Norm

NEN-EN-ISO 11616:2018 en

Medische Informatica - Identificatie van geneesmiddelen - Gegevenselementen en -structuren voor de unieke identificatie en uitwisseling van gereguleerde farmaceutische productinformatie

124,99 151,24 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 33
Gepubliceerd op 01-01-2018
Taal Engels
NEN-EN-ISO 11616 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, this document is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. This document is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level. References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of this document. Medicinal products for veterinary use are out of scope of this document.

Details

ICS-code 35.240.80
Nederlandse titel Medische Informatica - Identificatie van geneesmiddelen - Gegevenselementen en -structuren voor de unieke identificatie en uitwisseling van gereguleerde farmaceutische productinformatie
Engelse titel Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information
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