1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Health informatics Identification of medicinal products Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS
2、20443:2017)PD CEN ISO/TS 20443:2018TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 20443 May 2018 ICS 35.240.80 English Version Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the
3、unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017) Informatique de sant - Identification des mdicaments - Lignes directrices pour limplmentation des lments de donnes et structures ISO 11615 pour lidentification unique et lchange dinformations rglementes
4、 sur les mdicaments (ISO/TS 20443:2017) Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation von Arzneimitteln fr den Austausch von behrdlich genehmigten Arzneimittelinformationen (ISO/TS 20443:2017) This Technical Specification (CEN/TS) was a
5、pproved 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 whether the CEN/TS can be converted into a European Standa
6、rd. 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 (in parallel to the CEN/TS) until the final decisio
7、n 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, France, Germany, Greece, Hungary, Iceland, Ireland, Ita
8、ly, 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 EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Cen
9、tre: 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 20443:2018 ENational forewordThis Published Document is the UK implementation of CEN ISO/TS 20443:2018. It is identical to ISO/
10、TS 20443:2017.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 purport to include all the necessary provisions of a contr
11、act. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 91310 5ICS 35.240.80Compliance with a British Standard cannot confer immunity from legal obligations.This Published Document was published under the au
12、thority of the Standards Policy and Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CEN ISO/TS 20443:2018TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 20443 May 2018 ICS 35.240.80 English Vers
13、ion Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017) Informatique de sant - Identification des mdicaments - Lignes
14、 directrices pour limplmentation des lments de donnes et structures ISO 11615 pour lidentification unique et lchange dinformations rglementes sur les mdicaments (ISO/TS 20443:2017) Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation von Arzne
15、imitteln fr den Austausch von behrdlich genehmigten Arzneimittelinformationen (ISO/TS 20443:2017) 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 membe
16、rs 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 this CEN/TS in the same way as for an EN and to make the CEN/TS available promptly at national level
17、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 reached. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cypr
18、us, 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, Turkey and Un
19、ited 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 rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. N
20、o. CEN ISO/TS 20443:2018 EPD CEN ISO/TS 20443:2018CEN ISO/TS 20443:2018 (E) 3 European foreword This document (CEN ISO/TS 20443:2018) has been prepared by Technical Committee ISO/TC 215 “ Health informatics “ in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat o
21、f 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 all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards org
22、anizations 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, Italy, Latvia, Lithuania, Luxembourg
23、, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/TS 20443:2017 has been approved by CEN as CEN ISO/TS 20443:2018 without any modification. PD CEN ISO/TS 20443:2018ISO/TS
24、20443:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 24 Message exchange . 24.1 General . 24.2 Message exchange format 24.3 Controlled vocabularies 35 Conformance terminology and context as it relates to the ISO IDMP standards and corresponding technical
25、 specifications 36 Maintenance of IDMP data elements and IDMP identifiers . 36.1 General . 36.2 Translation and language 37 Why standardisation of identification of Medicinal Products is needed . 48 General considerations 48.1 Overview 48.2 General considerations related to the description of the in
26、formation modelling principles and practices 58.2.1 Overview . 58.2.2 Conceptual overview diagrams . 58.2.3 Section high-level diagrams . 68.2.4 Detailed description diagrams . 78.2.5 Relationships between classes 88.2.6 Attributes of classes 98.2.7 Generalised classes and patterns 99 Information fo
27、r an authorised Medicinal Product 99.1 General . 99.2 Medicinal Product . 119.3 Header . 119.4 Medicinal Product name 119.5 Manufacturer/establishment (organisation) 119.6 Marketing authorisation 129.7 Packaged Medicinal Product 129.8 Pharmaceutical Product . 129.9 Ingredient . 139.10 Clinical parti
28、culars 1310 Investigational Medicinal Product Identifier (IMPID) .1310.1 Conceptual overview of the information for an Investigational Medicinal Product .1310.2 Investigational Medicinal Product 1510.3 Clinical trial authorisation . 1510.4 Investigational Medicinal Product name . 1510.5 Header . 151
29、0.6 Manufacturer/establishment (organisation) 1510.7 Pharmaceutical product . 1610.8 Investigational Packaged Medicinal Product .1610.9 Ingredient . 1710.10 Clinical particulars 17Annex A (normative) Medicinal Product .20 ISO 2017 All rights reserved iiiContents PagePD CEN ISO/TS 20443:2018ISO/TS 20
30、443:2017(E)Annex B (normative) Marketing authorisation 47Annex C (normative) Packaged Medicinal Product (including manufactured item and device) 71Annex D (normative) Ingredient, substance and strength . 110Annex E (normative) Pharmaceutical product and device . 125Annex F (normative) Clinical parti
31、culars . 133Annex G (normative) Organisation . 151Annex H (normative) Manufacturer/establishment . 156Annex I (normative) Investigational Medicinal Product 164Annex J (normative) SPL documents . 180Annex K (informative) Abbreviations . 200Bibliography . 202iv ISO 2017 All rights reservedPD CEN ISO/T
32、S 20443:2018ISO/TS 20443:2017(E)ForewordISO (the International Organization for Standardisation) 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 intere
33、sted in a subject for which a technical committee has been established 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
34、Commission (IEC) on all matters of electrotechnical standardization.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 documen
35、ts 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 elements of this document may be the subject of patent rights. ISO shall not be held responsible
36、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 (see www.iso.org/patents).Any trade name used in this document is information given for the
37、 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 as information about ISOs adherence to the World Trade Organization (WTO) principles in th
38、e 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. ISO 2017 All rights reserved vPD CEN ISO/TS 20443:2018ISO/TS 20443:2017(E)IntroductionThis document is a guide for implementing I
39、SO 11615, one of the five ISO IDMP standards. The five ISO standards and four ISO Technical Specifications, when used together, provide the basis for exchanging data elements that will support the unique and unambiguous identification of Medicinal Products. The primary purpose for this document is t
40、o provide technical guidance to software implementers. Short descriptions of business rationale are also included, where relevant, to provide context. Thus, this document focuses on business and technical considerations for implementation that will construct and parse well-formed, transmittable IDMP
41、 messages. Following transmission of required data elements, unique identifiers are to be produced in conformance with the standards to support applications where it is necessary to reliably identify and trace regulated biopharmaceutical products. However, this document does not include extensive in
42、formation on creation or maintenance of identifier repositories. Reference is made to regional guidance/implementation guides to support practical implementation within a given region/jurisdiction. The development of an ISO technical report for identifying core principles for the maintenance of iden
43、tifiers and terms for ISO IDMP is to be developed and referenced for applicable ISO IDMP standards and corresponding technical specifications.PurposeTo meet the primary objectives of the regulation of medicines (pharmacovigilance) it is necessary to reliably exchange Medicinal Product information in
44、 a robust and consistent manner. The data elements and message specifications described in this document support, at a minimum, the following interactions within the following scope: regulator to regulator; biopharmaceutical company to regulator; sponsor of clinical trials to regulator; regulator to
45、 other stakeholders; regulator to worldwide-maintained data sources.Unique identifiers produced in conformance with this document are aimed at supporting applications where it is necessary to reliably identify and trace the use of Medicinal Products.In the context of exchange of regulatory informati
46、on, the purpose of this document is twofold: to specify data elements, structures and relationships between the data elements which are required to uniquely identify Medicinal Products for human use; to specify definitions of terms for all data elements required to uniquely identify Medicinal Produc
47、ts for human use.vi ISO 2017 All rights reservedPD CEN ISO/TS 20443:2018Health informatics Identification of medicinal products Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information1 ScopeThis docume
48、nt defines concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.Taken together, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characteri
49、se, and uniquely identify regulated Medicinal Products for human use from approval, to post-marketing and renewal or withdrawal from the market, where applicable.Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in this
