Norm

ISO/DIS 11615:2016 en

Medische Informatica - Identificatie van Geneesmiddelen - Gegevenselementen en -structuren voor de unieke identificatie en uitwisseling van gereguleerde medicinale productinformatie

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Over deze norm

Status Ontwerp
Aantal pagina's 93
Gepubliceerd op 09-08-2016
Taal Engels
This International Standard establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, the standards listed in the introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of this International Standard.

Details

ICS-code 35.240.80
Nederlandse titel Medische Informatica - Identificatie van Geneesmiddelen - Gegevenselementen en -structuren voor de unieke identificatie en uitwisseling van gereguleerde medicinale productinformatie
Engelse titel Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information
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