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RS ISO 11616: 2017
Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

Abstract

This document 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, this document 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.
This document 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 this document.
Medicinal products for veterinary use are out of scope of this document.

General Information

Code	Classification	Theme	Pages	Publisher	Availability
RS ISO 11616: 2017	ADOPTED ISO STANDARDS	Health care technology	43	Second Edition	Available