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 |
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 |