HL7 Europe Medication Prescription and Dispense
0.1.0-ballot - ballot 150

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## Logical Model: MedProductEhn - Detailed Descriptions

Draft as of 2025-06-04

Definitions for the MedicinalProduct logical model.

- Key Elements Table
- Differential Elements Table
- Snapshot Elements Table

Guidance on how to interpret the contents of this table can be foundhere

0. MedicinalProduct
Definition | Identification of the prescribed product. Section A1.4 of the eHN guideline Base definition for all types defined in FHIR type system.
Short | A1.4 Identification of the prescribed productBase for all types and resources
Control | 0..*
Is Modifier | false
Logical Model | Instances of this logical model are not marked to be the target of a Reference
2. MedicinalProduct.name
Definition | Brand name of the authorised medicinal product. It has to be noted, that according to Implementing Directive 2012/52/EU additional requirements may apply. [not applicable for generic prescriptions]
Short | A.1.4.1 Name of the medicinal product
Control | 0..*
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
4. MedicinalProduct.mpid
Definition | Identifier of a medicinal product refers to the product inside the package, not the packaged item as such. It could be MPID according to ISO 11615, EMA PMS ID and/or a national identifier. [not applicable for generic prescriptions]
Short | A.1.4.2 Identifier of the medicinal product
Control | 0..*
Type | Identifier
6. MedicinalProduct.phpid
Definition | Identifier of a pharmaceutical product refers to unique PhPID according to ISO 11616. This could be a part of a description of a specific medicinal product or an attribute of a generic prescription. [not applicable for generic prescriptions]
Short | A.1.4.2.1 Identifier(s) of the pharmaceutical product
Control | 0..*
Type | Identifier
8. MedicinalProduct.pcid
Definition | Identifier of a packaged medicinal product refers to a specific pack size of a specific product. It could be PCID according to ISO 11615 and/or its national equivalent. [not applicable for generic prescriptions]
Short | A.1.4.2.2 Identifier(s) of the packaged medicinal product
Control | 0..*
Type | Identifier
10. MedicinalProduct.marketingAuthHolder
Definition | Organisation that holds the marketing authorisation of the prescribed product. [not applicable for generic prescriptions]
Short | A.1.4.3 Marketing authorisation holder
Control | 0..1
Type | Organization
12. MedicinalProduct.activeSubstance
Definition | All active substances according to ISO 11238. Referred to by ""common name"" in implementing directive 2012/52/EU.
Short | A.1.4.4 Active substance(s)
Control | 0..*
Binding | EMA SMS
Type | CodeableConcept
14. MedicinalProduct.strength
Definition | Presentation and/or concentration strength of the active substances. In addition, reference strength could be provided (Article 1 of Directive 2001/83/EC). Preferred codesystem UCUM and EDQM.
Short | A.1.4.4.1 Strength of the active substance(s)
Control | 0..*
Type | Ratio
16. MedicinalProduct.classification
Definition | WHO ATC code of the product
Short | A.1.4.5 Product classification
Control | 0..*
Binding | ATC
Type | CodeableConcept
18. MedicinalProduct.doseForm
Definition | Dose form of a product could be either authorised dose form (includes EDQM combination pack dose forms), administrable dose form or manufactured item dose form. It must be made clear which type of dose forms are provided. For example, for the same product several different dose forms can be provided: ?powder and solvent for solution for injection? as authorised dose form, ?solution for injection? as administrable dose form, and ?powder? and ?solvent? as the dose forms for the manufactured items in the inner packaging. Referred to by ""pharmaceutical formulation"" in implementing directive 2012/52/EU.
Short | A.1.4.6 Pharmaceutical dose form(s)
Control | 0..*
Binding | EDQM
Type | CodeableConcept
20. MedicinalProduct.unitOfPresentation
Definition | Unit of presentation is used as a unit when describing the strength, but according to ISO IDMP it is also a separate attribute of the pharmaceutical product and manufactured item.
Short | A.1.4.7 Unit of presentation(s)
Control | 0..*
Binding | EDQM
Type | CodeableConcept
22. MedicinalProduct.packageType
Definition | Type of the container, Examples: bottle, blister, box
Short | A.1.4.8 Package type
Control | 0..*
Binding | EDQM
Type | CodeableConcept
24. MedicinalProduct.packageSize
Definition | Typically, the pack size is the number of unit of presentations in the package. It could also be presented using units of measurement (ml, g). In some cases, there is a need to refine the package size that it describes the amounts of different manufactured items in more than one inner packages. However, the overall amount of a prescribed product must be calculable from the pack size description. Preferred system(s): UCUM; EDQM
Short | A.1.4.9 Pack size
Control | 0..*
Binding | UCUM, EDQM
Type | Quantity

Guidance on how to interpret the contents of this table can be foundhere

0. MedicinalProduct
Definition | Identification of the prescribed product. Section A1.4 of the eHN guideline
Short | A1.4 Identification of the prescribed product
Logical Model | Instances of this logical model are not marked to be the target of a Reference
2. MedicinalProduct.name
Definition | Brand name of the authorised medicinal product. It has to be noted, that according to Implementing Directive 2012/52/EU additional requirements may apply. [not applicable for generic prescriptions]
Short | A.1.4.1 Name of the medicinal product
Control | 0..*
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
4. MedicinalProduct.mpid
Definition | Identifier of a medicinal product refers to the product inside the package, not the packaged item as such. It could be MPID according to ISO 11615, EMA PMS ID and/or a national identifier. [not applicable for generic prescriptions]
Short | A.1.4.2 Identifier of the medicinal product
Control | 0..*
Type | Identifier
6. MedicinalProduct.phpid
Definition | Identifier of a pharmaceutical product refers to unique PhPID according to ISO 11616. This could be a part of a description of a specific medicinal product or an attribute of a generic prescription. [not applicable for generic prescriptions]
Short | A.1.4.2.1 Identifier(s) of the pharmaceutical product
Control | 0..*
Type | Identifier
8. MedicinalProduct.pcid
Definition | Identifier of a packaged medicinal product refers to a specific pack size of a specific product. It could be PCID according to ISO 11615 and/or its national equivalent. [not applicable for generic prescriptions]
Short | A.1.4.2.2 Identifier(s) of the packaged medicinal product
Control | 0..*
Type | Identifier
10. MedicinalProduct.marketingAuthHolder
Definition | Organisation that holds the marketing authorisation of the prescribed product. [not applicable for generic prescriptions]
Short | A.1.4.3 Marketing authorisation holder
Control | 0..1
Type | Organization
12. MedicinalProduct.activeSubstance
Definition | All active substances according to ISO 11238. Referred to by ""common name"" in implementing directive 2012/52/EU.
Short | A.1.4.4 Active substance(s)
Control | 0..*
Binding | EMA SMS
Type | CodeableConcept
14. MedicinalProduct.strength
Definition | Presentation and/or concentration strength of the active substances. In addition, reference strength could be provided (Article 1 of Directive 2001/83/EC). Preferred codesystem UCUM and EDQM.
Short | A.1.4.4.1 Strength of the active substance(s)
Control | 0..*
Type | Ratio
16. MedicinalProduct.classification
Definition | WHO ATC code of the product
Short | A.1.4.5 Product classification
Control | 0..*
Binding | ATC
Type | CodeableConcept
18. MedicinalProduct.doseForm
Definition | Dose form of a product could be either authorised dose form (includes EDQM combination pack dose forms), administrable dose form or manufactured item dose form. It must be made clear which type of dose forms are provided. For example, for the same product several different dose forms can be provided: ?powder and solvent for solution for injection? as authorised dose form, ?solution for injection? as administrable dose form, and ?powder? and ?solvent? as the dose forms for the manufactured items in the inner packaging. Referred to by ""pharmaceutical formulation"" in implementing directive 2012/52/EU.
Short | A.1.4.6 Pharmaceutical dose form(s)
Control | 0..*
Binding | EDQM
Type | CodeableConcept
20. MedicinalProduct.unitOfPresentation
Definition | Unit of presentation is used as a unit when describing the strength, but according to ISO IDMP it is also a separate attribute of the pharmaceutical product and manufactured item.
Short | A.1.4.7 Unit of presentation(s)
Control | 0..*
Binding | EDQM
Type | CodeableConcept
22. MedicinalProduct.packageType
Definition | Type of the container, Examples: bottle, blister, box
Short | A.1.4.8 Package type
Control | 0..*
Binding | EDQM
Type | CodeableConcept
24. MedicinalProduct.packageSize
Definition | Typically, the pack size is the number of unit of presentations in the package. It could also be presented using units of measurement (ml, g). In some cases, there is a need to refine the package size that it describes the amounts of different manufactured items in more than one inner packages. However, the overall amount of a prescribed product must be calculable from the pack size description. Preferred system(s): UCUM; EDQM
Short | A.1.4.9 Pack size
Control | 0..*
Binding | UCUM, EDQM
Type | Quantity

Guidance on how to interpret the contents of this table can be foundhere

0. MedicinalProduct
Definition | Identification of the prescribed product. Section A1.4 of the eHN guideline
Short | A1.4 Identification of the prescribed product
Control | 0..*
Is Modifier | false
Logical Model | Instances of this logical model are not marked to be the target of a Reference
2. MedicinalProduct.name
Definition | Brand name of the authorised medicinal product. It has to be noted, that according to Implementing Directive 2012/52/EU additional requirements may apply. [not applicable for generic prescriptions]
Short | A.1.4.1 Name of the medicinal product
Control | 0..*
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
4. MedicinalProduct.mpid
Definition | Identifier of a medicinal product refers to the product inside the package, not the packaged item as such. It could be MPID according to ISO 11615, EMA PMS ID and/or a national identifier. [not applicable for generic prescriptions]
Short | A.1.4.2 Identifier of the medicinal product
Control | 0..*
Type | Identifier
6. MedicinalProduct.phpid
Definition | Identifier of a pharmaceutical product refers to unique PhPID according to ISO 11616. This could be a part of a description of a specific medicinal product or an attribute of a generic prescription. [not applicable for generic prescriptions]
Short | A.1.4.2.1 Identifier(s) of the pharmaceutical product
Control | 0..*
Type | Identifier
8. MedicinalProduct.pcid
Definition | Identifier of a packaged medicinal product refers to a specific pack size of a specific product. It could be PCID according to ISO 11615 and/or its national equivalent. [not applicable for generic prescriptions]
Short | A.1.4.2.2 Identifier(s) of the packaged medicinal product
Control | 0..*
Type | Identifier
10. MedicinalProduct.marketingAuthHolder
Definition | Organisation that holds the marketing authorisation of the prescribed product. [not applicable for generic prescriptions]
Short | A.1.4.3 Marketing authorisation holder
Control | 0..1
Type | Organization
12. MedicinalProduct.activeSubstance
Definition | All active substances according to ISO 11238. Referred to by ""common name"" in implementing directive 2012/52/EU.
Short | A.1.4.4 Active substance(s)
Control | 0..*
Binding | EMA SMS
Type | CodeableConcept
14. MedicinalProduct.strength
Definition | Presentation and/or concentration strength of the active substances. In addition, reference strength could be provided (Article 1 of Directive 2001/83/EC). Preferred codesystem UCUM and EDQM.
Short | A.1.4.4.1 Strength of the active substance(s)
Control | 0..*
Type | Ratio
16. MedicinalProduct.classification
Definition | WHO ATC code of the product
Short | A.1.4.5 Product classification
Control | 0..*
Binding | ATC
Type | CodeableConcept
18. MedicinalProduct.doseForm
Definition | Dose form of a product could be either authorised dose form (includes EDQM combination pack dose forms), administrable dose form or manufactured item dose form. It must be made clear which type of dose forms are provided. For example, for the same product several different dose forms can be provided: ?powder and solvent for solution for injection? as authorised dose form, ?solution for injection? as administrable dose form, and ?powder? and ?solvent? as the dose forms for the manufactured items in the inner packaging. Referred to by ""pharmaceutical formulation"" in implementing directive 2012/52/EU.
Short | A.1.4.6 Pharmaceutical dose form(s)
Control | 0..*
Binding | EDQM
Type | CodeableConcept
20. MedicinalProduct.unitOfPresentation
Definition | Unit of presentation is used as a unit when describing the strength, but according to ISO IDMP it is also a separate attribute of the pharmaceutical product and manufactured item.
Short | A.1.4.7 Unit of presentation(s)
Control | 0..*
Binding | EDQM
Type | CodeableConcept
22. MedicinalProduct.packageType
Definition | Type of the container, Examples: bottle, blister, box
Short | A.1.4.8 Package type
Control | 0..*
Binding | EDQM
Type | CodeableConcept
24. MedicinalProduct.packageSize
Definition | Typically, the pack size is the number of unit of presentations in the package. It could also be presented using units of measurement (ml, g). In some cases, there is a need to refine the package size that it describes the amounts of different manufactured items in more than one inner packages. However, the overall amount of a prescribed product must be calculable from the pack size description. Preferred system(s): UCUM; EDQM
Short | A.1.4.9 Pack size
Control | 0..*
Binding | UCUM, EDQM
Type | Quantity