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DIN EN ISO 11615

2018 Edition, April 2018

Complete Document

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)



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Active, Most Current

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ENGLISH * SAME AS ISO 11615
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Product Details:

  • Revision: 2018 Edition, April 2018
  • Published Date: April 2018
  • Status: Active, Most Current
  • Document Language: English
  • Published By: Deutsches Institut fur Normung E.V. (DIN)
  • Page Count: 91
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

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

Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable.

Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of this document.