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BS EN ISO 11615:2017+A1:2022 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product information >
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BS EN ISO 11615:2017+A1:2022 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product information, 2022
- undefined [Go to Page]
- 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
- Blank Page
- Bibliography [Go to Page]