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BS EN ISO 11615:2012

BS EN ISO 11615:2012

$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 2012 128
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PDF Catalog

PDF Pages PDF Title
7 Foreword
8 Introduction
11 1 Scope
2 Normative references
3 Terms, definitions and abbreviations
3.1 Terms and definitions
22 3.2 Abbreviations
24 4 Requirements
4.1 Concepts required for the unique Identification of Medicinal Products
27 5 Description of the information modelling principles and practices
5.1 General considerations
28 5.2 Conceptual overview diagrams
29 5.3 Section high-level diagrams
30 5.4 Detailed description diagrams
33 6 Identifying characteristics for authorized Medicinal Products
6.1 Primary identifiers
6.2 Medicinal Product Identifier (MPID)
34 6.3 Packaged Medicinal Product Identifier (PCID)
35 6.4 Medicinal Product Batch Identifier (BAID_1)
6.5 Medicinal Product Batch Identifier (BAID_2)
7 Information for an authorized Medicinal Product
7.1 Authorized Medicinal Product — Information overview
37 7.2 Medicinal Product
42 7.3 Marketing Authorization
48 7.4 Organization
50 7.5 Manufacturer/Establishment
51 7.6 Packaged Medicinal Product, including Manufactured Item and Device
60 7.7 Ingredient, Substance and Strength
64 7.8 Pharmaceutical Product and Device
68 7.9 Clinical Particulars
76 8 Identifying characteristics for Investigational Medicinal Products
8.1 General
8.2 Primary identifiers
77 8.3 Investigational Medicinal Product Identifier (IMPID)
78 8.4 Investigational Medicinal Product Package Identifier (IPCID)
8.5 Investigational Medicinal Product Batch Identifier (IBAID_1)
8.6 Investigational Medicinal Product Batch Identifier (IBAID_2)
79 9 Information for an Investigational Medicinal Product
9.1 Conceptual overview of the information for an Investigational Medicinal Product
80 9.2 Investigational Medicinal Product
82 9.3 Clinical Trial Authorization
85 9.4 Manufacturer/Establishment
9.5 Investigational Packaged Medicinal Product
86 9.6 Pharmaceutical Product
87 9.7 Ingredient
9.8 Clinical particulars
88 Annex A
(informative)

Full model — Authorized Medicinal Products conceptual level

89 Annex B
(informative)

Full model — Authorized Medicinal Products detailed diagram

90 Annex C
(informative)

Full model — Investigational Medicinal Products conceptual level

91 Annex D
(informative)

Full Model — Investigational Medicinal Products detailed diagram

92 Annex E
(informative)

Worked example in tabular form

101 Annex F
(informative)

Class and attribute listing

115 Annex G
(informative)

Example implementation of Medicinal Product information

123 Bibliography

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BS EN ISO 11615:2012
$215.11