BS EN ISO 11239-2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on phat.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11239:2012Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on ph

2、armaceutical dose forms, units of presentation, routes of administration and packagingBS EN ISO 11239:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11239:2012.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health

3、informatics.A list of organizations represented on this committee can be obtained 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

4、by BSI Standards Limited 2012ISBN 978 0 580 71936 3 ICS 35.240.80 Compliance with 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 public

5、ationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11239 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

6、pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239:2012) Informatique de sant - Identification des mdicaments - lments de donnes et structures pour lidentification unique et lchange dinformations rglementes sur les formes des doses pharmaceutiques, le

7、s units de prsentation, les voies dadministration et les emballages (ISO 11239:2012) Medizinische Informatik - Identifikation von Arzneimitteln - Struktur und kontrollierte Vokabularien zur Identifikation vonpharmazeutischen Darreichungsformen, pharmazeutischen Konventionseinheiten, Anwendungsarten

8、und Verpackungen (ISO 11239:2012) 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

9、 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 u

10、nder 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, Forme

11、r 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 COMIT E

12、UROPEN DE 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 11239:2012: EBS EN ISO 11239:2012EN ISO 11239:2012 (E) 3 Foreword

13、This document (EN ISO 11239:2012) 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, eithe

14、r 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 CENELE

15、C 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

16、, 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. Endorsem

17、ent notice The text of ISO 11239:2012 has been approved by CEN as a EN ISO 11239:2012 without any modification. BS EN ISO 11239:2012ISO 11239:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 12 Normative references . 13 Terms, definitions and abbreviations 13.1 T

18、erms and definitions . 13.2 Abbreviations . 54 Requirements . 64.1 General requirements for controlled vocabularies 64.2 Requirements for use within the IDMP set of standards 75 Schema . 75.1 General . 75.2 Conceptual models Supporting concepts . 85.3 Conceptual models High-level concepts .10Annex A

19、 (informative) Examples of controlled vocabularies 17Annex B (informative) Examples of controlled vocabularies to describe medicinal products .23Bibliography .28BS EN ISO 11239:2012ISO 11239:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national

20、 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. Internationa

21、l 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 g

22、iven 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

23、 75 % 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 11239 was prepared by Technical Committee ISO/TC 215, He

24、alth informatics.iv ISO 2012 All rights reservedBS EN ISO 11239:2012ISO 11239:2012(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 pro

25、vide the basis for the unique identification of medicinal products. The group of standards comprises:ISO 11615, Health informatics I dentification of medicinal products D ata elements and structures for the unique identification and exchange of regulated medicinal product information;ISO 11616, Heal

26、th informatics I dentification of medicinal products D ata elements and structures for the unique identification and exchange of regulated pharmaceutical product information;ISO 11238, Health informatics I dentification of medicinal products D ata elements and structures for the unique identificatio

27、n and exchange of regulated information on substances;ISO 11239, Health informatics I dentification of medicinal products D ata elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration an

28、d packaging;ISO 11240, Health informatics I dentification of medicinal products D ata 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

29、 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 i

30、s necessary to exchange medicinal product information in a robust and reliable manner. The IDMP standards therefore support the following interactions (this is not an exhaustive list): regulator to regulator; pharmaceutical company to regulator; sponsor of clinical trial to regulator; regulator to o

31、ther stakeholders; 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 whe

32、re 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 described i

33、n this International Standard are to be applied for the concepts which are required in order 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 interpr

34、etation 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.In the context of identification of pharmaceutical dose forms,

35、 units of presentation, routes of administration and packaging, this International Standard describes the essential elements for the specification, translation and versioning of the specified controlled terms. Also described are recommendations concerning the mapping of terms that are already used b

36、y stakeholders to the concepts arising from the implementation of this International Standard. ISO 2012 All rights reserved vBS EN ISO 11239:2012ISO 11239:2012(E)The high-level concepts defined consist of: pharmaceutical dose form; unit of presentation; route of administration; packaging.The support

37、ing, more mechanical, components are described separately from the high-level clinical concepts. The supporting concepts consist of: a) terms and codes; b) translations; c) versioning; d) mapping.vi ISO 2012 All rights reservedBS EN ISO 11239:2012INTERNATIONAL STANDARD ISO 11239:2012(E)Health inform

38、atics 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 packaging1 ScopeThis International Standard specifies: the data elements, stru

39、ctures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicina

40、l products; a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange; a mechanism for the versioning of the concepts in order to track their evolution; rules to allow regional authorities to map existing regio

41、nal terms to the terms created using this International Standard, in a harmonized and meaningful way.In addition, to support the successful application of this International Standard, references to standards concerned with identification of medicinal products (IDMP) and messaging for medicinal produ

42、ct information are provided as required.2 Normative referencesThe 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 amendmen

43、ts) applies.ISO 639 (all parts), Codes for the representation of names of languagesISO 3166 (all parts), Codes for the representation of names of countries and their subdivisionsISO 21090, Health informatics Harmonized data types for information interchange3 Terms, definitions and abbreviations3.1 T

44、erms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1.1administrable dose formpharmaceutical dose form for administration to the patient, after any necessary transformation of the manufactured dose form has been carried outEXAMPLES Solution for injectio

45、n, 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). ISO 2012 All rights

46、 reserved 1BS EN ISO 11239:2012ISO 11239:2012(E)3.1.2administration deviceequipment intended for correct administration of the medicinal productEXAMPLES Needle, oral syringe.NOTE 1 An administration device may be an integral part of an immediate container or a closure.NOTE 2 Adapted from ENV 12610:1

47、997.3.1.3administration methodgeneral method by which a pharmaceutical product is intended to be administered to the patientEXAMPLES Application, inhalation, injection.NOTE The administration method is a general term that is used to group related pharmaceutical dose form concepts, and is not intende

48、d to describe a precise method or route of administration.3.1.4basic dose formgeneralised version of the pharmaceutical dose form, used to group together related pharmaceutical dose formsEXAMPLES Capsule, tablet, powder, solution.3.1.5closureitem used to close a container for the purpose of the corr

49、ect storage and (where appropriate) use of the productEXAMPLES Cap, child-resistant closure, screw cap.NOTE 1 A closure may have an administration device incorporated into it.NOTE 2 A closure may be an integral part of an immediate container.3.1.6coded conceptdata type that groups together a set of code term pairs that represent a single concept but differ in language and/or geographical regionNOTE The coded concept is used to manage translations, and is the basic data type that is found in all of the h