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: EHDSImmunisationObligations - Detailed Descriptions

Draft as of 2026-03-03

Definitions for the EHDSImmunisationObligations 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. EHDSImmunisation
Definition | Model describes the administration of immunisation products, including vaccines and immunoglobulins, covering active and passive immunisations. It focuses on immunisation as a clinical procedure rather than the resulting immunity. The model supports routine immunisations at standard doses and may overlap with medication summaries or prescription lists. Natural immunity, immunisation outcomes, refusals, and administration or planning details are out of scope. Base definition for all types defined in FHIR type system.
Short | Immunisation 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. EHDSImmunisation.header
Definition | Basic metadata for this information
Short | Basic metadata for this information
Control | 1..1
Type | Base
4. EHDSImmunisation.header.subject
Definition | Patient/subject information
Short | Patient/subject information
Control | 1..1
Type | http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSPatient
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
6. EHDSImmunisation.header.identifier
Definition | Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).
Short | Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
Type | Identifier
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
8. EHDSImmunisation.header.author[x]
Definition | The author of the immunisation statement.
Short | The author of the immunisation statement.
Control | 0..*
Type | Choice of: http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSHealthProfessional, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSOrganisation, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSDevice
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
10. EHDSImmunisation.header.date
Definition | Date and optionally time of authoring/issuing
Short | Date and optionally time of authoring/issuing
Control | 0..1
Type | dateTime
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
12. EHDSImmunisation.header.status
Definition | Status of the immunisation event (completed, not-done).
Short | Status of the immunisation event (completed, not-done).
Control | 1..1
Type | CodeableConcept
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
14. EHDSImmunisation.header.source
Definition | Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information.
Short | Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information.
Control | 0..1
Type | CodeableConcept
16. EHDSImmunisation.header.language
Definition | Language in which the resource is written. Language is expressed by the IETF language tag.
Short | Language in which the resource is written. Language is expressed by the IETF language tag.
Control | 0..1
Binding | BCP 47
Type | CodeableConcept
18. EHDSImmunisation.diseaseOrAgentTargeted
Definition | Disease or agent that the vaccination provides protection against (e.g. 76902006 Tetanus).
Short | Disease or agent that the vaccination provides protection against (e.g. 76902006 Tetanus).
Control | 0..*
Binding | ICD-10, SNOMED CT
Type | CodeableConcept
20. EHDSImmunisation.vaccine
Definition | Type of immunisation, e.g. J07AM01 Tetanus toxoid; or 871803007 Hepatitis A and Hepatitis B virus antigens only vaccine product.
Short | Type of immunisation, e.g. J07AM01 Tetanus toxoid; or 871803007 Hepatitis A and Hepatitis B virus antigens only vaccine product.
Control | 1..1
Binding | SNOMED CT, ATC
Type | CodeableConcept
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
22. EHDSImmunisation.administeredProduct
Definition | Administered medicinal product (e.g. TETAVAX suspension for injection), including batch/lot details when necessary.
Short | Administered medicinal product (e.g. TETAVAX suspension for injection), including batch/lot details when necessary.
Control | 0..1
Type | http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSMedication
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
24. EHDSImmunisation.administeredProduct.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
SHOULD:able-to-populate | Producer
26. EHDSImmunisation.administeredProduct.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
28. EHDSImmunisation.administeredProduct.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
30. EHDSImmunisation.administeredProduct.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
32. EHDSImmunisation.administeredProduct.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
34. EHDSImmunisation.administeredProduct.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
36. EHDSImmunisation.administeredProduct.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
38. EHDSImmunisation.administeredProduct.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
40. EHDSImmunisation.administeredProduct.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
42. EHDSImmunisation.administeredProduct.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
44. EHDSImmunisation.administeredProduct.item.ingredient
Definition | Ingredients
Short | Ingredients
Control | 1..*
Type | Base
46. EHDSImmunisation.administeredProduct.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
48. EHDSImmunisation.administeredProduct.item.ingredient.substance
Definition | Substance
Short | Substance
Control | 1..1
Binding | EMA SPOR SMS
Type | CodeableConcept
50. EHDSImmunisation.administeredProduct.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
52. EHDSImmunisation.administeredProduct.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
54. EHDSImmunisation.administeredProduct.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
56. EHDSImmunisation.administeredProduct.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
58. EHDSImmunisation.administeredProduct.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
60. EHDSImmunisation.administeredProduct.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
62. EHDSImmunisation.administeredProduct.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
64. EHDSImmunisation.administeredProduct.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
66. EHDSImmunisation.administeredProduct.device.deviceQuantity
Definition | Number of such devices
Short | Number of such devices
Control | 1..1
Type | Quantity
68. EHDSImmunisation.administeredProduct.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]
70. EHDSImmunisation.administeredProduct.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
72. EHDSImmunisation.administeredProduct.characteristic.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic.
Control | 1..1
Type | CodeableConcept
74. EHDSImmunisation.administeredProduct.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
76. EHDSImmunisation.administeredProduct.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
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
78. EHDSImmunisation.administeredProduct.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
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
80. EHDSImmunisation.administeredProduct.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
82. EHDSImmunisation.administrationTime
Definition | The date and optionally the exact time when the vaccination was administered.
Short | The date and optionally the exact time when the vaccination was administered.
Control | 1..1
Type | dateTime
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
84. EHDSImmunisation.administeringCentre
Definition | Administering centre or a health authority responsible for the vaccination event
Short | Administering centre or a health authority responsible for the vaccination event
Control | 0..1
Type | http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSOrganisation
86. EHDSImmunisation.administrator
Definition | Health professional responsible for administering the immunisation product.
Short | Health professional responsible for administering the immunisation product.
Control | 0..1
Type | http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSHealthProfessional
88. EHDSImmunisation.note
Definition | Any additional free-text information about the immunisation
Short | Any additional free-text information about the immunisation
Control | 0..1
Type | string
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. EHDSImmunisation
Logical Model | Instances of this logical model are not marked to be the target of a Reference
2. EHDSImmunisation.header
4. EHDSImmunisation.header.subject
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
6. EHDSImmunisation.header.identifier
Note | This is a business identifier, not a resource identifier (see discussion)
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
8. EHDSImmunisation.header.status
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
10. EHDSImmunisation.vaccine
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
12. EHDSImmunisation.administeredProduct
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
14. EHDSImmunisation.administeredProduct.identifyingCode[x]
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
16. EHDSImmunisation.administeredProduct.productName
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
18. EHDSImmunisation.administeredProduct.batch
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
20. EHDSImmunisation.administeredProduct.batch.lotNumber
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
22. EHDSImmunisation.administrationTime
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer

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

0. EHDSImmunisation
Definition | Model describes the administration of immunisation products, including vaccines and immunoglobulins, covering active and passive immunisations. It focuses on immunisation as a clinical procedure rather than the resulting immunity. The model supports routine immunisations at standard doses and may overlap with medication summaries or prescription lists. Natural immunity, immunisation outcomes, refusals, and administration or planning details are out of scope.
Short | Immunisation model
Control | 0..*
Is Modifier | false
Logical Model | Instances of this logical model are not marked to be the target of a Reference
2. EHDSImmunisation.header
Definition | Basic metadata for this information
Short | Basic metadata for this information
Control | 1..1
Type | Base
4. EHDSImmunisation.header.subject
Definition | Patient/subject information
Short | Patient/subject information
Control | 1..1
Type | http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSPatient
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
6. EHDSImmunisation.header.identifier
Definition | Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).
Short | Business identifier for the object, unique within its system. Supporting disambiguation between different contexts (systems/countries).
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
Type | Identifier
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
8. EHDSImmunisation.header.author[x]
Definition | The author of the immunisation statement.
Short | The author of the immunisation statement.
Control | 0..*
Type | Choice of: http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSHealthProfessional, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSOrganisation, http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSDevice
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
10. EHDSImmunisation.header.date
Definition | Date and optionally time of authoring/issuing
Short | Date and optionally time of authoring/issuing
Control | 0..1
Type | dateTime
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
12. EHDSImmunisation.header.status
Definition | Status of the immunisation event (completed, not-done).
Short | Status of the immunisation event (completed, not-done).
Control | 1..1
Type | CodeableConcept
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
14. EHDSImmunisation.header.source
Definition | Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information.
Short | Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information.
Control | 0..1
Type | CodeableConcept
16. EHDSImmunisation.header.language
Definition | Language in which the resource is written. Language is expressed by the IETF language tag.
Short | Language in which the resource is written. Language is expressed by the IETF language tag.
Control | 0..1
Binding | BCP 47
Type | CodeableConcept
18. EHDSImmunisation.diseaseOrAgentTargeted
Definition | Disease or agent that the vaccination provides protection against (e.g. 76902006 Tetanus).
Short | Disease or agent that the vaccination provides protection against (e.g. 76902006 Tetanus).
Control | 0..*
Binding | ICD-10, SNOMED CT
Type | CodeableConcept
20. EHDSImmunisation.vaccine
Definition | Type of immunisation, e.g. J07AM01 Tetanus toxoid; or 871803007 Hepatitis A and Hepatitis B virus antigens only vaccine product.
Short | Type of immunisation, e.g. J07AM01 Tetanus toxoid; or 871803007 Hepatitis A and Hepatitis B virus antigens only vaccine product.
Control | 1..1
Binding | SNOMED CT, ATC
Type | CodeableConcept
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
22. EHDSImmunisation.administeredProduct
Definition | Administered medicinal product (e.g. TETAVAX suspension for injection), including batch/lot details when necessary.
Short | Administered medicinal product (e.g. TETAVAX suspension for injection), including batch/lot details when necessary.
Control | 0..1
Type | http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSMedication
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
24. EHDSImmunisation.administeredProduct.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
SHOULD:able-to-populate | Producer
26. EHDSImmunisation.administeredProduct.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
28. EHDSImmunisation.administeredProduct.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
30. EHDSImmunisation.administeredProduct.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
32. EHDSImmunisation.administeredProduct.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
34. EHDSImmunisation.administeredProduct.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
36. EHDSImmunisation.administeredProduct.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
38. EHDSImmunisation.administeredProduct.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
40. EHDSImmunisation.administeredProduct.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
42. EHDSImmunisation.administeredProduct.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
44. EHDSImmunisation.administeredProduct.item.ingredient
Definition | Ingredients
Short | Ingredients
Control | 1..*
Type | Base
46. EHDSImmunisation.administeredProduct.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
48. EHDSImmunisation.administeredProduct.item.ingredient.substance
Definition | Substance
Short | Substance
Control | 1..1
Binding | EMA SPOR SMS
Type | CodeableConcept
50. EHDSImmunisation.administeredProduct.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
52. EHDSImmunisation.administeredProduct.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
54. EHDSImmunisation.administeredProduct.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
56. EHDSImmunisation.administeredProduct.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
58. EHDSImmunisation.administeredProduct.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
60. EHDSImmunisation.administeredProduct.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
62. EHDSImmunisation.administeredProduct.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
64. EHDSImmunisation.administeredProduct.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
66. EHDSImmunisation.administeredProduct.device.deviceQuantity
Definition | Number of such devices
Short | Number of such devices
Control | 1..1
Type | Quantity
68. EHDSImmunisation.administeredProduct.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]
70. EHDSImmunisation.administeredProduct.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
72. EHDSImmunisation.administeredProduct.characteristic.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic.
Control | 1..1
Type | CodeableConcept
74. EHDSImmunisation.administeredProduct.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
76. EHDSImmunisation.administeredProduct.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
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
78. EHDSImmunisation.administeredProduct.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
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Producer
80. EHDSImmunisation.administeredProduct.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
82. EHDSImmunisation.administrationTime
Definition | The date and optionally the exact time when the vaccination was administered.
Short | The date and optionally the exact time when the vaccination was administered.
Control | 1..1
Type | dateTime
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Obligations |
Obligations | Actor
SHALL:able-to-populate | Producer
84. EHDSImmunisation.administeringCentre
Definition | Administering centre or a health authority responsible for the vaccination event
Short | Administering centre or a health authority responsible for the vaccination event
Control | 0..1
Type | http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSOrganisation
86. EHDSImmunisation.administrator
Definition | Health professional responsible for administering the immunisation product.
Short | Health professional responsible for administering the immunisation product.
Control | 0..1
Type | http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSHealthProfessional
88. EHDSImmunisation.note
Definition | Any additional free-text information about the immunisation
Short | Any additional free-text information about the immunisation
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension