1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11615:2012Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated medicinal product
2、 informationBS EN ISO 11615:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11615:2012.The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e I S T / 3 5 , H e a l t h i n f o r m a t i c s .A list of organizations
3、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 by BSI Standards Limited 2012.ISBN 9
4、78 0 580 71938 7 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 publicationDate T e x t a f f e c t e dEU
5、ROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11615 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 medicinal product information (ISO 11615:2012) Inf
6、ormatique de sant - Identification des mdicaments - lments de donnes et structures pour lidentification unique et lchange dinformations rglementes sur les mdicaments (ISO 11615:2012) Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation von Arz
7、neimitteln fr den Austausch von behrdlich genehmigten Arzneimittelinformationen (ISO 11615:2012)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 st
8、atus 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, French,
9、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, Cro
10、atia, 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
11、United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN 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 1161
12、5:2012: EBS EN ISO 11615:2012 EN ISO 11615:2012 (E) 3 Foreword This document (EN ISO 11615:2012) 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 S
13、tandard shall be given the status of a national standard, either 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
14、document may be the subject of patent rights. CEN and/or CENELEC 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 Standa
15、rd: 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, Slovakia, Slovenia, Spai
16、n, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11615:2012 has been approved by CEN as a EN ISO 11615:2012 without any modification. BS EN ISO 11615:2012ISO 11615:2012(E) ISO 2012 All rights reserved iiiContents PageForeword . vIntroduction . vi1 Scope 12 No
17、rmative references . 13 Terms, definitions and abbreviations 13.1 Terms and definitions . 13.2 Abbreviations .124 Requirements .144.1 Concepts required for the unique Identification of Medicinal Products 145 Description of the information modelling principles and practices 175.1 General consideratio
18、ns .175.2 Conceptual overview diagrams .185.3 Section high-level diagrams .195.4 Detailed description diagrams .206 Identifying characteristics for authorized Medicinal Products .236.1 Primary identifiers .236.2 Medicinal Product Identifier (MPID) 236.3 Packaged Medicinal Product Identifier (PCID) 2
19、46.4 Medicinal Product Batch Identifier (BAID_1) .256.5 Medicinal Product Batch Identifier (BAID_2) .257 Information for an authorized Medicinal Product .257.1 Authorized Medicinal Product Information overview .257.2 Medicinal Product .277.3 Marketing Authorization 327.4 Organization .387.5 Manufact
20、urer/Establishment 407.6 Packaged Medicinal Product, including Manufactured Item and Device .417.7 Ingredient, Substance and Strength 507.8 Pharmaceutical Product and Device 547.9 Clinical Particulars 588 Identifying characteristics for Investigational Medicinal Products .668.1 General .668.2 Primar
21、y identifiers .668.3 Investigational Medicinal Product Identifier (IMPID)678.4 Investigational Medicinal Product Package Identifier (IPCID) .688.5 Investigational Medicinal Product Batch Identifier (IBAID_1) .688.6 Investigational Medicinal Product Batch Identifier (IBAID_2) .689 Information for an
22、Investigational Medicinal Product .699.1 Conceptual overview of the information for an Investigational Medicinal Product 699.2 Investigational Medicinal Product 709.3 Clinical Trial Authorization 729.4 Manufacturer/Establishment 759.5 Investigational Packaged Medicinal Product .759.6 Pharmaceutical
23、Product 769.7 Ingredient .779.8 Clinical particulars 77Annex A (informative) Full model Authorized Medicinal Products conceptual level 78Annex B (informative) Full model Authorized Medicinal Products detailed diagram .79Annex C (informative) Full model Investigational Medicinal Products conceptual l
24、evel .80BS EN ISO 11615:2012ISO 11615:2012(E)iv ISO 2012 All rights reservedAnnex D (informative) Full Model Investigational Medicinal Products detailed diagram 81Annex E (informative) Worked example in tabular form 82Annex F (informative) Class and attribute listing 91Annex G (informative) Example
25、implementation of Medicinal Product information 105Bibliography .113BS EN ISO 11615:2012ISO 11615:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is norma
26、lly 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 non-governmental, in liaison with ISO, also take part in th
27、e 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 given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare In
28、ternational 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 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of
29、the elements of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 11615 was prepared by Technical Committee ISO/TC 215, Health informatics. ISO 2012 All rights reserved vBS EN ISO 11615:2012ISO 11615:2
30、012(E)IntroductionThis International Standard was developed in response to a worldwide demand for internationally harmonized specifications for Medicinal Products. It is one of five standards which together provide the basis for the unique Identification of Medicinal Products. The group of standards
31、 comprises:ISO 11615, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated medicinal product information;ISO 11616, Health informatics Identification of medicinal products Data elements and structures for the uni
32、que identification and exchange of regulated pharmaceutical product information;ISO 11238, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances;ISO 11239, Health informatics Identificati
33、on 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 packaging;ISO 11240, Health informatics Identification of medicinal products Data elements and s
34、tructures 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 worldwide by jurisdiction. These include a variety of regulatory activities related to development,
35、 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 is necessary to reliably exchange Medicinal Product information in a robust and consistent manner. T
36、he IDMP standards therefore support, at a minimum, the following interactions: regulator to regulator; pharmaceutical company to regulator; sponsor of clinical trial to regulator; regulator to other stakeholder; regulator to worldwide-maintained data sources.The necessary messaging specifications ar
37、e 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 where it is necessary to reliably identify and trace the use of Medicinal Products.There are many terms in use
38、 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 International Standard are to be applied for the concepts which are required to uniquely identify, chara
39、cterize and exchange regulated Medicinal Products and associated information.The terms and definitions adopted in this International Standard are intended to facilitate the interpretation and application of legal and regulatory requirements but they are without prejudice to any legally binding docum
40、ent. In case of doubt or potential conflict, the terms and definitions contained in legally binding documents prevail.This International Standard has been developed in conjunction with the Common Product Model in HL7. It is anticipated that implementation will use HL7 V3 messaging to transmit inform
41、ation between stakeholders.vi ISO 2012 All rights reservedBS EN ISO 11615:2012ISO 11615:2012(E)In the context of exchange of regulatory information, the purpose of this International Standard is twofold: to specify data elements, structures and relationships between the data elements which are requi
42、red to uniquely and with certainty identify Medicinal Products for human use; to specify definitions of terms for all data elements required to uniquely and with certainty identify Medicinal Products for human use.In addition, reference to the use of other normative IDMP and messaging standards for
43、Medicinal Product information is included in this International Standard in order to support successful related information exchange. ISO 2012 All rights reserved viiBS EN ISO 11615:2012BS EN ISO 11615:2012Health informatics Identification of medicinal products Data elements and structures for the u
44、nique identification and exchange of regulated medicinal product information1 ScopeThis International Standard establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicin
45、al Products.Taken together, the standards listed in the introduction define, characterize and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorization, post-marketing and renewal or withdrawal from the market, where applicabl
46、e.Furthermore, to support successful information exchange in relation to the unique identification and characterization of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of this International Standard.2 Normative references
47、The 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 amendments) applies.ISO 639-2, Codes for the representation of names o
48、f languages Part 2: Alpha-3 codeISO 3166-1, Codes for the representation of names of countries and their subdivisions Part 1: Country codesISO 8601, Data elements and interchange formats Information interchange Representation of dates and timesISO 11616, Health informatics Identification of Medicina
49、l Products Data elements and structures for the unique identification and exchange of regulated pharmaceutical product informationISO 11238, Health informatics Identification of Medicinal Products 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
