CEN ISO/TS 20443:2018

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 20443:2017)

ISO/TS 20443:2017 defines 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, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to 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 normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in ISO/TS 20443:2017 to support successful information exchange.

Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für ISO 11615 Datenelemente und Strukturen zur eindeutigen Identifikation und zum Austausch von vorgeschriebenen Arzneimittelinformationen (ISO/TS 20443:2017)

Informatique de santé - Identification des médicaments - Lignes directrices pour l’implémentation des éléments de données et structures ISO 11615 pour l’identification unique et l’échange d’informations réglementées sur les médicaments (ISO/TS 20443:2017)

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Smernice za uporabo ISO 11615 podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo predpisanih informacij o medicinskih izdelkih (ISO/TS 20443:2017)

Standard ISO/TS 20443:2017 določa opredelitve ter opisuje podatkovne elemente in njihove strukturne povezave, ki so potrebni za enotno identifikacijo in podroben opis medicinskih izdelkov.
Vsi standardi ISO IDMP (ISO 11615, ISO 11616, ISO 11238, ISO 11239 in ISO 11240) opredeljujejo, označujejo in enotno določajo predpisane medicinske izdelke za uporabo pri ljudeh od odobritve do poprodaje in podaljšanja ali umika s trga, kjer je to primerno.
Poleg tega je za podporo uspešne izmenjave informacij v zvezi z enotno identifikacijo in karakterizacijo medicinskih izdelkov opisana normativna uporaba splošnega modela za izdelke HL7 (CPM) in strukturiranega označevanja izdelkov (SPL). Sklici na uporabo drugih ustreznih standardov za informacije o medicinskih izdelkih so vključeni v standardu ISO/TS 20443:2017 z namenom podpore uspešne izmenjave informacij.

General Information

• Status: Published
• Publication Date: 15-May-2018
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 1 - Information models
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 16-May-2018
• Due Date: 09-Apr-2017
• Completion Date: 16-May-2018
• Ref Project: SIST-TS CEN ISO/TS 20443:2018 - 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 20443:2017)

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2018
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Smernice za
uporabo ISO 11615 podatkovnih elementov in struktur za enotno identifikacijo in
izmenjavo predpisanih informacij o medicinskih izdelkih (ISO/TS 20443:2017)
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 20443:2017)
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -
strukturen zur Identifikation von Arzneimitteln für den Austausch von behördlich
genehmigten Arzneimittelinformationen (ISO/TS 20443:2017)
Informatique de santé - Identification des médicaments - Lignes directrices pour
l’implémentation des éléments de données et structures ISO 11615 pour l’identification
unique et l’échange d’informations réglementées sur les médicaments (ISO/TS
20443:2017)
Ta slovenski standard je istoveten z: CEN ISO/TS 20443:2018
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN ISO/TS 20443
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
May 2018
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
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
20443:2017)
Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von
- Lignes directrices pour l'implémentation des Arzneimitteln - Datenelemente und -strukturen zur
éléments de données et structures ISO 11615 pour Identifikation von Arzneimitteln für den Austausch von
l'identification unique et l'échange d'informations behördlich genehmigten Arzneimittelinformationen
réglementées sur les médicaments (ISO/TS (ISO/TS 20443:2017)
20443:2017)
This Technical Specification (CEN/TS) was approved by CEN on 13 May 2018 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 20443:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Endorsement notice . 3

European foreword
This document (CEN ISO/TS 20443:2018) 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.
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.
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/TS 20443:2017 has been approved by CEN as CEN ISO/TS 20443:2018 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 20443
First edition
2017-10
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
Informatique de santé — Identification des médicaments — Lignes
directrices pour l’implémentation des éléments de données et
structures ISO 11615 pour l’identification unique et l’échange
d’informations réglementées sur les médicaments
Reference number
ISO/TS 20443:2017(E)
©
ISO 2017
ISO/TS 20443:2017(E)
© 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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

ISO/TS 20443:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Message exchange . 2
4.1 General . 2
4.2 Message exchange format . 2
4.3 Controlled vocabularies . 3
5 Conformance terminology and context as it relates to the ISO IDMP standards and
corresponding technical specifications . 3
6 Maintenance of IDMP data elements and IDMP identifiers . 3
6.1 General . 3
6.2 Translation and language . 3
7 Why standardisation of identification of Medicinal Products is needed .4
8 General considerations . 4
8.1 Overview . 4
8.2 General considerations related to the description of the information modelling
principles and practices . 5
8.2.1 Overview . 5
8.2.2 Conceptual overview diagrams . 5
8.2.3 Section high-level diagrams . 6
8.2.4 Detailed description diagrams . 7
8.2.5 Relationships between classes . 8
8.2.6 Attributes of classes . 9
8.2.7 Generalised classes and patterns . 9
9 Information for an authorised Medicinal Product . 9
9.1 General . 9
9.2 Medicinal Product .11
9.3 Header .11
9.4 Medicinal Product name .11
9.5 Manufacturer/establishment (organisation) .11
9.6 Marketing authorisation .12
9.7 Packaged Medicinal Product .12
9.8 Pharmaceutical Product .12
9.9 Ingredient .13
9.10 Clinical particulars .13
10 Investigational Medicinal Product Identifier (IMPID) .13
10.1 Conceptual overview of the information for an Investigational Medicinal Product .13
10.2 Investigational Medicinal Product .15
10.3 Clinical trial authorisation .15
10.4 Investigational Medicinal Product name .15
10.5 Header .
...