BS EN IS0 11616:2017 BSl Standards Publication Health informatics Identification of medicinal products -Data elements and structures for unique identification and exchange of regulated pharmaceutical product information bsi. BSENIS011616:2017 BRITISH STANDARD Nationalforeword This British Standard is theUK implementation of ENIS011616:2017. It is identicalto IS011616:2017.It supersedes BSENIS011616:2012, which is withdrawn.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 requestto its secretary. This publication does not purport to include all the necessary provisions ofa contract.Users areresponsibleforits correctapplication. TheBritishStandardsInstitution2018 Published by BSI Standards Limited 2018 ISBN9780580948794 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 Amendments/corrigendaissuedsincepublication Date Textaffected BSENISO11616:2017 EN IS0 11616 EUROPEAN STANDARD NORME EUROPEENNE EUROPAISCHE NORM December2017 ICS 35.240.80 SupersedesENIS011616:2012 EnglishVersion Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (IS0 11616:2017) Informatique de sante - Identification des medicaments Medizinische Informatik -Identifikation von -Elements de donnees et structures pour Arzneimitteln-Datenelementeund-strukturenzur I'identification unique et l'echange d'informations Identifikation und zum Austausch von reglementées sur les produits pharmaceutiques (Iso pharmazeutischen Produktkennzeichen (ISo 11616:2017) 11616:2017) This European Standard was approvedby CEN on17November2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status 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, 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. 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 CEN-CENELEC Management Centre: Rue dela Science 23, B-1040 Brussels @2017CEN All rights of exploitation in any form and by any means reserved Ref.No.EN ISO 11616:2017E worldwide for CEN national Members.