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BS EN ISO 11616:2017:2018 Edition

BS EN ISO 11616:2017:2018 Edition

$167.15

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

Published By Publication Date Number of Pages
BSI 2018 44
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This document 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 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 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 document.

Medicinal products for veterinary use are out of scope of this document.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
10 1 Scope
2 Normative references
11 3 Terms, definitions and abbreviated terms
18 4 Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications
5 Requirements
5.1 Elements required for the unique identification of pharmaceutical products
19 5.2 Exchange of pharmaceutical product information
6 Description of the information modelling principles and practices
6.1 General considerations
20 6.2 Conceptual overview diagrams
6.3 High-level diagrams
21 6.4 Detailed description diagrams
6.4.1 General
22 6.4.2 Relationships between classes
23 6.4.3 Attributes of classes
6.4.4 Generalised classes and patterns
6.4.5 Translation and language
7 Identifying characteristics for the identification of pharmaceutical products
7.1 Pharmaceutical product identification strata and levels
7.1.1 General
24 7.1.2 PhPID specified substance
25 7.1.3 Pharmaceutical product specified substance identification (PhPID SpSub)
26 7.2 Cardinality
7.3 Representation of strength concentration
27 7.4 Pharmaceutical product identifier (PhPID)
7.5 Pharmaceutical product substance stratum elements (PhPID_SUB_Lx)
7.5.1 Construct of the pharmaceutical product substance stratum
7.5.2 Substance set
28 7.5.3 Administrable dose form
7.5.4 Unit of presentation
7.5.5 Medical device
7.6 Pharmaceutical product specified substance stratum elements (PhPID_SpSUB_Lx)
7.6.1 Construct of the pharmaceutical product specified substance stratum
29 7.6.2 Specified substance set
7.6.3 Administrable dose form
7.6.4 Unit of presentation
7.6.5 Medical device
7.7 Identifying characteristics to express strength
7.7.1 Expressing strength
30 7.7.2 Attributes for representation of strength in PhPID stratum elements
32 7.7.3 Representation of strength for a patch
8 Relationship between MPID/PCID and PhPID
8.1 Concepts required for the unique identification of a Medicinal Product and the association with PhPIDs
34 8.2 Pharmaceutical product identification criteria
8.2.1 General considerations
8.2.2 Multiple products packaged as a kit and administered as separate Medicinal Products
35 8.2.3 Multiple products packaged as a kit for reconstitution and administered as one Medicinal Product
8.2.4 Components of kits which are not packaged together (e.g. radiopharmaceutical kits)
8.2.5 Different representations of strength in two or more regions for identical products
36 8.2.6 Representation of PhPID for a patch
9 Relationship between IMPID/IPCID and PhPID
38 10 Conceptual model
39 Bibliography

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BS EN ISO 11616:2017
$167.15