GINAS

Global Ingredients Archiving System (GINAS) What is GINAS in relation to ISO 11238 GINAS and ISO 11238 specifically addresses the identification and exchange of regulated information on substances.  GINAS supports all substance types described in the 11238...

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...