Resumen
ϲʿ 11616:2012 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, ϲʿ 11616:2012 is essential to ensuring that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders. This ensures interoperability and compatibility for both the sender and the recipient.
Ciclo de vida
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Ahora
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Revisada por
Publicadoϲʿ 11616:2017
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