1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Health informatics Identification of medicinal products Data elements and structures for unique identification and exchange of regulated pharmaceutical product informationBS EN ISO 11616:2017EUROPEANSTANDARDNORME EUROPE
2、NNE EUROPISCHE NORMEN ISO 11616 December 2017ICS 35.240.80 Supersedes EN ISO 11616:2012EnglishVersionHealth informatics - Identification of medicinal products -Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical ProductInformation (ISO 11616:2017)Infor
3、matique de sant - Identification des mdicaments- lments de donnes et structures pourlidentification unique et lchange dinformationsrglementes sur lesproduits pharmaceutiques (ISO11616:2017)Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zurIdentifikation un
4、d zum Austausch von pharmazeutischen Produktkennzeichen (ISO11616:2017)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 thisEuropean Standard the status of a national sta
5、ndard without any alteration.Up-to-date lists and bibliographical referencesconcerning 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 an
6、y other language made bytranslation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC ManagementCentre has the same status as the officialversions.CEN members are the nationalstandards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,
7、 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.EUROPE
8、AN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2017 CEN All rights of exploitation in any form and by any means reservedworldwide for CENnational Members.Ref. No. EN ISO 11616:2017 ENati
9、onal forewordThis British Standard is the UK implementation of EN ISO 11616:2017. It is identical to ISO 11616:2017. It supersedes BS EN ISO 11616:2012, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations
10、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 2018 Published by BSI Standards Limited 2018ISBN 978
11、 0 580 94879 4ICS 35.240.80Compliance 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 31 January 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITIS
12、H STANDARDBS EN ISO 11616:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11616 December 2017 ICS 35.240.80 Supersedes EN ISO 11616:2012English Version Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of
13、regulated Pharmaceutical Product Information (ISO 11616:2017) Informatique de sant - Identification des mdicaments - lments de donnes et structures pour lidentification unique et lchange dinformations rglementes sur les produits pharmaceutiques (ISO 11616:2017) Medizinische Informatik - Identifikati
14、on von Arzneimitteln - Datenelemente und -strukturen zur Identifikation und zum Austausch von pharmazeutischen Produktkennzeichen (ISO 11616:2017) 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
15、 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 Stand
16、ard 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 nati
17、onal 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, Ser
18、bia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2017 CEN All rights of exploitation in any form an
19、d by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11616:2017 EBS EN ISO 11616:2017EN ISO 11616:2017 (E) 3 European foreword This document (EN ISO 11616:2017) has been prepared by Technical Committee ISO/TC 215 “Health informatics“ in collaboration with Technical Committee C
20、EN/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 late
21、st 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 11616:2012. According to the CEN-CENELEC Internal Re
22、gulations, 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,
23、 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 11616:2017 has been approved by CEN as EN ISO 11616:2017 without any modification. B
24、S EN ISO 11616:2017ISO 11616:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms, definitions and abbreviated terms 24 Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications . 95 Requirements 95.1 Elements re
25、quired for the unique identification of pharmaceutical products 95.2 Exchange of pharmaceutical product information .106 Description of the information modelling principles and practices .106.1 General considerations . 106.2 Conceptual overview diagrams . 116.3 High-level diagrams . 116.4 Detailed d
26、escription diagrams . 126.4.1 General. 126.4.2 Relationships between classes . 136.4.3 Attributes of classes .146.4.4 Generalised classes and patterns . 146.4.5 Translation and language 147 Identifying characteristics for the identification of pharmaceutical products 147.1 Pharmaceutical product ide
27、ntification strata and levels .147.1.1 General. 147.1.2 PhPID specified substance . 157.1.3 Pharmaceutical product specified substance identification (PhPID SpSub) 167.2 Cardinality 177.3 Representation of strength concentration . 177.4 Pharmaceutical product identifier (PhPID) 187.5 Pharmaceutical
28、product substance stratum elements (PhPID_SUB_Lx) .187.5.1 Construct of the pharmaceutical product substance stratum .187.5.2 Substance set187.5.3 Administrable dose form . 197.5.4 Unit of presentation .197.5.5 Medical device .197.6 Pharmaceutical product specified substance stratum elements (PhPID_
29、SpSUB_Lx) .197.6.1 Construct of the pharmaceutical product specified substance stratum .197.6.2 Specified substance set .207.6.3 Administrable dose form . 207.6.4 Unit of presentation .207.6.5 Medical device .207.7 Identifying characteristics to express strength .207.7.1 Expressing strength .207.7.2
30、 Attributes for representation of strength in PhPID stratum elements 217.7.3 Representation of strength for a patch 238 Relationship between MPID/PCID and PhPID 238.1 Concepts required for the unique identification of a Medicinal Product and the association with PhPIDs 238.2 Pharmaceutical product i
31、dentification criteria .258.2.1 General considerations 258.2.2 Multiple products packaged as a kit and administered as separate Medicinal Products .25 ISO 2017 All rights reserved iiiContents PageBS EN ISO 11616:2017ISO 11616:2017(E)8.2.3 Multiple products packaged as a kit for reconstitution and ad
32、ministered as one Medicinal Product . 268.2.4 Components of kits which are not packaged together (e.g. radiopharmaceutical kits) 268.2.5 Different representations of strength in two or more regions for identical products 268.2.6 Representation of PhPID for a patch .279 Relationship between IMPID/IPC
33、ID and PhPID 2710 Conceptual model .29Bibliography .30iv ISO 2017 All rights reservedBS EN ISO 11616:2017ISO 11616:2017(E)ForewordISO (the International Organization for Standardisation) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International S
34、tandards 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 organisations, governmental and non-governmental, in liaison with ISO, als
35、o take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardisation.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. I
36、n 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 element
37、s 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 (
38、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
39、as information about ISOs 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
40、 the first edition (ISO 11616:2012), which has been technically revised. ISO 2017 All rights reserved vBS EN ISO 11616:2017ISO 11616:2017(E)IntroductionThis document was developed in response to a worldwide demand for internationally harmonised specifications for Medicinal Products. It is part of a
41、set of five ISO Standards and four ISO Technical Specifications which together provide the basis for the unique Identification of Medicinal Products (IDMP).These sets of standards and technical specifications comprise: ISO 11615; ISO/TS 20443; ISO 11616; ISO/TS 20451; ISO 11238; ISO/TS 19844; ISO 11
42、239; ISO/TS 20440; ISO 11240.The purpose of this document is to present data elements, structures and their relationships in order to uniquely identify and exchange regulated pharmaceutical product information. This document provides an accurate and consistent mechanism to fully represent the relati
43、onship of pharmaceutical product identifier(s) (PhPID) with the following: Medicinal Product Identifier(s) (MPIDs); Package Component Identifier(s) (PCIDs); Investigational Medicinal Product Identifier(s) (IMPIDs); Investigational Package Component Identifier(s) (IPCIDs).These standards and technica
44、l specifications for the identification of Medicinal Products support the activities of medicines regulatory agencies worldwide by region. These include a variety of regulatory activities related to development, registration and life cycle management of Medicinal Products, as well as pharmacovigilan
45、ce and risk management.To meet the primary objectives of the regulation of medicines and pharmacovigilance, it is necessary to reliably exchange Medicinal Product information in a robust and consistent manner. The IDMP standards therefore support, at a minimum, the following interactions: regulatory
46、 medicines authority to regulatory medicines authority; pharmaceutical company to regulatory medicines authority; sponsor of a clinical trial to regulatory medicines authority; regulatory medicines authority to other stakeholders (as applicable); regulatory medicines authority to worldwide-maintaine
47、d data sources.The necessary messaging specifications are included as an integral part of the IDMP standards to secure the interactions above. This is critical to describing and protecting the integrity of the interactions listed above for the submission of regulated Medicinal Product information in
48、 the context of unique product identification and acknowledgement of receipt (which includes the validation of transmitted information).vi ISO 2017 All rights reservedBS EN ISO 11616:2017ISO 11616:2017(E)Unique identifiers produced in conformance with the IDMP standards are aimed at supporting appli
49、cations where 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 given in this document are to be applied for the concepts which are required to uniquely identify, characterise and exchange regulated Medicinal Products and associated information.The terms and definitions adopted in this
