IDMP

IDMP Definition of Identification of Medicinal Products IDMP defines the data elements and structures for the unique identification and exchange of medicinal products´ information. In June 2017, the first two so-called “Implementation Guides” for the...

ISO 11238

Regulated information on substances (ISO 11238) ISO 11238 defines substances by their main, general characteristics and Specified Substances (which are more granular, specific descriptions of a substance, e.g. including manufaturing information, purity, grade)....

ISO 11239

ISO 11239 IDMP Standard lists regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging. The ISO 11239 standard identifies for example injection solution, injection suspension, infusion solution (or a less...

ISO 11240

ISO 11240 – Units of Measurement What ISO 11240 does: specifies rules for the usage of units of measurement for IDMP specifies requirements for traceability to metrological standards establish reference code system for units provide structures and rules for...

ISO 11615

ISO 11615 establishes definitions and concepts required for the detailed description and unique identification of medicinal products. The scope of ISO 11615 ISO 11615 describes data elements and regulated medicinal product information during their entire life cycle...