1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Health informatics Identification of medicinal products Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (IS
2、O/TS 20451:2017)PD CEN ISO/TS 20451:2018TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 20451 May 2018 ICS 35.240.80 English Version Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for
3、 the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017) Informatique de sant - Identification des mdicaments - Lignes directrices pour limplmentation des lments de donnes et structures ISO 11616 pour lidentification unique et lchange dinformations
4、rglementes sur les produits pharmaceutiques (ISO/TS 20451:2017) Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden fr ISO 11616 Datenelemente und -strukturen zur eindeutigen Identifikation und zum Austausch von Informationen ber pharmazeutische Produkte (ISO/TS 20
5、451:2017)This Technical Specification (CEN/TS) was approved by CEN on 13 May 2018 for provisional application. The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whethe
6、r the CEN/TS can be converted into a European Standard. CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force
7、 (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Fra
8、nce, 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. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROP
9、ISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 20451:2018 ENational forewordThis Published Document is the UK implementati
10、on of CEN ISO/TS 20451:2018. It is identical to ISO/TS 20451:2017.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 obtained on request to its secretary.This publication does not purpor
11、t 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 0 580 91247 4ICS 35.240.80Compliance with a British Standard cannot confer immunity from legal obligation
12、s.This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CEN ISO/TS 20451:2018TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION
13、CEN ISO/TS 20451 May 2018 ICS 35.240.80 English Version Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017) Info
14、rmatique de sant - Identification des mdicaments - Lignes directrices pour limplmentation des lments de donnes et structures ISO 11616 pour lidentification unique et lchange dinformations rglementes sur les produits pharmaceutiques (ISO/TS 20451:2017) Medizinische Informatik - Identifikation von Arz
15、neimitteln - Implementierungsleitfaden fr ISO 11616 Datenelemente und -strukturen zur eindeutigen Identifikation und zum Austausch von Informationen ber pharmazeutische Produkte (ISO/TS 20451:2017)This Technical Specification (CEN/TS) was approved by CEN on 13 May 2018 for provisional application. T
16、he period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard. CEN members are required to announce the existence of th
17、is CEN/TS in the same way as for an EN and to make the CEN/TS available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is
18、reached. 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, Netherlands, Norwa
19、y, 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 2018 CEN All righ
20、ts of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 20451:2018 EPD CEN ISO/TS 20451:2018CEN ISO/TS 20451:2018 (E) 3 European foreword This document (CEN ISO/TS 20451:2018) has been prepared by Technical Committee ISO/TC 215 “ Health inform
21、atics “ in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. 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 al
22、l such patent rights. According to the CEN-CENELEC Internal Regulations, 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
23、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 the United Kingdom. Endorsement notice The text of ISO/TS 20451:2017 has been
24、 approved by CEN as CEN ISO/TS 20451:2018 without any modification. PD CEN ISO/TS 20451:2018ISO/TS 20451:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 24 Conformance . 25 Concepts required for the unique identification of pharmaceutical products 25.1 Ge
25、neral considerations for elements required for the unique identification of pharmaceutical products . 25.2 Principles required for the unique identification of a pharmaceutical product 26 Identifying characteristics for the identification of pharmaceutical products . 36.1 Pharmaceutical product iden
26、tification strata and levels 36.2 PhPID specified substance 46.3 Pharmaceutical product specified substance identification (PhPID SpSub) . 56.4 Cardinality . 56.5 Representation of strength concentration 66.6 Pharmaceutical product identifier (PhPID) . 66.7 PhPID algorithm and product code concept 7
27、7 Ingredient, substance and strength 87.1 General considerations 87.2 Ingredient 97.2.1 Ingredient role . 97.2.2 Substance 107.2.3 Specified substance 107.2.4 Specified substance group 107.2.5 Confidentiality indicator 117.2.6 Strength 117.2.7 Pharmaceutical product code concept for representing the
28、 normalised strength for liquid preparations 117.2.8 Strength (presentation) 127.2.9 Strength (concentration) . 127.2.10 Measurement point 137.2.11 Country 137.2.12 Reference strength 137.2.13 Reference substance 137.2.14 Reference specified substance 137.2.15 Reference strength 137.2.16 Reference s
29、trength measurement point .147.2.17 Reference strength country . 148 Pharmaceutical product: adjuvants and devices .148.1 General considerations . 148.1.1 Detailed description of pharmaceutical product and device information 148.1.2 Pharmaceutical product . 158.1.3 Pharmaceutical product characteris
30、tics .178.1.4 Device (pharmaceutical product) 18Annex A (normative) Messaging: Ingredient, substance and strength 19Annex B (normative) Messaging: Pharmaceutical product and device .33Annex C (informative) Examples 40Annex D (informative) Examples of representation of strength .45 ISO 2017 All right
31、s reserved iiiContents PagePD CEN ISO/TS 20451:2018ISO/TS 20451:2017(E)Bibliography .48iv ISO 2017 All rights reservedPD CEN ISO/TS 20451:2018ISO/TS 20451:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies
32、). 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 organizations, governmental and no
33、n-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.The procedures used to develop this document and those intended for its further maintenance are descri
34、bed 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 with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to
35、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 patent rights identified during the development of the document will be in the Introduction and/or on the IS
36、O 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.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions re
37、lated 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.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 215, Health informatics.
38、 ISO 2017 All rights reserved vPD CEN ISO/TS 20451:2018ISO/TS 20451:2017(E)IntroductionThis document gives guidelines for implementing ISO 11616, one of the five ISO IDMP standards. The five ISO Standards and four ISO Technical Specifications, when used together, provide the basis for exchanging dat
39、a elements that will support the unique and unambiguous identification of Medicinal Products. The primary purpose of this document is to provide technical guidance to software implementers; short descriptions of business rationale are also included, where relevant, to provide context. Thus, this doc
40、ument focuses on business and technical considerations for implementation that will construct and parse well-formed, transmittable IDMP messages. Following transmission of required data elements, unique identifiers are to be produced in conformance with the standards to support applications where it
41、 is necessary to reliably identify and trace regulated biopharmaceutical products. However, this document does not include extensive information on creation or maintenance of identifier repositories. Reference is made to regional guidance/implementation guides to support practical implementation wit
42、hin a given region/jurisdiction. The development of an ISO technical report for identifying core principles for the maintenance of identifiers and terms for ISO IDMP is to be developed and referenced for applicable ISO IDMP standards and corresponding technical specifications.vi ISO 2017 All rights
43、reservedPD CEN ISO/TS 20451:2018Health informatics Identification of medicinal products Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information1 ScopeThis document defines the concepts required to
44、 associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards
45、 can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of this document.Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7 Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured Prod
46、uct Labelling (SPL) can be applied for pharmaceutical product information in the context of this document.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only th
47、e edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 3166-1, Codes for the representation of names of countries and their subdivisions Part 1: Country codesISO 11238, Health informatics Identification of Medicinal Produ
48、cts Data elements and structures for the unique identification and exchange of regulated information on substancesISO 11239, Health informatics Identification of Medicinal Products Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose
49、 forms, units of presentation, routes of administration and packagingISO 11240, Health informatics Identification of Medicinal Products Data elements and structures for the unique identification and exchange of units of measurementISO 11615, Health informatics Identification of Medicinal Products Data elements and structures for the unique identification and exchange of regulated Medicinal Product informationISO/TS 19844, Health informatics Identification of Medicinal Products Implementation guidelines
