IDMP – Identification of Medicinal Products – is a set of five standards developed by the International Organization for Standardization (ISO) to create a universal framework of structured, coded data that uniquely identify and describe all key aspects of medicinal products.
Until now, national differences in how products and substances are identified and described have complicated global healthcare and pharmacovigilance. But ISO’s comprehensive set of standards aims to create a harmonised, structured body of definitions. The aim of IDMP is to increase clarity and efficiency in communications about medicines and provide greater certainty to patients no matter where they are.
The five standards in the IDMP suite are:
Medicinal Product Identification (MPID) – ISO 11615
Data elements and structures for unique identification and exchange of regulated medicinal product information. MPID describes the detailed data elements and their structural relationships required for the unique identification of regulated medicinal products. Data elements that identify and characterize a medicinal product include the product name (authorized by regulatory agency), clinical particulars (e.g. indications, contraindications), pharmaceutical product (substance, dosage form, route of administration), medicinal product packaging, marketing authorization (e.g., authorization number, application information), manufacturer/establishment, etc.
Pharmaceutical Product Identifier (PhPID) – ISO 11616
Data elements and structures for unique identification and exchange of regulated pharmaceutical product information. PhPID uniquely associates medical products with the same or similar pharmaceutical composition based on the following data elements: substance(s), strength(s) (units of measurement/presentation), reference strength(s), and dosage form.
Substance Identification (SubID) – ISO 11238
Data elements and structures for unique identification and exchange of regulated information on substances. Defines substances that constitute a medicinal product by their main, general characteristics.
Dosage Form and Route of Administration – ISO 11239
Data elements and structures for unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation and routes of administration.
Units of Measurement (UoM) – ISO 11240
Data elements and structures for unique identification and exchange of units of measurement. Specifies rules for the usage of units of measurement, establishes requirements to provide for traceability to international metrological standards, defines requirements for representation of units of measurement in coded form, provides structures and rules for mapping between different unit vocabularies and language translations.