ISO 11616:2012

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

Publication date:   Oct 26, 2012

95.99 Withdrawal of Standard   Oct 19, 2017

General information

95.99 Withdrawal of Standard   Oct 19, 2017

ISO

ISO/TC 215 Health informatics

International Standard

35.240.80   IT applications in health care technology

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Scope

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.

Life cycle

NOW

WITHDRAWN
ISO 11616:2012
95.99 Withdrawal of Standard
Oct 19, 2017

REVISED BY

PUBLISHED
ISO 11616:2017