Module 12 Presentations

ISO IDMP: what are the standards?

The 5 ISO-IDMP standards describe the Medicinal Product and its supporting components

The overall definition of a Medicinal Product is explained in the ISO IDMP 11615 standard, the definitions for the supporting components of the Medicinal Product come from the other ISO IDMP Standards – 11616, 11238, 11239 and 11240. Here is a scheme of their relation:

Data elements and structure for the unique identification and exchange of regulated information on pharmaceutical dose form, units of presentation, routes of administration and packaging

ISO 11239

ISO 11238

Data elements and structure for the unique identification and exchange of information on substances

Data elements and structure for the unique identification and

ISO 11240

exchange of regulated information of units of measurements

Data elements and structure for the unique identification and exchange of regulated medicinal product information

Data elements and structure for the unique identification and exchange of regulated pharmaceutical product information

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ISO 11615

ISO 11616

The Organisation for Professionals in Regulatory Affairs