Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)

This document 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, characterise and uniquely identify
regulated Medicinal Products for human use during their entire life cycle, i.e. from development to
authorisation, post-marketing and renewal or withdrawal from the market, where applicable.
Furthermore, to support successful information exchange in relation to the unique identification
and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is
included, which are to be applied in the context of this document.

Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation von Arzneimitteln für den Austausch von behördlich genehmigten Arzneimittelinformationen (ISO 11615:2017)

Informatique de santé - Identification des médicaments - Éléments de données et structures pour l'identification unique et l'échange d'informations sur les médicaments (ISO 11615:2017)

ISO 11615:2017 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 des médicaments.
Considérées ensemble, les normes listées dans l'introduction définissent, caractérisent et identifient de façon unique des médicaments réglementés à usage humain pendant leur cycle de vie complet, c'est-à-dire depuis leur développement jusqu'à leur autorisation, leur mise sur le marché consécutive et leur renouvellement ou leur retrait du marché, le cas échéant.
En outre, pour garantir l'échange satisfaisant des informations relatives à l'identification unique et à la caractérisation des médicaments, le recours à d'autres normes IDMP et de messagerie à appliquer dans le contexte du présent document est inclus.

Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za enotno identifikacijo in izmenjavo predpisanih informacij o zdravilih (ISO 11615:2017)

Ta dokument 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 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 11615:2018
01-april-2018
1DGRPHãþD
SIST EN ISO 11615:2013

Zdravstvena informatika - Identifikacija zdravil - Elementi in zgradba podatkov za

enotno identifikacijo in izmenjavo predpisanih informacij o zdravilih (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 11615:2017)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation von Arzneimitteln für den Austausch von behördlich
genehmigten Arzneimittelinformationen (ISO 11615:2017)
Informatique de santé - Identification des médicaments - Éléments de données et

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

(ISO 11615:2017)
Ta slovenski standard je istoveten z: EN ISO 11615:2017
ICS:
11.120.10 Zdravila Medicaments
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11615:2018 en,fr,de

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

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SIST EN ISO 11615:2018
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SIST EN ISO 11615:2018
EN ISO 11615
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2017
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 11615:2012
English Version
Health informatics - Identification of medicinal products -
Data elements and structures for the unique identification
and exchange of regulated medicinal product information
(ISO 11615:2017)

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 sur Identifikation von Arzneimitteln für den Austausch von

les médicaments contrôlés (ISO 11615:2017) behördlich genehmigten Arzneimittelinformationen

(ISO 11615:2017)
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 11615:2017 E

worldwide for CEN national Members.
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SIST EN ISO 11615:2018
EN ISO 11615:2017 (E)
Contents Page

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

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SIST EN ISO 11615:2018
EN ISO 11615:2017 (E)
European foreword

This document (EN ISO 11615:2017) 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 11615:2012.

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 11615:2017 has been approved by CEN as EN ISO 11615:2017 without any modification.

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SIST EN ISO 11615:2018
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SIST EN ISO 11615:2018
INTERNATIONAL ISO
STANDARD 11615
Second edition
2017-10
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 sur les médicaments contrôlés
Reference number
ISO 11615:2017(E)
ISO 2017
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SIST EN ISO 11615:2018
ISO 11615:2017(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 11615:2018
ISO 11615:2017(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................vi

Introduction ..............................................................................................................................................................................................................................vii

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

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

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

4 Message exchange format ........................................................................................................................................................................13

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

corresponding IDMP technical specifications ....................................................................................................................14

6 Concepts required for the unique identification of Medicinal Products.................................................14

6.1 General considerations .................................................................................................................................................................14

6.2 Authorised Medicinal Products .............................................................................................................................................14

6.3 Investigational Medicinal Products ....................................................................................................................................15

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

association with PhPID(s) ..........................................................................................................................................................15

6.5 Concepts required for the unique identification of Medicinal Products and the

association with the marketing authorisation number ....................................................................................15

6.6 Concepts required for the unique identification of Medicinal Products and the

association with data carrier identifiers .......................................................................................................................16

7 Description of the information modelling principles and practices ...........................................................17

7.1 General considerations .................................................................................................................................................................17

7.2 Conceptual overview diagrams .............................................................................................................................................17

7.3 High-level diagrams .........................................................................................................................................................................18

7.4 Detailed description diagrams ...............................................................................................................................................18

7.4.1 General...................................................................................................................................................................................18

7.4.2 Relationships between classes .........................................................................................................................19

7.4.3 Attributes of classes ...................................................................................................................................................20

7.4.4 Generalised classes and patterns ...................................................................................................................20

7.4.5 Translation and language ......................................................................................................................................20

8 Identifying characteristics for authorised Medicinal Products........................................................................20

8.1 Primary identifiers — General considerations ........................................................................................................20

8.2 Medicinal Product Identifier (MPID) ................................................................................................................................21

8.2.1 General considerations ............................................................................................................................................21

8.2.2 MPID code segments .................................................................................................................................................21

8.3 Packaged Medicinal Product Identifier (PCID) ........................................................................................................22

8.3.1 General considerations ............................................................................................................................................22

8.3.2 Package description (PCID) code segment.............................................................................................23

8.4 Medicinal Product Batch Identifier (BAID1) ..............................................................................................................23

8.5 Medicinal Product Batch Identifier (BAID2) ..............................................................................................................23

9 Information for an authorised Medicinal Product .........................................................................................................24

9.1 Authorised Medicinal Product — Information overview ................................................................................24

9.1.1 General...................................................................................................................................................................................24

9.1.2 Medicinal Product ........................................................................................................................................................24

9.1.3 Medicinal Product name ........................................................................................................................................24

9.1.4 Header ....................................................................................................................................................................................25

9.1.5 Manufacturer/Establishment (organisation) ......................................................................................25

9.1.6 Marketing authorisation ........................................................................................................................................25

9.1.7 Packaged Medicinal Product ...............................................................................................................................25

9.1.8 Pharmaceutical product .........................................................................................................................................25

9.1.9 Ingredient ...........................................................................................................................................................................25

9.1.10 Clinical particulars ......................................................................................................................................................25

9.2 Medicinal Product .............................................................................................................................................................................25

© ISO 2017 – All rights reserved iii
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SIST EN ISO 11615:2018
ISO 11615:2017(E)

9.2.1 General...................................................................................................................................................................................25

9.2.2 Detailed description of Medicinal Product information .............................................................26

9.3 Marketing authorisation ..............................................................................................................................................................32

9.3.1 General...................................................................................................................................................................................32

9.3.2 Detailed description of marketing authorisation information .............................................33

9.4 Organisation ...........................................................................................................................................................................................38

9.4.1 General...................................................................................................................................................................................38

9.4.2 Detailed description of organisation information ...........................................................................38

9.5 Manufacturer/Establishment (organisation) ............................................................................................................41

9.5.1 General...................................................................................................................................................................................41

9.5.2 Detailed description of manufacturer/establishment

(organisation) information ..................................................................................................................................41

9.6 Packaged Medicinal Product, including manufactured item and device ...........................................42

9.6.1 General...................................................................................................................................................................................42

9.6.2 Detailed description of Packaged Medicinal Product information ....................................43

9.7 Ingredient, substance and strength ...................................................................................................................................52

9.7.1 General...................................................................................................................................................................................52

9.7.2 Detailed description of ingredients, substance and strength information .................52

9.8 Pharmaceutical product and device ..................................................................................................................................55

9.8.1 General...................................................................................................................................................................................55

9.8.2 Detailed description of pharmaceutical product and device information ..................55

9.9 Clinical particulars ............................................................................................................................................................................57

9.9.1 General...................................................................................................................................................................................57

9.9.2 Detailed description for clinical particulars information ..........................................................58

10 Identifying characteristics for Investigational Medicinal Products .............................................................62

10.1 General ........................................................................................................................................................................................................62

10.2 Primary identifiers ...........................................................................................................................................................................62

10.2.1 General considerations ............................................................................................................................................62

10.3 Investigational Medicinal Product Identifier (IMPID) .......................................................................................63

10.3.1 General considerations ............................................................................................................................................63

10.3.2 IMPID code segments ...............................................................................................................................................63

10.4 Investigational Medicinal Product Package Identifier (IPCID) ...................................................................64

10.4.1 General provisions.......................................................................................................................................................64

10.4.2 Package description code segment ...............................................................................................................64

10.5 Investigational Medicinal Product Batch Identifier (BAID1) .......................................................................65

10.6 Investigational Medicinal Product Batch Identifier (BAID2) .......................................................................65

11 Information for an Investigational Medicinal Product ..............................................................................................65

11.1 General ........................................................................................................................................................................................................65

11.2 Conceptual overview of the information for an Investigational Medicinal Product ................65

11.2.1 General...................................................................................................................................................................................65

11.2.2 Investigational Medicinal Product .................................................................................................................66

11.2.3 Investigational Medicinal Product name .................................................................................................66

11.2.4 Header ....................................................................................................................................................................................66

11.2.5 Manufacturer/Establishment (organisation) ......................................................................................66

11.2.6 Clinical trial authorisation ....................................................................................................................................67

11.2.7 Investigational Packaged Medicinal Product ........................................................................................67

11.2.8 Pharmaceutical product .........................................................................................................................................67

11.2.9 Ingredient ...........................................................................................................................................................................67

11.2.10 Clinical particulars ......................................................................................................................................................67

11.3 Investigational Medicinal Product ......................................................................................................................................67

11.3.1 General...................................................................................................................................................................................67

11.3.2 Detailed description of Investigational Medicinal Product information ......................67

11.4 Clinical trial authorisation .........................................................................................................................................................70

11.4.1 General...................................................................................................................................................................................70

11.4.2 Detailed description of clinical trial authorisation information ..........................................70

11.5 Manufacturer/Establishment (organisation) ............................................................................................................72

11.6 Investigational Packaged Medicinal Product .............................................................................................................72

iv © ISO 2017 – All rights reserved
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SIST EN ISO 11615:2018
ISO 11615:2017(E)

11.7 Pharmaceutical product ...............................................................................................................................................................72

11.7.1 General...................................................................................................................................................................................72

11.7.2 Pharmaceutical product .........................................................................................................................................73

11.7.3 Dosing and route of administration .............................................................................................................73

11.8 Ingredient .................................................................................................................................................................................................73

11.9 Clinical particulars ............................................................................................................................................................................74

11.10 PhPID sets ................................................................................................................................................................................................74

11.11 Device nomenclature ......................................................................................................................................................................74

11.12 Device batch identifier ..................................................................................................................................................................74

11.13 Physical characteristics ................................................................................................................................................................74

11.14 Other characteristics .......................................................................................................................................................................74

Annex A (normative) Full model — Authorised Medicinal Products detailed diagram...............................75

Annex B (normative) Full model — Investigational Medicinal Products detailed diagram ....................76

Bibliography .............................................................................................................................................................................................................................77

© ISO 2017 – All rights reserved v
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SIST EN ISO 11615:2018
ISO 11615:2017(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.

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 11615:2012), which has been technically

revised.
vi © ISO 2017 – All rights reserved
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SIST EN ISO 11615:2018
ISO 11615:2017(E)
Introduction

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

specifications for Medicinal Pr
...

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