DIN Standards Committee Health Technologies
DIN EN ISO 11616
Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2012); German version EN ISO 11616:2012
Medizinische Informatik - Identifikation von Arzneimitteln - Datenelemente und -strukturen zur Identifikation und zum Austausch von pharmazeutischen Produktkennzeichen (ISO 11616:2012); Deutsche Fassung EN ISO 11616:2012
Overview
This standard defines data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. It is applicable to worldwide activities taking place related to the approval of medicinal products and pharmacovigilance. This standard is intended to introduce terms and definitions and to specify data elements and their structural relationships among each other in order to allow for a detailed description and unique identification of pharmaceutical products. References to other standards for identification of medicinal products and for transfer of messages related to pharmaceutical product information are given to be applied in the context of this standard. Medicinal products for veterinary use are out of scope of this standard. The purpose of this standard is to present data elements, structures and their relationships in order to identify and exchange regulated pharmaceutical product information. This standard is intended to provide an accurate and consistent mechanism to fully represent the relationship of Pharmaceutical Product Identifier(s) (PhPID) with the following identifiers: - Medicinal Product Identifiers (MPIDs); - Investigational Medicinal Product Identifiers (IMPIDs). The committee responsible for this standard is Committee NA 063-07-03 AA "Terminologie" ("Terminology") at DIN.
