ISO standards for Identification of Medicinal Products
ISO IDMP consists of set of five ISO standards which collectively and individually protect and illustrate the integrity of the communications for submission of regulated medicinal product information in the perspective of unique product identification. Messaging specifications are integral part of IDMP standards, (Health Level Seven (HL7)).
11238 Substances: Global Ingredient Archival System (GInAS):
Defines Substances by its general characteristics and Specifies Substances which are more granular, specific descriptions of a substance, for example including manufacturing information, grade, purity. This standard specifies specification of multiple component substances (Intermediate Products). Substances can have diverse roles in medicinal products such as active, excipient, adjuvant, basis of strength.
- 11239 Pharmaceutical dose forms /units of presentation/routes of administer (EDQM):
regulated information on, units of presentation, routes of administration, pharmaceutical dose forms and packaging. It defines and classifies concepts for does forms, routes administration and unit of representation.
- 11240 Unified Code for Units of Measure (UCUM):
Identifies/Specifies rules units of measurement usage for IDMP. Sets up reference code system for units; Specifies needs for traceability to metrological standards. Facilitates rules and structure for inter mapping between different language translations and unit vocabularies, dictionaries, repository units and linking existing system.
- 11615 Regulated medicinal product information:
Uniquely identifies regulated medicinal products for human use during its entire life cycle - development, post-marketing, authorization and renewal or withdrawal from market. It describes detail data elements and its structural relationships which distinctively identify a medicinal product.
- 11616 Pharmaceutical Product Identification (PhPID):
Uniquely identifies a generic (pharmaceutical) representation of a medicinal product at a variety of levels based on their subset of elements such as Specified Substances/ Substances,Strengths of units - unit of presentation/ units of measurement , Reference Strengths ,and Dose Form.