EHDS Logical Information Models
0.4.0 - draft

EHDS Logical Information Models, published by Xt-EHR. This guide is not an authorized publication; it is the continuous build for version 0.4.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/Xt-EHR/xt-ehr-common/ and changes regularly. See the Directory of published versions

## Logical Model: Medication model obligations

Official URL: http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSMedicationObligations | Version: 0.4.0
Draft as of 2026-03-03 | Computable Name: EHDSMedicationObligations

Obligations for the logical model for medication.

Usages:

- This Logical Model Profile is not used by any profiles in this Implementation Guide

You can also check for usages in the FHIR IG Statistics

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSMedication |  | 0..* | EHDSMedication | Medication model
identifyingCode[x] | O | 0..* |  | An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.
Obligations | Actor
SHALL:able-to-populate | Producer
identifyingCodeCodeableConcept |  |  | CodeableConcept |
identifyingCodeIdentifier |  |  | Identifier |
classification |  | 0..* | CodeableConcept | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.) Binding Description: (preferred): WHO ATC
productName | O | 0..1 | string | Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.
Obligations | Actor
SHOULD:able-to-populate | Producer
marketingAuthorisationHolder |  | 0..1 | Base | Marketing authorisation holder of the medicinal product. Relevant for identifying the exact product. If the product does not have a marketing authorisation, the manufacturer information may be used.
organisationName |  | 0..1 | string | Name of the organisation holding the authorisation for marketing/manufacturing
organisationIdentifier |  | 0..* | Identifier | Identifier of the organisation and/or its physical location
doseForm | O | 0..1 | CodeableConcept | Dose form at the package level (e.g. authorised dose form), corresponding to IDMP Combined Pharmaceutical Dose Form (this includes terms from EDQM Combination Pack or Combined Dose Form lists). Dose form for a single package item is defined in item.doseForm. Binding Description: (preferred): EDQM Standard Terms
Obligations | Actor
SHOULD:able-to-populate | Producer
description |  | 0..1 | string | Textual description of the product, e.g. including package description.
item | O | 0..* | Base | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
Obligations | Actor
SHOULD:able-to-populate | Producer
doseForm | O | 0..1 | CodeableConcept | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms. Binding Description: (preferred): EDQM Standard Terms
Obligations | Actor
SHOULD:able-to-populate | Producer
ingredient |  | 1..* | Base | Ingredients
isActive |  | 0..1 | boolean | Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.
substance | O | 1..1 | CodeableConcept | Substance Binding Description: (preferred): EMA SPOR SMS
Obligations | Actor
SHOULD:able-to-populate | Producer
strengthInfo | O | 0..1 | Base | Strength of the product - amount of substance per unit
Obligations | Actor
SHOULD:able-to-populate | Producer
strength | O | 1..1 | Ratio | Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet'
Obligations | Actor
SHALL:able-to-populate | Producer
basisOfStrengthSubstance |  | 0..1 | CodeableConcept | Substance that the strength refers to, especially when different from .item.strength.substance Binding Description: (preferred): EMA SPOR SMS
unitOfPresentation |  | 0..1 | CodeableConcept | Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package. Binding Description: (preferred): EDQM Standard Terms
containedQuantity |  | 0..1 | Ratio | Manufactured item quantity per one item (3 ml / 1 vial)
amount |  | 0..1 | Quantity | Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size. Binding Description: (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.
packageType |  | 0..1 | CodeableConcept | Type of package of the medication item Binding Description: (preferred): EDQM Standard Terms for packaging.
device |  | 0..* | Base | Administration device included in the product. Devices that are not inside the medication package are excluded.
deviceQuantity |  | 1..1 | Quantity | Number of such devices
device[x] |  | 1..1 |  | Device coded
deviceCodeableConcept |  |  | CodeableConcept |
deviceEHDSDevice |  |  | EHDSDevice |
characteristic |  | 0..* | Base | Additional features of the product (e.g. reimbursable, sugar-free, easy-open cap, score-lined). It is expected that implementers will define a valueset supporting their use cases.
type |  | 1..1 | CodeableConcept | A code expressing the type of characteristic.
value[x] |  | 0..1 |  | Description of the characteristic value.
valueBoolean |  |  | boolean |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueQuantity |  |  | Quantity |
valueDateTime |  |  | dateTime |
valueInteger |  |  | integer |
valueDecimal |  |  | decimal |
valueRatio |  |  | Ratio |
batch |  | 0..1 | Base | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
lotNumber |  | 0..1 | string | Batch identifier of the medicinal product.
expirationDate |  | 0..1 | dateTime | Batch expiration date of the medicinal product.
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
EHDSMedication.classification | Base | preferred |  | Not State | Unknown
EHDSMedication.doseForm | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​doseForm | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​ingredient.substance | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​ingredient.strengthInfo.​basisOfStrengthSubstance | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​unitOfPresentation | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​amount | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​packageType | Base | preferred |  | Not State | Unknown

This structure is derived from EHDSMedication

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSMedication |  | 0..* | EHDSMedication | Medication model
identifyingCode[x] | O | 0..* | CodeableConcept, Identifier | An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.
Obligations | Actor
SHALL:able-to-populate | Producer
productName | O | 0..1 | string | Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.
Obligations | Actor
SHOULD:able-to-populate | Producer
doseForm | O | 0..1 | CodeableConcept | Dose form at the package level (e.g. authorised dose form), corresponding to IDMP Combined Pharmaceutical Dose Form (this includes terms from EDQM Combination Pack or Combined Dose Form lists). Dose form for a single package item is defined in item.doseForm.
Obligations | Actor
SHOULD:able-to-populate | Producer
item | O | 0..* | Base | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
Obligations | Actor
SHOULD:able-to-populate | Producer
doseForm | O | 0..1 | CodeableConcept | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms.
Obligations | Actor
SHOULD:able-to-populate | Producer
ingredient |  |  |  |
substance | O | 1..1 | CodeableConcept | Substance
Obligations | Actor
SHOULD:able-to-populate | Producer
strengthInfo | O | 0..1 | Base | Strength of the product - amount of substance per unit
Obligations | Actor
SHOULD:able-to-populate | Producer
strength | O | 1..1 | Ratio | Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet'
Obligations | Actor
SHALL:able-to-populate | Producer
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSMedication |  | 0..* | EHDSMedication | Medication model
identifyingCode[x] | O | 0..* |  | An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.
Obligations | Actor
SHALL:able-to-populate | Producer
identifyingCodeCodeableConcept |  |  | CodeableConcept |
identifyingCodeIdentifier |  |  | Identifier |
classification |  | 0..* | CodeableConcept | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.) Binding Description: (preferred): WHO ATC
productName | O | 0..1 | string | Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.
Obligations | Actor
SHOULD:able-to-populate | Producer
marketingAuthorisationHolder |  | 0..1 | Base | Marketing authorisation holder of the medicinal product. Relevant for identifying the exact product. If the product does not have a marketing authorisation, the manufacturer information may be used.
organisationName |  | 0..1 | string | Name of the organisation holding the authorisation for marketing/manufacturing
organisationIdentifier |  | 0..* | Identifier | Identifier of the organisation and/or its physical location
doseForm | O | 0..1 | CodeableConcept | Dose form at the package level (e.g. authorised dose form), corresponding to IDMP Combined Pharmaceutical Dose Form (this includes terms from EDQM Combination Pack or Combined Dose Form lists). Dose form for a single package item is defined in item.doseForm. Binding Description: (preferred): EDQM Standard Terms
Obligations | Actor
SHOULD:able-to-populate | Producer
description |  | 0..1 | string | Textual description of the product, e.g. including package description.
item | O | 0..* | Base | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
Obligations | Actor
SHOULD:able-to-populate | Producer
doseForm | O | 0..1 | CodeableConcept | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms. Binding Description: (preferred): EDQM Standard Terms
Obligations | Actor
SHOULD:able-to-populate | Producer
ingredient |  | 1..* | Base | Ingredients
isActive |  | 0..1 | boolean | Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.
substance | O | 1..1 | CodeableConcept | Substance Binding Description: (preferred): EMA SPOR SMS
Obligations | Actor
SHOULD:able-to-populate | Producer
strengthInfo | O | 0..1 | Base | Strength of the product - amount of substance per unit
Obligations | Actor
SHOULD:able-to-populate | Producer
strength | O | 1..1 | Ratio | Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet'
Obligations | Actor
SHALL:able-to-populate | Producer
basisOfStrengthSubstance |  | 0..1 | CodeableConcept | Substance that the strength refers to, especially when different from .item.strength.substance Binding Description: (preferred): EMA SPOR SMS
unitOfPresentation |  | 0..1 | CodeableConcept | Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package. Binding Description: (preferred): EDQM Standard Terms
containedQuantity |  | 0..1 | Ratio | Manufactured item quantity per one item (3 ml / 1 vial)
amount |  | 0..1 | Quantity | Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size. Binding Description: (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.
packageType |  | 0..1 | CodeableConcept | Type of package of the medication item Binding Description: (preferred): EDQM Standard Terms for packaging.
device |  | 0..* | Base | Administration device included in the product. Devices that are not inside the medication package are excluded.
deviceQuantity |  | 1..1 | Quantity | Number of such devices
device[x] |  | 1..1 |  | Device coded
deviceCodeableConcept |  |  | CodeableConcept |
deviceEHDSDevice |  |  | EHDSDevice |
characteristic |  | 0..* | Base | Additional features of the product (e.g. reimbursable, sugar-free, easy-open cap, score-lined). It is expected that implementers will define a valueset supporting their use cases.
type |  | 1..1 | CodeableConcept | A code expressing the type of characteristic.
value[x] |  | 0..1 |  | Description of the characteristic value.
valueBoolean |  |  | boolean |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueQuantity |  |  | Quantity |
valueDateTime |  |  | dateTime |
valueInteger |  |  | integer |
valueDecimal |  |  | decimal |
valueRatio |  |  | Ratio |
batch |  | 0..1 | Base | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
lotNumber |  | 0..1 | string | Batch identifier of the medicinal product.
expirationDate |  | 0..1 | dateTime | Batch expiration date of the medicinal product.
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
EHDSMedication.classification | Base | preferred |  | Not State | Unknown
EHDSMedication.doseForm | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​doseForm | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​ingredient.substance | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​ingredient.strengthInfo.​basisOfStrengthSubstance | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​unitOfPresentation | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​amount | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​packageType | Base | preferred |  | Not State | Unknown

This structure is derived from EHDSMedication

Summary

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSMedication |  | 0..* | EHDSMedication | Medication model
identifyingCode[x] | O | 0..* |  | An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.
Obligations | Actor
SHALL:able-to-populate | Producer
identifyingCodeCodeableConcept |  |  | CodeableConcept |
identifyingCodeIdentifier |  |  | Identifier |
classification |  | 0..* | CodeableConcept | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.) Binding Description: (preferred): WHO ATC
productName | O | 0..1 | string | Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.
Obligations | Actor
SHOULD:able-to-populate | Producer
marketingAuthorisationHolder |  | 0..1 | Base | Marketing authorisation holder of the medicinal product. Relevant for identifying the exact product. If the product does not have a marketing authorisation, the manufacturer information may be used.
organisationName |  | 0..1 | string | Name of the organisation holding the authorisation for marketing/manufacturing
organisationIdentifier |  | 0..* | Identifier | Identifier of the organisation and/or its physical location
doseForm | O | 0..1 | CodeableConcept | Dose form at the package level (e.g. authorised dose form), corresponding to IDMP Combined Pharmaceutical Dose Form (this includes terms from EDQM Combination Pack or Combined Dose Form lists). Dose form for a single package item is defined in item.doseForm. Binding Description: (preferred): EDQM Standard Terms
Obligations | Actor
SHOULD:able-to-populate | Producer
description |  | 0..1 | string | Textual description of the product, e.g. including package description.
item | O | 0..* | Base | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
Obligations | Actor
SHOULD:able-to-populate | Producer
doseForm | O | 0..1 | CodeableConcept | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms. Binding Description: (preferred): EDQM Standard Terms
Obligations | Actor
SHOULD:able-to-populate | Producer
ingredient |  | 1..* | Base | Ingredients
isActive |  | 0..1 | boolean | Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.
substance | O | 1..1 | CodeableConcept | Substance Binding Description: (preferred): EMA SPOR SMS
Obligations | Actor
SHOULD:able-to-populate | Producer
strengthInfo | O | 0..1 | Base | Strength of the product - amount of substance per unit
Obligations | Actor
SHOULD:able-to-populate | Producer
strength | O | 1..1 | Ratio | Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet'
Obligations | Actor
SHALL:able-to-populate | Producer
basisOfStrengthSubstance |  | 0..1 | CodeableConcept | Substance that the strength refers to, especially when different from .item.strength.substance Binding Description: (preferred): EMA SPOR SMS
unitOfPresentation |  | 0..1 | CodeableConcept | Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package. Binding Description: (preferred): EDQM Standard Terms
containedQuantity |  | 0..1 | Ratio | Manufactured item quantity per one item (3 ml / 1 vial)
amount |  | 0..1 | Quantity | Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size. Binding Description: (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.
packageType |  | 0..1 | CodeableConcept | Type of package of the medication item Binding Description: (preferred): EDQM Standard Terms for packaging.
device |  | 0..* | Base | Administration device included in the product. Devices that are not inside the medication package are excluded.
deviceQuantity |  | 1..1 | Quantity | Number of such devices
device[x] |  | 1..1 |  | Device coded
deviceCodeableConcept |  |  | CodeableConcept |
deviceEHDSDevice |  |  | EHDSDevice |
characteristic |  | 0..* | Base | Additional features of the product (e.g. reimbursable, sugar-free, easy-open cap, score-lined). It is expected that implementers will define a valueset supporting their use cases.
type |  | 1..1 | CodeableConcept | A code expressing the type of characteristic.
value[x] |  | 0..1 |  | Description of the characteristic value.
valueBoolean |  |  | boolean |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueQuantity |  |  | Quantity |
valueDateTime |  |  | dateTime |
valueInteger |  |  | integer |
valueDecimal |  |  | decimal |
valueRatio |  |  | Ratio |
batch |  | 0..1 | Base | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
lotNumber |  | 0..1 | string | Batch identifier of the medicinal product.
expirationDate |  | 0..1 | dateTime | Batch expiration date of the medicinal product.
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
EHDSMedication.classification | Base | preferred |  | Not State | Unknown
EHDSMedication.doseForm | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​doseForm | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​ingredient.substance | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​ingredient.strengthInfo.​basisOfStrengthSubstance | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​unitOfPresentation | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​amount | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​packageType | Base | preferred |  | Not State | Unknown

Differential View

This structure is derived from EHDSMedication

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSMedication |  | 0..* | EHDSMedication | Medication model
identifyingCode[x] | O | 0..* | CodeableConcept, Identifier | An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.
Obligations | Actor
SHALL:able-to-populate | Producer
productName | O | 0..1 | string | Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.
Obligations | Actor
SHOULD:able-to-populate | Producer
doseForm | O | 0..1 | CodeableConcept | Dose form at the package level (e.g. authorised dose form), corresponding to IDMP Combined Pharmaceutical Dose Form (this includes terms from EDQM Combination Pack or Combined Dose Form lists). Dose form for a single package item is defined in item.doseForm.
Obligations | Actor
SHOULD:able-to-populate | Producer
item | O | 0..* | Base | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
Obligations | Actor
SHOULD:able-to-populate | Producer
doseForm | O | 0..1 | CodeableConcept | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms.
Obligations | Actor
SHOULD:able-to-populate | Producer
ingredient |  |  |  |
substance | O | 1..1 | CodeableConcept | Substance
Obligations | Actor
SHOULD:able-to-populate | Producer
strengthInfo | O | 0..1 | Base | Strength of the product - amount of substance per unit
Obligations | Actor
SHOULD:able-to-populate | Producer
strength | O | 1..1 | Ratio | Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet'
Obligations | Actor
SHALL:able-to-populate | Producer
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSMedication |  | 0..* | EHDSMedication | Medication model
identifyingCode[x] | O | 0..* |  | An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.
Obligations | Actor
SHALL:able-to-populate | Producer
identifyingCodeCodeableConcept |  |  | CodeableConcept |
identifyingCodeIdentifier |  |  | Identifier |
classification |  | 0..* | CodeableConcept | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.) Binding Description: (preferred): WHO ATC
productName | O | 0..1 | string | Current trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.
Obligations | Actor
SHOULD:able-to-populate | Producer
marketingAuthorisationHolder |  | 0..1 | Base | Marketing authorisation holder of the medicinal product. Relevant for identifying the exact product. If the product does not have a marketing authorisation, the manufacturer information may be used.
organisationName |  | 0..1 | string | Name of the organisation holding the authorisation for marketing/manufacturing
organisationIdentifier |  | 0..* | Identifier | Identifier of the organisation and/or its physical location
doseForm | O | 0..1 | CodeableConcept | Dose form at the package level (e.g. authorised dose form), corresponding to IDMP Combined Pharmaceutical Dose Form (this includes terms from EDQM Combination Pack or Combined Dose Form lists). Dose form for a single package item is defined in item.doseForm. Binding Description: (preferred): EDQM Standard Terms
Obligations | Actor
SHOULD:able-to-populate | Producer
description |  | 0..1 | string | Textual description of the product, e.g. including package description.
item | O | 0..* | Base | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
Obligations | Actor
SHOULD:able-to-populate | Producer
doseForm | O | 0..1 | CodeableConcept | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms. Binding Description: (preferred): EDQM Standard Terms
Obligations | Actor
SHOULD:able-to-populate | Producer
ingredient |  | 1..* | Base | Ingredients
isActive |  | 0..1 | boolean | Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.
substance | O | 1..1 | CodeableConcept | Substance Binding Description: (preferred): EMA SPOR SMS
Obligations | Actor
SHOULD:able-to-populate | Producer
strengthInfo | O | 0..1 | Base | Strength of the product - amount of substance per unit
Obligations | Actor
SHOULD:able-to-populate | Producer
strength | O | 1..1 | Ratio | Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet'
Obligations | Actor
SHALL:able-to-populate | Producer
basisOfStrengthSubstance |  | 0..1 | CodeableConcept | Substance that the strength refers to, especially when different from .item.strength.substance Binding Description: (preferred): EMA SPOR SMS
unitOfPresentation |  | 0..1 | CodeableConcept | Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package. Binding Description: (preferred): EDQM Standard Terms
containedQuantity |  | 0..1 | Ratio | Manufactured item quantity per one item (3 ml / 1 vial)
amount |  | 0..1 | Quantity | Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size. Binding Description: (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.
packageType |  | 0..1 | CodeableConcept | Type of package of the medication item Binding Description: (preferred): EDQM Standard Terms for packaging.
device |  | 0..* | Base | Administration device included in the product. Devices that are not inside the medication package are excluded.
deviceQuantity |  | 1..1 | Quantity | Number of such devices
device[x] |  | 1..1 |  | Device coded
deviceCodeableConcept |  |  | CodeableConcept |
deviceEHDSDevice |  |  | EHDSDevice |
characteristic |  | 0..* | Base | Additional features of the product (e.g. reimbursable, sugar-free, easy-open cap, score-lined). It is expected that implementers will define a valueset supporting their use cases.
type |  | 1..1 | CodeableConcept | A code expressing the type of characteristic.
value[x] |  | 0..1 |  | Description of the characteristic value.
valueBoolean |  |  | boolean |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueQuantity |  |  | Quantity |
valueDateTime |  |  | dateTime |
valueInteger |  |  | integer |
valueDecimal |  |  | decimal |
valueRatio |  |  | Ratio |
batch |  | 0..1 | Base | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
lotNumber |  | 0..1 | string | Batch identifier of the medicinal product.
expirationDate |  | 0..1 | dateTime | Batch expiration date of the medicinal product.
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
EHDSMedication.classification | Base | preferred |  | Not State | Unknown
EHDSMedication.doseForm | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​doseForm | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​ingredient.substance | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​ingredient.strengthInfo.​basisOfStrengthSubstance | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​unitOfPresentation | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​amount | Base | preferred |  | Not State | Unknown
EHDSMedication.item.​packageType | Base | preferred |  | Not State | Unknown

This structure is derived from EHDSMedication

Summary

Other representations of profile: CSV, Excel