EN ISO 11616:2012

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2012) EN ISO 11616:2012

Publication date:   Dec 18, 2012

General information

99.60 Withdrawal effective   Dec 6, 2017


CEN/TC 251 Health informatics

European Norm

35.240.80   IT applications in health care technology



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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


EN ISO 11616:2012
99.60 Withdrawal effective
Dec 6, 2017


EN ISO 11616:2017