ISO/TS TECHNICAL 20451 SPECIFICATION First edition 2017-10 Health informatics Identification of medicinal products - Implementation guidelines for IsO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information Informatiquedesanté-Identificationdesmedicaments-Lignes directrices pour I'implementation des élements dedonnees et structuresIs011616pourI'identificationuniqueetl'échange d'informations reglementees surlesproduitspharmaceutiques Reference number IS0/TS20451:2017(E) @IS02017 IS0/TS20451:2017(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior writtenpermission.Permission canberequestedfrom either Iso at the addressbelow or iso'smember body in the country of the requester. ISO copyright office Ch.de Blandonnet 8.CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org ii IS0 2017-All rights reserved IS0/TS 20451:2017(E) Contents Page Foreword V Introduction .vi 1 Scope 1 2 Normativereferences .1 3 Terms and definitions .2 4 Conformance .2 5 Conceptsrequiredfortheuniqueidentificationofpharmaceuticalproducts 2 5.1 Generalconsiderationsfor elements requiredfortheuniqueidentificationof pharmaceutical products 2 5.2 Principles required for the unique identification of a pharmaceutical product 2 6 Identifyingcharacteristicsfortheidentification ofpharmaceuticalproducts 3 6.1 Pharmaceutical product identification strata and levels. 3 6.2 PhPID specified substance 4 6.3 Pharmaceuticalproductspecifiedsubstanceidentification(PhPIDSpSub) 5 6.4 Cardinality. 5 6.5 Representationofstrengthconcentration 6 6.6 Pharmaceutical productidentifier (PhPID) 6 6.7 PhPID algorithmandproduct code concept. 7 7 Ingredient, substance and strength .8 7.1 Generalconsiderations 8 7.2 Ingredient 9 7.2.1 Ingredient role. .9 7.2.2 Substance 10 7.2.3 Specified substance 10 7.2.4 Specified substancegroup .10 7.2.5 Confidentiality indicator 11 7.2.6 Strength 11 7.2.7 Pharmaceuticalproductcodeconceptforrepresentingthenormalised strengthforliquidpreparations 11 7.2.8 Strength (presentation) 12 7.2.9 Strength (concentration) 12 7.2.10 Measurementpoint. 13 7.2.11 Country.. 13 7.2.12 Reference strength .13 7.2.13 Referencesubstance .13 7.2.14 Referencespecifiedsubstance 13 7.2.15 Reference strength 13 7.2.16 Reference strengthmeasurementpoint .14 7.2.17 Reference strength country. .14 Pharmaceutical product: adjuvants and devices .14 8 8.1 General considerations .14 8.1.1 Detailed description of pharmaceutical productand device information .14 8.1.2 Pharmaceutical product. 15 8.1.3 Pharmaceuticalproductcharacteristics. 17 8.1.4 Device (pharmaceutical product) .18 Annex A (normative) Messaging: Ingredient, substanceand strength .19 AnnexB (normative)Messaging:Pharmaceuticalproductand device .33 AnnexC(informative)Examples .40 AnnexD(informative)Examplesofrepresentationofstrength .45 @ IS0 2017 - All rights reserved ili