R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

Medicinalproductauthorization-example.ttl

Biomedical Research and Regulation Work GroupMaturity Level: N/ABallot Status: InformativeCompartments: Not linked to any defined compartments

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

Example of medicinalproductauthorization

@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 -------------------------------------------------------------------

<http://hl7.org/fhir/MedicinalProductAuthorization/example> a fhir:MedicinalProductAuthorization;
  fhir:nodeRole fhir:treeRoot;
  fhir:Resource.id [ fhir:value "example"];
  fhir:DomainResource.text [
     fhir:Narrative.status [ fhir:value "generated" ];
     fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative with Details</b></p><p><b>id</b>: example</p><p><b>identifier</b>: EU/1/11/999/001</p><p><b>country</b>: EU <span>(Details : {http://ema.europa.eu/example/country code 'EU' = 'EU)</span></p><p><b>legalStatusOfSupply</b>: Subjecttomedicalprescription <span>(Details : {http://ema.europa.eu/example/legalstatusofsupply code 'Subjecttomedicalprescription' = 'Subjecttomedicalprescription)</span></p><p><b>status</b>: active <span>(Details : {http://ema.europa.eu/example/authorisationstatus code 'active' = 'active)</span></p><p><b>statusDate</b>: 14/01/2015</p><p><b>validityPeriod</b>: 16/08/2015 --&gt; 20/05/2020</p><p><b>dataExclusivityPeriod</b>: 15/08/2010 --&gt; 15/08/2020</p><p><b>dateOfFirstAuthorization</b>: 15/08/2010</p><p><b>internationalBirthDate</b>: 15/08/2010</p><blockquote><p><b>jurisdictionalAuthorization</b></p><p><b>identifier</b>: 123-456-789</p><p><b>country</b>: NO <span>(Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)</span></p></blockquote><blockquote><p><b>jurisdictionalAuthorization</b></p><p><b>identifier</b>: 123-456-123</p><p><b>country</b>: NO <span>(Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)</span></p></blockquote><p><b>holder</b>: <a>Organization/example</a></p><p><b>regulator</b>: <a>Organization/example</a></p><blockquote><p><b>procedure</b></p><p><b>identifier</b>: EMEA/H/C/009999/IA/0099/G</p><p><b>type</b>: VariationTypeIA <span>(Details : {http://ema.europa.eu/example/marketingAuthorisationProcedureType code 'VariationTypeIA' = 'VariationTypeIA)</span></p><p><b>date</b>: 02/08/2015 --&gt; 21/08/2015</p><h3>Applications</h3><table><tr><td>-</td></tr><tr><td>*</td></tr></table></blockquote></div>"
  ];
  fhir:MedicinalProductAuthorization.identifier [
     fhir:index 0;
     fhir:Identifier.system [ fhir:value "http://ema.europa.eu/example/marketingAuthorisationNumber" ];
     fhir:Identifier.value [ fhir:value "EU/1/11/999/001" ]
  ];
  fhir:MedicinalProductAuthorization.country [
     fhir:index 0;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://ema.europa.eu/example/country" ];
       fhir:Coding.code [ fhir:value "EU" ]
     ]
  ];
  fhir:MedicinalProductAuthorization.legalStatusOfSupply [
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://ema.europa.eu/example/legalstatusofsupply" ];
       fhir:Coding.code [ fhir:value "Subjecttomedicalprescription" ]
     ]
  ];
  fhir:MedicinalProductAuthorization.status [
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://ema.europa.eu/example/authorisationstatus" ];
       fhir:Coding.code [ fhir:value "active" ]
     ]
  ];
  fhir:MedicinalProductAuthorization.statusDate [ fhir:value "2015-01-14"^^xsd:date];
  fhir:MedicinalProductAuthorization.validityPeriod [
     fhir:Period.start [ fhir:value "2015-08-16"^^xsd:date ];
     fhir:Period.end [ fhir:value "2020-05-20"^^xsd:date ]
  ];
  fhir:MedicinalProductAuthorization.dataExclusivityPeriod [
     fhir:Period.start [ fhir:value "2010-08-15"^^xsd:date ];
     fhir:Period.end [ fhir:value "2020-08-15"^^xsd:date ]
  ];
  fhir:MedicinalProductAuthorization.dateOfFirstAuthorization [ fhir:value "2010-08-15"^^xsd:date];
  fhir:MedicinalProductAuthorization.internationalBirthDate [ fhir:value "2010-08-15"^^xsd:date];
  fhir:MedicinalProductAuthorization.jurisdictionalAuthorization [
     fhir:index 0;
     fhir:Element.id [ fhir:value "1" ];
     fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.identifier [
       fhir:index 0;
       fhir:Identifier.system [ fhir:value "http://ema.europa.eu/example/marketingauthorisationnumber" ];
       fhir:Identifier.value [ fhir:value "123-456-789" ]
     ];
     fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.country [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://ema.europa.eu/example/countryCode" ];
         fhir:Coding.code [ fhir:value "NO" ]
       ]
     ]
  ], [
     fhir:index 1;
     fhir:Element.id [ fhir:value "2" ];
     fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.identifier [
       fhir:index 0;
       fhir:Identifier.system [ fhir:value "http://ema.europa.eu/example/marketingauthorisationnumber" ];
       fhir:Identifier.value [ fhir:value "123-456-123" ]
     ];
     fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.country [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://ema.europa.eu/example/countryCode" ];
         fhir:Coding.code [ fhir:value "NO" ]
       ]
     ]
  ];
  fhir:MedicinalProductAuthorization.holder [
     fhir:link <http://hl7.org/fhir/Organization/example>;
     fhir:Reference.reference [ fhir:value "Organization/example" ]
  ];
  fhir:MedicinalProductAuthorization.regulator [
     fhir:link <http://hl7.org/fhir/Organization/example>;
     fhir:Reference.reference [ fhir:value "Organization/example" ]
  ];
  fhir:MedicinalProductAuthorization.procedure [
     fhir:MedicinalProductAuthorization.procedure.identifier [
       fhir:Identifier.system [ fhir:value "http://ema.europa.eu/example/procedureidentifier-number" ];
       fhir:Identifier.value [ fhir:value "EMEA/H/C/009999/IA/0099/G" ]
     ];
     fhir:MedicinalProductAuthorization.procedure.type [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://ema.europa.eu/example/marketingAuthorisationProcedureType" ];
         fhir:Coding.code [ fhir:value "VariationTypeIA" ]
       ]
     ];
     fhir:MedicinalProductAuthorization.procedure.datePeriod [
       fhir:Period.start [ fhir:value "2015-08-02"^^xsd:date ];
       fhir:Period.end [ fhir:value "2015-08-21"^^xsd:date ]
     ];
     fhir:MedicinalProductAuthorization.procedure.application [
       fhir:index 0;
       fhir:MedicinalProductAuthorization.procedure.identifier [
         fhir:Identifier.system [ fhir:value "http://ema.europa.eu/example/applicationidentifier-number" ];
         fhir:Identifier.value [ fhir:value "IA38G" ]
       ];
       fhir:MedicinalProductAuthorization.procedure.type [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "http://ema.europa.eu/example/marketingAuthorisationApplicationType" ];
           fhir:Coding.code [ fhir:value "GroupTypeIAVariationNotification" ]
         ]
       ];
       fhir:MedicinalProductAuthorization.procedure.dateDateTime [ fhir:value "2015-08-01"^^xsd:date ]
     ]
  ] .

<http://hl7.org/fhir/Organization/example> a fhir:Organization .

# - ontology header ------------------------------------------------------------

<http://hl7.org/fhir/MedicinalProductAuthorization/example.ttl> a owl:Ontology;
  owl:imports fhir:fhir.ttl;
  owl:versionIRI <http://build.fhir.org/MedicinalProductAuthorization/example.ttl> .

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

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.