R6 Ballot (2nd Draft)

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Example RegulatedAuthorization/example (Turtle)

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: No defined compartments

Raw Turtle (+ also see Turtle/RDF Format Specification)

General example

@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

[a fhir:RegulatedAuthorization ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "example"] ; # 
  fhir:identifier ( [
     fhir:system [ fhir:v "http://ema.europa.eu/example/marketingAuthorizationNumber"^^xsd:anyURI ] ;
     fhir:value [ fhir:v "EU/1/11/999/001" ]
  ] ) ; # 
  fhir:region ( [
     fhir:coding ( [
       fhir:system [ fhir:v "http://ema.europa.eu/example/country"^^xsd:anyURI ] ;
       fhir:code [ fhir:v "EU" ]
     ] )
  ] ) ; # 
  fhir:status [
     fhir:coding ( [
       fhir:system [ fhir:v "http://ema.europa.eu/example/authorizationstatus"^^xsd:anyURI ] ;
       fhir:code [ fhir:v "active" ]
     ] )
  ] ; # 
  fhir:statusDate [ fhir:v "2015-01-14"^^xsd:date] ; # 
  fhir:validityPeriod [
     fhir:start [ fhir:v "2014-09-03"^^xsd:date ] ;
     fhir:end [ fhir:v "2020-05-20"^^xsd:date ]
  ] ; # 
  fhir:holder [
     fhir:reference [ fhir:v "Organization/example" ]
  ] ; #  dataExclusivityPeriod>
#    <start value="2010-08-15"/>
#    <end value="2020-08-15"/>
#  </dataExclusivityPeriod>
#  <dateOfFirstAuthorization value="2010-08-15"/>
#  <internationalBirthDate value="2010-08-15"/ ,  jurisdictionalAuthorization id="1">
#    <reference value="RegulatedAuthorization/Jurusdictional1"/>
#  </jurisdictionalAuthorization 
  fhir:regulator [
     fhir:reference [ fhir:v "Organization/example" ]
  ] ; # 
  fhir:case [
     fhir:identifier [
       fhir:system [ fhir:v "http://ema.europa.eu/example/procedureidentifier-number"^^xsd:anyURI ] ;
       fhir:value [ fhir:v "EMEA/H/C/009999/IA/0099/G" ]
     ] ;
     fhir:type [
       fhir:coding ( [
         fhir:system [ fhir:v "http://ema.europa.eu/example/marketingAuthorizationProcedureType"^^xsd:anyURI ] ;
         fhir:code [ fhir:v "VariationTypeIA" ]
       ] )
     ] ;
     fhir:date [
       a fhir:Period ;
       fhir:start [ fhir:v "2014-09-02"^^xsd:date ] ;
       fhir:end [ fhir:v "2015-08-21"^^xsd:date ]
     ] ;
     fhir:application ( [
       fhir:identifier [
         fhir:system [ fhir:v "http://ema.europa.eu/example/applicationidentifier-number"^^xsd:anyURI ] ;
         fhir:value [ fhir:v "IA38G" ]
       ] ;
       fhir:type [
         fhir:coding ( [
           fhir:system [ fhir:v "http://ema.europa.eu/example/marketingAuthorizationApplicationType"^^xsd:anyURI ] ;
           fhir:code [ fhir:v "GroupTypeIAVariationNotification" ]
         ] )
       ] ;
       fhir:date [ fhir:v "2015-08-01"^^xsd:date ]
     ] [
       fhir:identifier [
         fhir:system [ fhir:v "http://ema.europa.eu/example/applicationidentifier-number"^^xsd:anyURI ] ;
         fhir:value [ fhir:v "IA38F" ]
       ] ;
       fhir:type [
         fhir:coding ( [
           fhir:system [ fhir:v "http://ema.europa.eu/example/marketingAuthorizationApplicationType"^^xsd:anyURI ] ;
           fhir:code [ fhir:v "GroupTypeIAVariationNotification" ]
         ] )
       ] ;
       fhir:date [ fhir:v "2014-09-01"^^xsd:date ]
     ] )
  ]] . # 

# -------------------------------------------------------------------------------------


Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.