BS EN ISO 11238-2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on sub.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11238:2012Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on su

2、bstancesBS EN ISO 11238:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11238:2012.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtai

3、ned on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 2012ISBN 978 0 580 71935 6 ICS 35.240.80 Compliance w

4、ith a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2012.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE

5、NORM EN ISO 11238 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 information on substances (ISO 11238:2012) Informatique de sant - Identification des mdicamen

6、ts - lments de donnes et structures pour lidentification unique et lchange dinformations rglementes sur les substances (ISO 11238:2012) Medizinische Informatik - Identifikation von Arzneimitteln - Struktur und kontrollierte Vokabularien zur Identifikation und Beschreibung von Substanzen und Inhaltss

7、toffen (ISO 11238:2012) 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

8、 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 r

9、esponsibility 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

10、 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 COMIT EUROPEN DE

11、NORMALISATION EUROPISCHES KOMITEE FR NORMUNG 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. Ref. No. EN ISO 11238:2012: EBS EN ISO 11238:2012EN ISO 11238:2012 (E) 3 Foreword This docum

12、ent (EN ISO 11238:2012) 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 publi

13、cation 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 no

14、t 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,

15、 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

16、 The text of ISO 11238:2012 has been approved by CEN as a EN ISO 11238:2012 without any modification. BS EN ISO 11238:2012ISO 11238:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 12 Terms, definitions, symbols and abbreviated terms 12.1 Terms and definitions .

17、12.2 Symbols and abbreviated terms . 83 Requirements . 93.1 General . 93.2 Concepts required for the unique identification and description of substances 93.3 Concepts required for the description of specified substances 113.4 Naming of substances .123.5 Requirements for unique identifiers 133.6 Type

18、s of substances .143.7 Defining specified substances 27Annex A (informative) Existing identifiers and molecular structure representations 35Bibliography .38BS EN ISO 11238:2012ISO 11238:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national stan

19、dards 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 org

20、anizations, 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

21、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 %

22、 of the member bodies casting a vote.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.ISO 11238 was prepared by Technical Committee ISO/TC 215, Health

23、informatics.iv ISO 2012 All rights reservedBS EN ISO 11238:2012ISO 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 together provide

24、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 info

25、rmatics 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 excha

26、nge 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;I

27、SO 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 j

28、urisdiction. 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

29、 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 versa; between p

30、harmaceutical 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, e.g. UK Medi

31、cines 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 identifiers.The

32、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 of medicinal

33、 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 International St

34、andard 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 detailed mo

35、delling 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. It is antici

36、pated that a single organization will be ISO 2012 All rights reserved vBS EN ISO 11238:2012ISO 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 specifi

37、ed substance 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 nomencl

38、ature for 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 ch

39、allenging. 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 su

40、bstances. 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

41、critical 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 variab

42、le nature 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 lev

43、el, this 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 pro

44、duct. At 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

45、information 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, cha

46、racterize 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

47、document. In case of doubt or potential conflict, the terms and definitions contained in legally binding documents prevail.vi ISO 2012 All rights reservedBS EN ISO 11238:2012INTERNATIONAL STANDARD ISO 11238:2012(E)Health informatics Identification of medicinal products Data elements and structures f

48、or the unique identification and exchange of regulated information on substances1 ScopeThis International Standard provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics.

49、Other standards and external terminological resources are referenced that are applicable to this International Standard.2 Terms, definitions, symbols and abbreviated terms2.1 Terms and definitionsFor the purposes of this document, the following terms, definitions and abbreviations apply.2.1.1active markerconstituent, or groups of constituents, of an herbal substance, herbal preparation or herbal medicinal product which are of interest for control purposes and are generally accepted to contribute to therapeutic activityNOTE