BS EN IS0 11238:2018 BSl Standards Publication Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances bsi. BSENIS011238:2018 BRITISH STANDARD National foreword ThisBritishStandardistheUK implementationofENIS011238:2018. It is identical to IS0 11238:2018. It supersedes BS EN IS0 11238:2012 which is withdrawn. 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 requesttoits 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 PublishedbyBSIStandards Limited2018 ISBN9780580985201 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 31 August 2018 Amendments/corrigendaissued sincepublication Date Textaffected EN ISO 11238 EUROPEANSTANDARD NORME EUROPEENNE EUROPAISCHE NORM August 2018 ICS 35.240.80 SupersedesENIS011238:2012 EnglishVersion Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (IS0 11238:2018) Informatique de santé-Identification des produits Medizinische Informatik - Identifikation médicaux-Eléments de donnees et structures pour vonArzneimitteln-Datenelementeund I'identification unique etl'échange d'informations Strukturen zur eindeutigen Identifikation reglementees sur les substances (Is0 11238:2018) und zum Austausch von vorgeschriebenen Informationen zu Stoffen (IS011238:2018) This European Standard was approved by CEN on 24 July 2018. ortoanyCENmember This European Standard exists in three official versions (English, French, German). A version in any other language madebytranslation under the responsibilityofa CENmember into its ownlanguage and notified to the CEN-CENELEC ManagementCentrehasthesamestatusastheofficialversions CENmembers are the national standards bodies ofAustria, 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEE FUR NORMUNG @2018CEN All rights of exploitation in any form and by any means reserved Ref.No.ENISO 11238:2018:E worldwide for CEN national Members BS EN ISO 11238:2018 EN IS0 11238:2018 (E) European foreword This document (EN IS0 11238:2018) has been prepared by Technical Committee IS0/TC 215 "Health informatics"in collaboration with Technical Committee CEN/TC 251 “Health informatics"the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2019, and conflicting national standards shall be withdrawn atthe latestbyFebruary 2019. 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. This document supersedes EN IS0 11238:2012. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries areboundtoimplementthis 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, Luxembour