EN ISO 11616:2017

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, symbols, abbreviated terms
4 Conformance terminology and context as
   it relates to the ISO IDMP standards and
   corresponding IDMP technical specifications
5 Requirements
6 Description of the information modelling
   principles and practices
7 Identifying characteristics for the identification
   of pharmaceutical products
8 Relationship between MPID/PCID and PhPID
9 Relationship between IMPID/IPCID and PhPID
10 Conceptual model
Bibliography

ISO 11616:2017 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, ISO 11616:2017 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.ISO 11616:2017 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 ISO 11616:2017.Medicinal products for veterinary use are out of scope of ISO 11616:2017.