ÖNORM EN ISO 11616

This International Standard 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 International Standard 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 International Standard is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorized 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 International Standard. Medicinal products for veterinary use are out of scope of this International Standard.