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/emaWriteApiRegulatedAuthorization | Version: 1.2.0 | |||
| Draft as of 2025-08-08 | Computable Name: EmaWriteApiRegulatedAuthorization | |||
Defines the rules a Marketing or Manufacturing 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..* | EmaWriteApiRegulatedAuthorizationRestrictions | 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 validityPeriodIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the validity period is mandatory regionIsEmptyForManAuth: The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. statusDateIsEmptyForManAuth: The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. holderIsEmptyForManAuth: The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. caseIsEmptyForManAuth: The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization. extensionIsEmptyForManAuth: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization. marketingAuthorizationNumberIsMandatoryForMarktAuth: The RegulatedAuthorization must have the Marketing Authorization Number identifier. validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition. dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the Date of First Authorisation extension. internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the International Birth Date extension. caseIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition. holderIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a holder. |
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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..2 | 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 | 0..1 | EmaEudraGmpNumberIdentifier | 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/eudraGmpNumber |
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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 |
Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| RegulatedAuthorization.type | required | RegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)http://ema.europa.eu/fhir/vs/regulatoryEntitlementTypefrom this IG | |
| RegulatedAuthorization.type.coding | required | MarketingAndManufacturingTypesVshttp://ema.europa.eu/fhir/vs/marketingAndManufacturingTypesfrom this IG | |
| RegulatedAuthorization.status | required | RegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatusfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| caseIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (case.empty()) | |
| caseIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition. : subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists() | |
| dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have the Date of First Authorisation extension. : subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists() | |
| extensionIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (extension.empty()) | |
| holderIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (holder.empty()) | |
| holderIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a holder. : subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists() | |
| internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have the International Birth Date extension. : subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists() | |
| marketingAuthorizationNumberIsMandatoryForMarktAuth | error | RegulatedAuthorization | The RegulatedAuthorization must have the Marketing Authorization Number identifier. : (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists() | |
| regionIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (region.empty()) | |
| regulatorIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the regulator is mandatory : (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists() | |
| statusDateIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (statusDate.empty()) | |
| validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition. : subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists() | |
| validityPeriodIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the validity period is mandatory : (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists() |
This structure is derived from EmaWriteApiRegulatedAuthorizationRestrictions
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
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C | 0..* | EmaWriteApiRegulatedAuthorizationRestrictions | 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 validityPeriodIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the validity period is mandatory regionIsEmptyForManAuth: The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. statusDateIsEmptyForManAuth: The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. holderIsEmptyForManAuth: The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. caseIsEmptyForManAuth: The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization. extensionIsEmptyForManAuth: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization. marketingAuthorizationNumberIsMandatoryForMarktAuth: The RegulatedAuthorization must have the Marketing Authorization Number identifier. validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition. dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the Date of First Authorisation extension. internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the International Birth Date extension. caseIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition. holderIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a holder. |
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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..2 | 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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0..1 | EmaEudraGmpNumberIdentifier | 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/eudraGmpNumber | |
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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 | Identifier | Logical reference, when literal reference is not known | |
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1..1 | uri | The namespace for the identifier value Required Pattern: http://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: http://spor.ema.europa.eu/v1/locations | |
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1..1 | string | The value that is unique | |
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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 | |
Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| RegulatedAuthorization.type | required | RegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)http://ema.europa.eu/fhir/vs/regulatoryEntitlementTypefrom this IG | |
| RegulatedAuthorization.type.coding | required | MarketingAndManufacturingTypesVshttp://ema.europa.eu/fhir/vs/marketingAndManufacturingTypesfrom this IG | |
| RegulatedAuthorization.status | required | RegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatusfrom this IG | |
| RegulatedAuthorization.case.application.type | required | ApplicationSubmissionTypeVs (a valid code from Application Submission Type)http://ema.europa.eu/fhir/vs/applicationSubmissionTypefrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| caseIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (case.empty()) | |
| caseIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition. : subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists() | |
| dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have the Date of First Authorisation extension. : subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists() | |
| extensionIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (extension.empty()) | |
| holderIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (holder.empty()) | |
| holderIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a holder. : subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists() | |
| internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have the International Birth Date extension. : subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists() | |
| marketingAuthorizationNumberIsMandatoryForMarktAuth | error | RegulatedAuthorization | The RegulatedAuthorization must have the Marketing Authorization Number identifier. : (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists() | |
| regionIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (region.empty()) | |
| regulatorIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the regulator is mandatory : (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists() | |
| statusDateIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (statusDate.empty()) | |
| validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition. : subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists() | |
| validityPeriodIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the validity period is mandatory : (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists() |
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
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C | 0..* | EmaWriteApiRegulatedAuthorizationRestrictions | 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 validityPeriodIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the validity period is mandatory regionIsEmptyForManAuth: The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. statusDateIsEmptyForManAuth: The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. holderIsEmptyForManAuth: The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. caseIsEmptyForManAuth: The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization. extensionIsEmptyForManAuth: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization. marketingAuthorizationNumberIsMandatoryForMarktAuth: The RegulatedAuthorization must have the Marketing Authorization Number identifier. validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition. dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the Date of First Authorisation extension. internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the International Birth Date extension. caseIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition. holderIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a holder. |
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Σ | 0..1 | id | Logical id of this artifact |
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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..2 | 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 | 0..1 | EmaEudraGmpNumberIdentifier | 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/eudraGmpNumber |
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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 |
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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) |
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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..* | 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..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: http://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: http://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..* | Reference(DocumentReference) | Additional information or supporting documentation about the authorization |
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Σ | 0..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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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 | 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 |
Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| RegulatedAuthorization.type | required | RegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)http://ema.europa.eu/fhir/vs/regulatoryEntitlementTypefrom this IG | |
| RegulatedAuthorization.type.coding | required | MarketingAndManufacturingTypesVshttp://ema.europa.eu/fhir/vs/marketingAndManufacturingTypesfrom this IG | |
| RegulatedAuthorization.region | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| RegulatedAuthorization.status | required | RegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatusfrom this IG | |
| RegulatedAuthorization.holder.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-typesfrom the FHIR Standard | |
| RegulatedAuthorization.holder.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| RegulatedAuthorization.holder.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| RegulatedAuthorization.regulator.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-typesfrom the FHIR Standard | |
| RegulatedAuthorization.regulator.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| RegulatedAuthorization.regulator.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| RegulatedAuthorization.case.type | example | RegulatedAuthorizationCaseTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-case-typefrom the FHIR Standard | |
| RegulatedAuthorization.case.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| RegulatedAuthorization.case.application.type | required | ApplicationSubmissionTypeVs (a valid code from Application Submission Type)http://ema.europa.eu/fhir/vs/applicationSubmissionTypefrom this IG | |
| RegulatedAuthorization.case.application.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| caseIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (case.empty()) | |
| caseIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition. : subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists() | |
| dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have the Date of First Authorisation extension. : subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists() | |
| extensionIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (extension.empty()) | |
| holderIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (holder.empty()) | |
| holderIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a holder. : subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists() | |
| internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have the International Birth Date extension. : subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists() | |
| marketingAuthorizationNumberIsMandatoryForMarktAuth | error | RegulatedAuthorization | The RegulatedAuthorization must have the Marketing Authorization Number identifier. : (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists() | |
| regionIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (region.empty()) | |
| regulatorIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the regulator is mandatory : (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists() | |
| statusDateIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (statusDate.empty()) | |
| validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition. : subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists() | |
| validityPeriodIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the validity period is mandatory : (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists() |
This structure is derived from EmaWriteApiRegulatedAuthorizationRestrictions
Summary
Mandatory: 3 elements(10 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..* | EmaWriteApiRegulatedAuthorizationRestrictions | 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 validityPeriodIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the validity period is mandatory regionIsEmptyForManAuth: The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. statusDateIsEmptyForManAuth: The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. holderIsEmptyForManAuth: The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. caseIsEmptyForManAuth: The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization. extensionIsEmptyForManAuth: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization. marketingAuthorizationNumberIsMandatoryForMarktAuth: The RegulatedAuthorization must have the Marketing Authorization Number identifier. validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition. dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the Date of First Authorisation extension. internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the International Birth Date extension. caseIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition. holderIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a holder. |
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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..2 | 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 | 0..1 | EmaEudraGmpNumberIdentifier | 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/eudraGmpNumber |
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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 |
Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| RegulatedAuthorization.type | required | RegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)http://ema.europa.eu/fhir/vs/regulatoryEntitlementTypefrom this IG | |
| RegulatedAuthorization.type.coding | required | MarketingAndManufacturingTypesVshttp://ema.europa.eu/fhir/vs/marketingAndManufacturingTypesfrom this IG | |
| RegulatedAuthorization.status | required | RegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatusfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| caseIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (case.empty()) | |
| caseIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition. : subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists() | |
| dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have the Date of First Authorisation extension. : subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists() | |
| extensionIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (extension.empty()) | |
| holderIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (holder.empty()) | |
| holderIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a holder. : subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists() | |
| internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have the International Birth Date extension. : subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists() | |
| marketingAuthorizationNumberIsMandatoryForMarktAuth | error | RegulatedAuthorization | The RegulatedAuthorization must have the Marketing Authorization Number identifier. : (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists() | |
| regionIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (region.empty()) | |
| regulatorIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the regulator is mandatory : (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists() | |
| statusDateIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (statusDate.empty()) | |
| validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition. : subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists() | |
| validityPeriodIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the validity period is mandatory : (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists() |
Differential View
This structure is derived from EmaWriteApiRegulatedAuthorizationRestrictions
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
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C | 0..* | EmaWriteApiRegulatedAuthorizationRestrictions | 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 validityPeriodIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the validity period is mandatory regionIsEmptyForManAuth: The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. statusDateIsEmptyForManAuth: The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. holderIsEmptyForManAuth: The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. caseIsEmptyForManAuth: The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization. extensionIsEmptyForManAuth: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization. marketingAuthorizationNumberIsMandatoryForMarktAuth: The RegulatedAuthorization must have the Marketing Authorization Number identifier. validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition. dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the Date of First Authorisation extension. internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the International Birth Date extension. caseIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition. holderIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a holder. |
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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..2 | 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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0..1 | EmaEudraGmpNumberIdentifier | 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/eudraGmpNumber | |
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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 | Identifier | Logical reference, when literal reference is not known | |
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1..1 | uri | The namespace for the identifier value Required Pattern: http://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: http://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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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 | |
Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| RegulatedAuthorization.type | required | RegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)http://ema.europa.eu/fhir/vs/regulatoryEntitlementTypefrom this IG | |
| RegulatedAuthorization.type.coding | required | MarketingAndManufacturingTypesVshttp://ema.europa.eu/fhir/vs/marketingAndManufacturingTypesfrom this IG | |
| RegulatedAuthorization.status | required | RegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatusfrom this IG | |
| RegulatedAuthorization.case.application.type | required | ApplicationSubmissionTypeVs (a valid code from Application Submission Type)http://ema.europa.eu/fhir/vs/applicationSubmissionTypefrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| caseIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (case.empty()) | |
| caseIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition. : subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists() | |
| dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have the Date of First Authorisation extension. : subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists() | |
| extensionIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (extension.empty()) | |
| holderIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (holder.empty()) | |
| holderIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a holder. : subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists() | |
| internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have the International Birth Date extension. : subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists() | |
| marketingAuthorizationNumberIsMandatoryForMarktAuth | error | RegulatedAuthorization | The RegulatedAuthorization must have the Marketing Authorization Number identifier. : (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists() | |
| regionIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (region.empty()) | |
| regulatorIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the regulator is mandatory : (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists() | |
| statusDateIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (statusDate.empty()) | |
| validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition. : subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists() | |
| validityPeriodIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the validity period is mandatory : (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
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C | 0..* | EmaWriteApiRegulatedAuthorizationRestrictions | 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 validityPeriodIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the validity period is mandatory regionIsEmptyForManAuth: The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. statusDateIsEmptyForManAuth: The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. holderIsEmptyForManAuth: The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. caseIsEmptyForManAuth: The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization. extensionIsEmptyForManAuth: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization. marketingAuthorizationNumberIsMandatoryForMarktAuth: The RegulatedAuthorization must have the Marketing Authorization Number identifier. validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition. dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the Date of First Authorisation extension. internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the International Birth Date extension. caseIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition. holderIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a holder. |
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Σ | 0..1 | id | Logical id of this artifact |
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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..2 | 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 | 0..1 | EmaEudraGmpNumberIdentifier | 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/eudraGmpNumber |
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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 |
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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) |
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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..* | 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..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: http://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: http://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..* | Reference(DocumentReference) | Additional information or supporting documentation about the authorization |
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Σ | 0..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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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 | 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 |
Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| RegulatedAuthorization.type | required | RegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)http://ema.europa.eu/fhir/vs/regulatoryEntitlementTypefrom this IG | |
| RegulatedAuthorization.type.coding | required | MarketingAndManufacturingTypesVshttp://ema.europa.eu/fhir/vs/marketingAndManufacturingTypesfrom this IG | |
| RegulatedAuthorization.region | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| RegulatedAuthorization.status | required | RegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatusfrom this IG | |
| RegulatedAuthorization.holder.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-typesfrom the FHIR Standard | |
| RegulatedAuthorization.holder.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| RegulatedAuthorization.holder.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| RegulatedAuthorization.regulator.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-typesfrom the FHIR Standard | |
| RegulatedAuthorization.regulator.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| RegulatedAuthorization.regulator.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| RegulatedAuthorization.case.type | example | RegulatedAuthorizationCaseTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-case-typefrom the FHIR Standard | |
| RegulatedAuthorization.case.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| RegulatedAuthorization.case.application.type | required | ApplicationSubmissionTypeVs (a valid code from Application Submission Type)http://ema.europa.eu/fhir/vs/applicationSubmissionTypefrom this IG | |
| RegulatedAuthorization.case.application.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| caseIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (case.empty()) | |
| caseIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition. : subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists() | |
| dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have the Date of First Authorisation extension. : subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists() | |
| extensionIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (extension.empty()) | |
| holderIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (holder.empty()) | |
| holderIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a holder. : subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists() | |
| internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have the International Birth Date extension. : subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists() | |
| marketingAuthorizationNumberIsMandatoryForMarktAuth | error | RegulatedAuthorization | The RegulatedAuthorization must have the Marketing Authorization Number identifier. : (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists() | |
| regionIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (region.empty()) | |
| regulatorIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the regulator is mandatory : (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists() | |
| statusDateIsEmptyForManAuth | error | RegulatedAuthorization | The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. : (type.coding.exists(code = '200000051585')) implies (statusDate.empty()) | |
| validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd | error | RegulatedAuthorization | The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition. : subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists() | |
| validityPeriodIsMandatoryIfManufacturingIdentifierExists | error | RegulatedAuthorization | If there is a Manufacturing Identifier, then the validity period is mandatory : (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists() |
This structure is derived from EmaWriteApiRegulatedAuthorizationRestrictions
Summary
Mandatory: 3 elements(10 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