NF EN ISO 11616

Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information

Le présent document vise à fournir des niveaux d''informations spécifiques pertinents pour l''identification d''un médicament ou d''un groupe de médicaments. Il définit les éléments de données, les structures et les relations entre des éléments de données nécessaires à l''échange d''informations réglementées visant à identifier de façon unique des produits pharmaceutiques. Cette identification doit être appliquée tout au long du cycle de vie du produit afin de soutenir sur le plan mondial les activités réglementaires, de pharmacovigilance et autres. De plus, le présent document est essentiel pour garantir que les informations sur un produit pharmaceutique sont rassemblées dans un format structuré pouvant être transmis entre différentes parties prenantes, à des fins aussi bien réglementaires que cliniques (par exemple, ordonnances électroniques, aide à la décision clinique) . Cela permet d''assurer l''interopérabilité et la compatibilité entre émetteur et destinataire.

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