EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Official URL: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiMedicinalProductDefinition | Version: 1.0.0 | |||
Draft as of 2025-04-04 | Computable Name: EmaWriteApiMedicinalProductDefinition |
Profiled resource containing data about a Medicinal Product.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
Name | Flags | Card. | Type | Description & Constraints![]() | ||||
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0..* | MedicinalProductDefinition | Detailed definition of a medicinal product dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management | |||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children | ||||
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0..* | Resource | Contained, inline Resources | |||||
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1..* | EmaCoding | Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required) ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 0..* | Identifier | Business identifier for this product. Could be an MPID Slice: Unordered, Closed by value:system ele-1: All FHIR elements must have a @value or children | ||||
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Content/Rules for all slices | |||||||
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0..0 | |||||||
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Σ | 0..1 | EmaEurdIdentifier | Business identifier for this product. Could be an MPID ele-1: All FHIR elements must have a @value or children | ||||
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0..0 | |||||||
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Σ | 1..1 | uri | The namespace for the identifier value ele-1: All FHIR elements must have a @value or children Required Pattern: http://ema.europa.eu/fhir/eurdId | ||||
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ΣC | 1..1 | string | The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456 | ||||
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Σ | 0..1 | EmaMpIdentifier | Business identifier for this product. Could be an MPID ele-1: All FHIR elements must have a @value or children | ||||
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0..0 | |||||||
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Σ | 1..1 | uri | The namespace for the identifier value ele-1: All FHIR elements must have a @value or children Required Pattern: http://ema.europa.eu/fhir/mpId | ||||
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ΣC | 1..1 | string | The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456 | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | If this medicine applies to human or veterinary uses Binding: Domain (required) ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | markdown | Description of indication(s) for this product, used when structured indications are not required ele-1: All FHIR elements must have a @value or children | ||||
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1..1 | EmaCoding | Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required) ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status of Supply (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | If authorised for use in children Binding: Paediatric Use Indicator (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 4..* | CodeableConcept | Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | EmaXevmpdProductCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children | ||||
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0..0 | |||||||
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Σ | 1..1 | EmaLegalBasisCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children | ||||
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0..0 | |||||||
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Σ | 1..* | EmaLightAtcCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children | ||||
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0..0 | (Complex) | ||||||
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Content/Rules for all slices | |||||||
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Σ | 1..1 | EmaAtcCoding | Code defined by a terminology system ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | uri | Identity of the terminology system ele-1: All FHIR elements must have a @value or children Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533 | ||||
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ΣC | 1..1 | code | Symbol in syntax defined by the system ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..* | EmaProductCategoryCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children | ||||
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0..0 | |||||||
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Σ | 1..1 | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 0..1 | BackboneElement | A product specific contact, person (in a role), or an organization ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 0..1 | EmaQualifiedPersonTypeCodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | Reference(PractitionerRole) | A product specific contact, person (in a role), or an organization ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | string | The full product name ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 0..1 | EmaRefTermCodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Medicinal Product Name Part Type (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type ele-1: All FHIR elements must have a @value or children | ||||
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Content/Rules for all slices | |||||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | string | A fragment of a product name ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 0..* | EmaNamePartTypeCoding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 0..1 | BackboneElement | Coding words or phrases of the name ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | string | A fragment of a product name ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following | ||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000002 | |||||
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Σ | 0..1 | BackboneElement | Coding words or phrases of the name ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | string | A fragment of a product name ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following | ||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000001 | |||||
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Σ | 0..1 | BackboneElement | Coding words or phrases of the name ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | string | A fragment of a product name ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following | ||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000005 | |||||
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Σ | 1..1 | BackboneElement | Country and jurisdiction where the name applies ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | Country code for where this name applies Binding: Country (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | CodeableConcept | Language code for this name Binding: Language (required)
ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | CodeableReference(MedicinalProductDefinition) | Reference to another product, e.g. for linking authorised to investigational product ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: Product Cross Reference Type (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | BackboneElement | Key product features such as "sugar free", "modified release" ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | EmaGmoCodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children | ||||
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Path | Conformance | ValueSet / Code | URI |
MedicinalProductDefinition.type | required | MedicinalProductTypeVs (a valid code from Medicinal Product Type)http://ema.europa.eu/fhir/vs/medicinalProductType from this IG | |
MedicinalProductDefinition.domain | required | DomainVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/domain from this IG | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | CombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm from this IG | |
MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)http://ema.europa.eu/fhir/vs/legalStatusForTheSupply from this IG | |
MedicinalProductDefinition.additionalMonitoringIndicator | required | AdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator from this IG | |
MedicinalProductDefinition.pediatricUseIndicator | required | PaediatricUseIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/paediatricUseIndicator from this IG | |
MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:xevmpd | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:legalBasis | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:lightAtc | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:productCategory | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-type from the FHIR Standard | |
MedicinalProductDefinition.name.type | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part:inventedName.type | example | Pattern: 220000000002http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:fullName.type | example | Pattern: 220000000001http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type | example | Pattern: 220000000005http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.usage.country | required | CountryVs (a valid code from Country)http://ema.europa.eu/fhir/vs/country from this IG | |
MedicinalProductDefinition.name.usage.language | required | LanguageVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/language from this IG | |
MedicinalProductDefinition.crossReference.type | required | ProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)http://ema.europa.eu/fhir/vs/productcrossreferencetype from this IG | |
MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard |
This structure is derived from MedicinalProductDefinition
Name | Flags | Card. | Type | Description & Constraints![]() |
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MedicinalProductDefinition | |||
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1..* | EmaCoding | Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required) | |
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0..* | Identifier | Business identifier for this product. Could be an MPID Slice: Unordered, Closed by value:system | |
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Content/Rules for all slices | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
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0..1 | EmaEurdIdentifier | Business identifier for this product. Could be an MPID | |
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1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/eurdId | |
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0..1 | EmaMpIdentifier | Business identifier for this product. Could be an MPID | |
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1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId | |
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1..1 | EmaRefTermCodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (required) | |
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1..1 | EmaRefTermCodeableConcept | If this medicine applies to human or veterinary uses Binding: Domain (required) | |
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1..1 | EmaRefTermCodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (required) | |
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1..1 | markdown | Description of indication(s) for this product, used when structured indications are not required | |
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1..1 | EmaCoding | Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required) | |
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1..1 | EmaRefTermCodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status of Supply (required) | |
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1..1 | EmaRefTermCodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (required) | |
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1..1 | EmaRefTermCodeableConcept | If authorised for use in children Binding: Paediatric Use Indicator (required) | |
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4..* | CodeableConcept | Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system | |
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1..1 | EmaXevmpdProductCodeableConcept | Allows the product to be classified by various systems | |
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1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000324 | |
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1..1 | EmaLegalBasisCodeableConcept | Allows the product to be classified by various systems | |
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1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000116045 | |
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1..* | EmaLightAtcCodeableConcept | Allows the product to be classified by various systems | |
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1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533 | |
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1..* | EmaProductCategoryCodeableConcept | Allows the product to be classified by various systems | |
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1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000155526 | |
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1..1 | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) | |
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0..1 | BackboneElement | A product specific contact, person (in a role), or an organization | |
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0..1 | EmaQualifiedPersonTypeCodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information | |
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1..1 | Reference(PractitionerRole) | A product specific contact, person (in a role), or an organization | |
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1..1 | BackboneElement | The product's name, including full name and possibly coded parts | |
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0..1 | EmaRefTermCodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Medicinal Product Name Part Type (required) | |
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1..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type | |
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Content/Rules for all slices | |||
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0..* | EmaNamePartTypeCoding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) | |
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0..1 | BackboneElement | Coding words or phrases of the name | |
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1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000002 | |
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0..1 | BackboneElement | Coding words or phrases of the name | |
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1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000001 | |
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0..1 | BackboneElement | Coding words or phrases of the name | |
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1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000005 | |
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1..1 | BackboneElement | Country and jurisdiction where the name applies | |
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1..1 | EmaRefTermCodeableConcept | Country code for where this name applies Binding: Country (required) | |
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1..1 | CodeableConcept | Language code for this name Binding: Language (required) | |
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1..1 | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product | |
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1..1 | Identifier | Logical reference, when literal reference is not known | |
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0..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/crossReference | |
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1..1 | EmaRefTermCodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: Product Cross Reference Type (required) | |
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0..1 | CodeableReference(EMA Write API ActivityDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging | |
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0..1 | EmaRefTermCodeableConcept | Specifies whether this process is considered proprietary or confidential Binding: Data Classification (required) | |
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1..1 | BackboneElement | Key product features such as "sugar free", "modified release" | |
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1..1 | EmaGmoCodeableConcept | A code expressing the type of characteristic | |
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Path | Conformance | ValueSet | URI |
MedicinalProductDefinition.type | required | MedicinalProductTypeVs (a valid code from Medicinal Product Type)http://ema.europa.eu/fhir/vs/medicinalProductType from this IG | |
MedicinalProductDefinition.domain | required | DomainVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/domain from this IG | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | CombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm from this IG | |
MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)http://ema.europa.eu/fhir/vs/legalStatusForTheSupply from this IG | |
MedicinalProductDefinition.additionalMonitoringIndicator | required | AdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator from this IG | |
MedicinalProductDefinition.pediatricUseIndicator | required | PaediatricUseIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/paediatricUseIndicator from this IG | |
MedicinalProductDefinition.name.type | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.usage.country | required | CountryVs (a valid code from Country)http://ema.europa.eu/fhir/vs/country from this IG | |
MedicinalProductDefinition.name.usage.language | required | LanguageVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/language from this IG | |
MedicinalProductDefinition.crossReference.type | required | ProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)http://ema.europa.eu/fhir/vs/productcrossreferencetype from this IG | |
MedicinalProductDefinition.operation.confidentialityIndicator | required | DataClassificationVs (a valid code from Data Classification)http://ema.europa.eu/fhir/vs/dataClassification from this IG |
Name | Flags | Card. | Type | Description & Constraints![]() | ||||
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0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
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0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
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0..* | Resource | Contained, inline Resources | |||||
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1..* | EmaCoding | Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required) | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
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Σ | 0..* | Identifier | Business identifier for this product. Could be an MPID Slice: Unordered, Closed by value:system | ||||
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Content/Rules for all slices | |||||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | |||||||
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Σ | 0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
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ΣC | 0..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | EmaEurdIdentifier | Business identifier for this product. Could be an MPID | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | |||||||
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/eurdId | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | EmaMpIdentifier | Business identifier for this product. Could be an MPID | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | |||||||
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (required) | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | If this medicine applies to human or veterinary uses Binding: Domain (required) | ||||
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Σ | 0..1 | string | A business identifier relating to a specific version of the product | ||||
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?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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Σ | 0..1 | dateTime | The date at which the given status became applicable | ||||
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Σ | 0..1 | markdown | General description of this product | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (required) | ||||
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Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body. | ||||
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Σ | 1..1 | markdown | Description of indication(s) for this product, used when structured indications are not required | ||||
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0..1 | string | xml:id (or equivalent in JSON) | |||||
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1..1 | EmaCoding | Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required) | |||||
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0..1 | markdown | Primitive value for markdown | |||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status of Supply (required) | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (required) | ||||
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Σ | 0..* | CodeableConcept | Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | If authorised for use in children Binding: Paediatric Use Indicator (required) | ||||
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Σ | 4..* | CodeableConcept | Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. | ||||
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Σ | 1..1 | EmaXevmpdProductCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | |||||||
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Σ | 0..* | Coding | Code defined by a terminology system Binding: XEVMPD medicinal product type (required) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000324 | ||||
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Σ | 0..1 | string | Version of the system - if relevant | ||||
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ΣC | 0..1 | code | Symbol in syntax defined by the system | ||||
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ΣC | 0..1 | string | Representation defined by the system | ||||
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Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
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Σ | 1..1 | EmaLegalBasisCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | |||||||
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Σ | 0..* | Coding | Code defined by a terminology system Binding: XEVMPD medicinal product type (required) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000116045 | ||||
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Σ | 0..1 | string | Version of the system - if relevant | ||||
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ΣC | 0..1 | code | Symbol in syntax defined by the system | ||||
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ΣC | 0..1 | string | Representation defined by the system | ||||
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Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
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Σ | 1..* | EmaLightAtcCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | (Complex) | ||||||
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Content/Rules for all slices | |||||||
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Σ | 1..1 | EmaAtcCoding | Code defined by a terminology system | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533 | ||||
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0..1 | string | xml:id (or equivalent in JSON) | |||||
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0..* | string | Extension URL: http://ema.europa.eu/fhir/extension/codeSystemName | |||||
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0..1 | uri | Primitive value for uri | |||||
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ΣC | 1..1 | code | Symbol in syntax defined by the system | ||||
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ΣC | 0..1 | string | Representation defined by the system | ||||
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Σ | 1..* | EmaProductCategoryCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | |||||||
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Σ | 0..* | Coding | Code defined by a terminology system Binding: Product Category (required) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000155526 | ||||
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Σ | 0..1 | string | Version of the system - if relevant | ||||
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ΣC | 0..1 | code | Symbol in syntax defined by the system | ||||
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ΣC | 0..1 | string | Representation defined by the system | ||||
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Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
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Σ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorization | ||||
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Σ | 0..* | CodeableConcept | Package type for the product Binding: MedicinalProductPackageType (example): Types of medicinal product packs | ||||
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Σ | 0..* | Reference(ManufacturedItemDefinition | DeviceDefinition) | Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes | ||||
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Σ | 0..* | CodeableConcept | The ingredients of this medicinal product - when not detailed in other resources Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
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Σ | 0..* | CodeableReference(SubstanceDefinition) | Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
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Σ | 0..* | Reference(DocumentReference) | Additional documentation about the medicinal product | ||||
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Σ | 1..1 | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) | ||||
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Σ | 0..1 | BackboneElement | A product specific contact, person (in a role), or an organization | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | EmaQualifiedPersonTypeCodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | ||||
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Σ | 1..1 | Reference(PractitionerRole) | A product specific contact, person (in a role), or an organization | ||||
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Σ | 0..* | Reference(ResearchStudy) | Clinical trials or studies that this product is involved in | ||||
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Σ | 0..* | Coding | A code that this product is known by, within some formal terminology Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication. | ||||
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Σ | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | string | The full product name | ||||
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Σ | 0..1 | EmaRefTermCodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Medicinal Product Name Part Type (required) | ||||
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Σ | 1..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type | ||||
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Content/Rules for all slices | |||||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | string | A fragment of a product name | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | EmaNamePartTypeCoding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 0..1 | BackboneElement | Coding words or phrases of the name | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | string | A fragment of a product name | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |||||
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0..1 | string | Version of the system - if relevant | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000002 | |||||
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0..1 | string | Representation defined by the system | |||||
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0..1 | boolean | If this coding was chosen directly by the user | |||||
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0..1 | string | Plain text representation of the concept | |||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | EmaNamePartTypeCoding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 0..1 | BackboneElement | Coding words or phrases of the name | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | string | A fragment of a product name | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |||||
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0..1 | string | Version of the system - if relevant | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000001 | |||||
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0..1 | string | Representation defined by the system | |||||
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0..1 | boolean | If this coding was chosen directly by the user | |||||
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0..1 | string | Plain text representation of the concept | |||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | EmaNamePartTypeCoding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 0..1 | BackboneElement | Coding words or phrases of the name | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | string | A fragment of a product name | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |||||
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0..1 | string | Version of the system - if relevant | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000005 | |||||
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0..1 | string | Representation defined by the system | |||||
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0..1 | boolean | If this coding was chosen directly by the user | |||||
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0..1 | string | Plain text representation of the concept | |||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | EmaNamePartTypeCoding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 1..1 | BackboneElement | Country and jurisdiction where the name applies | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | Country code for where this name applies Binding: Country (required) | ||||
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Σ | 0..1 | CodeableConcept | Jurisdiction code for where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
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Σ | 1..1 | CodeableConcept | Language code for this name Binding: Language (required)
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Σ | 1..1 | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | CodeableReference(MedicinalProductDefinition) | Reference to another product, e.g. for linking authorised to investigational product | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..1 | CodeableConcept | Reference to a concept (by class) | ||||
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Σ | 0..1 | Reference() | Reference to a resource (by instance) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
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Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
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ΣC | 1..1 | Identifier | Logical reference, when literal reference is not known | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
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Σ | 0..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/crossReference | ||||
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ΣC | 0..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
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Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
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ΣC | 0..1 | string | Text alternative for the resource | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: Product Cross Reference Type (required) | ||||
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Σ | 0..* | BackboneElement | A manufacturing or administrative process for the medicinal product | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | CodeableReference(EMA Write API ActivityDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging | ||||
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Σ | 0..1 | Period | Date range of applicability | ||||
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Σ | 0..* | Reference(Organization) | The organization responsible for the particular process, e.g. the manufacturer or importer | ||||
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Σ | 0..1 | EmaRefTermCodeableConcept | Specifies whether this process is considered proprietary or confidential Binding: Data Classification (required) | ||||
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Σ | 1..1 | BackboneElement | Key product features such as "sugar free", "modified release" | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | EmaGmoCodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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Σ | 0..1 | A value for the characteristic | |||||
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CodeableConcept | |||||||
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markdown | |||||||
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Quantity | |||||||
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integer | |||||||
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date | |||||||
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boolean | |||||||
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Attachment | |||||||
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Path | Conformance | ValueSet / Code | URI |
MedicinalProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.type | required | MedicinalProductTypeVs (a valid code from Medicinal Product Type)http://ema.europa.eu/fhir/vs/medicinalProductType from this IG | |
MedicinalProductDefinition.domain | required | DomainVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/domain from this IG | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | CombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm from this IG | |
MedicinalProductDefinition.route | example | SNOMEDCTRouteCodeshttp://hl7.org/fhir/ValueSet/route-codes from the FHIR Standard | |
MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)http://ema.europa.eu/fhir/vs/legalStatusForTheSupply from this IG | |
MedicinalProductDefinition.additionalMonitoringIndicator | required | AdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator from this IG | |
MedicinalProductDefinition.specialMeasures | example | SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measures from the FHIR Standard | |
MedicinalProductDefinition.pediatricUseIndicator | required | PaediatricUseIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/paediatricUseIndicator from this IG | |
MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:xevmpd | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:xevmpd.coding | required | XevmpdMedicinalProductTypeVs (a valid code from XEVMPD Medicinal Product Type)http://ema.europa.eu/fhir/vs/xevmpdMedicinalProductType from this IG | |
MedicinalProductDefinition.classification:legalBasis | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:legalBasis.coding | required | MarketingAuthorisationApplicationLegalBasisVs (a valid code from Marketing Authorisation Application Legal Basis)http://ema.europa.eu/fhir/vs/marketingAuthorisationApplicationLegalBasis from this IG | |
MedicinalProductDefinition.classification:lightAtc | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:productCategory | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:productCategory.coding | required | ProductCategoryVs (a valid code from Product Category)http://ema.europa.eu/fhir/vs/productCategory from this IG | |
MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-type from the FHIR Standard | |
MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-type from the FHIR Standard | |
MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codes from the FHIR Standard | |
MedicinalProductDefinition.name.type | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part:inventedName.type | example | Pattern: 220000000002http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:inventedName.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part:fullName.type | example | Pattern: 220000000001http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:fullName.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type | example | Pattern: 220000000005http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.usage.country | required | CountryVs (a valid code from Country)http://ema.europa.eu/fhir/vs/country from this IG | |
MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name.usage.language | required | LanguageVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/language from this IG | |
MedicinalProductDefinition.crossReference.product.reference.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard | |
MedicinalProductDefinition.crossReference.product.reference.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.crossReference.product.reference.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
MedicinalProductDefinition.crossReference.type | required | ProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)http://ema.europa.eu/fhir/vs/productcrossreferencetype from this IG | |
MedicinalProductDefinition.operation.confidentialityIndicator | required | DataClassificationVs (a valid code from Data Classification)http://ema.europa.eu/fhir/vs/dataClassification from this IG | |
MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard |
This structure is derived from MedicinalProductDefinition
Summary
Mandatory: 20 elements(6 nested mandatory elements)
Prohibited: 5 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Key Elements View
Name | Flags | Card. | Type | Description & Constraints![]() | ||||
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0..* | MedicinalProductDefinition | Detailed definition of a medicinal product dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management | |||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children | ||||
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0..* | Resource | Contained, inline Resources | |||||
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1..* | EmaCoding | Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required) ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 0..* | Identifier | Business identifier for this product. Could be an MPID Slice: Unordered, Closed by value:system ele-1: All FHIR elements must have a @value or children | ||||
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Content/Rules for all slices | |||||||
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0..0 | |||||||
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Σ | 0..1 | EmaEurdIdentifier | Business identifier for this product. Could be an MPID ele-1: All FHIR elements must have a @value or children | ||||
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0..0 | |||||||
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Σ | 1..1 | uri | The namespace for the identifier value ele-1: All FHIR elements must have a @value or children Required Pattern: http://ema.europa.eu/fhir/eurdId | ||||
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ΣC | 1..1 | string | The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456 | ||||
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Σ | 0..1 | EmaMpIdentifier | Business identifier for this product. Could be an MPID ele-1: All FHIR elements must have a @value or children | ||||
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0..0 | |||||||
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Σ | 1..1 | uri | The namespace for the identifier value ele-1: All FHIR elements must have a @value or children Required Pattern: http://ema.europa.eu/fhir/mpId | ||||
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ΣC | 1..1 | string | The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456 | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | If this medicine applies to human or veterinary uses Binding: Domain (required) ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | markdown | Description of indication(s) for this product, used when structured indications are not required ele-1: All FHIR elements must have a @value or children | ||||
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1..1 | EmaCoding | Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required) ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status of Supply (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | If authorised for use in children Binding: Paediatric Use Indicator (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 4..* | CodeableConcept | Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | EmaXevmpdProductCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children | ||||
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0..0 | |||||||
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Σ | 1..1 | EmaLegalBasisCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children | ||||
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0..0 | |||||||
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Σ | 1..* | EmaLightAtcCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children | ||||
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0..0 | (Complex) | ||||||
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Content/Rules for all slices | |||||||
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Σ | 1..1 | EmaAtcCoding | Code defined by a terminology system ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | uri | Identity of the terminology system ele-1: All FHIR elements must have a @value or children Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533 | ||||
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ΣC | 1..1 | code | Symbol in syntax defined by the system ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..* | EmaProductCategoryCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children | ||||
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0..0 | |||||||
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Σ | 1..1 | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 0..1 | BackboneElement | A product specific contact, person (in a role), or an organization ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 0..1 | EmaQualifiedPersonTypeCodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | Reference(PractitionerRole) | A product specific contact, person (in a role), or an organization ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | string | The full product name ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 0..1 | EmaRefTermCodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Medicinal Product Name Part Type (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type ele-1: All FHIR elements must have a @value or children | ||||
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Content/Rules for all slices | |||||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | string | A fragment of a product name ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 0..* | EmaNamePartTypeCoding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 0..1 | BackboneElement | Coding words or phrases of the name ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | string | A fragment of a product name ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following | ||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000002 | |||||
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Σ | 0..1 | BackboneElement | Coding words or phrases of the name ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | string | A fragment of a product name ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following | ||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000001 | |||||
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Σ | 0..1 | BackboneElement | Coding words or phrases of the name ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | string | A fragment of a product name ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following | ||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000005 | |||||
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Σ | 1..1 | BackboneElement | Country and jurisdiction where the name applies ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | Country code for where this name applies Binding: Country (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | CodeableConcept | Language code for this name Binding: Language (required)
ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | CodeableReference(MedicinalProductDefinition) | Reference to another product, e.g. for linking authorised to investigational product ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: Product Cross Reference Type (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 1..1 | BackboneElement | Key product features such as "sugar free", "modified release" ele-1: All FHIR elements must have a @value or children | ||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | ||||
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Σ | 1..1 | EmaGmoCodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children | ||||
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Path | Conformance | ValueSet / Code | URI |
MedicinalProductDefinition.type | required | MedicinalProductTypeVs (a valid code from Medicinal Product Type)http://ema.europa.eu/fhir/vs/medicinalProductType from this IG | |
MedicinalProductDefinition.domain | required | DomainVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/domain from this IG | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | CombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm from this IG | |
MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)http://ema.europa.eu/fhir/vs/legalStatusForTheSupply from this IG | |
MedicinalProductDefinition.additionalMonitoringIndicator | required | AdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator from this IG | |
MedicinalProductDefinition.pediatricUseIndicator | required | PaediatricUseIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/paediatricUseIndicator from this IG | |
MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:xevmpd | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:legalBasis | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:lightAtc | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:productCategory | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-type from the FHIR Standard | |
MedicinalProductDefinition.name.type | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part:inventedName.type | example | Pattern: 220000000002http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:fullName.type | example | Pattern: 220000000001http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type | example | Pattern: 220000000005http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.usage.country | required | CountryVs (a valid code from Country)http://ema.europa.eu/fhir/vs/country from this IG | |
MedicinalProductDefinition.name.usage.language | required | LanguageVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/language from this IG | |
MedicinalProductDefinition.crossReference.type | required | ProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)http://ema.europa.eu/fhir/vs/productcrossreferencetype from this IG | |
MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard |
Differential View
This structure is derived from MedicinalProductDefinition
Name | Flags | Card. | Type | Description & Constraints![]() |
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MedicinalProductDefinition | |||
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1..* | EmaCoding | Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required) | |
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0..* | Identifier | Business identifier for this product. Could be an MPID Slice: Unordered, Closed by value:system | |
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Content/Rules for all slices | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
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0..0 | |||
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0..1 | EmaEurdIdentifier | Business identifier for this product. Could be an MPID | |
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1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/eurdId | |
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0..1 | EmaMpIdentifier | Business identifier for this product. Could be an MPID | |
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1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId | |
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1..1 | EmaRefTermCodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (required) | |
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1..1 | EmaRefTermCodeableConcept | If this medicine applies to human or veterinary uses Binding: Domain (required) | |
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1..1 | EmaRefTermCodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (required) | |
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1..1 | markdown | Description of indication(s) for this product, used when structured indications are not required | |
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1..1 | EmaCoding | Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required) | |
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1..1 | EmaRefTermCodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status of Supply (required) | |
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1..1 | EmaRefTermCodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (required) | |
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1..1 | EmaRefTermCodeableConcept | If authorised for use in children Binding: Paediatric Use Indicator (required) | |
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4..* | CodeableConcept | Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system | |
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1..1 | EmaXevmpdProductCodeableConcept | Allows the product to be classified by various systems | |
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1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000324 | |
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1..1 | EmaLegalBasisCodeableConcept | Allows the product to be classified by various systems | |
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1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000116045 | |
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1..* | EmaLightAtcCodeableConcept | Allows the product to be classified by various systems | |
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1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533 | |
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1..* | EmaProductCategoryCodeableConcept | Allows the product to be classified by various systems | |
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1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000155526 | |
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1..1 | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) | |
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0..1 | BackboneElement | A product specific contact, person (in a role), or an organization | |
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0..1 | EmaQualifiedPersonTypeCodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information | |
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1..1 | Reference(PractitionerRole) | A product specific contact, person (in a role), or an organization | |
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1..1 | BackboneElement | The product's name, including full name and possibly coded parts | |
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0..1 | EmaRefTermCodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Medicinal Product Name Part Type (required) | |
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1..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type | |
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Content/Rules for all slices | |||
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0..* | EmaNamePartTypeCoding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) | |
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0..1 | BackboneElement | Coding words or phrases of the name | |
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1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000002 | |
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0..1 | BackboneElement | Coding words or phrases of the name | |
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1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000001 | |
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0..1 | BackboneElement | Coding words or phrases of the name | |
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1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000005 | |
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1..1 | BackboneElement | Country and jurisdiction where the name applies | |
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1..1 | EmaRefTermCodeableConcept | Country code for where this name applies Binding: Country (required) | |
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1..1 | CodeableConcept | Language code for this name Binding: Language (required) | |
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1..1 | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product | |
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1..1 | Identifier | Logical reference, when literal reference is not known | |
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0..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/crossReference | |
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1..1 | EmaRefTermCodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: Product Cross Reference Type (required) | |
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0..1 | CodeableReference(EMA Write API ActivityDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging | |
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0..1 | EmaRefTermCodeableConcept | Specifies whether this process is considered proprietary or confidential Binding: Data Classification (required) | |
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1..1 | BackboneElement | Key product features such as "sugar free", "modified release" | |
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1..1 | EmaGmoCodeableConcept | A code expressing the type of characteristic | |
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Path | Conformance | ValueSet | URI |
MedicinalProductDefinition.type | required | MedicinalProductTypeVs (a valid code from Medicinal Product Type)http://ema.europa.eu/fhir/vs/medicinalProductType from this IG | |
MedicinalProductDefinition.domain | required | DomainVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/domain from this IG | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | CombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm from this IG | |
MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)http://ema.europa.eu/fhir/vs/legalStatusForTheSupply from this IG | |
MedicinalProductDefinition.additionalMonitoringIndicator | required | AdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator from this IG | |
MedicinalProductDefinition.pediatricUseIndicator | required | PaediatricUseIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/paediatricUseIndicator from this IG | |
MedicinalProductDefinition.name.type | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.usage.country | required | CountryVs (a valid code from Country)http://ema.europa.eu/fhir/vs/country from this IG | |
MedicinalProductDefinition.name.usage.language | required | LanguageVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/language from this IG | |
MedicinalProductDefinition.crossReference.type | required | ProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)http://ema.europa.eu/fhir/vs/productcrossreferencetype from this IG | |
MedicinalProductDefinition.operation.confidentialityIndicator | required | DataClassificationVs (a valid code from Data Classification)http://ema.europa.eu/fhir/vs/dataClassification from this IG |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints![]() | ||||
---|---|---|---|---|---|---|---|---|
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0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
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0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
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0..* | Resource | Contained, inline Resources | |||||
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1..* | EmaCoding | Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required) | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
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Σ | 0..* | Identifier | Business identifier for this product. Could be an MPID Slice: Unordered, Closed by value:system | ||||
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Content/Rules for all slices | |||||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | |||||||
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Σ | 0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
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ΣC | 0..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | EmaEurdIdentifier | Business identifier for this product. Could be an MPID | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | |||||||
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/eurdId | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | EmaMpIdentifier | Business identifier for this product. Could be an MPID | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | |||||||
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/mpId | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (required) | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | If this medicine applies to human or veterinary uses Binding: Domain (required) | ||||
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Σ | 0..1 | string | A business identifier relating to a specific version of the product | ||||
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?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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Σ | 0..1 | dateTime | The date at which the given status became applicable | ||||
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Σ | 0..1 | markdown | General description of this product | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (required) | ||||
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Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body. | ||||
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Σ | 1..1 | markdown | Description of indication(s) for this product, used when structured indications are not required | ||||
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0..1 | string | xml:id (or equivalent in JSON) | |||||
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1..1 | EmaCoding | Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required) | |||||
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0..1 | markdown | Primitive value for markdown | |||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status of Supply (required) | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (required) | ||||
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Σ | 0..* | CodeableConcept | Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | If authorised for use in children Binding: Paediatric Use Indicator (required) | ||||
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Σ | 4..* | CodeableConcept | Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. | ||||
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Σ | 1..1 | EmaXevmpdProductCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | |||||||
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Σ | 0..* | Coding | Code defined by a terminology system Binding: XEVMPD medicinal product type (required) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000324 | ||||
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Σ | 0..1 | string | Version of the system - if relevant | ||||
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ΣC | 0..1 | code | Symbol in syntax defined by the system | ||||
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ΣC | 0..1 | string | Representation defined by the system | ||||
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Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
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Σ | 1..1 | EmaLegalBasisCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | |||||||
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Σ | 0..* | Coding | Code defined by a terminology system Binding: XEVMPD medicinal product type (required) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000116045 | ||||
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Σ | 0..1 | string | Version of the system - if relevant | ||||
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ΣC | 0..1 | code | Symbol in syntax defined by the system | ||||
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ΣC | 0..1 | string | Representation defined by the system | ||||
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Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
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Σ | 1..* | EmaLightAtcCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | (Complex) | ||||||
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Content/Rules for all slices | |||||||
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Σ | 1..1 | EmaAtcCoding | Code defined by a terminology system | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533 | ||||
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0..1 | string | xml:id (or equivalent in JSON) | |||||
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0..* | string | Extension URL: http://ema.europa.eu/fhir/extension/codeSystemName | |||||
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0..1 | uri | Primitive value for uri | |||||
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ΣC | 1..1 | code | Symbol in syntax defined by the system | ||||
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ΣC | 0..1 | string | Representation defined by the system | ||||
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Σ | 1..* | EmaProductCategoryCodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..0 | |||||||
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Σ | 0..* | Coding | Code defined by a terminology system Binding: Product Category (required) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000155526 | ||||
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Σ | 0..1 | string | Version of the system - if relevant | ||||
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ΣC | 0..1 | code | Symbol in syntax defined by the system | ||||
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ΣC | 0..1 | string | Representation defined by the system | ||||
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Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
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Σ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorization | ||||
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Σ | 0..* | CodeableConcept | Package type for the product Binding: MedicinalProductPackageType (example): Types of medicinal product packs | ||||
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Σ | 0..* | Reference(ManufacturedItemDefinition | DeviceDefinition) | Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes | ||||
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Σ | 0..* | CodeableConcept | The ingredients of this medicinal product - when not detailed in other resources Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
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Σ | 0..* | CodeableReference(SubstanceDefinition) | Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
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Σ | 0..* | Reference(DocumentReference) | Additional documentation about the medicinal product | ||||
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Σ | 1..1 | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) | ||||
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Σ | 0..1 | BackboneElement | A product specific contact, person (in a role), or an organization | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | EmaQualifiedPersonTypeCodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | ||||
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Σ | 1..1 | Reference(PractitionerRole) | A product specific contact, person (in a role), or an organization | ||||
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Σ | 0..* | Reference(ResearchStudy) | Clinical trials or studies that this product is involved in | ||||
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Σ | 0..* | Coding | A code that this product is known by, within some formal terminology Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication. | ||||
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Σ | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | string | The full product name | ||||
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Σ | 0..1 | EmaRefTermCodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Medicinal Product Name Part Type (required) | ||||
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Σ | 1..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type | ||||
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Content/Rules for all slices | |||||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | string | A fragment of a product name | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | EmaNamePartTypeCoding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 0..1 | BackboneElement | Coding words or phrases of the name | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | string | A fragment of a product name | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |||||
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0..1 | string | Version of the system - if relevant | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000002 | |||||
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0..1 | string | Representation defined by the system | |||||
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0..1 | boolean | If this coding was chosen directly by the user | |||||
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0..1 | string | Plain text representation of the concept | |||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | EmaNamePartTypeCoding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 0..1 | BackboneElement | Coding words or phrases of the name | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | string | A fragment of a product name | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |||||
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0..1 | string | Version of the system - if relevant | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000001 | |||||
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0..1 | string | Representation defined by the system | |||||
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0..1 | boolean | If this coding was chosen directly by the user | |||||
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0..1 | string | Plain text representation of the concept | |||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | EmaNamePartTypeCoding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 0..1 | BackboneElement | Coding words or phrases of the name | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | string | A fragment of a product name | ||||
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Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000 | |||||
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0..1 | string | Version of the system - if relevant | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000005 | |||||
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0..1 | string | Representation defined by the system | |||||
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0..1 | boolean | If this coding was chosen directly by the user | |||||
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0..1 | string | Plain text representation of the concept | |||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | EmaNamePartTypeCoding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 1..1 | BackboneElement | Country and jurisdiction where the name applies | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | Country code for where this name applies Binding: Country (required) | ||||
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Σ | 0..1 | CodeableConcept | Jurisdiction code for where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
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Σ | 1..1 | CodeableConcept | Language code for this name Binding: Language (required)
| ||||
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Σ | 1..1 | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | CodeableReference(MedicinalProductDefinition) | Reference to another product, e.g. for linking authorised to investigational product | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..1 | CodeableConcept | Reference to a concept (by class) | ||||
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Σ | 0..1 | Reference() | Reference to a resource (by instance) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
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Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
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ΣC | 1..1 | Identifier | Logical reference, when literal reference is not known | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
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Σ | 0..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/crossReference | ||||
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ΣC | 0..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
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Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
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ΣC | 0..1 | string | Text alternative for the resource | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: Product Cross Reference Type (required) | ||||
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Σ | 0..* | BackboneElement | A manufacturing or administrative process for the medicinal product | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | CodeableReference(EMA Write API ActivityDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging | ||||
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Σ | 0..1 | Period | Date range of applicability | ||||
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Σ | 0..* | Reference(Organization) | The organization responsible for the particular process, e.g. the manufacturer or importer | ||||
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Σ | 0..1 | EmaRefTermCodeableConcept | Specifies whether this process is considered proprietary or confidential Binding: Data Classification (required) | ||||
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Σ | 1..1 | BackboneElement | Key product features such as "sugar free", "modified release" | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | EmaGmoCodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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Σ | 0..1 | A value for the characteristic | |||||
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CodeableConcept | |||||||
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markdown | |||||||
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Quantity | |||||||
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integer | |||||||
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date | |||||||
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boolean | |||||||
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Attachment | |||||||
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Path | Conformance | ValueSet / Code | URI |
MedicinalProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.type | required | MedicinalProductTypeVs (a valid code from Medicinal Product Type)http://ema.europa.eu/fhir/vs/medicinalProductType from this IG | |
MedicinalProductDefinition.domain | required | DomainVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/domain from this IG | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | CombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm from this IG | |
MedicinalProductDefinition.route | example | SNOMEDCTRouteCodeshttp://hl7.org/fhir/ValueSet/route-codes from the FHIR Standard | |
MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)http://ema.europa.eu/fhir/vs/legalStatusForTheSupply from this IG | |
MedicinalProductDefinition.additionalMonitoringIndicator | required | AdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator from this IG | |
MedicinalProductDefinition.specialMeasures | example | SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measures from the FHIR Standard | |
MedicinalProductDefinition.pediatricUseIndicator | required | PaediatricUseIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/paediatricUseIndicator from this IG | |
MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:xevmpd | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:xevmpd.coding | required | XevmpdMedicinalProductTypeVs (a valid code from XEVMPD Medicinal Product Type)http://ema.europa.eu/fhir/vs/xevmpdMedicinalProductType from this IG | |
MedicinalProductDefinition.classification:legalBasis | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:legalBasis.coding | required | MarketingAuthorisationApplicationLegalBasisVs (a valid code from Marketing Authorisation Application Legal Basis)http://ema.europa.eu/fhir/vs/marketingAuthorisationApplicationLegalBasis from this IG | |
MedicinalProductDefinition.classification:lightAtc | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:productCategory | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:productCategory.coding | required | ProductCategoryVs (a valid code from Product Category)http://ema.europa.eu/fhir/vs/productCategory from this IG | |
MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-type from the FHIR Standard | |
MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-type from the FHIR Standard | |
MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codes from the FHIR Standard | |
MedicinalProductDefinition.name.type | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part:inventedName.type | example | Pattern: 220000000002http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:inventedName.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part:fullName.type | example | Pattern: 220000000001http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:fullName.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type | example | Pattern: 220000000005http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartType from this IG | |
MedicinalProductDefinition.name.usage.country | required | CountryVs (a valid code from Country)http://ema.europa.eu/fhir/vs/country from this IG | |
MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name.usage.language | required | LanguageVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/language from this IG | |
MedicinalProductDefinition.crossReference.product.reference.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard | |
MedicinalProductDefinition.crossReference.product.reference.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.crossReference.product.reference.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
MedicinalProductDefinition.crossReference.type | required | ProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)http://ema.europa.eu/fhir/vs/productcrossreferencetype from this IG | |
MedicinalProductDefinition.operation.confidentialityIndicator | required | DataClassificationVs (a valid code from Data Classification)http://ema.europa.eu/fhir/vs/dataClassification from this IG | |
MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard |
This structure is derived from MedicinalProductDefinition
Summary
Mandatory: 20 elements(6 nested mandatory elements)
Prohibited: 5 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron