| Package | hl7.fhir.eu.imaging-manifest-r5 |
| Type | StructureDefinition |
| Id | EHDSMedication |
| FHIR Version | R5 |
| Source | http://hl7.eu/fhir/imaging-manifest-r5/https://build.fhir.org/ig/hl7-eu/imaging-manifest/StructureDefinition-EHDSMedication.html |
| URL | https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSMedication |
| Version | 0.1.0 |
| Status | active |
| Date | 2025-03-21T08:17:12+00:00 |
| Name | EHDSMedication |
| Title | Medicinal product model |
| Realm | eu |
| Authority | hl7 |
| Description | Logical model for prescribed/dispensed medication. The model is shared by statements, requests, dispensations, and treatment lines. Each of those may have different restrictions in FHIR profile. |
| Copyright | Used by permission of HL7 Europe, all rights reserved Creative Commons License |
| Type | https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSMedication |
| Kind | logical |
| ConceptMap | |
| EHDSMedicationMap | EHDSMedication Mapping |
| EHDSMedicationMap | EHDSMedication Mapping |
| StructureDefinition | |
| EHDSImmunization | Immunization model |
| EHDSMedicationAdministration | Medication administration model |
| EHDSMedicationDispense | Medication dispensation model |
| EHDSMedicationPrescription | Medication prescription model |
| EHDSServiceRequest | Service request model |
| EHDSImmunisation | Immunisation model |
| EHDSMedicationStatement | Medication statement model |
| EHDSImmunization | Immunization model |
| EHDSMedicationAdministration | Medication administration model |
| EHDSMedicationDispense | Medication dispensation model |
| EHDSMedicationPrescription | Medication prescription model |
| EHDSServiceRequest | Service request model |
| StructureDefinition | |
| EHDSDevice | Device model |
| EHDSDevice | Device model |
Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition EHDSMedication
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  EHDSMedication | 0..* | Base | Medicinal product model Instances of this logical model can be the target of a Reference | |
  identifyingCode[x] | 0..* | Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. | ||
  identifyingCodeCodeableConcept | CodeableConcept | |||
 identifyingCodeIdentifier | Identifier | |||
| classification | 0..* | CodeableConcept | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.) Binding Description: (preferred): WHO ATC | |
 productName | 0..1 | string | Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided. | |
| marketingAuthorisationHolder | 0..1 | Base | Marketing authorisation holder or manufacturer of the medicinal product. Relevant for identifying the exact product. | |
| organizationName | 0..1 | string | Name of the organisation holding the authorisation for marketing/mahufacturing | |
| organizationIdentifier | 0..* | Identifier | Identifier of the organisation and/or its physical location | |
| doseForm | 0..1 | CodeableConcept | Dose form(s) on a product level. Dose form for a single package item is defined below. Binding Description: (preferred): EDQM Standard Terms | |
| packSize | 0..* | Quantity | Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries) Binding Description: (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation. | |
| item | 0..* | Base | A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined | |
| doseForm | 0..1 | CodeableConcept | Dose form Binding Description: (preferred): EDQM Standard Terms | |
| ingredient | 1..* | Base | Ingredients | |
| isActive | 0..1 | boolean | Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected. | |
| substance | 1..1 | CodeableConcept | Substance Binding Description: (preferred): EMA SPOR SMS | |
| strengthInfo | 0..1 | Base | Strength of the product - amount of substance per unit | |
 strength | 1..1 | Ratio | Concentration or presentation strength, e.g 100mg/1ml or 500mg per 1 tablet | |
| basisOfStrengthSubstance | 0..1 | CodeableConcept | Substance that the strength refers to, in case it's different from the main 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 for liquids (3ml / 1 vial) | |
| amount | 0..1 | Quantity | Number of such manufactured items in this product (5 vials) 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 | |
| deviceQuantity | 1..1 | Quantity | Number of such devices | |
| device[x] | 1..1 | Device coded | ||
| deviceCodeableConcept | CodeableConcept | |||
 deviceReference | Reference(Device model) | |||
| characteristic | 0..* | Base | Other features of the product | |
| type | 1..1 | CodeableConcept | A code expressing the type of characteristic | |
| value[x] | 0..1 | Description of the characteristic | ||
| 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 | ||||
FHIR{
"resourceType": "StructureDefinition",
"id": "EHDSMedication",
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics",
"valueCode": "can-be-target"
}
],
"url": "https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSMedication",
"version": "0.1.0",
"name": "EHDSMedication",
"title": "Medicinal product model",
"status": "active",
"date": "2025-03-21T08:17:12+00:00",
"publisher": "HL7 Europe",
"contact": [
{
"name": "Xt-EHR",
"telecom": [
{
"system": "url",
"value": "http://Xt-EHR.eu"
}
]
}
],
"description": "Logical model for prescribed/dispensed medication. The model is shared by statements, requests, dispensations, and treatment lines. Each of those may have different restrictions in FHIR profile.",
"jurisdiction": [
{
"coding": [
{
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code": "150",
"display": "Europe"
}
]
}
],
"copyright": "Used by permission of HL7 Europe, all rights reserved Creative Commons License",
"fhirVersion": "5.0.0",
"mapping": [
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
}
],
"kind": "logical",
"abstract": false,
"type": "https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSMedication",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Base",
"derivation": "specialization",
"snapshot": {
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "5.0.0"
}
],
"element": [
{
"id": "EHDSMedication",
"path": "EHDSMedication",
"short": "Medicinal product model",
"definition": "Logical model for prescribed/dispensed medication. The model is shared by statements, requests, dispensations, and treatment lines. Each of those may have different restrictions in FHIR profile.",
"min": 0,
"max": "*",
"base": {
"path": "Base",
"min": 0,
"max": "*"
},
"isModifier": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "EHDSMedication.identifyingCode[x]",
"path": "EHDSMedication.identifyingCode[x]",
"short": "Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.",
"definition": "Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.",
"comment": "Non-conflicting change",
"min": 0,
"max": "*",
"base": {
"path": "EHDSMedication.identifyingCode[x]",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
},
{
"code": "Identifier"
}
]
},
{
"id": "EHDSMedication.classification",
"path": "EHDSMedication.classification",
"short": "Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)",
"definition": "Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)",
"comment": "No change",
"min": 0,
"max": "*",
"base": {
"path": "EHDSMedication.classification",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "WHO ATC"
}
},
{
"id": "EHDSMedication.productName",
"path": "EHDSMedication.productName",
"short": "Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.",
"definition": "Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.",
"comment": "No change",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.productName",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "EHDSMedication.marketingAuthorisationHolder",
"path": "EHDSMedication.marketingAuthorisationHolder",
"short": "Marketing authorisation holder or manufacturer of the medicinal product. Relevant for identifying the exact product.",
"definition": "Marketing authorisation holder or manufacturer of the medicinal product. Relevant for identifying the exact product.",
"comment": "No change, but subelements added",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.marketingAuthorisationHolder",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.marketingAuthorisationHolder.organizationName",
"path": "EHDSMedication.marketingAuthorisationHolder.organizationName",
"short": "Name of the organisation holding the authorisation for marketing/mahufacturing",
"definition": "Name of the organisation holding the authorisation for marketing/mahufacturing",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.marketingAuthorisationHolder.organizationName",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "EHDSMedication.marketingAuthorisationHolder.organizationIdentifier",
"path": "EHDSMedication.marketingAuthorisationHolder.organizationIdentifier",
"short": "Identifier of the organisation and/or its physical location",
"definition": "Identifier of the organisation and/or its physical location",
"min": 0,
"max": "*",
"base": {
"path": "EHDSMedication.marketingAuthorisationHolder.organizationIdentifier",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Identifier"
}
]
},
{
"id": "EHDSMedication.doseForm",
"path": "EHDSMedication.doseForm",
"short": "Dose form(s) on a product level. Dose form for a single package item is defined below.",
"definition": "Dose form(s) on a product level. Dose form for a single package item is defined below.",
"comment": "No change",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.doseForm",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "EDQM Standard Terms"
}
},
{
"id": "EHDSMedication.packSize",
"path": "EHDSMedication.packSize",
"short": "Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)",
"definition": "Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)",
"comment": "No change",
"min": 0,
"max": "*",
"base": {
"path": "EHDSMedication.packSize",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Quantity"
}
],
"binding": {
"strength": "preferred",
"description": "UCUM for units of measure. EDQM Standard Terms for units of presentation."
}
},
{
"id": "EHDSMedication.item",
"path": "EHDSMedication.item",
"short": "A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined",
"definition": "A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined",
"comment": "Structure changed, elements repeated for complex packages",
"min": 0,
"max": "*",
"base": {
"path": "EHDSMedication.item",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.item.doseForm",
"path": "EHDSMedication.item.doseForm",
"short": "Dose form",
"definition": "Dose form",
"comment": "No change",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.item.doseForm",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "EDQM Standard Terms"
}
},
{
"id": "EHDSMedication.item.ingredient",
"path": "EHDSMedication.item.ingredient",
"short": "Ingredients",
"definition": "Ingredients",
"comment": "No conflicting change",
"min": 1,
"max": "*",
"base": {
"path": "EHDSMedication.item.ingredient",
"min": 1,
"max": "*"
},
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.item.ingredient.isActive",
"path": "EHDSMedication.item.ingredient.isActive",
"short": "Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.",
"definition": "Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.",
"comment": "Added",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.item.ingredient.isActive",
"min": 0,
"max": "1"
},
"type": [
{
"code": "boolean"
}
]
},
{
"id": "EHDSMedication.item.ingredient.substance",
"path": "EHDSMedication.item.ingredient.substance",
"short": "Substance",
"definition": "Substance",
"min": 1,
"max": "1",
"base": {
"path": "EHDSMedication.item.ingredient.substance",
"min": 1,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "EMA SPOR SMS"
}
},
{
"id": "EHDSMedication.item.ingredient.strengthInfo",
"path": "EHDSMedication.item.ingredient.strengthInfo",
"short": "Strength of the product - amount of substance per unit",
"definition": "Strength of the product - amount of substance per unit",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.item.ingredient.strengthInfo",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.item.ingredient.strengthInfo.strength",
"path": "EHDSMedication.item.ingredient.strengthInfo.strength",
"short": "Concentration or presentation strength, e.g 100mg/1ml or 500mg per 1 tablet",
"definition": "Concentration or presentation strength, e.g 100mg/1ml or 500mg per 1 tablet",
"comment": "No change",
"min": 1,
"max": "1",
"base": {
"path": "EHDSMedication.item.ingredient.strengthInfo.strength",
"min": 1,
"max": "1"
},
"type": [
{
"code": "Ratio"
}
]
},
{
"id": "EHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstance",
"path": "EHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstance",
"short": "Substance that the strength refers to, in case it's different from the main substance",
"definition": "Substance that the strength refers to, in case it's different from the main substance",
"comment": "Added (eHN guidelines A.1.4.4.1 'in addition reference strength could be provided')",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstance",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "EMA SPOR SMS"
}
},
{
"id": "EHDSMedication.item.unitOfPresentation",
"path": "EHDSMedication.item.unitOfPresentation",
"short": "Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.",
"definition": "Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.",
"comment": "No change",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.item.unitOfPresentation",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "EDQM Standard Terms"
}
},
{
"id": "EHDSMedication.item.containedQuantity",
"path": "EHDSMedication.item.containedQuantity",
"short": "Manufactured item quantity for liquids (3ml / 1 vial)",
"definition": "Manufactured item quantity for liquids (3ml / 1 vial)",
"comment": "Added (eHN guidelines A.1.4.9 mention layered structure for describing a package)",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.item.containedQuantity",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Ratio"
}
]
},
{
"id": "EHDSMedication.item.amount",
"path": "EHDSMedication.item.amount",
"short": "Number of such manufactured items in this product (5 vials)",
"definition": "Number of such manufactured items in this product (5 vials)",
"comment": "Added (eHN guidelines A.1.4.9 mention layered structure for describing a package)",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.item.amount",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Quantity"
}
],
"binding": {
"strength": "preferred",
"description": "UCUM for units of measure. EDQM Standard Terms for units of presentation."
}
},
{
"id": "EHDSMedication.item.packageType",
"path": "EHDSMedication.item.packageType",
"short": "Type of package of the medication item",
"definition": "Type of package of the medication item",
"comment": "Added (eHN guidelines A.1.4.8 Package type)",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.item.packageType",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "EDQM Standard Terms for packaging."
}
},
{
"id": "EHDSMedication.device",
"path": "EHDSMedication.device",
"short": "Administration device included in the product",
"definition": "Administration device included in the product",
"min": 0,
"max": "*",
"base": {
"path": "EHDSMedication.device",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.device.deviceQuantity",
"path": "EHDSMedication.device.deviceQuantity",
"short": "Number of such devices",
"definition": "Number of such devices",
"min": 1,
"max": "1",
"base": {
"path": "EHDSMedication.device.deviceQuantity",
"min": 1,
"max": "1"
},
"type": [
{
"code": "Quantity"
}
]
},
{
"id": "EHDSMedication.device.device[x]",
"path": "EHDSMedication.device.device[x]",
"short": "Device coded",
"definition": "Device coded",
"comment": "Added",
"min": 1,
"max": "1",
"base": {
"path": "EHDSMedication.device.device[x]",
"min": 1,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
},
{
"code": "Reference",
"targetProfile": [
"https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSDevice"
]
}
]
},
{
"id": "EHDSMedication.characteristic",
"path": "EHDSMedication.characteristic",
"short": "Other features of the product",
"definition": "Other features of the product",
"comment": "Added for any other information.",
"min": 0,
"max": "*",
"base": {
"path": "EHDSMedication.characteristic",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.characteristic.type",
"path": "EHDSMedication.characteristic.type",
"short": "A code expressing the type of characteristic",
"definition": "A code expressing the type of characteristic",
"min": 1,
"max": "1",
"base": {
"path": "EHDSMedication.characteristic.type",
"min": 1,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
]
},
{
"id": "EHDSMedication.characteristic.value[x]",
"path": "EHDSMedication.characteristic.value[x]",
"short": "Description of the characteristic",
"definition": "Description of the characteristic",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.characteristic.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "boolean"
},
{
"code": "CodeableConcept"
},
{
"code": "string"
},
{
"code": "Quantity"
},
{
"code": "dateTime"
},
{
"code": "integer"
},
{
"code": "decimal"
},
{
"code": "Ratio"
}
]
},
{
"id": "EHDSMedication.batch",
"path": "EHDSMedication.batch",
"short": "Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.",
"definition": "Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.",
"comment": "Added from Patient Summary",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.batch",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.batch.lotNumber",
"path": "EHDSMedication.batch.lotNumber",
"short": "Batch identifier of the medicinal product",
"definition": "Batch identifier of the medicinal product",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.batch.lotNumber",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "EHDSMedication.batch.expirationDate",
"path": "EHDSMedication.batch.expirationDate",
"short": "Batch expiration date of the medicinal product.",
"definition": "Batch expiration date of the medicinal product.",
"min": 0,
"max": "1",
"base": {
"path": "EHDSMedication.batch.expirationDate",
"min": 0,
"max": "1"
},
"type": [
{
"code": "dateTime"
}
]
}
]
},
"differential": {
"element": [
{
"id": "EHDSMedication",
"path": "EHDSMedication",
"short": "Medicinal product model",
"definition": "Logical model for prescribed/dispensed medication. The model is shared by statements, requests, dispensations, and treatment lines. Each of those may have different restrictions in FHIR profile."
},
{
"id": "EHDSMedication.identifyingCode[x]",
"path": "EHDSMedication.identifyingCode[x]",
"short": "Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.",
"definition": "Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.",
"comment": "Non-conflicting change",
"min": 0,
"max": "*",
"type": [
{
"code": "CodeableConcept"
},
{
"code": "Identifier"
}
]
},
{
"id": "EHDSMedication.classification",
"path": "EHDSMedication.classification",
"short": "Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)",
"definition": "Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)",
"comment": "No change",
"min": 0,
"max": "*",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "WHO ATC"
}
},
{
"id": "EHDSMedication.productName",
"path": "EHDSMedication.productName",
"short": "Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.",
"definition": "Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.",
"comment": "No change",
"min": 0,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "EHDSMedication.marketingAuthorisationHolder",
"path": "EHDSMedication.marketingAuthorisationHolder",
"short": "Marketing authorisation holder or manufacturer of the medicinal product. Relevant for identifying the exact product.",
"definition": "Marketing authorisation holder or manufacturer of the medicinal product. Relevant for identifying the exact product.",
"comment": "No change, but subelements added",
"min": 0,
"max": "1",
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.marketingAuthorisationHolder.organizationName",
"path": "EHDSMedication.marketingAuthorisationHolder.organizationName",
"short": "Name of the organisation holding the authorisation for marketing/mahufacturing",
"definition": "Name of the organisation holding the authorisation for marketing/mahufacturing",
"min": 0,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "EHDSMedication.marketingAuthorisationHolder.organizationIdentifier",
"path": "EHDSMedication.marketingAuthorisationHolder.organizationIdentifier",
"short": "Identifier of the organisation and/or its physical location",
"definition": "Identifier of the organisation and/or its physical location",
"min": 0,
"max": "*",
"type": [
{
"code": "Identifier"
}
]
},
{
"id": "EHDSMedication.doseForm",
"path": "EHDSMedication.doseForm",
"short": "Dose form(s) on a product level. Dose form for a single package item is defined below.",
"definition": "Dose form(s) on a product level. Dose form for a single package item is defined below.",
"comment": "No change",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "EDQM Standard Terms"
}
},
{
"id": "EHDSMedication.packSize",
"path": "EHDSMedication.packSize",
"short": "Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)",
"definition": "Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)",
"comment": "No change",
"min": 0,
"max": "*",
"type": [
{
"code": "Quantity"
}
],
"binding": {
"strength": "preferred",
"description": "UCUM for units of measure. EDQM Standard Terms for units of presentation."
}
},
{
"id": "EHDSMedication.item",
"path": "EHDSMedication.item",
"short": "A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined",
"definition": "A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined",
"comment": "Structure changed, elements repeated for complex packages",
"min": 0,
"max": "*",
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.item.doseForm",
"path": "EHDSMedication.item.doseForm",
"short": "Dose form",
"definition": "Dose form",
"comment": "No change",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "EDQM Standard Terms"
}
},
{
"id": "EHDSMedication.item.ingredient",
"path": "EHDSMedication.item.ingredient",
"short": "Ingredients",
"definition": "Ingredients",
"comment": "No conflicting change",
"min": 1,
"max": "*",
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.item.ingredient.isActive",
"path": "EHDSMedication.item.ingredient.isActive",
"short": "Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.",
"definition": "Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.",
"comment": "Added",
"min": 0,
"max": "1",
"type": [
{
"code": "boolean"
}
]
},
{
"id": "EHDSMedication.item.ingredient.substance",
"path": "EHDSMedication.item.ingredient.substance",
"short": "Substance",
"definition": "Substance",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "EMA SPOR SMS"
}
},
{
"id": "EHDSMedication.item.ingredient.strengthInfo",
"path": "EHDSMedication.item.ingredient.strengthInfo",
"short": "Strength of the product - amount of substance per unit",
"definition": "Strength of the product - amount of substance per unit",
"min": 0,
"max": "1",
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.item.ingredient.strengthInfo.strength",
"path": "EHDSMedication.item.ingredient.strengthInfo.strength",
"short": "Concentration or presentation strength, e.g 100mg/1ml or 500mg per 1 tablet",
"definition": "Concentration or presentation strength, e.g 100mg/1ml or 500mg per 1 tablet",
"comment": "No change",
"min": 1,
"max": "1",
"type": [
{
"code": "Ratio"
}
]
},
{
"id": "EHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstance",
"path": "EHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstance",
"short": "Substance that the strength refers to, in case it's different from the main substance",
"definition": "Substance that the strength refers to, in case it's different from the main substance",
"comment": "Added (eHN guidelines A.1.4.4.1 'in addition reference strength could be provided')",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "EMA SPOR SMS"
}
},
{
"id": "EHDSMedication.item.unitOfPresentation",
"path": "EHDSMedication.item.unitOfPresentation",
"short": "Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.",
"definition": "Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.",
"comment": "No change",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "EDQM Standard Terms"
}
},
{
"id": "EHDSMedication.item.containedQuantity",
"path": "EHDSMedication.item.containedQuantity",
"short": "Manufactured item quantity for liquids (3ml / 1 vial)",
"definition": "Manufactured item quantity for liquids (3ml / 1 vial)",
"comment": "Added (eHN guidelines A.1.4.9 mention layered structure for describing a package)",
"min": 0,
"max": "1",
"type": [
{
"code": "Ratio"
}
]
},
{
"id": "EHDSMedication.item.amount",
"path": "EHDSMedication.item.amount",
"short": "Number of such manufactured items in this product (5 vials)",
"definition": "Number of such manufactured items in this product (5 vials)",
"comment": "Added (eHN guidelines A.1.4.9 mention layered structure for describing a package)",
"min": 0,
"max": "1",
"type": [
{
"code": "Quantity"
}
],
"binding": {
"strength": "preferred",
"description": "UCUM for units of measure. EDQM Standard Terms for units of presentation."
}
},
{
"id": "EHDSMedication.item.packageType",
"path": "EHDSMedication.item.packageType",
"short": "Type of package of the medication item",
"definition": "Type of package of the medication item",
"comment": "Added (eHN guidelines A.1.4.8 Package type)",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "preferred",
"description": "EDQM Standard Terms for packaging."
}
},
{
"id": "EHDSMedication.device",
"path": "EHDSMedication.device",
"short": "Administration device included in the product",
"definition": "Administration device included in the product",
"min": 0,
"max": "*",
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.device.deviceQuantity",
"path": "EHDSMedication.device.deviceQuantity",
"short": "Number of such devices",
"definition": "Number of such devices",
"min": 1,
"max": "1",
"type": [
{
"code": "Quantity"
}
]
},
{
"id": "EHDSMedication.device.device[x]",
"path": "EHDSMedication.device.device[x]",
"short": "Device coded",
"definition": "Device coded",
"comment": "Added",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
},
{
"code": "Reference",
"targetProfile": [
"https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSDevice"
]
}
]
},
{
"id": "EHDSMedication.characteristic",
"path": "EHDSMedication.characteristic",
"short": "Other features of the product",
"definition": "Other features of the product",
"comment": "Added for any other information. ",
"min": 0,
"max": "*",
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.characteristic.type",
"path": "EHDSMedication.characteristic.type",
"short": "A code expressing the type of characteristic",
"definition": "A code expressing the type of characteristic",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
]
},
{
"id": "EHDSMedication.characteristic.value[x]",
"path": "EHDSMedication.characteristic.value[x]",
"short": "Description of the characteristic",
"definition": "Description of the characteristic",
"min": 0,
"max": "1",
"type": [
{
"code": "boolean"
},
{
"code": "CodeableConcept"
},
{
"code": "string"
},
{
"code": "Quantity"
},
{
"code": "dateTime"
},
{
"code": "integer"
},
{
"code": "decimal"
},
{
"code": "Ratio"
}
]
},
{
"id": "EHDSMedication.batch",
"path": "EHDSMedication.batch",
"short": "Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.",
"definition": "Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.",
"comment": "Added from Patient Summary",
"min": 0,
"max": "1",
"type": [
{
"code": "Base"
}
]
},
{
"id": "EHDSMedication.batch.lotNumber",
"path": "EHDSMedication.batch.lotNumber",
"short": "Batch identifier of the medicinal product",
"definition": "Batch identifier of the medicinal product",
"min": 0,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "EHDSMedication.batch.expirationDate",
"path": "EHDSMedication.batch.expirationDate",
"short": "Batch expiration date of the medicinal product.",
"definition": "Batch expiration date of the medicinal product.",
"min": 0,
"max": "1",
"type": [
{
"code": "dateTime"
}
]
}
]
}
}