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BS EN ISO 11615:2017+A1:2022

$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 2022 94
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PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
5 European foreword
Endorsement notice
9 Foreword
10 Introduction
12 1 Scope
2 Normative references
13 3 Terms, definitions and abbreviated terms
24 4 Message exchange format
25 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
26 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
27 6.6 Concepts required for the unique identification of Medicinal Products and the association with data carrier identifiers
28 7 Description of the information modelling principles and practices
7.1 General considerations
7.2 Conceptual overview diagrams
29 7.3 High-level diagrams
7.4 Detailed description diagrams
7.4.1 General
30 7.4.2 Relationships between classes
31 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
32 8.2 Medicinal Product Identifier (MPID)
8.2.1 General considerations
8.2.2 MPID code segments
33 8.3 Packaged Medicinal Product Identifier (PCID)
8.3.1 General considerations
34 8.3.2 Package description (PCID) code segment
8.4 Medicinal Product Batch Identifier (BAID1)
8.5 Medicinal Product Batch Identifier (BAID2)
35 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
36 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
37 9.2.2 Detailed description of Medicinal Product information
43 9.3 Marketing authorisation
9.3.1 General
44 9.3.2 Detailed description of marketing authorisation information
49 9.4 Organisation
9.4.1 General
9.4.2 Detailed description of organisation information
52 9.5 Manufacturer/Establishment (organisation)
9.5.1 General
9.5.2 Detailed description of manufacturer/establishment (organisation) information
53 9.6 Packaged Medicinal Product, including manufactured item and device
9.6.1 General
54 9.6.2 Detailed description of Packaged Medicinal Product information
63 9.7 Ingredient, substance and strength
9.7.1 General
9.7.2 Detailed description of ingredients, substance and strength information
66 9.8 Pharmaceutical product and device
9.8.1 General
9.8.2 Detailed description of pharmaceutical product and device information
68 9.9 Clinical particulars
9.9.1 General
69 9.9.2 Detailed description for clinical particulars information
73 10 Identifying characteristics for Investigational Medicinal Products
10.1 General
10.2 Primary identifiers
10.2.1 General considerations
74 10.3 Investigational Medicinal Product Identifier (IMPID)
10.3.1 General considerations
10.3.2 IMPID code segments
75 10.4 Investigational Medicinal Product Package Identifier (IPCID)
10.4.1 General provisions
10.4.2 Package description code segment
76 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
77 11.2.2 Investigational Medicinal Product
11.2.3 Investigational Medicinal Product name
11.2.4 Header
11.2.5 Manufacturer/Establishment (organisation)
78 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
81 11.4 Clinical trial authorisation
11.4.1 General
11.4.2 Detailed description of clinical trial authorisation information
83 11.5 Manufacturer/Establishment (organisation)
11.6 Investigational Packaged Medicinal Product
11.7 Pharmaceutical product
11.7.1 General
84 11.7.2 Pharmaceutical product
11.7.3 Dosing and route of administration
11.8 Ingredient
85 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
86 Annex A (normative) Full model — Authorised Medicinal Products detailed diagram
87 Annex B (normative) Full model — Investigational Medicinal Products detailed diagram
88 Blank Page
89 Bibliography
BS EN ISO 11615:2017+A1:2022
$215.11