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",
"type" : "transaction",
"entry" : [
{
"fullUrl" : "urn:uuid:task-002",
"resource" : {
"resourceType" : "Task",
"id" : "task-002",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Task_task-002\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Task task-002</b></p><a name=\"task-002\"> </a><a name=\"hctask-002\"> </a><p><b>status</b>: Requested</p><p><b>intent</b>: order</p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/task-code respond-to-questions}\">Respond to List of Questions</span></p><p><b>description</b>: Provide 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 17:56:00-0400</p><p><b>requester</b>: <a href=\"Organization/ema\">Organization/ema</a></p><p><b>owner</b>: <a href=\"Organization/pharma-inc\">Organization/pharma-inc</a></p></div>"
},
"status" : "requested",
"intent" : "order",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/task-code",
"code" : "respond-to-questions",
"display" : "Respond to List of Questions"
}
]
},
"description" : "Provide responses to the List of Questions for Type II variation (shelf life extension)",
"for" : {
"reference" : "MedicinalProductDefinition/mpd-001"
},
"authoredOn" : "2025-06-29T17:56:00-04:00",
"requester" : {
"reference" : "Organization/ema"
},
"owner" : {
"reference" : "Organization/pharma-inc"
}
},
"request" : {
"method" : "POST",
"url" : "Task"
}
},
{
"fullUrl" : "urn:uuid:loq-bundle-001",
"resource" : {
"resourceType" : "Bundle",
"id" : "loq-bundle-001",
"type" : "collection",
"entry" : [
{
"fullUrl" : "urn:uuid:questionnaire-001",
"resource" : {
"resourceType" : "Questionnaire",
"id" : "questionnaire-001",
"title" : "List of Questions for Type II Variation (Shelf Life Extension)",
"status" : "active",
"item" : [
{
"extension" : [
{
"url" : "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding" : {
"system" : "http://example.org/codes",
"code" : "administrative"
}
}
],
"linkId" : "admin-1",
"text" : "Is the fee for the Type II variation fully paid and documented?",
"type" : "string"
},
{
"extension" : [
{
"url" : "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding" : {
"system" : "http://example.org/codes",
"code" : "administrative"
}
}
],
"linkId" : "admin-2",
"text" : "Are all required metadata fields in the application form complete?",
"type" : "string"
},
{
"extension" : [
{
"url" : "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding" : {
"system" : "http://example.org/codes",
"code" : "labeling-storage"
}
}
],
"linkId" : "labeling-1",
"text" : "Do the updated storage conditions (2-8°C for 36 months) require additional patient guidance?",
"type" : "string"
},
{
"extension" : [
{
"url" : "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding" : {
"system" : "http://example.org/codes",
"code" : "labeling-patient-info"
}
}
],
"linkId" : "labeling-2",
"text" : "Is the patient leaflet revised to clarify the extended shelf life?",
"type" : "string"
},
{
"extension" : [
{
"url" : "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding" : {
"system" : "http://example.org/codes",
"code" : "labeling-clarity"
}
}
],
"linkId" : "labeling-3",
"text" : "Is the updated ePI text sufficiently clear for all EU languages?",
"type" : "string"
},
{
"extension" : [
{
"url" : "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding" : {
"system" : "http://example.org/codes",
"code" : "cmc-stability"
}
}
],
"linkId" : "cmc-1",
"text" : "Are there any new stability studies conducted, or the submission includes only the data available from additional timepoints from previously submitted studies?",
"type" : "string"
},
{
"extension" : [
{
"url" : "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding" : {
"system" : "http://example.org/codes",
"code" : "cmc-analytical"
}
}
],
"linkId" : "cmc-2",
"text" : "Are there any new stability studies conducted, or the submission includes only the data available from additional timepoints from previously submitted studies?",
"type" : "string"
},
{
"extension" : [
{
"url" : "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding" : {
"system" : "http://example.org/codes",
"code" : "cmc-impurities"
}
}
],
"linkId" : "cmc-3",
"text" : "Are the test methods used the same as in the previously submitted stability information?",
"type" : "string"
},
{
"extension" : [
{
"url" : "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding" : {
"system" : "http://example.org/codes",
"code" : "cmc-container"
}
}
],
"linkId" : "cmc-4",
"text" : " Are there any new degradation products identified within the newly submitted data? ",
"type" : "string"
},
{
"extension" : [
{
"url" : "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding" : {
"system" : "http://example.org/codes",
"code" : "cmc-degradation"
}
}
],
"linkId" : "cmc-5",
"text" : "Any changes in the packaging configuration and/or storage of the samples during stability?",
"type" : "string"
}
]
}
}
]
},
"request" : {
"method" : "POST",
"url" : "Bundle"
}
},
{
"fullUrl" : "urn:uuid:provenance-002",
"resource" : {
"resourceType" : "Provenance",
"id" : "provenance-002",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Provenance_provenance-002\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Provenance provenance-002</b></p><a name=\"provenance-002\"> </a><a name=\"hcprovenance-002\"> </a><p>Provenance for <a href=\"Bundle-List-Of-Questions.html#Bundle_loq-bundle-001\">Bundle: type = transaction</a></p><p>Summary</p><table class=\"grid\"><tr><td>Recorded</td><td>2025-06-29 17:56:00-0400</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/ema\">Organization/ema</a></td></tr></table></div>"
},
"target" : [
{
"reference" : "Bundle/loq-bundle-001"
}
],
"recorded" : "2025-06-29T17:56:00-04:00",
"agent" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/provenance-participant-type",
"code" : "author"
}
]
},
"who" : {
"reference" : "Organization/ema"
}
}
],
"signature" : [
{
"type" : [
{
"system" : "urn:iso-astm:E1762-95:2013",
"code" : "1.2.840.10065.1.12.1.1"
}
],
"when" : "2025-06-29T17:56:00-04:00",
"who" : {
"reference" : "Organization/ema"
}
}
]
},
"request" : {
"method" : "POST",
"url" : "Provenance"
}
}
]
}