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 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.
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CVP_Secretariat_Loca
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviations
3.1 Terms and definitions
3.2 Abbreviations
4 Requirements
4.1 Elements required for the unique identification of pharmaceutical products
4.2 Exchange of pharmaceutical product information
5 Identifying characteristics for the identification of pharmaceutical products
5.1 Pharmaceutical product identification strata and levels
5.2 Cardinality
5.3 Representation of strength concentration
5.4 Pharmaceutical product identifier (PhPID)
5.5 Pharmaceutical product substance stratum elements (PhPID_SUB_Lx)
5.6 Pharmaceutical Product Specified Substance Stratum Elements (PhPID_SpSUB_Lx)
5.7 Identifying characteristics to express strength
6 Relationship between MPID and PhPID
6.1 Concepts required for the unique identification of a medicinal product and the association with PhPIDs
6.2 Pharmaceutical product identification criteria
7 Relationship between IMPID and PhPID
8 Conceptual model
Annex A (informative) Examples
Annex B (informative) Tabled examples
Bibliography
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CVP_Secretariat_Loca
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviations
3.1 Terms and definitions
3.2 Abbreviations
4 Requirements
4.1 Elements required for the unique identification of pharmaceutical products
4.2 Exchange of pharmaceutical product information
5 Identifying characteristics for the identification of pharmaceutical products
5.1 Pharmaceutical product identification strata and levels
5.2 Cardinality
5.3 Representation of strength concentration
5.4 Pharmaceutical product identifier (PhPID)
5.5 Pharmaceutical product substance stratum elements (PhPID_SUB_Lx)
5.6 Pharmaceutical Product Specified Substance Stratum Elements (PhPID_SpSUB_Lx)
5.7 Identifying characteristics to express strength
6 Relationship between MPID and PhPID
6.1 Concepts required for the unique identification of a medicinal product and the association with PhPIDs
6.2 Pharmaceutical product identification criteria
7 Relationship between IMPID and PhPID
8 Conceptual model
Annex A (informative) Examples
Annex B (informative) Tabled examples
Bibliography