EMA Write PMS API Implementation Guide - Enrichments
1.2.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.0) 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: 1.2.0 | |||
| Draft as of 2025-08-08 | Computable Name: EmaWriteApiMedicinalProductDefinition | |||
Defines the rules a MedicinalProductDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints![]() | ||||
|---|---|---|---|---|---|---|---|---|
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0..* | EmaWriteApiMedicinalProductDefinitionRestrictions | 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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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..3 | 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 | 0..1 | EmaApiV2Identifier | 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://spor.azure-api.net/pms/api/v2 | ||||
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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 | 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 | 1..1 | EmaRefTermCodeableConcept | The status within the lifecycle of this product record Binding: Record Status (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 0..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 | 1..* | 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 | 0..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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Σ | 0..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 | 0..* | 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 | 2..2 | BackboneElement | A product specific contact, person (in a role), or an organization Slice: Unordered, Closed by value:type.coding.code 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 | Reference(Organization | 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 | 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 | EmaPharmacovigilanceQualifiedPersonTypeCodeableConcept | 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 | 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 | EmaPharmacovigilanceEnquiryContactCodeableConcept | 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(Organization) | 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 | 0..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 | ||||
Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| MedicinalProductDefinition.type | required | MedicinalProductTypeVs (a valid code from Medicinal Product Type)http://ema.europa.eu/fhir/vs/medicinalProductTypefrom this IG | |
| MedicinalProductDefinition.domain | required | DomainVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/domainfrom this IG | |
| MedicinalProductDefinition.status | required | RecordStatusVs (a valid code from Record Status)http://ema.europa.eu/fhir/vs/recordStatusfrom this IG | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | CombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseFormfrom this IG | |
| MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)http://ema.europa.eu/fhir/vs/legalStatusForTheSupplyfrom this IG | |
| MedicinalProductDefinition.additionalMonitoringIndicator | required | AdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/additionalMonitoringIndicatorfrom this IG | |
| MedicinalProductDefinition.pediatricUseIndicator | required | PaediatricUseIndicatorVs (a valid code from Paediatric Use Indicator)http://ema.europa.eu/fhir/vs/paediatricUseIndicatorfrom this IG | |
| MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:xevmpd | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:legalBasis | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:lightAtc | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:productCategory | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.type | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom 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/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part:inventedName.type | example | Pattern: 220000000002http://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.part:fullName.type | example | Pattern: 220000000001http://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type | example | Pattern: 220000000005http://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.country | required | CountryVs (a valid code from Country)http://ema.europa.eu/fhir/vs/countryfrom this IG | |
| MedicinalProductDefinition.name.usage.language | required | LanguageVs (a valid code from Language)http://ema.europa.eu/fhir/vs/languagefrom this IG | |
| MedicinalProductDefinition.crossReference.type | required | ProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)http://ema.europa.eu/fhir/vs/productcrossreferencetypefrom this IG | |
| MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard |
This structure is derived from EmaWriteApiMedicinalProductDefinitionRestrictions
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
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EmaWriteApiMedicinalProductDefinitionRestrictions | |||
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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..3 | 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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0..1 | EmaApiV2Identifier | 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://spor.azure-api.net/pms/api/v2 | |
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0..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 status within the lifecycle of this product record Binding: Record Status (required) | |
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0..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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1..* | CodeableConcept | Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system | |
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0..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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0..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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0..* | 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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2..2 | BackboneElement | A product specific contact, person (in a role), or an organization Slice: Unordered, Closed by value:type.coding.code | |
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1..1 | BackboneElement | A product specific contact, person (in a role), or an organization | |
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0..1 | EmaPharmacovigilanceQualifiedPersonTypeCodeableConcept | 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 | A product specific contact, person (in a role), or an organization | |
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0..1 | EmaPharmacovigilanceEnquiryContactCodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information | |
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1..1 | Reference(Organization) | 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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0..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 | |
Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| MedicinalProductDefinition.type | required | MedicinalProductTypeVs (a valid code from Medicinal Product Type)http://ema.europa.eu/fhir/vs/medicinalProductTypefrom this IG | |
| MedicinalProductDefinition.domain | required | DomainVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/domainfrom this IG | |
| MedicinalProductDefinition.status | required | RecordStatusVs (a valid code from Record Status)http://ema.europa.eu/fhir/vs/recordStatusfrom this IG | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | CombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseFormfrom this IG | |
| MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)http://ema.europa.eu/fhir/vs/legalStatusForTheSupplyfrom this IG | |
| MedicinalProductDefinition.additionalMonitoringIndicator | required | AdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/additionalMonitoringIndicatorfrom this IG | |
| MedicinalProductDefinition.pediatricUseIndicator | required | PaediatricUseIndicatorVs (a valid code from Paediatric Use Indicator)http://ema.europa.eu/fhir/vs/paediatricUseIndicatorfrom this IG | |
| MedicinalProductDefinition.name.type | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.usage.country | required | CountryVs (a valid code from Country)http://ema.europa.eu/fhir/vs/countryfrom this IG | |
| MedicinalProductDefinition.name.usage.language | required | LanguageVs (a valid code from Language)http://ema.europa.eu/fhir/vs/languagefrom this IG | |
| MedicinalProductDefinition.crossReference.type | required | ProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)http://ema.europa.eu/fhir/vs/productcrossreferencetypefrom this IG | |
| MedicinalProductDefinition.operation.confidentialityIndicator | required | DataClassificationVshttp://ema.europa.eu/fhir/vs/dataClassificationfrom this IG |
| Name | Flags | Card. | Type | Description & Constraints![]() | ||||
|---|---|---|---|---|---|---|---|---|
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0..* | EmaWriteApiMedicinalProductDefinitionRestrictions | 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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1..* | EmaCoding | Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required) | |||||
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Σ | 0..3 | 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 | 0..1 | EmaApiV2Identifier | 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://spor.azure-api.net/pms/api/v2 | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..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 | 1..1 | EmaRefTermCodeableConcept | The status within the lifecycle of this product record Binding: Record Status (required) | ||||
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Σ | 0..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 | 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 | 1..1 | EmaRefTermCodeableConcept | If authorised for use in children Binding: Paediatric Use Indicator (required) | ||||
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Σ | 1..* | 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 | 0..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 | 0..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 | Code System Name 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 | 0..* | 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..* | 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..* | 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 | 2..2 | BackboneElement | A product specific contact, person (in a role), or an organization Slice: Unordered, Closed by value:type.coding.code | ||||
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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 | 0..1 | CodeableConcept | 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(Organization | PractitionerRole) | A product specific contact, person (in a role), or an organization | ||||
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Σ | 1..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 | EmaPharmacovigilanceQualifiedPersonTypeCodeableConcept | 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 | 1..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 | EmaPharmacovigilanceEnquiryContactCodeableConcept | 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(Organization) | 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 | 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 | 0..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 | |||||||
Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| MedicinalProductDefinition.type | required | MedicinalProductTypeVs (a valid code from Medicinal Product Type)http://ema.europa.eu/fhir/vs/medicinalProductTypefrom this IG | |
| MedicinalProductDefinition.domain | required | DomainVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/domainfrom this IG | |
| MedicinalProductDefinition.status | required | RecordStatusVs (a valid code from Record Status)http://ema.europa.eu/fhir/vs/recordStatusfrom this IG | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | CombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseFormfrom this IG | |
| MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)http://ema.europa.eu/fhir/vs/legalStatusForTheSupplyfrom this IG | |
| MedicinalProductDefinition.additionalMonitoringIndicator | required | AdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/additionalMonitoringIndicatorfrom this IG | |
| MedicinalProductDefinition.pediatricUseIndicator | required | PaediatricUseIndicatorVs (a valid code from Paediatric Use Indicator)http://ema.europa.eu/fhir/vs/paediatricUseIndicatorfrom this IG | |
| MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:xevmpd | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:xevmpd.coding | required | XevmpdMedicinalProductTypeVs (a valid code from XEVMPD Medicinal Product Type)http://ema.europa.eu/fhir/vs/xevmpdMedicinalProductTypefrom this IG | |
| MedicinalProductDefinition.classification:legalBasis | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:legalBasis.coding | required | MarketingAuthorisationApplicationLegalBasisVs (a valid code from Marketing Authorisation Application Legal Basis)http://ema.europa.eu/fhir/vs/marketingAuthorisationApplicationLegalBasisfrom this IG | |
| MedicinalProductDefinition.classification:lightAtc | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:productCategory | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:productCategory.coding | required | ProductCategoryVs (a valid code from Product Category)http://ema.europa.eu/fhir/vs/productCategoryfrom this IG | |
| MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.type | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom 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/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part:inventedName.type | example | Pattern: 220000000002http://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom 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/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part:fullName.type | example | Pattern: 220000000001http://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom 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/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type | example | Pattern: 220000000005http://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom 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/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.usage.country | required | CountryVs (a valid code from Country)http://ema.europa.eu/fhir/vs/countryfrom this IG | |
| MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.language | required | LanguageVs (a valid code from Language)http://ema.europa.eu/fhir/vs/languagefrom this IG | |
| MedicinalProductDefinition.crossReference.product.reference.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-typesfrom the FHIR Standard | |
| MedicinalProductDefinition.crossReference.product.reference.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.crossReference.product.reference.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| MedicinalProductDefinition.crossReference.type | required | ProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)http://ema.europa.eu/fhir/vs/productcrossreferencetypefrom this IG | |
| MedicinalProductDefinition.operation.confidentialityIndicator | required | DataClassificationVshttp://ema.europa.eu/fhir/vs/dataClassificationfrom this IG | |
| MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard |
This structure is derived from EmaWriteApiMedicinalProductDefinitionRestrictions
Summary
Mandatory: 17 elements(8 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..* | EmaWriteApiMedicinalProductDefinitionRestrictions | 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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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..3 | 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 | 0..1 | EmaApiV2Identifier | 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://spor.azure-api.net/pms/api/v2 | ||||
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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 | 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 | 1..1 | EmaRefTermCodeableConcept | The status within the lifecycle of this product record Binding: Record Status (required) ele-1: All FHIR elements must have a @value or children | ||||
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Σ | 0..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 | 1..* | 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 | 0..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 | 0..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 | 0..* | 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 | 2..2 | BackboneElement | A product specific contact, person (in a role), or an organization Slice: Unordered, Closed by value:type.coding.code 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 | Reference(Organization | 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 | 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 | EmaPharmacovigilanceQualifiedPersonTypeCodeableConcept | 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 | 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 | EmaPharmacovigilanceEnquiryContactCodeableConcept | 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(Organization) | 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 | 0..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 | ||||
Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| MedicinalProductDefinition.type | required | MedicinalProductTypeVs (a valid code from Medicinal Product Type)http://ema.europa.eu/fhir/vs/medicinalProductTypefrom this IG | |
| MedicinalProductDefinition.domain | required | DomainVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/domainfrom this IG | |
| MedicinalProductDefinition.status | required | RecordStatusVs (a valid code from Record Status)http://ema.europa.eu/fhir/vs/recordStatusfrom this IG | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | CombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseFormfrom this IG | |
| MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)http://ema.europa.eu/fhir/vs/legalStatusForTheSupplyfrom this IG | |
| MedicinalProductDefinition.additionalMonitoringIndicator | required | AdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/additionalMonitoringIndicatorfrom this IG | |
| MedicinalProductDefinition.pediatricUseIndicator | required | PaediatricUseIndicatorVs (a valid code from Paediatric Use Indicator)http://ema.europa.eu/fhir/vs/paediatricUseIndicatorfrom this IG | |
| MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:xevmpd | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:legalBasis | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:lightAtc | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:productCategory | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.type | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom 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/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part:inventedName.type | example | Pattern: 220000000002http://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.part:fullName.type | example | Pattern: 220000000001http://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type | example | Pattern: 220000000005http://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.country | required | CountryVs (a valid code from Country)http://ema.europa.eu/fhir/vs/countryfrom this IG | |
| MedicinalProductDefinition.name.usage.language | required | LanguageVs (a valid code from Language)http://ema.europa.eu/fhir/vs/languagefrom this IG | |
| MedicinalProductDefinition.crossReference.type | required | ProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)http://ema.europa.eu/fhir/vs/productcrossreferencetypefrom this IG | |
| MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard |
Differential View
This structure is derived from EmaWriteApiMedicinalProductDefinitionRestrictions
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
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EmaWriteApiMedicinalProductDefinitionRestrictions | |||
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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..3 | 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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0..1 | EmaApiV2Identifier | 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://spor.azure-api.net/pms/api/v2 | |
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0..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 status within the lifecycle of this product record Binding: Record Status (required) | |
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0..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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1..* | CodeableConcept | Allows the product to be classified by various systems Slice: Unordered, Closed by value:coding.system | |
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0..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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0..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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0..* | 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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2..2 | BackboneElement | A product specific contact, person (in a role), or an organization Slice: Unordered, Closed by value:type.coding.code | |
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1..1 | BackboneElement | A product specific contact, person (in a role), or an organization | |
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0..1 | EmaPharmacovigilanceQualifiedPersonTypeCodeableConcept | 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 | A product specific contact, person (in a role), or an organization | |
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0..1 | EmaPharmacovigilanceEnquiryContactCodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information | |
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1..1 | Reference(Organization) | 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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0..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 | |
Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| MedicinalProductDefinition.type | required | MedicinalProductTypeVs (a valid code from Medicinal Product Type)http://ema.europa.eu/fhir/vs/medicinalProductTypefrom this IG | |
| MedicinalProductDefinition.domain | required | DomainVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/domainfrom this IG | |
| MedicinalProductDefinition.status | required | RecordStatusVs (a valid code from Record Status)http://ema.europa.eu/fhir/vs/recordStatusfrom this IG | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | CombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseFormfrom this IG | |
| MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)http://ema.europa.eu/fhir/vs/legalStatusForTheSupplyfrom this IG | |
| MedicinalProductDefinition.additionalMonitoringIndicator | required | AdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/additionalMonitoringIndicatorfrom this IG | |
| MedicinalProductDefinition.pediatricUseIndicator | required | PaediatricUseIndicatorVs (a valid code from Paediatric Use Indicator)http://ema.europa.eu/fhir/vs/paediatricUseIndicatorfrom this IG | |
| MedicinalProductDefinition.name.type | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.usage.country | required | CountryVs (a valid code from Country)http://ema.europa.eu/fhir/vs/countryfrom this IG | |
| MedicinalProductDefinition.name.usage.language | required | LanguageVs (a valid code from Language)http://ema.europa.eu/fhir/vs/languagefrom this IG | |
| MedicinalProductDefinition.crossReference.type | required | ProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)http://ema.europa.eu/fhir/vs/productcrossreferencetypefrom this IG | |
| MedicinalProductDefinition.operation.confidentialityIndicator | required | DataClassificationVshttp://ema.europa.eu/fhir/vs/dataClassificationfrom this IG |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints![]() | ||||
|---|---|---|---|---|---|---|---|---|
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0..* | EmaWriteApiMedicinalProductDefinitionRestrictions | 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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1..* | EmaCoding | Authorised Dose Form URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm Binding: Authorised Dose Form (required) | |||||
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Σ | 0..3 | 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 | 0..1 | EmaApiV2Identifier | 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://spor.azure-api.net/pms/api/v2 | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..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 | 1..1 | EmaRefTermCodeableConcept | The status within the lifecycle of this product record Binding: Record Status (required) | ||||
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Σ | 0..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 | 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 | 1..1 | EmaRefTermCodeableConcept | If authorised for use in children Binding: Paediatric Use Indicator (required) | ||||
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Σ | 1..* | 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 | 0..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 | 0..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 | Code System Name 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 | 0..* | 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..* | 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..* | 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 | 2..2 | BackboneElement | A product specific contact, person (in a role), or an organization Slice: Unordered, Closed by value:type.coding.code | ||||
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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 | 0..1 | CodeableConcept | 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(Organization | PractitionerRole) | A product specific contact, person (in a role), or an organization | ||||
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Σ | 1..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 | EmaPharmacovigilanceQualifiedPersonTypeCodeableConcept | 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 | 1..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 | EmaPharmacovigilanceEnquiryContactCodeableConcept | 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(Organization) | 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 | 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 | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
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 | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
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 | |||||
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | boolean | If this coding was chosen directly by the user | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Plain text representation of the concept | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
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 | |||||
![]() ![]() ![]() ![]() ![]() |
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 | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
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 | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Plain text representation of the concept | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
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 | 0..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 | |||||||
Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| MedicinalProductDefinition.type | required | MedicinalProductTypeVs (a valid code from Medicinal Product Type)http://ema.europa.eu/fhir/vs/medicinalProductTypefrom this IG | |
| MedicinalProductDefinition.domain | required | DomainVs (a valid code from Domain)http://ema.europa.eu/fhir/vs/domainfrom this IG | |
| MedicinalProductDefinition.status | required | RecordStatusVs (a valid code from Record Status)http://ema.europa.eu/fhir/vs/recordStatusfrom this IG | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | CombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseFormfrom this IG | |
| MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)http://ema.europa.eu/fhir/vs/legalStatusForTheSupplyfrom this IG | |
| MedicinalProductDefinition.additionalMonitoringIndicator | required | AdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)http://ema.europa.eu/fhir/vs/additionalMonitoringIndicatorfrom this IG | |
| MedicinalProductDefinition.pediatricUseIndicator | required | PaediatricUseIndicatorVs (a valid code from Paediatric Use Indicator)http://ema.europa.eu/fhir/vs/paediatricUseIndicatorfrom this IG | |
| MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:xevmpd | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:xevmpd.coding | required | XevmpdMedicinalProductTypeVs (a valid code from XEVMPD Medicinal Product Type)http://ema.europa.eu/fhir/vs/xevmpdMedicinalProductTypefrom this IG | |
| MedicinalProductDefinition.classification:legalBasis | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:legalBasis.coding | required | MarketingAuthorisationApplicationLegalBasisVs (a valid code from Marketing Authorisation Application Legal Basis)http://ema.europa.eu/fhir/vs/marketingAuthorisationApplicationLegalBasisfrom this IG | |
| MedicinalProductDefinition.classification:lightAtc | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:productCategory | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.classification:productCategory.coding | required | ProductCategoryVs (a valid code from Product Category)http://ema.europa.eu/fhir/vs/productCategoryfrom this IG | |
| MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.type | required | MedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)http://ema.europa.eu/fhir/vs/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom 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/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part:inventedName.type | example | Pattern: 220000000002http://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom 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/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part:fullName.type | example | Pattern: 220000000001http://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom 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/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type | example | Pattern: 220000000005http://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom 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/productNamePartTypefrom this IG | |
| MedicinalProductDefinition.name.usage.country | required | CountryVs (a valid code from Country)http://ema.europa.eu/fhir/vs/countryfrom this IG | |
| MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.language | required | LanguageVs (a valid code from Language)http://ema.europa.eu/fhir/vs/languagefrom this IG | |
| MedicinalProductDefinition.crossReference.product.reference.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-typesfrom the FHIR Standard | |
| MedicinalProductDefinition.crossReference.product.reference.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.crossReference.product.reference.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| MedicinalProductDefinition.crossReference.type | required | ProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)http://ema.europa.eu/fhir/vs/productcrossreferencetypefrom this IG | |
| MedicinalProductDefinition.operation.confidentialityIndicator | required | DataClassificationVshttp://ema.europa.eu/fhir/vs/dataClassificationfrom this IG | |
| MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard |
This structure is derived from EmaWriteApiMedicinalProductDefinitionRestrictions
Summary
Mandatory: 17 elements(8 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