ISO 11615:2017
Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
ISO 11615:2017 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 ISO 11615:2017.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Message exchange format
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
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
6.6 Concepts required for the unique identification of Medicinal Products and the association with data carrier identifiers
7 Description of the information modelling principles and practices
7.1 General considerations
7.2 Conceptual overview diagrams
7.3 High-level diagrams
7.4 Detailed description diagrams
7.4.1 General
7.4.2 Relationships between classes
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
8.2 Medicinal Product Identifier (MPID)
8.2.1 General considerations
8.2.2 MPID code segments
8.3 Packaged Medicinal Product Identifier (PCID)
8.3.1 General considerations
8.3.2 Package description (PCID) code segment
8.4 Medicinal Product Batch Identifier (BAID1)
8.5 Medicinal Product Batch Identifier (BAID2)
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
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
9.2.2 Detailed description of Medicinal Product information
9.3 Marketing authorisation
9.3.1 General
9.3.2 Detailed description of marketing authorisation information
9.4 Organisation
9.4.1 General
9.4.2 Detailed description of organisation information
9.5 Manufacturer/Establishment (organisation)
9.5.1 General
9.5.2 Detailed description of manufacturer/establishment (organisation) information
9.6 Packaged Medicinal Product, including manufactured item and device
9.6.1 General
9.6.2 Detailed description of Packaged Medicinal Product information
9.7 Ingredient, substance and strength
9.7.1 General
9.7.2 Detailed description of ingredients, substance and strength information
9.8 Pharmaceutical product and device
9.8.1 General
9.8.2 Detailed description of pharmaceutical product and device information
9.9 Clinical particulars
9.9.1 General
9.9.2 Detailed description for clinical particulars information
10 Identifying characteristics for Investigational Medicinal Products
10.1 General
10.2 Primary identifiers
10.2.1 General considerations
10.3 Investigational Medicinal Product Identifier (IMPID)
10.3.1 General considerations
10.3.2 IMPID code segments
10.4 Investigational Medicinal Product Package Identifier (IPCID)
10.4.1 General provisions
10.4.2 Package description code segment
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
11.2.2 Investigational Medicinal Product
11.2.3 Investigational Medicinal Product name
11.2.4 Header
11.2.5 Manufacturer/Establishment (organisation)
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
11.4 Clinical trial authorisation
11.4.1 General
11.4.2 Detailed description of clinical trial authorisation information
11.5 Manufacturer/Establishment (organisation)
11.6 Investigational Packaged Medicinal Product
11.7 Pharmaceutical product
11.7.1 General
11.7.2 Pharmaceutical product
11.7.3 Dosing and route of administration
11.8 Ingredient
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
Annex A (normative) Full model — Authorised Medicinal Products detailed diagram
Annex B (normative) Full model — Investigational Medicinal Products detailed diagram
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Message exchange format
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
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
6.6 Concepts required for the unique identification of Medicinal Products and the association with data carrier identifiers
7 Description of the information modelling principles and practices
7.1 General considerations
7.2 Conceptual overview diagrams
7.3 High-level diagrams
7.4 Detailed description diagrams
7.4.1 General
7.4.2 Relationships between classes
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
8.2 Medicinal Product Identifier (MPID)
8.2.1 General considerations
8.2.2 MPID code segments
8.3 Packaged Medicinal Product Identifier (PCID)
8.3.1 General considerations
8.3.2 Package description (PCID) code segment
8.4 Medicinal Product Batch Identifier (BAID1)
8.5 Medicinal Product Batch Identifier (BAID2)
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
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
9.2.2 Detailed description of Medicinal Product information
9.3 Marketing authorisation
9.3.1 General
9.3.2 Detailed description of marketing authorisation information
9.4 Organisation
9.4.1 General
9.4.2 Detailed description of organisation information
9.5 Manufacturer/Establishment (organisation)
9.5.1 General
9.5.2 Detailed description of manufacturer/establishment (organisation) information
9.6 Packaged Medicinal Product, including manufactured item and device
9.6.1 General
9.6.2 Detailed description of Packaged Medicinal Product information
9.7 Ingredient, substance and strength
9.7.1 General
9.7.2 Detailed description of ingredients, substance and strength information
9.8 Pharmaceutical product and device
9.8.1 General
9.8.2 Detailed description of pharmaceutical product and device information
9.9 Clinical particulars
9.9.1 General
9.9.2 Detailed description for clinical particulars information
10 Identifying characteristics for Investigational Medicinal Products
10.1 General
10.2 Primary identifiers
10.2.1 General considerations
10.3 Investigational Medicinal Product Identifier (IMPID)
10.3.1 General considerations
10.3.2 IMPID code segments
10.4 Investigational Medicinal Product Package Identifier (IPCID)
10.4.1 General provisions
10.4.2 Package description code segment
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
11.2.2 Investigational Medicinal Product
11.2.3 Investigational Medicinal Product name
11.2.4 Header
11.2.5 Manufacturer/Establishment (organisation)
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
11.4 Clinical trial authorisation
11.4.1 General
11.4.2 Detailed description of clinical trial authorisation information
11.5 Manufacturer/Establishment (organisation)
11.6 Investigational Packaged Medicinal Product
11.7 Pharmaceutical product
11.7.1 General
11.7.2 Pharmaceutical product
11.7.3 Dosing and route of administration
11.8 Ingredient
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
Annex A (normative) Full model — Authorised Medicinal Products detailed diagram
Annex B (normative) Full model — Investigational Medicinal Products detailed diagram
Bibliography