1、March 2013Translation by DIN-Sprachendienst.English price group 19No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 3
2、5.240.80!$O“1959444www.din.deDDIN EN ISO 11238Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchangeof regulated information on substances (ISO 11238:2012);English version EN ISO 11238:2012,English translation of DIN EN ISO 112
3、38:2013-03Medizinische Informatik Identifikation von Arzneimitteln Struktur und kontrollierte Vokabularien zur Identifikation und Beschreibung vonSubstanzen und Inhaltsstoffen (ISO 11238:2012);Englische Fassung EN ISO 11238:2012,Englische bersetzung von DIN EN ISO 11238:2013-03Informatique de sant I
4、dentification des mdicaments lments de donnes et structures pour lidentification unique et lchange dinformationsrglementes sur les substances (ISO 11238:2012);Version anglaise EN ISO 11238:2012,Traduction anglaise de DIN EN ISO 11238:2013-03www.beuth.deIn case of doubt, the German-language original
5、shall be considered authoritative.Document comprises 48 pages02.13 DIN EN ISO 11238:2013-03 2 A comma is used as the decimal marker. National foreword This document (EN ISO 11238:2012) has been prepared by Technical Committee ISO/TC 215 “Health infor-matics” in collaboration with Technical Committee
6、 CEN/TC 251 “Health informatics” (Secretariat: NEN, Netherlands). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-07-03 AA Terminologie of Section 7 Medizinische Informatik. The DIN Standards correspondin
7、g to the International Standards referred to in this document are as follows: ISO 3166-1 DIN EN ISO 3166-1 ISO 8601 DIN ISO 8601 ISO 11239 DIN EN ISO 11239 ISO 11240 DIN EN ISO 11240 ISO 11615 DIN EN ISO 11615 ISO 11616 DIN EN ISO 11616 ISO 27953-1 DIN EN ISO 27953-1 ISO 27953-2 DIN EN ISO 27953-2 N
8、ational Annex NA (informative) Bibliography DIN EN ISO 3166-1, Codes for the representation of names of countries and their subdivisions Part 1: Country codes DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times DIN EN ISO 11615, Health inform
9、atics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated medicinal product information DIN EN ISO 11616, Health informatics Identification of medicinal products Data elements and structures for unique identification and exchange
10、of regulated pharmaceutical product information DIN EN 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
11、 packaging DIN EN ISO 11240, Health informatics Identification of medicinal products Data elements and structures for unique identification and exchange of units of measurement DIN EN ISO 27953-1, Health informatics Individual case safety reports (ICSRs) in pharmacovigilance Part 1: Framework for ad
12、verse event reporting DIN EN ISO 27953-2, Health informatics Individual case safety reports (ICSRs) in pharmacovigilance Part 2: Human pharmaceutical reporting requirements for ICSR EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11238 November 2012 ICS 35.240.80 English Version Health info
13、rmatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances Informatique de sant - Identification des mdicaments - lments de donnes et structures pour lidentification unique et lchange dinformations r
14、glementes sur les substances (ISO 11238:2012) Medizinische Informatik - Identifikation von Arzneimitteln - Struktur und kontrollierte Vokabularien zur Identifikation und Beschreibung von Substanzen und Inhaltsstoffen This European Standard was approved by CEN on 24 May 2012. CEN members are bound to
15、 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-CE
16、NELEC 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 t
17、he 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, Luxem
18、bourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.
19、Ref. No. EN ISO 11238:2012: EEUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG (ISO 11238:2012) (ISO 11238:2012) Contents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Terms, definitions, symbols and abbreviated terms 5 2.1 Terms and definitions
20、5 2.2 Symbols and abbreviated terms . 12 3 Requirements . 13 3.1 General 13 3.2 Concepts required for the unique identification and description of substances . 13 3.3 Concepts required for the description of specified substances . 15 3.4 Naming of substances . 16 3.5 Requirements for unique identifi
21、ers 17 3.6 Types of substances 18 3.7 Defining specified substances . 31 Annex A (informative) Existing identifiers and molecular structure representations 39 Bibliography 42 2DIN EN ISO 11238:2013-03 EN ISO 11238:2012 (E) Foreword This document (EN ISO 11238:2012) has been prepared by Technical Com
22、mittee 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
23、 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
24、 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, Fr
25、ance, 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 11238:2012 has been approved by CEN as a EN
26、 ISO 11238:2012 without any modification. “”3DIN EN ISO 11238:2013-03 EN ISO 11238:2012 (E) IntroductionThis International Standard was developed in response to a worldwide demand for internationally harmonized specifications for medicinal products. It is one of a group of five standards which toget
27、her 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,
28、 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 identificati
29、on 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
30、 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 wo
31、rldwide 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
32、necessary to reliably exchange medicinal product information in a robust and reliable manner. The IDMP standards therefore support the following interactions: between one medicine regulatory agency and another, e.g. European Medicines Agency to the US Food and Drug Administration (FDA), or vice vers
33、a; between pharmaceutical companies and medicine regulatory agencies, e.g. “Pharma Company A” to Health Canada; between the sponsor of a clinical trial to a medicine regulatory agency, e.g. “University X” to the Austrian Medicines Agency; between a medicine regulatory agency and other stakeholders,
34、e.g. UK Medicines and Health Care Products Regulatory Agency (MHRA) to the National Health Service (NHS); between medicine regulatory agencies and worldwide-maintained data sources, e.g. the Pharmaceutical and Medical Device Agency (PMDA) and the organization responsible for assigning substance iden
35、tifiers.The necessary messaging specifications are included as an integral part of the IDMP standards to secure the interactions listed above.Unique identifiers produced in conformance with the IDMP standards will support applications for which it is necessary to reliably identify and trace the use
36、of medicinal products and the materials within medicinal products.This International Standard provides a structure that enables the assignment and maintenance of unique identifiers for all substances in medicinal products or in packaging materials in which medicinal products are contained. This Inte
37、rnational Standard sets out the general rules for defining and distinguishing substances, and provides a high-level model that structures substances and specified substances for the organization and capturing of data.This International Standard has been developed using HL7s Common Product Model, and
38、 detailed modelling of substances and specified substances has been undertaken in that domain. It is anticipated that implementation will use the HL7 substances implementation guide and messaging to deliver a strong, non-semantic unique identifier for every substance present in a medicinal product.
39、It is anticipated that a single organization will be 4DIN EN ISO 11238:2013-03 EN ISO 11238:2012 (E) responsible for the generation of identifiers for every substance and that such an organization would retain the defining elements upon which the substance identifier was based. At the specified subs
40、tance level, a more regional approach may be necessary because of the proprietary nature of much of the information.The use of the identifier is essential for the description of substances in medicinal products on a global scale. This International Standard does not involve developing nomenclature f
41、or substances or specified substances, but common and official substance names in current use can be mapped to each identifier.Materials used in medicinal products range from simple chemicals to gene-modified cells to animal tissues. To unambiguously define these substances is particularly challengi
42、ng. This International Standard defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production. Molecular structure or other immutable properties, such as taxonomic, anatomical and/or fractionation information, are used to define substance
43、s. This International Standard contains five groups of elements that are sufficient to define all substances. Although it is certainly possible to define or classify substances in other ways, this International Standard uses a minimalist structured scientific concept approach focusing on the critica
44、l elements necessary to distinguish two substances from one another. There are frequently interactions between substances when they are mixed together, but this International Standard has intentionally not included these supramolecular interactions at the substance level because of the variable natu
45、re and strength of such interactions. This International Standard also allows for the capture of multiple terms which refer to a given substance and a variety of reference information that could be used to classify substances or relate one substance to another.In addition to the substance level, thi
46、s International Standard also provides elements for the capture of further information on substances, such as grade, manufacturer, manufacturing specifications, and also to capture information on substances that are frequently combined together in commerce but are not strictly a medicinal product. A
47、t the specified substance level, four groups of elements provide information essential to the tracking and description of substances in medicinal products.The basic concepts in the regulatory and pharmaceutical standards development domain use a wide variety of terms in various contexts. The informa
48、tion models presented in this International Standard depict elements and the relationship between elements that are necessary to define substances. The terms and definitions described in this International Standard are to be applied for the concepts that are required to uniquely identify, characteri
49、ze and exchange information on substances in regulated medicinal products.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.5DIN
