1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11616:2012Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated pharmaceutical pr
2、oduct informationBS EN ISO 11616:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11616:2012.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 organizat
3、ions 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.I
4、SBN 978 0 580 71939 4 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
5、e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11616 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 pharmaceutical product information (ISO 11616
6、:2012) Informatique de sant - Identification des mdicaments - lments de donnes et structures pour lidentification unique et lchange dinformations rglementes sur les produits pharmaceutiques (ISO 11616:2012) Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zu
7、r Identifikation und zum Austausch von pharmazeutischen Produktkennzeichen (ISO 11616:2012) 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 status
8、 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, Germ
9、an). 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, Croatia
10、, 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 Unit
11、ed 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 11616:20
12、12: EBS EN ISO 11616:2012 EN ISO 11616:2012 (E) 3 Foreword This document (EN ISO 11616:2012) 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 Stand
13、ard 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 docu
14、ment 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 Standard:
15、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, Spain, S
16、weden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11616:2012 has been approved by CEN as a EN ISO 11616:2012 without any modification. BS EN ISO 11616:2012ISO 11616:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 12 Normative
17、references . 13 Terms, definitions and abbreviations 23.1 Terms and definitions . 23.2 Abbreviations . 74 Requirements . 84.1 Elements required for the unique identification of pharmaceutical products 84.2 Exchange of pharmaceutical product information . 95 Identifying characteristics for the identi
18、fication of pharmaceutical products . 95.1 Pharmaceutical product identification strata and levels 95.2 Cardinality . 115.3 Representation of strength concentration .125.4 Pharmaceutical product identifier (PhPID) .125.5 Pharmaceutical product substance stratum elements (PhPID_SUB_Lx) 135.6 Pharmace
19、utical Product Specified Substance Stratum Elements (PhPID_SpSUB_Lx) .155.7 Identifying characteristics to express strength 176 Relationship between MPID and PhPID .196.1 Concepts required for the unique identification of a medicinal product and the association with PhPIDs .196.2 Pharmaceutical prod
20、uct identification criteria 217 Relationship between IMPID and PhPID .238 Conceptual model .25Annex A (informative) Examples 27Annex B (informative) Tabled examples .35Bibliography .38BS EN ISO 11616:2012ISO 11616:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide
21、 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 established has the right to be represented on that
22、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 standardization.International Standards are drafted in acco
23、rdance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requir
24、es approval by at least 75 % of the member bodies casting a vote.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.ISO 11616 was prepared by Technical C
25、ommittee ISO/TC 215, Health informatics.iv ISO 2012 All rights reservedBS EN ISO 11616:2012ISO 11616:2012(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
26、together provide the basis for the unique identification of medicinal products. The group of standards 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 1
27、1616, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information;ISO 11238, Health informatics Identification of medicinal products Data elements and structures for the unique identif
28、ication and exchange of regulated information on substances;ISO 11239, Health informatics Identification 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 administratio
29、n and packaging;ISO 11240, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement.The purpose of this International Standard is to present data elements, structures and their relationships in order to un
30、iquely identify and exchange regulated pharmaceutical product information. This International Standard provides an accurate and consistent mechanism to fully represent the relationship of Pharmaceutical Product Identifier(s) (PhPID) with the following: Medicinal Product Identifier(s) (MPIDs); Invest
31、igational Medicinal Product Identifier(s) (IMPIDs).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, registration and life cyc
32、le 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 reliable manner. The IDMP standards therefore
33、support the following interactions: Regulatory 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); Regulat
34、ory Medicines Authority to worldwide-maintained data sources.Unique identifiers produced in conformance with the IDMP standards are intended to support applications where it is necessary to reliably identify and trace the use of medicinal and pharmaceutical products.Messaging specifications are incl
35、uded as an integral part of the IDMP standards. This is critical to describing and protecting the integrity of the interactions listed above for the submission of regulated medicinal product information in the context of unique product identification and acknowledgement of receipt (which includes th
36、e validation of transmitted information).There are many terms in use to describe basic concepts in the regulatory and pharmaceutical standards development domain for different purposes and in different contexts. The terms and definitions described in this International Standard are to be applied for
37、 the concepts required to uniquely identify, characterize and exchange regulated medicinal products and associated information. ISO 2012 All rights reserved vBS EN ISO 11616:2012ISO 11616:2012(E)The terms and definitions adopted in this International Standard are intended to facilitate the interpret
38、ation and application of legal and regulatory requirements but they are without prejudice to any legally binding document. 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 wi
39、th the Common Product Model in HL7. It is anticipated that implementation will use HL7 V3 messaging to transmit information between stakeholders.vi ISO 2012 All rights reservedBS EN ISO 11616:2012INTERNATIONAL STANDARD ISO 11616:2012(E)Health informatics Identification of medicinal products Data ele
40、ments and structures for unique identification and exchange of regulated pharmaceutical product information1 ScopeThis International Standard is intended to provide specific levels of information relevant to the identification of a medicinal product or group of medicinal products. It defines the dat
41、a elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other
42、activities worldwide. In addition, this International Standard is essential to ensuring that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders. This ensures interoperability and compatibility for both the sender and the rec
43、ipient.This International Standard is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorized in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This a
44、llows for medicinal products to be unequivocally identified.References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of this International Standard.Medicinal products for veterinary use are out of scope o
45、f this International Standard.2 Normative referencesThe 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) applie
46、s.ISO 3166-1, Codes for the representation of names of countries and their subdivisions Part 1: Country codesISO 11615, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated medicinal product informationISO 11238,
47、 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 exc
48、hange of regulated information on pharmaceutical dose 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 measurementHL7 Version 3 St
49、andard, Common Clinical Product ModelHL7 Version 3 Standard, Common Product Model CMETSHL7 Version 3 Standard, Regulated Product SubmissionHL7 Version 3 Standard, Structured Product Labeling ISO 2012 All rights reserved 1BS EN ISO 11616:2012ISO 11616:2012(E)3 Terms, definitions and abbreviations3.1 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1.1administrable dose formpharmaceutical dose form as administered to the patient, after any necessary trans
