ÖNORM EN ISO 11616

This document is intended to provide specific levels of information relevant to the identification of a Pharmaceutical Product or groups of Pharmaceutical 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 Pharmaceutical Products to be unequivocally identified on a global level. References to other normative IDMP standards and specifications for data exchange mechanisms 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.