API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build

API for the Exchange of Medicinal Product Information (APIX), published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions

: ema-questionnaire-request-001 - TTL Representation

Raw ttl | Download


@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

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

 a fhir:Task ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "ema-questionnaire-request-001"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "1" ] ;
fhir:lastUpdated [ fhir:v "2025-11-13T09:15:00Z"^^xsd:dateTime ]
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n      <p>EMA requests AcmePharm to complete structured questionnaire on post-market pediatric safety data for Aspirin 100mg Tablets.</p>\n      <p><b>From:</b> Dr. Elena Rossi, EMA Pharmacovigilance Unit (elena.rossi@ema.europa.eu)</p>\n      <p><b>To:</b> Mr. James Carter, AcmePharm Regulatory Affairs (james.carter@acmepharm.com)</p>\n    </div>"^^rdf:XMLLiteral ]
  ] ; #  Narrative with proper escaping and contact names 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [
fhir:v "https://acmepharm.com/identifiers/task"^^xsd:anyURI ;
fhir:l <https://acmepharm.com/identifiers/task>     ] ;
fhir:value [ fhir:v "ACME-REQ-2025-078" ]
  ] [
fhir:use [ fhir:v "official" ] ;
fhir:system [
fhir:v "https://ema.europa.eu/identifiers/task"^^xsd:anyURI ;
fhir:l <https://ema.europa.eu/identifiers/task>     ] ;
fhir:value [ fhir:v "EMA-INFOREQ-2025-112" ]
  ] ) ; #  Sponsor-defined identifier 
  fhir:groupIdentifier [
fhir:value [ fhir:v "GRP-2025-PV-EMA-EU" ]
  ] ; # 
  fhir:status [ fhir:v "requested"] ; # 
  fhir:intent [ fhir:v "proposal"] ; # 
  fhir:code [
    ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/CodeSystem/task-code"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/CodeSystem/task-code>       ] ;
fhir:code [ fhir:v "questionnaire-distribution" ] ;
fhir:display [ fhir:v "Questionnaire Distribution" ]     ] )
  ] ; # 
  fhir:description [ fhir:v "EMA issues structured questionnaire to AcmePharm regarding observed adverse reactions and usage patterns for Aspirin 100mg Tablets in pediatric populations."] ; # 
  fhir:authoredOn [ fhir:v "2025-11-13T08:00:00Z"^^xsd:dateTime] ; # 
  fhir:lastModified [ fhir:v "2025-11-13T09:15:00Z"^^xsd:dateTime] ; # 
  fhir:requester [
fhir:l <#ema-org> ;
fhir:reference [ fhir:v "#ema-org" ] ;
fhir:display [ fhir:v "European Medicines Agency (EMA)" ]
  ] ; #  Requester: EMA 
  fhir:requestedPerformer ( [
fhir:reference [ ]
  ] ) ; #  Requested Performer: AcmePharm 
  fhir:owner [
fhir:l <#acmepharm-org> ;
fhir:reference [ fhir:v "#acmepharm-org" ] ;
fhir:display [ fhir:v "Acme Pharmaceuticals Inc." ]
  ] ; #  Owner: AcmePharm 
  fhir:requestedPeriod [
fhir:start [ fhir:v "2025-11-13"^^xsd:date ] ;
fhir:end [ fhir:v "2025-11-27"^^xsd:date ]
  ] ; # 
  fhir:contained ( [
a fhir:Organization ;
fhir:id [ fhir:v "ema-org" ] ;
fhir:name [ fhir:v "European Medicines Agency (EMA)" ] ;
    ( fhir:contact [
fhir:purpose [
        ( fhir:coding [
fhir:system [
fhir:v "http://terminology.hl7.org/CodeSystem/contactentity-type"^^xsd:anyURI ;
fhir:l <http://terminology.hl7.org/CodeSystem/contactentity-type>           ] ;
fhir:code [ fhir:v "ADMIN" ] ;
fhir:display [ fhir:v "Administrative" ]         ] ) ;
fhir:text [ fhir:v "Regulatory Contact" ]       ] ; #  Use standard contact purpose via code (no extension needed) 
      ( fhir:name [
fhir:use [ fhir:v "official" ] ;
fhir:family [ fhir:v "Rossi" ] ;
        ( fhir:given [ fhir:v "Elena" ] ) ;
        ( fhir:prefix [ fhir:v "Dr." ] )       ] ) ;
      ( fhir:telecom [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "elena.rossi@ema.europa.eu" ] ;
fhir:use [ fhir:v "work" ]       ] [
fhir:system [ fhir:v "phone" ] ;
fhir:value [ fhir:v "+31-88-781-6000" ] ;
fhir:use [ fhir:v "work" ]       ] )     ] )
  ] [
a fhir:Organization ;
fhir:id [ fhir:v "acmepharm-org" ] ;
fhir:name [ fhir:v "Acme Pharmaceuticals Inc." ] ;
    ( fhir:contact [
fhir:purpose [
        ( fhir:coding [
fhir:system [
fhir:v "http://terminology.hl7.org/CodeSystem/contactentity-type"^^xsd:anyURI ;
fhir:l <http://terminology.hl7.org/CodeSystem/contactentity-type>           ] ;
fhir:code [ fhir:v "ADMIN" ] ;
fhir:display [ fhir:v "Administrative" ]         ] ) ;
fhir:text [ fhir:v "Response Contact" ]       ] ;
      ( fhir:name [
fhir:use [ fhir:v "official" ] ;
fhir:family [ fhir:v "Carter" ] ;
        ( fhir:given [ fhir:v "James" ] ) ;
        ( fhir:prefix [ fhir:v "Mr." ] )       ] ) ;
      ( fhir:telecom [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "james.carter@acmepharm.com" ] ;
fhir:use [ fhir:v "work" ]       ] [
fhir:system [ fhir:v "phone" ] ;
fhir:value [ fhir:v "+1-555-123-4567" ] ;
fhir:use [ fhir:v "work" ]       ] )     ] )
  ] [
a fhir:Questionnaire ;
fhir:id [ fhir:v "ema-pediatric-safety-q1" ] ;
fhir:url [
fhir:v "http://ema.europa.eu/questionnaire/2025/pediatric-aspirin-safety-v1"^^xsd:anyURI ;
fhir:l <http://ema.europa.eu/questionnaire/2025/pediatric-aspirin-safety-v1>     ] ;
fhir:version [ fhir:v "1.0" ] ;
fhir:status [ fhir:v "draft" ] ;
fhir:title [ fhir:v "Post-Market Pediatric Safety Data Request – Aspirin 100mg" ] ;
    ( fhir:subjectType [ fhir:v "MedicinalProduct" ] ) ;
    ( fhir:item [
fhir:linkId [ fhir:v "1" ] ;
fhir:text [ fhir:v "Number of pediatric AE reports in past 12 months" ] ;
fhir:type [ fhir:v "integer" ]     ] )
  ] ) ; # 
  fhir:input ( [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/ValueSet/task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/ValueSet/task-input-type>         ] ;
fhir:code [ fhir:v "attachment" ] ;
fhir:display [ fhir:v "Attachment" ]       ] )     ] ;
fhir:value [
a fhir:Attachment ;
fhir:contentType [ fhir:v "application/fhir+xml" ] ;
fhir:data [ fhir:v ""^^xsd:base64Binary ] ;
fhir:title [ fhir:v "EMA_Pediatric_Safety_Questionnaire_v1.xml" ] ;
fhir:creation [ fhir:v "2025-11-13T08:00:00Z"^^xsd:dateTime ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/ValueSet/task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/ValueSet/task-input-type>         ] ;
fhir:code [ fhir:v "reference" ] ;
fhir:display [ fhir:v "Reference" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#ema-pediatric-safety-q1> ;
fhir:reference [ fhir:v "#ema-pediatric-safety-q1" ]     ]
  ] ) . #  Input: Base64-encoded Questionnaire payload