Intersection of http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi and http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi

This is the set of resources that conform to both RegulatedAuthorization (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi) and RegulatedAuthorization (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi).

Structure

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. RegulatedAuthorization 0..*Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: ?? (required): IETF language tag for a human language
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... identifier Σ1..*Identifierleft: Identifier assigned by the health authority to a single medicinal product; right: Business identifier for the authorization, typically assigned by the authorizing body
.... extension 0..*ExtensionAdditional content defined by implementations
.... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: ?? (required): Identifies the purpose for this identifier, if known .
.... type Σ0..1CodeableConceptDescription of identifier
Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ1..1uriThe namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value Σ1..1stringThe value that is unique
Example General: 123456
.... period Σ0..1PeriodTime period when id is/was valid for use
.... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... subject Σ1..*Reference(MedicinalProductDefinition (ePI) | #sd+3-MedicinalProductDefinition-uv-epi-MedicinalProductDefinition-uv-epi)The product type, treatment, facility or activity that is being authorized
... type Σ0..1CodeableConceptleft: Overall type of this authorization, for example drug marketing approval, orphan drug designation.; right: Overall type of this authorization, for example drug marketing approval, orphan drug designation
Binding: ?? (example): Overall type of this authorization.
... description Σ0..1markdownleft: Brief description of the authorization; right: General textual supporting information
... region Σ0..*CodeableConceptThe territory in which the authorization has been granted
Binding: ?? (preferred)
... status Σ0..1CodeableConceptleft: The current status of this authorization; right: The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
Binding: ?? (preferred): The lifecycle status of an artifact.
... statusDate Σ0..1dateTimeThe date at which the current status was assigned.
... validityPeriod Σ0..1PeriodThe 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
... indication Σ0..*CodeableReference(ClinicalUseDefinition Indication (ePI))left: Reference to the Clinical Use Definition; right: Condition for which the use of the regulated product applies
.... extension 0..*ExtensionAdditional content defined by implementations
.... concept Σ0..1CodeableConceptReference to a concept (by class)
.... reference Σ1..1Reference()Reference to a resource (by instance)
... intendedUse Σ0..1CodeableConceptThe intended use of the product, e.g. prevention, treatment
Binding: ?? (preferred): The overall intended use of a product.
... basis Σ0..*CodeableConceptThe legal/regulatory framework or reasons under which this authorization is granted
Binding: ?? (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it.
... holder Σ1..1Reference(Organization (ePI) | #sd+29-Organization-uv-epi-Organization-uv-epi)The organization that has been granted this authorization, by the regulator
... regulator Σ0..1Reference(Organization (ePI) | #sd+29-Organization-uv-epi-Organization-uv-epi)The regulatory authority or authorizing body granting the authorization
... attachedDocument Σ0..*Reference(DocumentReference)Additional information or supporting documentation about the authorization
... case Σ0..1BackboneElementleft: 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); right: The case or regulatory procedure for granting or amending a regulated authorization.
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... identifier Σ0..1Identifierleft: Identifier by which this case can be referenced.; right: Identifier by which this case can be referenced
.... type Σ0..1CodeableConceptleft: The defining type of case.; right: The defining type of case
Binding: ?? (example): The type of a case involved in an application.
.... status Σ0..1CodeableConceptleft: The status associated with the case.; right: The status associated with the case
Binding: ?? (preferred): The lifecycle status of an artifact.
.... date[x] Σ0..1left: Relevant date for this case.; right: Relevant date for this case
..... datePeriodPeriod
..... dateDateTimedateTime
.... application Σ0..*Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure

doco Documentation for this format