Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Message exchange<br>5 Conformance terminology and context <br>&nbsp;&nbsp;&nbsp;as it relates to the ISO IDMP standards <br>&nbsp;&nbsp;&nbsp;and corresponding technical specifications<br>6 Maintenance of IDMP data elements <br>&nbsp;&nbsp;&nbsp;and IDMP identifiers<br>7 Why standardisation of identification of <br>&nbsp;&nbsp;&nbsp;Medicinal Products is needed<br>8 General considerations<br>9 Information for an authorised Medicinal <br>&nbsp;&nbsp;&nbsp;Product<br>10 Investigational Medicinal Product <br>&nbsp;&nbsp;&nbsp;Identifier (IMPID)<br>Annex A (normative) - Medicinal Product<br>Annex B (normative) - Marketing authorisation<br>Annex C (normative) - Packaged Medicinal <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Product (including manufactured item <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and device)<br>Annex D (normative) - Ingredient, substance <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and strength<br>Annex E (normative) - Pharmaceutical product <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and device<br>Annex F (normative) - Clinical particulars<br>Annex G (normative) - Organisation<br>Annex H (normative) - Manufacturer/<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;establishment<br>Annex I (normative) - Investigational <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Medicinal Product<br>Annex J (normative) - SPL documents<br>Annex K (informative) - Abbreviations<br>Bibliography

Abstract

Specifies concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 215