EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Official URL: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization | Version: 1.0.0 | |||
Draft as of 2025-04-04 | Computable Name: EmaWriteApiRegulatedAuthorization |
Defines the rule a Marketing RegulatedAuthorization 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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C | 0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for 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 regulatorIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the regulator is mandatory |
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?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children |
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0..* | Resource | Contained, inline Resources | |
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0..* | Extension | Extension Slice: Unordered, Open by value:url 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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0..1 | date | Regulated Authorization - Date of First Authorisation URL: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation 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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0..1 | date | Regulated Authorization - International Birth Date URL: http://ema.europa.eu/fhir/extension/internationalBirthDate ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
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Σ | 0..1 | Identifier | Business identifier for the authorization, typically assigned by the authorizing body Slice: Unordered, Open by value:system ele-1: All FHIR elements must have a @value or children |
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Σ | 0..1 | EmaMarketingAuthorizationIdentifier | Business identifier for the authorization, typically assigned by the authorizing body 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/marketingAuthorizationNumber |
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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 | EmaManufacturingAuthNumberIdentifier | Business identifier for the authorization, typically assigned by the authorizing body 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/manufacturingAuthorizationNumber |
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ΣC | 1..1 | string | The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456 |
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Σ | 1..1 | Reference(EMA Write API MedicinalProductDefinition | EMA Write API PackagedProductDefinition | EMA Write API ActivityDefinition) | The product type, treatment, facility or activity that is being authorized ele-1: All FHIR elements must have a @value or children |
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Σ | 1..1 | EmaRefTermCodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: Regulatory Entitlement Type (required) ele-1: All FHIR elements must have a @value or children |
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0..0 | |||
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Σ | 1..1 | EmaCoding | Code defined by a terminology system Binding: Marketing and Manufacturing types (required) ele-1: All FHIR elements must have a @value or children |
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Σ | 1..1 | EmaRefTermCodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: Regulatory Entitlement Status (required) ele-1: All FHIR elements must have a @value or children |
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Σ | 1..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator ele-1: All FHIR elements must have a @value or children |
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ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL ele-1: All FHIR elements must have a @value or children |
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ΣC | 1..1 | Identifier | Logical reference, when literal reference is not known ele-1: All FHIR elements must have a @value or children |
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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 . ele-1: All FHIR elements must have a @value or children |
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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: https://spor.ema.europa.eu/v1/locations |
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ΣC | 1..1 | string | The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456 |
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Σ | 1..1 | BackboneElement | The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) ele-1: All FHIR elements must have a @value or children |
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1..1 | EmaCoding | Regulated Authorization - Paediatric - Reference Country URL: http://ema.europa.eu/fhir/extension/referenceCountry Binding: Country (required) ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored 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 | Relevant date for this case Slice: Unordered, Open by type:$this ele-1: All FHIR elements must have a @value or children | |
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Period | |||
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dateTime | |||
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Σ | 0..1 | Period | Relevant date for this case ele-1: All FHIR elements must have a @value or children |
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Σ | 0..1 | BackboneElement | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure ele-1: All FHIR elements must have a @value or children |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
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Σ | 0..1 | EmaApplicationIdentifierNumber | Identifier by which this case can be referenced ele-1: All FHIR elements must have a @value or children |
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Σ | 0..1 | CodeableConcept | The defining type of case Binding: Application Submission Type (required) ele-1: All FHIR elements must have a @value or children |
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Σ | 1..1 | dateTime | Relevant date for this case Slice: Unordered, Closed by type:$this ele-1: All FHIR elements must have a @value or children |
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Σ | 1..1 | dateTime | Relevant date for this case ele-1: All FHIR elements must have a @value or children |
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Path | Conformance | ValueSet | URI |
RegulatedAuthorization.type | required | RegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)http://ema.europa.eu/fhir/vs/regulatoryEntitlementType from this IG | |
RegulatedAuthorization.type.coding | required | MarketingAndManufacturingTypesVshttp://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes from this IG | |
RegulatedAuthorization.status | required | RegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus from this IG | |
RegulatedAuthorization.holder.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
RegulatedAuthorization.case.application.type | required | ApplicationSubmissionTypeVs (a valid code from Application Submission Type)http://ema.europa.eu/fhir/vs/applicationSubmissionType from this IG |
Id | Grade | Path(s) | Details | Requirements |
regulatorIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the regulator is mandatory : (type.coding.code = '220000000099' and identifier.exists()) implies regulator.exists() |
This structure is derived from RegulatedAuthorization
Name | Flags | Card. | Type | Description & Constraints![]() |
---|---|---|---|---|
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C | 0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product regulatorIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the regulator is mandatory |
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0..* | Extension | Extension Slice: Unordered, Open by value:url | |
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0..1 | date | Regulated Authorization - Date of First Authorisation URL: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation | |
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0..1 | date | Regulated Authorization - International Birth Date URL: http://ema.europa.eu/fhir/extension/internationalBirthDate | |
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0..1 | Identifier | Business identifier for the authorization, typically assigned by the authorizing body Slice: Unordered, Open by value:system | |
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0..1 | EmaMarketingAuthorizationIdentifier | Business identifier for the authorization, typically assigned by the authorizing body | |
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1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber | |
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0..1 | EmaManufacturingAuthNumberIdentifier | Business identifier for the authorization, typically assigned by the authorizing body | |
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1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber | |
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1..1 | Reference(EMA Write API MedicinalProductDefinition | EMA Write API PackagedProductDefinition | EMA Write API ActivityDefinition) | The product type, treatment, facility or activity that is being authorized | |
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1..1 | EmaRefTermCodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: Regulatory Entitlement Type (required) | |
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1..1 | EmaCoding | Code defined by a terminology system Binding: Marketing and Manufacturing types (required) | |
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1..1 | EmaRefTermCodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: Regulatory Entitlement Status (required) | |
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1..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator | |
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1..1 | Identifier | Logical reference, when literal reference is not known | |
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1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/v1/locations | |
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1..1 | string | The value that is unique | |
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1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/v1/locations | |
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1..1 | string | The value that is unique | |
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1..1 | BackboneElement | The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) | |
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1..1 | EmaCoding | Regulated Authorization - Paediatric - Reference Country URL: http://ema.europa.eu/fhir/extension/referenceCountry Binding: Country (required) | |
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0..1 | Period, dateTime | Relevant date for this case Slice: Unordered, Open by type:$this | |
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0..1 | Period | Relevant date for this case | |
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0..1 | BackboneElement | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure | |
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0..1 | EmaApplicationIdentifierNumber | Identifier by which this case can be referenced | |
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0..1 | CodeableConcept | The defining type of case Binding: Application Submission Type (required) | |
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1..1 | dateTime | Relevant date for this case Slice: Unordered, Open by type:$this | |
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1..1 | dateTime | Relevant date for this case | |
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Path | Conformance | ValueSet | URI |
RegulatedAuthorization.type | required | RegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)http://ema.europa.eu/fhir/vs/regulatoryEntitlementType from this IG | |
RegulatedAuthorization.type.coding | required | MarketingAndManufacturingTypesVshttp://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes from this IG | |
RegulatedAuthorization.status | required | RegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus from this IG | |
RegulatedAuthorization.case.application.type | required | ApplicationSubmissionTypeVs (a valid code from Application Submission Type)http://ema.europa.eu/fhir/vs/applicationSubmissionType from this IG |
Id | Grade | Path(s) | Details | Requirements |
regulatorIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the regulator is mandatory : (type.coding.code = '220000000099' and identifier.exists()) implies regulator.exists() |
Name | Flags | Card. | Type | Description & Constraints![]() | ||||
---|---|---|---|---|---|---|---|---|
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C | 0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product regulatorIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the regulator is mandatory | ||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
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0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
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0..* | Resource | Contained, inline Resources | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
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0..1 | date | Regulated Authorization - Date of First Authorisation URL: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation | |||||
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0..1 | date | Regulated Authorization - International Birth Date URL: http://ema.europa.eu/fhir/extension/internationalBirthDate | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
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Σ | 0..1 | Identifier | Business identifier for the authorization, typically assigned by the authorizing body Slice: Unordered, Open by value:system | ||||
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Σ | 0..1 | EmaMarketingAuthorizationIdentifier | Business identifier for the authorization, typically assigned by the authorizing body | ||||
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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/marketingAuthorizationNumber | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | EmaManufacturingAuthNumberIdentifier | Business identifier for the authorization, typically assigned by the authorizing body | ||||
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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/manufacturingAuthorizationNumber | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 1..1 | Reference(EMA Write API MedicinalProductDefinition | EMA Write API PackagedProductDefinition | EMA Write API ActivityDefinition) | The product type, treatment, facility or activity that is being authorized | ||||
![]() ![]() ![]() |
Σ | 1..1 | EmaRefTermCodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: Regulatory Entitlement Type (required) | ||||
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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 | EmaCoding | Code defined by a terminology system Binding: Marketing and Manufacturing types (required) | ||||
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Σ | 0..1 | markdown | General textual supporting information | ||||
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Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: Regulatory Entitlement Status (required) | ||||
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Σ | 0..1 | dateTime | The date at which the current status was assigned | ||||
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Σ | 0..1 | Period | The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date | ||||
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Σ | 0..* | CodeableReference(ClinicalUseDefinition) | Condition for which the use of the regulated product applies | ||||
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Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment Binding: ProductIntendedUse (preferred): The overall intended use of a product. | ||||
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Σ | 0..* | CodeableConcept | The legal/regulatory framework or reasons under which this authorization is granted Binding: RegulatedAuthorizationBasis (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it. | ||||
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Σ | 1..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator | ||||
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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 | 1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/v1/locations | ||||
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ΣC | 1..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 | 0..1 | Reference(Organization) | The regulatory authority or authorizing body granting the authorization | ||||
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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 | 0..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 | 1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/v1/locations | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
![]() ![]() ![]() ![]() ![]() |
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 | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the authorization | ||||
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Σ | 1..1 | BackboneElement | The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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1..1 | EmaCoding | Regulated Authorization - Paediatric - Reference Country URL: http://ema.europa.eu/fhir/extension/referenceCountry Binding: Country (required) | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | Identifier | Identifier by which this case can be referenced | ||||
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Σ | 0..1 | CodeableConcept | The defining type of case Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application. | ||||
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Σ | 0..1 | CodeableConcept | The status associated with the case Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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Σ | 0..1 | Relevant date for this case Slice: Unordered, Open by type:$this | |||||
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Period | |||||||
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dateTime | |||||||
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Σ | 0..1 | Period | Relevant date for this case | ||||
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Σ | 0..1 | BackboneElement | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | EmaApplicationIdentifierNumber | Identifier by which this case can be referenced | ||||
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Σ | 0..1 | CodeableConcept | The defining type of case Binding: Application Submission Type (required) | ||||
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Σ | 0..1 | CodeableConcept | The status associated with the case Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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Σ | 1..1 | dateTime | Relevant date for this case Slice: Unordered, Closed by type:$this | ||||
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Σ | 1..1 | dateTime | Relevant date for this case | ||||
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Σ | 0..* | See case (RegulatedAuthorization) | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure | ||||
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Path | Conformance | ValueSet | URI |
RegulatedAuthorization.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
RegulatedAuthorization.type | required | RegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)http://ema.europa.eu/fhir/vs/regulatoryEntitlementType from this IG | |
RegulatedAuthorization.type.coding | required | MarketingAndManufacturingTypesVshttp://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes from this IG | |
RegulatedAuthorization.region | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
RegulatedAuthorization.status | required | RegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus from this IG | |
RegulatedAuthorization.intendedUse | preferred | ProductIntendedUsehttp://hl7.org/fhir/ValueSet/product-intended-use from the FHIR Standard | |
RegulatedAuthorization.basis | example | RegulatedAuthorizationBasishttp://hl7.org/fhir/ValueSet/regulated-authorization-basis from the FHIR Standard | |
RegulatedAuthorization.holder.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard | |
RegulatedAuthorization.holder.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
RegulatedAuthorization.holder.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
RegulatedAuthorization.regulator.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard | |
RegulatedAuthorization.regulator.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
RegulatedAuthorization.regulator.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
RegulatedAuthorization.case.type | example | RegulatedAuthorizationCaseTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-case-type from the FHIR Standard | |
RegulatedAuthorization.case.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
RegulatedAuthorization.case.application.type | required | ApplicationSubmissionTypeVs (a valid code from Application Submission Type)http://ema.europa.eu/fhir/vs/applicationSubmissionType from this IG | |
RegulatedAuthorization.case.application.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
regulatorIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the regulator is mandatory : (type.coding.code = '220000000099' and identifier.exists()) implies regulator.exists() |
This structure is derived from RegulatedAuthorization
Summary
Mandatory: 9 elements(6 nested mandatory 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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C | 0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for 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 regulatorIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the regulator is mandatory |
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?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children |
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0..* | Resource | Contained, inline Resources | |
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0..* | Extension | Extension Slice: Unordered, Open by value:url 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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0..1 | date | Regulated Authorization - Date of First Authorisation URL: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation 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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0..1 | date | Regulated Authorization - International Birth Date URL: http://ema.europa.eu/fhir/extension/internationalBirthDate ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
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Σ | 0..1 | Identifier | Business identifier for the authorization, typically assigned by the authorizing body Slice: Unordered, Open by value:system ele-1: All FHIR elements must have a @value or children |
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Σ | 0..1 | EmaMarketingAuthorizationIdentifier | Business identifier for the authorization, typically assigned by the authorizing body 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/marketingAuthorizationNumber |
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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 | EmaManufacturingAuthNumberIdentifier | Business identifier for the authorization, typically assigned by the authorizing body 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/manufacturingAuthorizationNumber |
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ΣC | 1..1 | string | The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456 |
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Σ | 1..1 | Reference(EMA Write API MedicinalProductDefinition | EMA Write API PackagedProductDefinition | EMA Write API ActivityDefinition) | The product type, treatment, facility or activity that is being authorized ele-1: All FHIR elements must have a @value or children |
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Σ | 1..1 | EmaRefTermCodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: Regulatory Entitlement Type (required) ele-1: All FHIR elements must have a @value or children |
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0..0 | |||
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Σ | 1..1 | EmaCoding | Code defined by a terminology system Binding: Marketing and Manufacturing types (required) ele-1: All FHIR elements must have a @value or children |
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Σ | 1..1 | EmaRefTermCodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: Regulatory Entitlement Status (required) ele-1: All FHIR elements must have a @value or children |
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Σ | 1..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator ele-1: All FHIR elements must have a @value or children |
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ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL ele-1: All FHIR elements must have a @value or children |
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ΣC | 1..1 | Identifier | Logical reference, when literal reference is not known ele-1: All FHIR elements must have a @value or children |
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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 . ele-1: All FHIR elements must have a @value or children |
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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: https://spor.ema.europa.eu/v1/locations |
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ΣC | 1..1 | string | The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456 |
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Σ | 1..1 | BackboneElement | The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) ele-1: All FHIR elements must have a @value or children |
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1..1 | EmaCoding | Regulated Authorization - Paediatric - Reference Country URL: http://ema.europa.eu/fhir/extension/referenceCountry Binding: Country (required) ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored 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 | Relevant date for this case Slice: Unordered, Open by type:$this ele-1: All FHIR elements must have a @value or children | |
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Period | |||
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dateTime | |||
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Σ | 0..1 | Period | Relevant date for this case ele-1: All FHIR elements must have a @value or children |
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Σ | 0..1 | BackboneElement | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure ele-1: All FHIR elements must have a @value or children |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
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Σ | 0..1 | EmaApplicationIdentifierNumber | Identifier by which this case can be referenced ele-1: All FHIR elements must have a @value or children |
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Σ | 0..1 | CodeableConcept | The defining type of case Binding: Application Submission Type (required) ele-1: All FHIR elements must have a @value or children |
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Σ | 1..1 | dateTime | Relevant date for this case Slice: Unordered, Closed by type:$this ele-1: All FHIR elements must have a @value or children |
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Σ | 1..1 | dateTime | Relevant date for this case ele-1: All FHIR elements must have a @value or children |
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Path | Conformance | ValueSet | URI |
RegulatedAuthorization.type | required | RegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)http://ema.europa.eu/fhir/vs/regulatoryEntitlementType from this IG | |
RegulatedAuthorization.type.coding | required | MarketingAndManufacturingTypesVshttp://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes from this IG | |
RegulatedAuthorization.status | required | RegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus from this IG | |
RegulatedAuthorization.holder.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
RegulatedAuthorization.case.application.type | required | ApplicationSubmissionTypeVs (a valid code from Application Submission Type)http://ema.europa.eu/fhir/vs/applicationSubmissionType from this IG |
Id | Grade | Path(s) | Details | Requirements |
regulatorIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the regulator is mandatory : (type.coding.code = '220000000099' and identifier.exists()) implies regulator.exists() |
Differential View
This structure is derived from RegulatedAuthorization
Name | Flags | Card. | Type | Description & Constraints![]() |
---|---|---|---|---|
![]() ![]() |
C | 0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product regulatorIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the regulator is mandatory |
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0..* | Extension | Extension Slice: Unordered, Open by value:url | |
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0..1 | date | Regulated Authorization - Date of First Authorisation URL: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation | |
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0..1 | date | Regulated Authorization - International Birth Date URL: http://ema.europa.eu/fhir/extension/internationalBirthDate | |
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0..1 | Identifier | Business identifier for the authorization, typically assigned by the authorizing body Slice: Unordered, Open by value:system | |
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0..1 | EmaMarketingAuthorizationIdentifier | Business identifier for the authorization, typically assigned by the authorizing body | |
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1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber | |
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0..1 | EmaManufacturingAuthNumberIdentifier | Business identifier for the authorization, typically assigned by the authorizing body | |
![]() ![]() ![]() ![]() ![]() |
1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber | |
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1..1 | Reference(EMA Write API MedicinalProductDefinition | EMA Write API PackagedProductDefinition | EMA Write API ActivityDefinition) | The product type, treatment, facility or activity that is being authorized | |
![]() ![]() ![]() |
1..1 | EmaRefTermCodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: Regulatory Entitlement Type (required) | |
![]() ![]() ![]() ![]() |
1..1 | EmaCoding | Code defined by a terminology system Binding: Marketing and Manufacturing types (required) | |
![]() ![]() ![]() |
1..1 | EmaRefTermCodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: Regulatory Entitlement Status (required) | |
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1..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator | |
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1..1 | Identifier | Logical reference, when literal reference is not known | |
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1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/v1/locations | |
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1..1 | string | The value that is unique | |
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||||
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||||
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1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/v1/locations | |
![]() ![]() ![]() ![]() ![]() |
1..1 | string | The value that is unique | |
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1..1 | BackboneElement | The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) | |
![]() ![]() ![]() ![]() |
1..1 | EmaCoding | Regulated Authorization - Paediatric - Reference Country URL: http://ema.europa.eu/fhir/extension/referenceCountry Binding: Country (required) | |
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0..1 | Period, dateTime | Relevant date for this case Slice: Unordered, Open by type:$this | |
![]() ![]() ![]() ![]() ![]() |
0..1 | Period | Relevant date for this case | |
![]() ![]() ![]() ![]() |
0..1 | BackboneElement | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure | |
![]() ![]() ![]() ![]() ![]() |
0..1 | EmaApplicationIdentifierNumber | Identifier by which this case can be referenced | |
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0..1 | CodeableConcept | The defining type of case Binding: Application Submission Type (required) | |
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1..1 | dateTime | Relevant date for this case Slice: Unordered, Open by type:$this | |
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1..1 | dateTime | Relevant date for this case | |
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Path | Conformance | ValueSet | URI |
RegulatedAuthorization.type | required | RegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)http://ema.europa.eu/fhir/vs/regulatoryEntitlementType from this IG | |
RegulatedAuthorization.type.coding | required | MarketingAndManufacturingTypesVshttp://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes from this IG | |
RegulatedAuthorization.status | required | RegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus from this IG | |
RegulatedAuthorization.case.application.type | required | ApplicationSubmissionTypeVs (a valid code from Application Submission Type)http://ema.europa.eu/fhir/vs/applicationSubmissionType from this IG |
Id | Grade | Path(s) | Details | Requirements |
regulatorIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the regulator is mandatory : (type.coding.code = '220000000099' and identifier.exists()) implies regulator.exists() |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints![]() | ||||
---|---|---|---|---|---|---|---|---|
![]() ![]() |
C | 0..* | RegulatedAuthorization | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product regulatorIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the regulator is mandatory | ||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
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0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
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0..* | Resource | Contained, inline Resources | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
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0..1 | date | Regulated Authorization - Date of First Authorisation URL: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation | |||||
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0..1 | date | Regulated Authorization - International Birth Date URL: http://ema.europa.eu/fhir/extension/internationalBirthDate | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
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Σ | 0..1 | Identifier | Business identifier for the authorization, typically assigned by the authorizing body Slice: Unordered, Open by value:system | ||||
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Σ | 0..1 | EmaMarketingAuthorizationIdentifier | Business identifier for the authorization, typically assigned by the authorizing body | ||||
![]() ![]() ![]() ![]() ![]() |
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/marketingAuthorizationNumber | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | EmaManufacturingAuthNumberIdentifier | Business identifier for the authorization, typically assigned by the authorizing body | ||||
![]() ![]() ![]() ![]() ![]() |
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/manufacturingAuthorizationNumber | ||||
![]() ![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
![]() ![]() ![]() |
Σ | 1..1 | Reference(EMA Write API MedicinalProductDefinition | EMA Write API PackagedProductDefinition | EMA Write API ActivityDefinition) | The product type, treatment, facility or activity that is being authorized | ||||
![]() ![]() ![]() |
Σ | 1..1 | EmaRefTermCodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: Regulatory Entitlement Type (required) | ||||
![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..0 | |||||||
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Σ | 1..1 | EmaCoding | Code defined by a terminology system Binding: Marketing and Manufacturing types (required) | ||||
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Σ | 0..1 | markdown | General textual supporting information | ||||
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Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
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Σ | 1..1 | EmaRefTermCodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: Regulatory Entitlement Status (required) | ||||
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Σ | 0..1 | dateTime | The date at which the current status was assigned | ||||
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Σ | 0..1 | Period | The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date | ||||
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Σ | 0..* | CodeableReference(ClinicalUseDefinition) | Condition for which the use of the regulated product applies | ||||
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Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment Binding: ProductIntendedUse (preferred): The overall intended use of a product. | ||||
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Σ | 0..* | CodeableConcept | The legal/regulatory framework or reasons under which this authorization is granted Binding: RegulatedAuthorizationBasis (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it. | ||||
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Σ | 1..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator | ||||
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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 | 1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/v1/locations | ||||
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ΣC | 1..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) | ||||
![]() ![]() ![]() ![]() |
ΣC | 0..1 | string | Text alternative for the resource | ||||
![]() ![]() ![]() |
Σ | 0..1 | Reference(Organization) | The regulatory authority or authorizing body granting the authorization | ||||
![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() ![]() |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
![]() ![]() ![]() ![]() |
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 | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
![]() ![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
![]() ![]() ![]() ![]() ![]() |
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 | 1..1 | uri | The namespace for the identifier value Required Pattern: https://spor.ema.europa.eu/v1/locations | ||||
![]() ![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
![]() ![]() ![]() ![]() ![]() |
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 | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the authorization | ||||
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Σ | 1..1 | BackboneElement | The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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1..1 | EmaCoding | Regulated Authorization - Paediatric - Reference Country URL: http://ema.europa.eu/fhir/extension/referenceCountry Binding: Country (required) | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | Identifier | Identifier by which this case can be referenced | ||||
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Σ | 0..1 | CodeableConcept | The defining type of case Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application. | ||||
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Σ | 0..1 | CodeableConcept | The status associated with the case Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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Σ | 0..1 | Relevant date for this case Slice: Unordered, Open by type:$this | |||||
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Period | |||||||
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dateTime | |||||||
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Σ | 0..1 | Period | Relevant date for this case | ||||
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Σ | 0..1 | BackboneElement | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | EmaApplicationIdentifierNumber | Identifier by which this case can be referenced | ||||
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Σ | 0..1 | CodeableConcept | The defining type of case Binding: Application Submission Type (required) | ||||
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Σ | 0..1 | CodeableConcept | The status associated with the case Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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Σ | 1..1 | dateTime | Relevant date for this case Slice: Unordered, Closed by type:$this | ||||
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Σ | 1..1 | dateTime | Relevant date for this case | ||||
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Σ | 0..* | See case (RegulatedAuthorization) | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure | ||||
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Path | Conformance | ValueSet | URI |
RegulatedAuthorization.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
RegulatedAuthorization.type | required | RegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)http://ema.europa.eu/fhir/vs/regulatoryEntitlementType from this IG | |
RegulatedAuthorization.type.coding | required | MarketingAndManufacturingTypesVshttp://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes from this IG | |
RegulatedAuthorization.region | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
RegulatedAuthorization.status | required | RegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus from this IG | |
RegulatedAuthorization.intendedUse | preferred | ProductIntendedUsehttp://hl7.org/fhir/ValueSet/product-intended-use from the FHIR Standard | |
RegulatedAuthorization.basis | example | RegulatedAuthorizationBasishttp://hl7.org/fhir/ValueSet/regulated-authorization-basis from the FHIR Standard | |
RegulatedAuthorization.holder.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard | |
RegulatedAuthorization.holder.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
RegulatedAuthorization.holder.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
RegulatedAuthorization.regulator.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard | |
RegulatedAuthorization.regulator.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
RegulatedAuthorization.regulator.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
RegulatedAuthorization.case.type | example | RegulatedAuthorizationCaseTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-case-type from the FHIR Standard | |
RegulatedAuthorization.case.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
RegulatedAuthorization.case.application.type | required | ApplicationSubmissionTypeVs (a valid code from Application Submission Type)http://ema.europa.eu/fhir/vs/applicationSubmissionType from this IG | |
RegulatedAuthorization.case.application.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
regulatorIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the regulator is mandatory : (type.coding.code = '220000000099' and identifier.exists()) implies regulator.exists() |
This structure is derived from RegulatedAuthorization
Summary
Mandatory: 9 elements(6 nested mandatory 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