SIST EN ISO 11615:2013
(Main)Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2012)
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2012)
This International Standard establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, the standards listed in the introduction define, characterize and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorization, postmarketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterization of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of this International Standard.
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen für den Austausch von zulassungsbezogenen Produktinformationen für Arzneimittelverzeichnisse (ISO 11615:2012)
Die in der Einleitung aufgelisteten Normen definieren, charakterisieren und identifizieren zulassungsbedürftige
Humanarzneimittel während ihres gesamten Lebenszyklus, d. h. von der Entwicklung bis zur Zulassung des
Arzneimittels, nachdem es in den Verkehr gebracht wurde, wenn eine Verlängerung der Zulassung ansteht
oder das Arzneimittel gegebenenfalls aus dem Verkehr zu ziehen ist.
Genauer gesagt, legt diese Norm Definitionen und Begriffe fest und beschreibt Datenelemente und deren
strukturelle Beziehungen, die für eine detaillierte Beschreibung und eine eindeutige Identifikation von
Arzneimitteln erforderlich sind.
Des Weiteren sind zur Unterstützung des erfolgreichen Informationsaustausches im Zusammenhang mit der
eindeutigen Identifikation und der Charakterisierung von Arzneimitteln weitere Normen zur
Nachrichtenübermittlung angegeben, die im Kontext der vorliegenden Norm ebenfalls anzuwenden sind.
Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations réglementées sur les médicaments (ISO 11615:2012)
L'ISO 11615:2012 établit des définitions et des concepts, et décrit des éléments de données et leurs relations structurelles, nécessaires à l'identification unique et à la description détaillée de médicaments.
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o medicinskih izdelkih (ISO 11615:2012)
Ta mednarodni standard določa opredelitve in pojme ter opisuje podatkovne elemente in njihove strukturne povezave, ki so potrebni za enotno identifikacijo in podroben opis medicinskih izdelkov. V uvodu navedeni standardi torej opredeljujejo, označujejo in enotno določajo predpisane medicinske izdelke za ljudi v času njihovega celotnega življenjskega cikla, tj. od razvoja do izdaje dovoljenja, poprodaje in podaljšanja ali umika s trga, kjer je to primerno. Poleg tega je zaradi podpore uspešne izmenjave informacij v zvezi z enotno identifikacijo in določanjem lastnosti medicinskih izdelkov vključena uporaba drugih normativnih standardov o sporočanju in identifikaciji medicinskih izdelkov(IDMP) za uporabo v okviru tega mednarodnega standarda.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11615:2013
01-februar-2013
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Elementi in zgradba
podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o
medicinskih izdelkih (ISO 11615:2012)
Health informatics - Identification of medicinal products - Data elements and structures
for the unique identification and exchange of regulated medicinal product information
(ISO 11615:2012)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen für den Austausch von zulassungsbezogenen Produktinformationen für
Arzneimittelverzeichnisse (ISO 11615:2012)
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Ta slovenski standard je istoveten z: EN ISO 11615:2012
ICS:
11.020 0HGLFLQVNHYHGHLQ Medical sciences and health
]GUDYVWYHQRYDUVWYHQL care facilities in general
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SIST EN ISO 11615:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11615:2013
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SIST EN ISO 11615:2013
EUROPEAN STANDARD
EN ISO 11615
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2012
ICS 35.240.80
English Version
Health informatics - Identification of medicinal products - Data
elements and structures for the unique identification and
exchange of regulated medicinal product information (ISO
11615:2012)
Informatique de santé - Identification des médicaments - Medizinische Informatik - Identifikation von Arzneimitteln -
Éléments de données et structures pour l'identification Datenelemente und -strukturen zur Identifikation von
unique et l'échange d'informations réglementées sur les Arzneimitteln für den Austausch von behördlich
médicaments (ISO 11615:2012) genehmigten Arzneimittelinformationen (ISO 11615:2012)
This European Standard was approved by CEN on 24 May 2012.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11615:2012: E
worldwide for CEN national Members.
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SIST EN ISO 11615:2013
EN ISO 11615:2012 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 11615:2013
EN ISO 11615:2012 (E)
Foreword
This document (EN ISO 11615:2012) 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 May 2013, and conflicting national standards shall be withdrawn at the
latest by May 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11615:2012 has been approved by CEN as a EN ISO 11615:2012 without any modification.
3
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SIST EN ISO 11615:2013
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SIST EN ISO 11615:2013
INTERNATIONAL ISO
STANDARD 11615
First edition
2012-11-01
Health informatics — Identification of
medicinal products — Data elements and
structures for the unique identification
and exchange of regulated medicinal
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 médicaments
Reference number
ISO 11615:2012(E)
©
ISO 2012
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SIST EN ISO 11615:2013
ISO 11615:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
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SIST EN ISO 11615:2013
ISO 11615:2012(E)
Contents Page
Foreword . v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviations . 1
3.1 Terms and definitions . 1
3.2 Abbreviations .12
4 Requirements .14
4.1 Concepts required for the unique Identification of Medicinal Products .14
5 Description of the information modelling principles and practices .17
5.1 General considerations .17
5.2 Conceptual overview diagrams .18
5.3 Section high-level diagrams .19
5.4 Detailed description diagrams .20
6 Identifying characteristics for authorized Medicinal Products .23
6.1 Primary identifiers .23
6.2 Medicinal Product Identifier (MPID) .23
6.3 Packaged Medicinal Product Identifier (PCID) .24
6.4 Medicinal Product Batch Identifier (BAID_1) .25
6.5 Medicinal Product Batch Identifier (BAID_2) .25
7 Information for an authorized Medicinal Product .25
7.1 Authorized Medicinal Product — Information overview .25
7.2 Medicinal Product .27
7.3 Marketing Authorization .32
7.4 Organization .38
7.5 Manufacturer/Establishment .40
7.6 Packaged Medicinal Product, including Manufactured Item and Device .41
7.7 Ingredient, Substance and Strength .50
7.8 Pharmaceutical Product and Device .54
7.9 Clinical Particulars .58
8 Identifying characteristics for Investigational Medicinal Products .66
8.1 General .66
8.2 Primary identifiers .66
8.3 Investigational Medicinal Product Identifier (IMPID).67
8.4 Investigational Medicinal Product Package Identifier (IPCID) .68
8.5 Investigational Medicinal Product Batch Identifier (IBAID_1) .68
8.6 Investigational Medicinal Product Batch Identifier (IBAID_2) .68
9 Information for an Investigational Medicinal Product .69
9.1 Conceptual overview of the information for an Investigational Medicinal Product .69
9.2 Investigational Medicinal Product .70
9.3 Clinical Trial Authorization .72
9.4 Manufacturer/Establishment .75
9.5 Investigational Packaged Medicinal Product .75
9.6 Pharmaceutical Product .76
9.7 Ingredient .77
9.8 Clinical particulars .77
Annex A (informative) Full model — Authorized Medicinal Products conceptual level .78
Annex B (informative) Full model — Authorized Medicinal Products detailed diagram .79
Annex C (informative) Full model — Investigational Medicinal Products conceptual level .80
© ISO 2012 – All rights reserved iii
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SIST EN ISO 11615:2013
ISO 11615:2012(E)
Annex D (informative) Full Model — Investigational Medicinal Products detailed diagram .81
Annex E (informative) Worked example in tabular form .82
Annex F (informative) Class and attribute listing .91
Annex G (informative) Example implementation of Medicinal Product information .105
Bibliography .113
iv © ISO 2012 – All rights reserved
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SIST EN ISO 11615:2013
ISO 11615:2012(E)
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11615 was prepared by Technical Committee ISO/TC 215, Health informatics.
© ISO 2012 – All rights reserved v
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SIST EN ISO 11615:2013
ISO 11615:2012(E)
Introduction
This International Standard was developed in response to a worldwide demand for internationally harmonized
specifications for Medicinal Products. It is one of five standards which together provide the basis for the unique
Identification of Medicinal Products. The group of standards comprises:
ISO 11615, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated medicinal product information;
ISO 11616, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated pharmaceutical product information;
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.
These standards for the Identification of Medicinal Products (IDMP) support the activities of medicines
regulatory agencies worldwide by jurisdiction. 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:
— regulator to regulator;
— pharmaceutical company to regulator;
— sponsor of clinical trial to regulator;
— regulator to other stakeholder;
— regulator to worldwide-maintained data sources.
The necessary messaging specifications are included as an integral part of the IDMP standards to secure the
interactions above.
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 International Standard are to be applied for the concepts which are required to uniquely identify,
characterize and exchange regulated Medicinal Products and associated information.
The terms and definitions adopted in this International Standard 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 International Standard has been developed in conjunction with the Common Product Model in HL7. It is
anticipated that implementation will use HL7 V3 messaging to transmit information between stakeholders.
vi © ISO 2012 – All rights reserved
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SIST EN ISO 11615:2013
ISO 11615:2012(E)
In the context of exchange of regulatory information, the purpose of this International Standard is twofold:
— to specify data elements, structures and relationships between the data elements which are required to
uniquely and with certainty identify Medicinal Products for human use;
— to specify definitions of terms for all data elements required to uniquely and with certainty identify Medicinal
Products for human use.
In addition, reference to the use of other normative IDMP and messaging standards for Medicinal Product
information is included in this International Standard in order to support successful related information exchange.
© ISO 2012 – All rights reserved vii
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SIST EN ISO 11615:2013
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SIST EN ISO 11615:2013
INTERNATIONAL STANDARD ISO 11615:2012(E)
Health informatics — Identification of medicinal products —
Data elements and structures for the unique identification and
exchange of regulated medicinal product information
1 Scope
This International Standard establishes definitions and concepts and describes data elements and their structural
relationships, which are required for the unique identification and the detailed description of Medicinal Products.
Taken together, the standards listed in the introduction define, characterize and uniquely identify regulated
Medicinal Products for human use during their entire life cycle, i.e. from development to authorization, post-
marketing and renewal or withdrawal from the market, where applicable.
Furthermore, to support successful information exchange in relation to the unique identification and
characterization of Medicinal Products, the use of other normative IDMP messaging standards is included,
which are to be applied in the context of this International Standard.
2 Normative references
The following referenced documents are indispensable for the application 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 639-2, Codes for the representation of names of languages — Part 2: Alpha-3 code
ISO 3166-1, Codes for the representation of names of countries and their subdivisions — Part 1: Country codes
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times
ISO 11616, Health informatics — Identification of Medicinal Products — Data elements and structures for the
unique identification and exchange of regulated pharmaceutical product information
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 21090, Health informatics — Harmonized data types for information interchange
ISO/IEC 5218, Information technology — Codes for the representation of human sexes
3 Terms, definitions and abbreviations
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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SIST EN ISO 11615:2013
ISO 11615:2012(E)
3.1.1
administrable dose form
pharmaceutical dose form for administration to the patient, after any necessary transformation of the
manufactured dose form has been carried out
EXAMPLES Solution for injection, tablet for oral use, hard-capsule powder for inhalation.
NOTE 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).
3.1.2
administration device
equipment intended for correct administration of the Medicinal Product
EXAMPLES Applicator, oral syringe.
NOTE An administration device may be an integral part of an immediate container or a closure.
[ENV 12610:1997]
3.1.3
allergens
materials of concern
ingredients in a device capable of stimulating a type-I hypersensitivity or allergic reaction in atopic individuals
EXAMPLE Latex.
3.1.4
authorization date
date when the authorization was granted by a Medicines Regulatory Agency for a specific activity
EXAMPLE The date of the marketing authorization, which allows the Marketing Authorization Holder to put a
Medicinal Product on the market.
3.1.5
authorization procedure
marketing authorization procedure
formal procedure applied by a Medicines Regulatory Agency to grant a marketing authorization, to amend an
existing one, to extend its duration or to revoke it
EXAMPLE Revocation of a marketing authorization due to an unfavourable benefit/risk balance of the medicine.
NOTE The terms authorization procedure and marketing authorization procedure are synonymous.
3.1.6
authorization status
actual state of the marketing authorization
EXAMPLES Active, suspended, expired, revoked.
3.1.7
batch
specific manufacturing release of a Medicinal Product or item by the manufacturer
3.1.8
batch number
identifier assigned to a specific batch of a Medicinal Product or item resulting from a manufacturing process at
a specific point of time
3.1.9
characteristic
abstraction of a property of an object
2 © ISO 2012 – All rights reserved
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SIST EN ISO 11615:2013
ISO 11615:2012(E)
3.1.10
clinical trial
clinical study
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), 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 The terms clinical trial and clinical study are synonymous.
3.1.11
clinical trial authorization
authorization granted by a Medicines Regulatory Agency to conduct a clinical trial in a jurisdiction
3.1.12
combined pharmaceutical dose form
single term to describe two or more manufactured items that are intended to be combined in a specific way
to produce a single pharmaceutical product, and that includes information on the manufactured dose form of
each manufactured item and the administrable dose form of the pharmaceutical product
EXAMPLE Powder and solvent for solution for injection. The Medicinal Product contains two manufactured items: a
powder for solution for injection and a solvent for solution for injection. The pharmaceutical product that is prepared from
the two manufactured items is a solution for injection; the combined pharmaceutical dose form for the Medicinal Product
is “powder and solvent for solution for injection”.
3.1.13
common name
generic name
international nonproprietary name recommended by the World Health Organization (WHO), or, if one does not
exist, a nonproprietary name recommended by the jurisdiction within which the name is used
[WHO 46th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances]
3.1.14
concept
unit of knowledge constructed through combining characteristics expressed in words
3.1.15
container
item of packaging that is part of a Medicinal Product and is used for storage, identification and/or transport of
the components of the Medicinal Product
3.1.16
controlled vocabulary
finite set of values that represent the only allowed values for a data item
NOTE The allowed values can be codes, text or numeric.
[CDISC Clinical Research Glossary V8.0, 2009]
3.1.17
datatype
set of distinct values, characterized by properties of those values, and by operations on those values
[ISO 11404:2007, definition 3.12]
3.1.18
distributor
organization in possession of a licence covering the procuring, holding, supplying or exporting of Medicinal
Products, apart from supplying Medicinal Products to the public
NOTE This is applicable to “wholesale distribution of Medicinal Products”.
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SIST EN ISO 11615:2013
ISO 11615:2012(E)
3.1.19
dose
specified quantity of a medicine, to be taken at one time or at stated intervals
3.1.20
dose form
dosage form
pharmaceutical dose form
physical manifestation of a Medicinal Product that contains the active ingredient(s) and/or inactive ingredient(s)
that are intended to be delivered to the patient
NOTE 1 Dose form, dosage form and pharmaceutical dose form are synonymous.
NOTE 2 “Pharmaceutical dose form” can refer to the administered dose form or the manufactured dose form.
3.1.21
Global Trade Identification Number
GTIN
GS1 unique identifier of items that are traded (e.g. pharmaceuticals, medical devices) in the supply chain
NOTE A GTIN is used to identify any item upon which there is a need to retrieve pre-defined information and that may
be priced, ordered or invoiced at any point in any supply chain. GTINs may be 8, 12, 13 or 14 digits in length.
3.1.22
identifier
ID
description that is sufficient to represent an object in a given environment
NOTE 1 In the context of this International Standard, this is a list of identifying characteristics that together unambiguously
identify a Medicinal Product, pharmaceutical product, substance, specified substance, route of administration,
pharmac
...
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