Category
Standard
Organisation
ID
ISO 11615:2017
Type
Standard
Version
2
Access
Fees apply to access
Status
Active
Created
Oct 2017
This standard defines the data elements and structural relationships required for the unique identification and detailed description of medicinal products.
The document describes how to define, characterise and uniquely identify regulated medicinal products for human use throughout their entire life cycle, from development to authorisation, postmarketing and renewal or withdrawal from the market, where applicable.
This is 1 of 5 ISO identification of medicinal products (IDMP) standards.
Main sections:
· Scope
· Normative references
· Terms, definitions and abbreviated terms
· Message exchange format
· Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications
· Concepts required for the unique identification of medicinal products
· Description of the information modelling principles and practices
· Identifying characteristics for authorised medicinal products
· Information for an authorised medicinal product
· Identifying characteristics for investigational medicinal products
· Information for an investigational medicinal product
The document describes how to define, characterise and uniquely identify regulated medicinal products for human use throughout their entire life cycle, from development to authorisation, postmarketing and renewal or withdrawal from the market, where applicable.
This is 1 of 5 ISO identification of medicinal products (IDMP) standards.
Main sections:
· Scope
· Normative references
· Terms, definitions and abbreviated terms
· Message exchange format
· Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications
· Concepts required for the unique identification of medicinal products
· Description of the information modelling principles and practices
· Identifying characteristics for authorised medicinal products
· Information for an authorised medicinal product
· Identifying characteristics for investigational medicinal products
· Information for an investigational medicinal product
Access Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information
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