ISO 11615:2012
Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
ISO 11615:2012 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.
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CVP_Secretariat_Loca
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviations
3.1 Terms and definitions
3.2 Abbreviations
4 Requirements
4.1 Concepts required for the unique Identification of Medicinal Products
5 Description of the information modelling principles and practices
5.1 General considerations
5.2 Conceptual overview diagrams
5.3 Section high-level diagrams
5.4 Detailed description diagrams
6 Identifying characteristics for authorized Medicinal Products
6.1 Primary identifiers
6.2 Medicinal Product Identifier (MPID)
6.3 Packaged Medicinal Product Identifier (PCID)
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
7.2 Medicinal Product
7.3 Marketing Authorization
7.4 Organization
7.5 Manufacturer/Establishment
7.6 Packaged Medicinal Product, including Manufactured Item and Device
7.7 Ingredient, Substance and Strength
7.8 Pharmaceutical Product and Device
7.9 Clinical Particulars
8 Identifying characteristics for Investigational Medicinal Products
8.1 General
8.2 Primary identifiers
8.3 Investigational Medicinal Product Identifier (IMPID)
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)
9 Information for an Investigational Medicinal Product
9.1 Conceptual overview of the information for an Investigational Medicinal Product
9.2 Investigational Medicinal Product
9.3 Clinical Trial Authorization
9.4 Manufacturer/Establishment
9.5 Investigational Packaged Medicinal Product
9.6 Pharmaceutical Product
9.7 Ingredient
9.8 Clinical particulars
Annex A (informative) Full model — Authorized Medicinal Products conceptual level
Annex B (informative) Full model — Authorized Medicinal Products detailed diagram
Annex C (informative) Full model — Investigational Medicinal Products conceptual level
Annex D (informative) Full Model — Investigational Medicinal Products detailed diagram
Annex E (informative) Worked example in tabular form
Annex F (informative) Class and attribute listing
Annex G (informative) Example implementation of Medicinal Product information
Bibliography
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CVP_Secretariat_Loca
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviations
3.1 Terms and definitions
3.2 Abbreviations
4 Requirements
4.1 Concepts required for the unique Identification of Medicinal Products
5 Description of the information modelling principles and practices
5.1 General considerations
5.2 Conceptual overview diagrams
5.3 Section high-level diagrams
5.4 Detailed description diagrams
6 Identifying characteristics for authorized Medicinal Products
6.1 Primary identifiers
6.2 Medicinal Product Identifier (MPID)
6.3 Packaged Medicinal Product Identifier (PCID)
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
7.2 Medicinal Product
7.3 Marketing Authorization
7.4 Organization
7.5 Manufacturer/Establishment
7.6 Packaged Medicinal Product, including Manufactured Item and Device
7.7 Ingredient, Substance and Strength
7.8 Pharmaceutical Product and Device
7.9 Clinical Particulars
8 Identifying characteristics for Investigational Medicinal Products
8.1 General
8.2 Primary identifiers
8.3 Investigational Medicinal Product Identifier (IMPID)
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)
9 Information for an Investigational Medicinal Product
9.1 Conceptual overview of the information for an Investigational Medicinal Product
9.2 Investigational Medicinal Product
9.3 Clinical Trial Authorization
9.4 Manufacturer/Establishment
9.5 Investigational Packaged Medicinal Product
9.6 Pharmaceutical Product
9.7 Ingredient
9.8 Clinical particulars
Annex A (informative) Full model — Authorized Medicinal Products conceptual level
Annex B (informative) Full model — Authorized Medicinal Products detailed diagram
Annex C (informative) Full model — Investigational Medicinal Products conceptual level
Annex D (informative) Full Model — Investigational Medicinal Products detailed diagram
Annex E (informative) Worked example in tabular form
Annex F (informative) Class and attribute listing
Annex G (informative) Example implementation of Medicinal Product information
Bibliography