Draft
International Standard
ISO/DIS 11616
Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
Reference number
ISO/DIS 11616
Edition 3
© ISO 2026
Draft International Standard
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Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 11616:2017

ISO/DIS 11616

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Abstract

ISO 11616:2017 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 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient.

ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level.

References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of ISO 11616:2017.

Medicinal products for veterinary use are out of scope of ISO 11616:2017.

General information

  • Status
     : Under development
    Stage
    : Full report circulated: DIS approved for registration as FDIS [40.99]
  • Edition
     : 3
    Number of pages
     : 40
  • Technical Committee :
    ISO/TC 215
    ICS :
    35.240.80 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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