ISO 11616:2012 PDF

Scope: This International Standard 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 International Standard 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. This International Standard is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorized in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for medicinal products to be unequivocally identified. 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 International Standard. Medicinal products for veterinary use are out of scope of this International Standard.

ISO 11616:2012 Referenced Document

ISO 11238 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances*， 2018-07-01 Update
ISO 11239 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and…*， 2023-06-06 Update
ISO 11240 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement
ISO 11615 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information — Amendment 1*， 2022-08-25 Update
ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code*， 2020-08-25 Update

2017 ISO 11616:2017 Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
2012 ISO 11616:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information