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BS EN ISO 11615:2017:2018 Edition

BS EN ISO 11615:2017:2018 Edition

$215.11

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

Published By Publication Date Number of Pages
BSI 2018 90
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This document establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.

Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable.

Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of this document.

PDF Catalog

PDF Pages PDF Title
2 undefined
10 Foreword
11 Introduction
13 1 Scope
2 Normative references
14 3 Terms, definitions and abbreviated terms
25 4 Message exchange format
26 5 Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications
6 Concepts required for the unique identification of Medicinal Products
6.1 General considerations
6.2 Authorised Medicinal Products
27 6.3 Investigational Medicinal Products
6.4 Concepts required for the unique identification of a Medicinal Product and the association with PhPID(s)
6.5 Concepts required for the unique identification of Medicinal Products and the association with the marketing authorisation number
28 6.6 Concepts required for the unique identification of Medicinal Products and the association with data carrier identifiers
29 7 Description of the information modelling principles and practices
7.1 General considerations
7.2 Conceptual overview diagrams
30 7.3 High-level diagrams
7.4 Detailed description diagrams
7.4.1 General
31 7.4.2 Relationships between classes
32 7.4.3 Attributes of classes
7.4.4 Generalised classes and patterns
7.4.5 Translation and language
8 Identifying characteristics for authorised Medicinal Products
8.1 Primary identifiers — General considerations
33 8.2 Medicinal Product Identifier (MPID)
8.2.1 General considerations
8.2.2 MPID code segments
34 8.3 Packaged Medicinal Product Identifier (PCID)
8.3.1 General considerations
35 8.3.2 Package description (PCID) code segment
8.4 Medicinal Product Batch Identifier (BAID1)
8.5 Medicinal Product Batch Identifier (BAID2)
36 9 Information for an authorised Medicinal Product
9.1 Authorised Medicinal Product — Information overview
9.1.1 General
9.1.2 Medicinal Product
9.1.3 Medicinal Product name
37 9.1.4 Header
9.1.5 Manufacturer/Establishment (organisation)
9.1.6 Marketing authorisation
9.1.7 Packaged Medicinal Product
9.1.8 Pharmaceutical product
9.1.9 Ingredient
9.1.10 Clinical particulars
9.2 Medicinal Product
9.2.1 General
38 9.2.2 Detailed description of Medicinal Product information
44 9.3 Marketing authorisation
9.3.1 General
45 9.3.2 Detailed description of marketing authorisation information
50 9.4 Organisation
9.4.1 General
9.4.2 Detailed description of organisation information
53 9.5 Manufacturer/Establishment (organisation)
9.5.1 General
9.5.2 Detailed description of manufacturer/establishment (organisation) information
54 9.6 Packaged Medicinal Product, including manufactured item and device
9.6.1 General
55 9.6.2 Detailed description of Packaged Medicinal Product information
64 9.7 Ingredient, substance and strength
9.7.1 General
9.7.2 Detailed description of ingredients, substance and strength information
67 9.8 Pharmaceutical product and device
9.8.1 General
9.8.2 Detailed description of pharmaceutical product and device information
69 9.9 Clinical particulars
9.9.1 General
70 9.9.2 Detailed description for clinical particulars information
74 10 Identifying characteristics for Investigational Medicinal Products
10.1 General
10.2 Primary identifiers
10.2.1 General considerations
75 10.3 Investigational Medicinal Product Identifier (IMPID)
10.3.1 General considerations
10.3.2 IMPID code segments
76 10.4 Investigational Medicinal Product Package Identifier (IPCID)
10.4.1 General provisions
10.4.2 Package description code segment
77 10.5 Investigational Medicinal Product Batch Identifier (BAID1)
10.6 Investigational Medicinal Product Batch Identifier (BAID2)
11 Information for an Investigational Medicinal Product
11.1 General
11.2 Conceptual overview of the information for an Investigational Medicinal Product
11.2.1 General
78 11.2.2 Investigational Medicinal Product
11.2.3 Investigational Medicinal Product name
11.2.4 Header
11.2.5 Manufacturer/Establishment (organisation)
79 11.2.6 Clinical trial authorisation
11.2.7 Investigational Packaged Medicinal Product
11.2.8 Pharmaceutical product
11.2.9 Ingredient
11.2.10 Clinical particulars
11.3 Investigational Medicinal Product
11.3.1 General
11.3.2 Detailed description of Investigational Medicinal Product information
82 11.4 Clinical trial authorisation
11.4.1 General
11.4.2 Detailed description of clinical trial authorisation information
84 11.5 Manufacturer/Establishment (organisation)
11.6 Investigational Packaged Medicinal Product
11.7 Pharmaceutical product
11.7.1 General
85 11.7.2 Pharmaceutical product
11.7.3 Dosing and route of administration
11.8 Ingredient
86 11.9 Clinical particulars
11.10 PhPID sets
11.11 Device nomenclature
11.12 Device batch identifier
11.13 Physical characteristics
11.14 Other characteristics
87 Annex A (normative) Full model — Authorised Medicinal Products detailed diagram
88 Annex B (normative) Full model — Investigational Medicinal Products detailed diagram
89 Bibliography

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BS EN ISO 11615:2017
$215.11