Category
Standard
Organisation
ID
ISO 11616:2017
Type
Standard
Version
2
Access
Fees apply to access
Status
Active
Created
Oct 2017
This standard provides information relevant to the identification of a medicinal product or group of medicinal products. It defines the data elements, structures and relationships required for the exchange of regulated information to uniquely identify pharmaceutical products.
This standard supports interoperability and compatibility by ensuring 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 is 1 of 5 ISO IDMP standards. Medicinal products for veterinary use are not within the scope of this document.
Main sections:
· Scope
· Normative references
· Terms, definitions and abbreviated terms
· Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications
· Requirements
· Description of the information modelling principles and practices
· Identifying characteristics for the identification of pharmaceutical products
· Relationship between MPID/PCID and PhPID
· Relationship between IMPID/IPCID and PhPID
· Conceptual model
This standard supports interoperability and compatibility by ensuring 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 is 1 of 5 ISO IDMP standards. Medicinal products for veterinary use are not within the scope of this document.
Main sections:
· Scope
· Normative references
· Terms, definitions and abbreviated terms
· Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications
· Requirements
· Description of the information modelling principles and practices
· Identifying characteristics for the identification of pharmaceutical products
· Relationship between MPID/PCID and PhPID
· Relationship between IMPID/IPCID and PhPID
· Conceptual model
Access Health informatics – Identification of medicinal products – Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
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