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
{
"resourceType" : "Task",
"id" : "scenario1-06-technical-response",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-03-15T10:00:00+01:00",
"profile" : [
🔗 "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Response to Questions: Submission of additional stability data</div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "org-synthpharma-ag",
"name" : "SynthPharma AG",
"contact" : [
{
"name" : [
{
"text" : "Dr. John Doe, Head of Regulatory Affairs"
}
],
"telecom" : [
{
"system" : "email",
"value" : "john.doe@synthpharma.example",
"use" : "work"
}
]
}
]
},
{
"resourceType" : "Organization",
"id" : "org-ema-srm-hmed",
"name" : "European Medicines Agency – Human Medicines Evaluation Division",
"contact" : [
{
"name" : [
{
"text" : "Scientific and Regulatory Management"
}
],
"telecom" : [
{
"system" : "email",
"value" : "srm@ema.example.eu",
"use" : "work"
}
]
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "docref-responses-qresponse",
"version" : "1.0",
"status" : "current",
"docStatus" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "1.0",
"display" : "Cover Letter / Response"
}
]
},
"date" : "2025-03-15T10:00:00+01:00",
"relatesTo" : [
{
"target" : {
"reference" : "DocumentReference/docref-list-of-questions",
"display" : "List of Questions (LoQ)"
}
}
],
"content" : [
{
"attachment" : {
"contentType" : "application/fhir+json",
"url" : "https://api.synthpharma.example/questionnaire-responses/qr123.json",
"size" : "18400",
"title" : "Response to Questions (QuestionnaireResponse)",
"creation" : "2025-03-15T09:45:00+01:00"
}
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "docref-stability-data-annex",
"version" : "1.0",
"status" : "current",
"docStatus" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "3.2.P.8.3",
"display" : "Stability Data"
}
]
},
"date" : "2025-03-15T10:00:00+01:00",
"content" : [
{
"attachment" : {
"contentType" : "application/fhir+json",
"url" : "https://api.synthpharma.example/bundles/submission-123/m3/stability-data-v2.json",
"size" : "5800000",
"title" : "Updated Stability Data (Transaction Bundle)",
"creation" : "2025-03-14T11:00:00+01:00"
}
}
]
}
],
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-identifier-type",
"code" : "task-instance-uuid",
"display" : "Task Instance UUID"
}
]
},
"system" : "urn:ietf:rfc:3986",
"value" : "urn:uuid:888e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3c"
}
],
"groupIdentifier" : {
"use" : "official",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-identifier-type",
"code" : "submission-group-uuid",
"display" : "Submission Group UUID"
}
]
},
"system" : "urn:ietf:rfc:3986",
"value" : "urn:uuid:workflow-group-id-12345"
},
"partOf" : [
{
🔗 "reference" : "Task/scenario1-05-technical-question",
"display" : "Technical Question Task"
}
],
"status" : "in-progress",
"businessStatus" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status",
"code" : "submitted",
"display" : "Submitted"
}
]
},
"intent" : "proposal",
"priority" : "routine",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code",
"code" : "response-to-questions",
"display" : "Response to Information Request"
}
]
},
"for" : {
"reference" : "MedicinalProductDefinition/example-ma",
"display" : "WonderDrug 50mg Tablets"
},
"authoredOn" : "2025-03-15T10:00:00+01:00",
"lastModified" : "2025-03-15T10:00:00+01:00",
"requester" : {
"reference" : "#org-synthpharma-ag",
"display" : "SynthPharma AG"
},
"requestedPerformer" : [
{
"reference" : {
"reference" : "#org-ema-srm-hmed",
"display" : "European Medicines Agency"
}
}
],
"output" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-output-type",
"code" : "regulatory-document",
"display" : "Regulatory Document"
}
]
},
"valueReference" : {
"reference" : "#docref-responses-qresponse",
"display" : "Applicant QuestionnaireResponse"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-output-type",
"code" : "regulatory-document",
"display" : "Regulatory Document"
}
]
},
"valueReference" : {
"reference" : "#docref-stability-data-annex",
"display" : "Annex: Updated Stability Data"
}
}
]
}