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/cander2/apix-ig/ and changes regularly. See the Directory of published versions
{
"resourceType" : "Bundle",
"id" : "List-Of-Questions-Response",
"type" : "transaction",
"entry" : [
{
"fullUrl" : "urn:uuid:task-003",
"resource" : {
"resourceType" : "Task",
"id" : "task-003",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Task_task-003\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Task task-003</b></p><a name=\"task-003\"> </a><a name=\"hctask-003\"> </a><p><b>status</b>: Completed</p><p><b>intent</b>: order</p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/task-code submit-response}\">Submit Response to List of Questions</span></p><p><b>description</b>: Submission of responses to the List of Questions for Type II variation (shelf life extension)</p><p><b>for</b>: <a href=\"MedicinalProductDefinition/mpd-001\">MedicinalProductDefinition/mpd-001</a></p><p><b>authoredOn</b>: 2025-06-29 18:15:00-0400</p><p><b>requester</b>: <a href=\"Organization/pharma-inc\">Organization/pharma-inc</a></p><p><b>owner</b>: <a href=\"Organization/ema\">Organization/ema</a></p></div>"
},
"status" : "completed",
"intent" : "order",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/task-code",
"code" : "submit-response",
"display" : "Submit Response to List of Questions"
}
]
},
"description" : "Submission of responses to the List of Questions for Type II variation (shelf life extension)",
"for" : {
"reference" : "MedicinalProductDefinition/mpd-001"
},
"authoredOn" : "2025-06-29T18:15:00-04:00",
"requester" : {
"reference" : "Organization/pharma-inc"
},
"owner" : {
"reference" : "Organization/ema"
}
},
"request" : {
"method" : "POST",
"url" : "Task"
}
},
{
"fullUrl" : "urn:uuid:response-bundle-001",
"resource" : {
"resourceType" : "Bundle",
"id" : "response-bundle-001",
"type" : "collection",
"entry" : [
{
"fullUrl" : "urn:uuid:questionnaire-response-001",
"resource" : {
"resourceType" : "QuestionnaireResponse",
"id" : "questionnaire-response-001",
"questionnaire" : "Questionnaire/questionnaire-001",
"status" : "completed",
"authored" : "2025-06-29T18:15:00-04:00",
"item" : [
{
"linkId" : "admin-1",
"text" : "Is the fee for the Type II variation fully paid and documented?",
"answer" : [
{
"valueString" : "Yes, the fee was paid on June 25, 2025, with documentation included in the application form."
}
]
},
{
"linkId" : "admin-2",
"text" : "Are all required metadata fields in the application form complete?",
"answer" : [
{
"valueString" : "All metadata fields are complete, as verified against EMA guidelines."
}
]
},
{
"linkId" : "labeling-1",
"text" : "Do the updated storage conditions (2-8°C for 36 months) require additional patient guidance?",
"answer" : [
{
"valueString" : "No additional guidance is needed; the ePI clearly states storage at 2-8°C for 36 months."
}
]
},
{
"linkId" : "labeling-2",
"text" : "Is the patient leaflet revised to clarify the extended shelf life?",
"answer" : [
{
"valueString" : "Yes, the patient leaflet has been updated to reflect the 36-month shelf life."
}
]
},
{
"linkId" : "labeling-3",
"text" : "Is the updated ePI text sufficiently clear for all EU languages?",
"answer" : [
{
"valueString" : "The ePI text has been translated and reviewed for clarity in all EU languages."
}
]
},
{
"linkId" : "cmc-1",
"text" : "Do stability studies cover all required environmental conditions for 36 months?",
"answer" : [
{
"valueString" : "Yes, stability studies include temperature, humidity, and light conditions for 36 months, per ICH guidelines."
}
]
},
{
"linkId" : "cmc-2",
"text" : "Are analytical methods validated for detecting degradation over 36 months?",
"answer" : [
{
"valueString" : "Analytical methods are fully validated, with results included in the PQI submission."
}
]
},
{
"linkId" : "cmc-3",
"text" : "Are new impurities identified in extended stability studies?",
"answer" : [
{
"valueString" : "No new impurities were identified; all impurities are within acceptable limits."
}
]
},
{
"linkId" : "cmc-4",
"text" : "Is the container closure system validated for 36 months?",
"answer" : [
{
"valueString" : "The container closure system is validated for 36 months, with supporting data in the PQI Bundle."
},
{
"valueAttachment" : {
"contentType" : "image/svg+xml",
"data" : "PHN2ZyB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciIHdpZHRoPSIxMDAiIGhlaWdodD0iMTAwIj48cmVjdCB3aWR0aD0iMTAwIiBoZWlnaHQ9IjEwMCIgZmlsbD0iI2ZmZiIvPjx0ZXh0IHg9IjUwIiB5PSI1MCIgZm9udC1zaXplPSIxNSIgZmlsbD0iIzAwMCIgdGV4dC1hbmNob3I9Im1pZGRsZSI+U1ZHIFBsYWNlaG9sZGVyPC90ZXh0Pjwvc3ZnPg==",
"title" : "Container Closure System Diagram"
}
}
]
},
{
"linkId" : "cmc-5",
"text" : "Are degradation products fully characterized for 36 months?",
"answer" : [
{
"valueString" : "Degradation products are fully characterized. No significant changes were observed in the 36-month stability studies.\nAll identified degradation products remain within acceptable limits, as detailed in the PQI submission."
}
]
}
]
}
}
]
},
"request" : {
"method" : "POST",
"url" : "Bundle"
}
},
{
"fullUrl" : "urn:uuid:provenance-003",
"resource" : {
"resourceType" : "Provenance",
"id" : "provenance-003",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Provenance_provenance-003\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Provenance provenance-003</b></p><a name=\"provenance-003\"> </a><a name=\"hcprovenance-003\"> </a><p>Provenance for <a href=\"Bundle-List-Of-Questions-Response.html#Bundle_response-bundle-001\">Bundle: type = transaction</a></p><p>Summary</p><table class=\"grid\"><tr><td>Recorded</td><td>2025-06-29 18:15:00-0400</td></tr></table><p><b>Agents</b></p><table class=\"grid\"><tr><td><b>Type</b></td><td><b>who</b></td></tr><tr><td><span title=\"Codes:{http://hl7.org/fhir/provenance-participant-type author}\">author</span></td><td><a href=\"Organization/pharma-inc\">Organization/pharma-inc</a></td></tr></table></div>"
},
"target" : [
{
"reference" : "Bundle/response-bundle-001"
}
],
"recorded" : "2025-06-29T18:15:00-04:00",
"agent" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/provenance-participant-type",
"code" : "author"
}
]
},
"who" : {
"reference" : "Organization/pharma-inc"
}
}
],
"signature" : [
{
"type" : [
{
"system" : "urn:iso-astm:E1762-95:2013",
"code" : "1.2.840.10065.1.12.1.1"
}
],
"when" : "2025-06-29T18:15:00-04:00",
"who" : {
"reference" : "Organization/pharma-inc"
}
}
]
},
"request" : {
"method" : "POST",
"url" : "Provenance"
}
}
]
}