2017(E)
3.1.4
controlled vocabulary
finite set of values that represent the only allowed values for a data item
Note 1 to entry: These values may be codes, text, or numeric.

[SOURCE: CDISC Clinical Research Glossary V10, 2016, modified — “These values may be codes, text, or

numeric” has been set as note to entry.]
3.1.5
controlled vocabulary term identifier

concept identifier (3.1.10) intended to be used as the preferred unique identifier for that concept in that

code system and which is published by the author of a code system

Note 1 to entry: The TermID remains constant over time, independent of the particular version of the knowledge

resource.
Note 2 to entry: This definition is adapted from HL7 Core Principles.
Note 3 to entry: TermID is a synonym of controlled vocabulary term identifier.
3.1.6
designation
symbolic representation of a concept
3.1.7
dose form
physical manifestation of a Medicinal Product (3.1.19
...

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