ISO/TS 20451:2017
Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
ISO/TS 20451:2017 defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.
Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of ISO/TS 20451:2017.
Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7 Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured Product Labelling (SPL) can be applied for pharmaceutical product information in the context of ISO/TS 20451:2017.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Conformance
5 Concepts required for the unique identification of pharmaceutical products
5.1 General considerations for elements required for the unique identification of pharmaceutical products
5.2 Principles required for the unique identification of a pharmaceutical product
6 Identifying characteristics for the identification of pharmaceutical products
6.1 Pharmaceutical product identification strata and levels
6.2 PhPID specified substance
6.3 Pharmaceutical product specified substance identification (PhPID SpSub)
6.4 Cardinality
6.5 Representation of strength concentration
6.6 Pharmaceutical product identifier (PhPID)
6.7 PhPID algorithm and product code concept
7 Ingredient, substance and strength
7.1 General considerations
7.2 Ingredient
7.2.1 Ingredient role
7.2.2 Substance
7.2.3 Specified substance
7.2.4 Specified substance group
7.2.5 Confidentiality indicator
7.2.6 Strength
7.2.7 Pharmaceutical product code concept for representing the normalised strength for liquid preparations
7.2.8 Strength (presentation)
7.2.9 Strength (concentration)
7.2.10 Measurement point
7.2.11 Country
7.2.12 Reference strength
7.2.13 Reference substance
7.2.14 Reference specified substance
7.2.15 Reference strength
7.2.16 Reference strength measurement point
7.2.17 Reference strength country
8 Pharmaceutical product: adjuvants and devices
8.1 General considerations
8.1.1 Detailed description of pharmaceutical product and device information
8.1.2 Pharmaceutical product
8.1.3 Pharmaceutical product characteristics
8.1.4 Device (pharmaceutical product)
Annex A (normative) Messaging: Ingredient, substance and strength
Annex B (normative) Messaging: Pharmaceutical product and device
Annex C (informative) Examples
Annex D (informative) Examples of representation of strength
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Conformance
5 Concepts required for the unique identification of pharmaceutical products
5.1 General considerations for elements required for the unique identification of pharmaceutical products
5.2 Principles required for the unique identification of a pharmaceutical product
6 Identifying characteristics for the identification of pharmaceutical products
6.1 Pharmaceutical product identification strata and levels
6.2 PhPID specified substance
6.3 Pharmaceutical product specified substance identification (PhPID SpSub)
6.4 Cardinality
6.5 Representation of strength concentration
6.6 Pharmaceutical product identifier (PhPID)
6.7 PhPID algorithm and product code concept
7 Ingredient, substance and strength
7.1 General considerations
7.2 Ingredient
7.2.1 Ingredient role
7.2.2 Substance
7.2.3 Specified substance
7.2.4 Specified substance group
7.2.5 Confidentiality indicator
7.2.6 Strength
7.2.7 Pharmaceutical product code concept for representing the normalised strength for liquid preparations
7.2.8 Strength (presentation)
7.2.9 Strength (concentration)
7.2.10 Measurement point
7.2.11 Country
7.2.12 Reference strength
7.2.13 Reference substance
7.2.14 Reference specified substance
7.2.15 Reference strength
7.2.16 Reference strength measurement point
7.2.17 Reference strength country
8 Pharmaceutical product: adjuvants and devices
8.1 General considerations
8.1.1 Detailed description of pharmaceutical product and device information
8.1.2 Pharmaceutical product
8.1.3 Pharmaceutical product characteristics
8.1.4 Device (pharmaceutical product)
Annex A (normative) Messaging: Ingredient, substance and strength
Annex B (normative) Messaging: Pharmaceutical product and device
Annex C (informative) Examples
Annex D (informative) Examples of representation of strength
Bibliography