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: EHDSMedicationObligations - Detailed Descriptions

Draft as of 2026-03-03

Definitions for the EHDSMedicationObligations 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. EHDSMedication
Definition | Logical model for prescribed/dispensed medication. The model is shared by statements, requests, dispensations, and administrations. Each of those may have different restrictions in a FHIR profile. The model is suitable for generic/virtual medications as well as branded/real products. The model aims to have basic alignment with ISO IDMP but it does not cover the full complexity needed for medication registries. Base definition for all types defined in FHIR type system.
Short | Medication modelBase 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. EHDSMedication.identifyingCode[x]
Definition | 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.
Short | 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.
Control | 0..*
Type | Choice of: CodeableConcept, Identifier
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
4. EHDSMedication.classification
Definition | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)
Short | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)
Control | 0..*
Binding | WHO ATC
Type | CodeableConcept
6. EHDSMedication.productName
Definition | 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.
Short | 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.
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
8. EHDSMedication.marketingAuthorisationHolder
Definition | 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.
Short | 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.
Control | 0..1
Type | Base
10. EHDSMedication.marketingAuthorisationHolder.organisationName
Definition | Name of the organisation holding the authorisation for marketing/manufacturing
Short | Name of the organisation holding the authorisation for marketing/manufacturing
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
12. EHDSMedication.marketingAuthorisationHolder.organisationIdentifier
Definition | Identifier of the organisation and/or its physical location
Short | Identifier of the organisation and/or its physical location
Control | 0..*
Type | Identifier
14. EHDSMedication.doseForm
Definition | 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.
Short | 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.
Control | 0..1
Binding | EDQM Standard Terms
Type | CodeableConcept
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
16. EHDSMedication.description
Definition | Textual description of the product, e.g. including package description.
Short | Textual description of the product, e.g. including package description.
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
18. EHDSMedication.item
Definition | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
Short | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
Control | 0..*
Type | Base
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
20. EHDSMedication.item.doseForm
Definition | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms.
Short | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms.
Control | 0..1
Binding | EDQM Standard Terms
Type | CodeableConcept
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
22. EHDSMedication.item.ingredient
Definition | Ingredients
Short | Ingredients
Control | 1..*
Type | Base
24. EHDSMedication.item.ingredient.isActive
Definition | Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.
Short | Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.
Control | 0..1
Type | boolean
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
26. EHDSMedication.item.ingredient.substance
Definition | Substance
Short | Substance
Control | 1..1
Binding | EMA SPOR SMS
Type | CodeableConcept
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
28. EHDSMedication.item.ingredient.strengthInfo
Definition | Strength of the product - amount of substance per unit
Short | Strength of the product - amount of substance per unit
Control | 0..1
Type | Base
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
30. EHDSMedication.item.ingredient.strengthInfo.strength
Definition | Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet'
Short | Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet'
Control | 1..1
Type | Ratio
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
32. EHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstance
Definition | Substance that the strength refers to, especially when different from .item.strength.substance
Short | Substance that the strength refers to, especially when different from .item.strength.substance
Control | 0..1
Binding | EMA SPOR SMS
Type | CodeableConcept
34. EHDSMedication.item.unitOfPresentation
Definition | Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.
Short | Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.
Control | 0..1
Binding | EDQM Standard Terms
Type | CodeableConcept
36. EHDSMedication.item.containedQuantity
Definition | Manufactured item quantity per one item (3 ml / 1 vial)
Short | Manufactured item quantity per one item (3 ml / 1 vial)
Control | 0..1
Type | Ratio
38. EHDSMedication.item.amount
Definition | Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size.
Short | Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size.
Control | 0..1
Binding | UCUM for units of measure. EDQM Standard Terms for units of presentation.
Type | Quantity
40. EHDSMedication.item.packageType
Definition | Type of package of the medication item
Short | Type of package of the medication item
Control | 0..1
Binding | EDQM Standard Terms for packaging.
Type | CodeableConcept
42. EHDSMedication.device
Definition | Administration device included in the product. Devices that are not inside the medication package are excluded.
Short | Administration device included in the product. Devices that are not inside the medication package are excluded.
Control | 0..*
Type | Base
44. EHDSMedication.device.deviceQuantity
Definition | Number of such devices
Short | Number of such devices
Control | 1..1
Type | Quantity
46. EHDSMedication.device.device[x]
Definition | Device coded
Short | Device coded
Control | 1..1
Type | Choice of: CodeableConcept, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSDevice
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
48. EHDSMedication.characteristic
Definition | 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.
Short | 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.
Control | 0..*
Type | Base
50. EHDSMedication.characteristic.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic.
Control | 1..1
Type | CodeableConcept
52. EHDSMedication.characteristic.value[x]
Definition | Description of the characteristic value.
Short | Description of the characteristic value.
Control | 0..1
Type | Choice of: boolean, CodeableConcept, string, Quantity, dateTime, integer, decimal, Ratio
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
54. EHDSMedication.batch
Definition | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
Short | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
Control | 0..1
Type | Base
56. EHDSMedication.batch.lotNumber
Definition | Batch identifier of the medicinal product.
Short | Batch identifier of the medicinal product.
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
58. EHDSMedication.batch.expirationDate
Definition | Batch expiration date of the medicinal product.
Short | Batch expiration date of the medicinal product.
Control | 0..1
Type | dateTime
Primitive Value | This primitive element may be present, or absent, or replaced by an extension

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

0. EHDSMedication
Logical Model | Instances of this logical model are not marked to be the target of a Reference
2. EHDSMedication.identifyingCode[x]
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
4. EHDSMedication.productName
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
6. EHDSMedication.doseForm
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
8. EHDSMedication.item
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
10. EHDSMedication.item.doseForm
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
12. EHDSMedication.item.ingredient
14. EHDSMedication.item.ingredient.substance
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
16. EHDSMedication.item.ingredient.strengthInfo
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
18. EHDSMedication.item.ingredient.strengthInfo.strength
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer

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

0. EHDSMedication
Definition | Logical model for prescribed/dispensed medication. The model is shared by statements, requests, dispensations, and administrations. Each of those may have different restrictions in a FHIR profile. The model is suitable for generic/virtual medications as well as branded/real products. The model aims to have basic alignment with ISO IDMP but it does not cover the full complexity needed for medication registries.
Short | Medication model
Control | 0..*
Is Modifier | false
Logical Model | Instances of this logical model are not marked to be the target of a Reference
2. EHDSMedication.identifyingCode[x]
Definition | 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.
Short | 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.
Control | 0..*
Type | Choice of: CodeableConcept, Identifier
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
4. EHDSMedication.classification
Definition | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)
Short | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)
Control | 0..*
Binding | WHO ATC
Type | CodeableConcept
6. EHDSMedication.productName
Definition | 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.
Short | 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.
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
8. EHDSMedication.marketingAuthorisationHolder
Definition | 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.
Short | 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.
Control | 0..1
Type | Base
10. EHDSMedication.marketingAuthorisationHolder.organisationName
Definition | Name of the organisation holding the authorisation for marketing/manufacturing
Short | Name of the organisation holding the authorisation for marketing/manufacturing
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
12. EHDSMedication.marketingAuthorisationHolder.organisationIdentifier
Definition | Identifier of the organisation and/or its physical location
Short | Identifier of the organisation and/or its physical location
Control | 0..*
Type | Identifier
14. EHDSMedication.doseForm
Definition | 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.
Short | 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.
Control | 0..1
Binding | EDQM Standard Terms
Type | CodeableConcept
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
16. EHDSMedication.description
Definition | Textual description of the product, e.g. including package description.
Short | Textual description of the product, e.g. including package description.
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
18. EHDSMedication.item
Definition | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
Short | A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
Control | 0..*
Type | Base
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
20. EHDSMedication.item.doseForm
Definition | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms.
Short | Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms.
Control | 0..1
Binding | EDQM Standard Terms
Type | CodeableConcept
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
22. EHDSMedication.item.ingredient
Definition | Ingredients
Short | Ingredients
Control | 1..*
Type | Base
24. EHDSMedication.item.ingredient.isActive
Definition | Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.
Short | Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.
Control | 0..1
Type | boolean
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
26. EHDSMedication.item.ingredient.substance
Definition | Substance
Short | Substance
Control | 1..1
Binding | EMA SPOR SMS
Type | CodeableConcept
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
28. EHDSMedication.item.ingredient.strengthInfo
Definition | Strength of the product - amount of substance per unit
Short | Strength of the product - amount of substance per unit
Control | 0..1
Type | Base
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
30. EHDSMedication.item.ingredient.strengthInfo.strength
Definition | Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet'
Short | Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet'
Control | 1..1
Type | Ratio
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
32. EHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstance
Definition | Substance that the strength refers to, especially when different from .item.strength.substance
Short | Substance that the strength refers to, especially when different from .item.strength.substance
Control | 0..1
Binding | EMA SPOR SMS
Type | CodeableConcept
34. EHDSMedication.item.unitOfPresentation
Definition | Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.
Short | Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.
Control | 0..1
Binding | EDQM Standard Terms
Type | CodeableConcept
36. EHDSMedication.item.containedQuantity
Definition | Manufactured item quantity per one item (3 ml / 1 vial)
Short | Manufactured item quantity per one item (3 ml / 1 vial)
Control | 0..1
Type | Ratio
38. EHDSMedication.item.amount
Definition | Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size.
Short | Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size.
Control | 0..1
Binding | UCUM for units of measure. EDQM Standard Terms for units of presentation.
Type | Quantity
40. EHDSMedication.item.packageType
Definition | Type of package of the medication item
Short | Type of package of the medication item
Control | 0..1
Binding | EDQM Standard Terms for packaging.
Type | CodeableConcept
42. EHDSMedication.device
Definition | Administration device included in the product. Devices that are not inside the medication package are excluded.
Short | Administration device included in the product. Devices that are not inside the medication package are excluded.
Control | 0..*
Type | Base
44. EHDSMedication.device.deviceQuantity
Definition | Number of such devices
Short | Number of such devices
Control | 1..1
Type | Quantity
46. EHDSMedication.device.device[x]
Definition | Device coded
Short | Device coded
Control | 1..1
Type | Choice of: CodeableConcept, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSDevice
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
48. EHDSMedication.characteristic
Definition | 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.
Short | 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.
Control | 0..*
Type | Base
50. EHDSMedication.characteristic.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic.
Control | 1..1
Type | CodeableConcept
52. EHDSMedication.characteristic.value[x]
Definition | Description of the characteristic value.
Short | Description of the characteristic value.
Control | 0..1
Type | Choice of: boolean, CodeableConcept, string, Quantity, dateTime, integer, decimal, Ratio
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
54. EHDSMedication.batch
Definition | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
Short | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
Control | 0..1
Type | Base
56. EHDSMedication.batch.lotNumber
Definition | Batch identifier of the medicinal product.
Short | Batch identifier of the medicinal product.
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
58. EHDSMedication.batch.expirationDate
Definition | Batch expiration date of the medicinal product.
Short | Batch expiration date of the medicinal product.
Control | 0..1
Type | dateTime
Primitive Value | This primitive element may be present, or absent, or replaced by an extension