R4 Ballot #1 #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: (v3.5.0: R4 Ballot 2). #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 Group Maturity Level : N/A Ballot Status : Informative Compartments : 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 sct: <http://snomed.info/id/> .

@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

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

<http://hl7.org/fhir/AdverseEvent/example> a fhir:AdverseEvent;

<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>: 49476534</p><p><b>actuality</b>: actual</p><p><b>event</b>: This was a mild rash on the left forearm <span>(Details : {SNOMED CT code '304386008' = 'O/E - itchy rash', given as 'O/E - itchy rash'})</span></p><p><b>subject</b>: <a>Patient/example</a></p><p><b>date</b>: 29/01/2017 12:34:56 PM</p><p><b>seriousness</b>: Non-serious <span>(Details : {http://hl7.org/fhir/adverse-event-seriousness code 'Non-serious' = 'Non-serious', given as 'Non-serious'})</span></p><p><b>severity</b>: Mild <span>(Details : {http://hl7.org/fhir/adverse-event-severity code 'Mild' = 'Mild', given as 'Mild'})</span></p><p><b>recorder</b>: <a>Practitioner/example</a></p><h3>SuspectEntities</h3><table><tr><td>-</td><td><b>Instance</b></td></tr><tr><td>*</td><td><a>Medication/example</a></td></tr></table></div>"

     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:AdverseEvent.identifier [
     fhir:Identifier.system [ fhir:value "http://acme.com/ids/patients/risks" ];
     fhir:Identifier.value [ fhir:value "49476534" ]

  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:AdverseEvent.actuality [ fhir:value "actual"];
  fhir:AdverseEvent.event [

  fhir:MedicinalProductAuthorization.country [
     fhir:index 0;

     fhir:CodeableConcept.coding [
       fhir:index 0;
       a sct:304386008;
       fhir:Coding.system [ fhir:value "http://snomed.info/sct" ];
       fhir:Coding.code [ fhir:value "304386008" ];
       fhir:Coding.display [ fhir:value "O/E - itchy rash" ]
     ];
     fhir:CodeableConcept.text [ fhir:value "This was a mild rash on the left forearm" ]
  ];
  fhir:AdverseEvent.subject [
     fhir:link <http://hl7.org/fhir/Patient/example>;
     fhir:Reference.reference [ fhir:value "Patient/example" ]

       fhir:Coding.system [ fhir:value "http://ema.europa.eu/example/country" ];
       fhir:Coding.code [ fhir:value "EU" ]
     ]

  ];
  fhir:AdverseEvent.date [ fhir:value "2017-01-29T12:34:56+00:00"^^xsd:dateTime];
  fhir:AdverseEvent.seriousness [

  fhir:MedicinalProductAuthorization.legalStatusOfSupply [

     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://hl7.org/fhir/adverse-event-seriousness" ];
       fhir:Coding.code [ fhir:value "Non-serious" ];
       fhir:Coding.display [ fhir:value "Non-serious" ]

       fhir:Coding.system [ fhir:value "http://ema.europa.eu/example/legalstatusofsupply" ];
       fhir:Coding.code [ fhir:value "Subjecttomedicalprescription" ]

     ]
  ];
  fhir:AdverseEvent.severity [

  fhir:MedicinalProductAuthorization.status [

     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://hl7.org/fhir/adverse-event-severity" ];
       fhir:Coding.code [ fhir:value "Mild" ];
       fhir:Coding.display [ fhir:value "Mild" ]

       fhir:Coding.system [ fhir:value "http://ema.europa.eu/example/authorisationstatus" ];
       fhir:Coding.code [ fhir:value "active" ]

     ]
  ];
  fhir:AdverseEvent.recorder [
     fhir:link <http://hl7.org/fhir/Practitioner/example>;
     fhir:Reference.reference [ fhir:value "Practitioner/example" ]

  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:AdverseEvent.suspectEntity [

  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:AdverseEvent.suspectEntity.instance [
       fhir:link <http://hl7.org/fhir/Medication/example>;
       fhir:Reference.reference [ fhir:value "Medication/example" ]

     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/Patient/example> a fhir:Patient .

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

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

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


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

<http://hl7.org/fhir/AdverseEvent/example.ttl> a owl:Ontology;

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

  owl:imports fhir:fhir.ttl;
  owl:versionIRI <http://build.fhir.org/AdverseEvent/example.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.