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Category
Standard
ID
ISO 11239:2023
Type
Standard
Version
2
Access
Fees apply to access
Status
Active
Created
Jun 2023
This standard specifies the data elements, structures and relationships between data elements required for the exchange of identifying information for pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products.

It also contains a mechanism for the association of translations of a single concept into different languages, a mechanism for the versioning of the concepts to track their evolution, and rules to help regional authorities map existing regional terms to the terms created using this document in a harmonised and meaningful way.

This is 1 of 5 ISO identification of medicinal products (IDMP) standards.

Main sections:

· Scope

· Normative references

· Terms, definitions and abbreviated terms

· Requirements

· Schema

· Annex A: Examples of controlled vocabularies

· Annex B: Examples of controlled vocabularies to describe medicinal products