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 the unique identification and exchange of regulated medicinal product informationBS EN ISO 11615:2017EUROPEAN STANDARD NORME EUROP
2、ENNE EUROPISCHE NORM EN ISO 11615 December 2017 ICS 35.240.80 Supersedes EN ISO 11615:2012English Version Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017) In
3、formatique de sant - Identification des mdicaments - lments de donnes et structures pour lidentification unique et lchange dinformations sur les mdicaments contrls (ISO 11615:2017) Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation von Arzne
4、imitteln fr den Austausch von behrdlich genehmigten Arzneimittelinformationen (ISO 11615:2017) 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 this European Standard th
5、e 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 Standard exists in three official versions (English, Fren
6、ch, 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 national standards bodies of Austria, Belgium, Bulgaria,
7、 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,
8、 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 and by any means reserved worldwide for CEN national M
9、embers. Ref. No. EN ISO 11615:2017 ENational forewordThis British Standard is the UK implementation of EN ISO 11615:2017. It is identical to ISO 11615:2017. It supersedes BS EN ISO 11615:2012, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee IST/35, Hea
10、lth 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 2018 Publish
11、ed by BSI Standards Limited 2018ISBN 978 0 580 94880 0ICS 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 s
12、ince publicationDate Text affectedBRITISH STANDARDBS EN ISO 11615:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11615 December 2017 ICS 35.240.80 Supersedes EN ISO 11615:2012English Version Health informatics - Identification of medicinal products - Data elements and structures for th
13、e unique identification and exchange of regulated medicinal product information (ISO 11615:2017) Informatique de sant - Identification des mdicaments - lments de donnes et structures pour lidentification unique et lchange dinformations sur les mdicaments contrls (ISO 11615:2017) Medizinische Informa
14、tik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation von Arzneimitteln fr den Austausch von behrdlich genehmigten Arzneimittelinformationen (ISO 11615:2017) This European Standard was approved by CEN on 17 November 2017. CEN members are bound to comply with the C
15、EN/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-CENELEC Management C
16、entre 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 the same status as
17、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, Luxembourg, Malta, Neth
18、erlands, Norway, Poland, Portugal, Romania, Serbia, 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 201
19、7 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11615:2017 EBS EN ISO 11615:2017EN ISO 11615:2017 (E) 2 Contents Page European foreword . 3 BS EN ISO 11615:2017 ISO 2017Health informatics Identification of medicinal products
20、Data elements and structures for the unique identification and exchange of regulated medicinal product informationInformatique de sant Identification des mdicaments lments de donnes et structures pour lidentification unique et lchange dinformations sur les mdicaments contrlsINTERNATIONAL STANDARDISO
21、11615Second edition2017-10Reference numberISO 11615:2017(E)BS EN ISO 11615:2017ISO 11615:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized oth
22、erwise 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 ISOs member body in the country of the requester.ISO copyright office
23、Ch. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS EN ISO 11615:2017ISO 11615:2017(E)Foreword viIntroduction vii1 Scope . 12 Normative references 13 Terms, definitions and abbreviated terms 24 Message exchange format 1
24、35 Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications 146 Concepts required for the unique identification of Medicinal Products.146.1 General considerations . 146.2 Authorised Medicinal Products . 146.3 Investigational Medicina
25、l Products 156.4 Concepts required for the unique identification of a Medicinal Product and the association with PhPID(s) 156.5 Concepts required for the unique identification of Medicinal Products and the association with the marketing authorisation number 156.6 Concepts required for the unique ide
26、ntification of Medicinal Products and the association with data carrier identifiers . 167 Description of the information modelling principles and practices .177.1 General considerations . 177.2 Conceptual overview diagrams . 177.3 High-level diagrams . 187.4 Detailed description diagrams . 187.4.1 G
27、eneral. 187.4.2 Relationships between classes . 197.4.3 Attributes of classes .207.4.4 Generalised classes and patterns . 207.4.5 Translation and language 208 Identifying characteristics for authorised Medicinal Products208.1 Primary identifiers General considerations 208.2 Medicinal Product Identif
28、ier (MPID) 218.2.1 General considerations 218.2.2 MPID code segments .218.3 Packaged Medicinal Product Identifier (PCID) 228.3.1 General considerations 228.3.2 Package description (PCID) code segment.238.4 Medicinal Product Batch Identifier (BAID1) 238.5 Medicinal Product Batch Identifier (BAID2) 23
29、9 Information for an authorised Medicinal Product .249.1 Authorised Medicinal Product Information overview 249.1.1 General. 249.1.2 Medicinal Product 249.1.3 Medicinal Product name 249.1.4 Header 259.1.5 Manufacturer/Establishment (organisation) 259.1.6 Marketing authorisation 259.1.7 Packaged Medic
30、inal Product . 259.1.8 Pharmaceutical product . 259.1.9 Ingredient . 259.1.10 Clinical particulars 259.2 Medicinal Product . 25 ISO 2017 All rights reserved iiiContents PageBS EN ISO 11615:2017ISO 11615:2017(E)9.2.1 General. 259.2.2 Detailed description of Medicinal Product information .269.3 Market
31、ing authorisation 329.3.1 General. 329.3.2 Detailed description of marketing authorisation information .339.4 Organisation . 389.4.1 General. 389.4.2 Detailed description of organisation information .389.5 Manufacturer/Establishment (organisation) 419.5.1 General. 419.5.2 Detailed description of man
32、ufacturer/establishment (organisation) information 419.6 Packaged Medicinal Product, including manufactured item and device .429.6.1 General. 429.6.2 Detailed description of Packaged Medicinal Product information 439.7 Ingredient, substance and strength . 529.7.1 General. 529.7.2 Detailed descriptio
33、n of ingredients, substance and strength information .529.8 Pharmaceutical product and device 559.8.1 General. 559.8.2 Detailed description of pharmaceutical product and device information 559.9 Clinical particulars 579.9.1 General. 579.9.2 Detailed description for clinical particulars information 5
34、810 Identifying characteristics for Investigational Medicinal Products .6210.1 General 6210.2 Primary identifiers . 6210.2.1 General considerations 6210.3 Investigational Medicinal Product Identifier (IMPID) .6310.3.1 General considerations 6310.3.2 IMPID code segments .6310.4 Investigational Medici
35、nal Product Package Identifier (IPCID) .6410.4.1 General provisions.6410.4.2 Package description code segment .6410.5 Investigational Medicinal Product Batch Identifier (BAID1) .6510.6 Investigational Medicinal Product Batch Identifier (BAID2) .6511 Information for an Investigational Medicinal Produ
36、ct 6511.1 General 6511.2 Conceptual overview of the information for an Investigational Medicinal Product 6511.2.1 General. 6511.2.2 Investigational Medicinal Product .6611.2.3 Investigational Medicinal Product name .6611.2.4 Header 6611.2.5 Manufacturer/Establishment (organisation) 6611.2.6 Clinical
37、 trial authorisation 6711.2.7 Investigational Packaged Medicinal Product 6711.2.8 Pharmaceutical product . 6711.2.9 Ingredient . 6711.2.10 Clinical particulars 6711.3 Investigational Medicinal Product 6711.3.1 General. 6711.3.2 Detailed description of Investigational Medicinal Product information 67
38、11.4 Clinical trial authorisation . 7011.4.1 General. 7011.4.2 Detailed description of clinical trial authorisation information 7011.5 Manufacturer/Establishment (organisation) 7211.6 Investigational Packaged Medicinal Product . 72iv ISO 2017 All rights reservedBS EN ISO 11615:2017ISO 11615:2017(E)1
39、1.7 Pharmaceutical product . 7211.7.1 General. 7211.7.2 Pharmaceutical product . 7311.7.3 Dosing and route of administration .7311.8 Ingredient . 7311.9 Clinical particulars 7411.10 PhPID sets 7411.11 Device nomenclature 7411.12 Device batch identifier 7411.13 Physical characteristics 7411.14 Other
40、characteristics . 74Annex A (normative) Full model Authorised Medicinal Products detailed diagram .75Annex B (normative) Full model Investigational Medicinal Products detailed diagram 76Bibliography .77 ISO 2017 All rights reserved vBS EN ISO 11615:2017ISO 11615:2017(E)ForewordISO (the International
41、 Organization for Standardization) is a worldwide federation of national 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 est
42、ablished has the right to be represented on that committee. International 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 standardiz
43、ation.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance wi
44、th 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 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. Details of any
45、patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (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.F
46、or an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www
47、.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 215, Health informatics.This second edition cancels and replaces the first edition (ISO 11615:2012), which has been technically revised.vi ISO 2017 All rights reservedBS EN ISO 11615:2017ISO 11615:2017(E)Introduction
48、This document was developed in response to a worldwide demand for internationally harmonised specifications for Medicinal Products. It is part of a set of five ISO Standards and four ISO Technical Specifications which together provide the basis for the unique Identification of Medicinal Products (ID
49、MP).These sets of standards and technical specifications comprise: ISO 11615 ISO/TS 20443; ISO 11616; ISO/TS 20451; ISO 11238; ISO/TS 19844; ISO 11239; ISO/TS 20440; ISO 11240.These standards and technical specifications for the identification of Medicinal Products (IDMP) 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
