Reference number
ISO 11616:2012
© ISO 2024
ISO 11616:2012
Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
Edition 1
2012-11
Withdrawn
Withdrawn (Edition 1, 2012)

Abstract

ISO 11616:2012 is intended to provide specific levels of information relevant to the identification of a medicinal product or group of medicinal products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2012 is essential to ensuring that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders. This ensures interoperability and compatibility for both the sender and the recipient.

General information

  • Status
     : Withdrawn
    Publication date
     : 2012-11
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 40
  • Technical Committee :
    ISO/TC 215
    ICS :
    35.240.80 
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